Report On

Industrial Training at Labaid Pharmaceuticals

Limited

Submitted to
Sukhi karan
GM & Head of Quality Assurance

Submitted by
S M Shahidur Rahman Rajib
Khadija Akter Tisha
Bidisha Howlader
Rumi Akter
Umme Farhana

State University of Bangladesh

Date of Submission: 25-09-2022

To,
The General Manager,
Sukhi Karan
GM, Head of Quality Assurance
Labaid Pharmaceuticals Ltd.
15 Genda, Savar, Dhaka-1340, Bangladesh.

Subject: Submission of In-Plant training report.

Dear Sir,

We, the trainee from State University of Bangladesh have successfully completed our in-
plant training program. First and foremost, we would like to convey our sincere and
deepest gratitude to you for allowing us with the opportunity to attend in-plant training
program from September 10, 2022 to September 25, 2022 in your distinguished company
as per our academic requirement. We take immense pleasure in informing you that we
have successfully completed the training program. As a part of our end of in plant
training, we have tried to prepare comprehensive report on various aspects of Labaid
Pharmaceuticals Ltd.

We therefore will be much grateful to you if you will be kind enough to accept the report
and forgive our mistakes that might have taken place involuntarily.

Sincerely,

S M Shahidur Rahman Rajib

Khadija Akter Tisha
Bidisha Howlader
Rumi Akter
Umme Farhana

1
Acknowledgement

We would like to begin by thanking Allah who gave us the strength and patience and
made us strong to complete this in-plant training. This would not have been possible
without the help of some respective individuals acknowledged below.

We are extremely indebted and thankful to; Mrs. Sukhi Karan, GM, Head Quality
Assurance ; Mr. Md. Habibur Rahman, Deputy Manager, Production, Cephalosporin;
Mr. Sumon Saha, Assistant Manager, Microbiology; Mr. Md. Razibul Haq, Assistant
Manager, QC. Without their kind supervision, tremendous support, guidance, and
patience preparing this in-plant training program would have been very difficult.

We wish to express our deepest sense of gratitude and thanks to coordinator of our
training program Mr. Md. Habibur Rahman, Deputy Manager, Production,
Cephalosporin.

During our two weeks of training in Labaid Pharmaceuticals Limited, we have got lots of
generous cooperation from every people at every sector. We are thankful to all the
officers and workers of the factory for treating us as family and helping us to widen our
knowledge.

Last but not the least, we would like show our gratitude, honor and unremitting respect
and thanks to Professor Dr. M.A. Rashid, Honorary Advisor, Department of pharmacy,
State University of Bangladesh, and Professor Md. Saiful Islam Pathan, Head of the
Department, Department of Pharmacy, State University of Bangladesh for giving us
scope, support and opportunity to over past our in-plant training.

Executive Summery

2
This industrial training report is based on our experience throughout the training and our

academic learning. It had been a tremendous opportunity to experience the work of

different sectors of a pharmaceutical organization. Firstly, the report discusses about the

history of Labaid Pharmaceuticals Limited. Then the report discusses about the products

they are manufacturing. Lastly, the working processes of different sectors in Labaid

pharmaceuticals Limited were briefly discussed.

In plant Training Schedule

3
 Date Respective Department Responsible person

20-02-21 Introduction to honorable site Head GM and Head of Plant Operations

22-02-21 Cepha Production (Solid) Respective Department Head

23-02-21 Cepha Production (Sterile) Respective Department Head

24-02-21 Cepha Production (Packaging & Respective Department Head

Warehouse)
25-02-21 Quality Assurance (Cephalosporin QC, Respective Department Head
QA, Microbiology)
27-02-21 General Production (Solid) Respective Department Head

28-02-21 Quality Assurance- General Block Respective Department Head

(Product Development)
01-03-21 General Production (Packaging & Respective Department Head
General Warehouse)
02-03-21 General Production (KDF, Liquid) Respective Department Head

03 & 04/03/21 Quality Assurance- General Block DGM, QA & Respective Department
(Quality Compliance) Head
05 & 06/03/21 Quality Assurance- General Block DGM, QA & Respective Department
(Quality Control) Head
08-03-21 Quality Assurance (Microbiology)- DGM, QA & Respective Department
General Block Head
09-03-21 Engineering (Over- all) Respective Department Head

10-03-21 PPIC & HR- Admin Respective Department Head

11-03-21 Presentation, Viva & Certification GM and Head of Plant Operations

Index

4
 List of Contents Page Number
Introduction 6-9

HR & Admin 10-14

Environment Health & Safety (EHS) 15-17

Warehouse 18-21

Product development 22-28

Quality Management System 29-38

 Quality Control
39-45
 Quality Assurance

Production 46-67

Engineering 68-72

Conclusion 73

Introduction

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Pharmaceutical sector in Bangladesh is one of the most expanded hi tech sector

contributing in the country's economy. It is the second-largest contributor to the

government exchequer. There are about 257 licensed pharmaceutical manufacturers in

this sector and about 150 are functional, according to Bangladesh Association of

Pharmaceutical Industries (BAPI) and Directorate General of Drug Administration

(DGDA). These manufacturing companies meet around 98% of local demands.

Among them, Labaid Pharma has been designed to conform world standards like FDA-

USA, MHRA-UK, TGA-Australia and cGMP-WHO. The strategic intent of Labaid

Pharma is to provide highest quality products from its specialized manufacturing plant

that make the most meaningful difference for the patients and add value to our

stakeholders and society.

Labaid Pharmaceuticals Limited is a newly established innovation and vision driven

company that offers quality medicines to improve the lives. The manufacturing plant has

been designed by a leading Australian consulting company – APC. Labaid Pharma has

been designed to conform world standards like FDA-USA. The strategic intent of Labaid

Pharma is to provide highest quality products from its specialized manufacturing plant for

the patients and add value to stakeholders and society. Having a robust product

development department, this state of art facility has core focus to produce sophisticated

products like antibiotics, sterile products.

Their aim is to make a positive impact in many ways: through their brands, their

commercial operations and relationships, through voluntary contributions, and through

the various other ways in which they engage with society.

6
They’re also committed to continuously improving the way we manage our

environmental impacts and are working towards our longer-term goal of developing a

sustainable business.

 Mission

Their mission is to provide highest possible standard quality medicine at an affordable

price for the patients in the country, to reach global market within short span of time, to

focus R & D extensively by building strategic partnership.

 Vision

The vision of Labaid Pharmaceuticals is to become a research based local pharmaceutical

company and help people live healthier by delivering great medicine through innovation.

 Core Values

 Integrity with high Ethical standard

 Respect for all Individuals

 Reward for Excellence

 Empathy to Environment

 Pursue growth and learning

 Products of Labaid Pharmaceuticals Limited

Labaid Pharmaceutical is now producing 109 products in various type of dosage forms

such as- tablets, capsules, powder for suspension, KDF (Kidney Dialysis Fluid), syrups.

7
Examples of few distinctive brands given below-

Figure: Examples of some distinct

brands of Labaid Pharmaceuticals
Limited

 Labaid consists of two blocks,

General Block, where they produce
 Tablets
 Capsules
 Powder for Suspension
 KDF (Kidney Dialysis fluid)
 Liquids
Cephalosporin Block, where they produce

8
  Tablets
 Capsules
 Powder for Suspension

Figure: General Block and Cephalosporin Block

Human Resource and Administration Department

Human resource is the set of individuals who make up the workforce of an organization,

business sector, or economy. It is the department or support systems responsible for

personnel sourcing and hiring, applicant tracking, skills development and tracking,

benefits administration and compliance with associated government regulations. Human

Resource Management is the department within an organization that focuses on

9
management, recruitment and provides direction for the people who work in the

organization. Human Resource Management (HRM) is the organizational function that

deals with issues related to people such as compensation, hiring, performance

management, organizational development, benefits, employee motivation,

communication, administration and training.

Human Resource Departments are the entities organizations form to organize people,

reporting relationships, and work in a way that best supports the accomplishment of the

organization's goals. The definition of human resource management emphasizes the

sphere of influence to encompass 'the strategic approach to manpower management in an

organization‟. On the other hand, HRM is the organizational function that deals with

issues to people such as compensation, hiring, performance management, organization

development, benefits and disputes, employee motivation, communication,

administration and training. Examples of core qualities of HR management are extensive

knowledge of the industry, effective.

Labaid Pharmaceuticals Limited is one of the leading corporate houses of the country and

has a handsome amount of workforce led by the HRD.

 Function of HR

The functions of HRM hold great significance in the growth and overall development of

the organizations. After all, when the employees grow and develop their skills, the

organization will automatically experience growth and expansion. Some of the primary

functions of HRM include job design and job analysis, recruitment/ hiring and selection,

10
training and development, compensation and benefits, performance management,

managerial relations and labor relations.

 Job design and job analysis

 Recruitment and selection

 Orientation

 Performance management

 Trainee assessment

 Compensation and benefits

 HR compliance

 Employee relationship

 Motivation

 Job design and job analysis

Job design includes the process of describing responsibilities, duties and operations of the

job. It is imperative to identify the traits of an ideal candidate who would be suitable for

the job to hire the right employees based on rationality and research. This can be

accomplished by describing the skills and character traits of your top-performing

employee.

Job analysis includes depicting the job requirements, such as skills, qualification and

work experience. The vital day-to-day functions need to be identified and described in

detail, as they will decide the future course of action while recruiting.

 Recruitment and selection

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It is the preliminary responsibility of the HR team. This part of the job often entails

advertising open positions, selecting, interviewing, and hiring candidates through various

process.

 Orientation

There are three phases of orientation:

First phage: In this phage candidates are introduced to each people of various

department, of the company within one day.

Second phage: In this phage four to five new candidates are oriented along 7 days. They

are trained about the Standard Operating Procedure (SOP) of every department. Later an

examination is taken to evaluate performance of the candidates. If they do not achieve

specific marks, then they are re-trained.

Third phage: In this stage the candidates are trained about the SOP and other procedures

of the department where they joined until they he/ she can perform it individually.

 Performance Management

Labaid Pharmaceuticals ltd. coordinate and monitor performance appraisal of employees

on an annual basis.

 Trainee Assessment

HRD assess the training needs of personnel in light with cGMP& others related to

HRD issues. The training includes: GMP; Safety; Training on performance

12
 appraisal management; SOP for HR & Administration; Labor standard & work

place environment in pharmaceutical industry.

 HR Compliance

HR compliance is a process of defining policies and procedures to ensure your

employment and work practices demonstrate a thorough understanding of applicable laws

and regulations, while also being aware of the company's larger human capital resources

objectives.

Proper compliance activities have an influence on employee development, retention, and

hiring. It is important to understand your objectives and your current growth strategy,

since it will help you understand how compliance practices may impact decisions, or vice

versa.

 Employee Relationship

In this field of study which analyses the relationship among the management and the

employees of an organization at the workplace and provides a mechanism to settle down

the various industrial disputes.

 Administration

Administration, also referred to as business administration, is the management of an

office, business, or organization. It involves the efficient organization of people,

information, and other resources to achieve organizational objectives. The management

of administration has become an important function for every successful organization and

plays an essential role in ensuring that businesses run smoothly.

13
Some administrative functions are:

Transportation: Labaid Pharmaceuticals ltd. provide transportation to its every employee.

Canteen: Daily about 300 people take their food in the company.

Security: Full plant is guarded properly to ensure the safety of both products and

employee.

Housekeeping: Housekeeping is very crucial in pharmaceutical industry and admin

handle it very carefully.

Environment Health and Safety (EHS)

14
An environment health and safety management system has been established in Labaid

Pharmaceuticals Ltd. It covers all Healthcare operations carried out at any locations in

factories, offices and warehouse. This system is designed to ensure health and safety of

each employee working at Healthcare, to develop safe industrial processes, and to limit

the environmental impacts of Healthcare activities and products and through all these to

ensure sustainable development.

Environment Health and Safety (EHS) Policy

 To become one of the leading companies with regard to Environment, Health and

Safety performance

 Committed to increase awareness and motivate employees on EHS culture

through training at all levels

 To respect local laws and regulations to conduct EHS activities

 Committed to provide a safe and healthy working environment to ensure the

health and safety of our employees, contractors, visitors and neighbors

 To avoid all the risks related to occupation by identifying and evaluating in time

and take necessary preventive measures at an early stage

 To identify all environmental hazards utilizing qualitative and quantitative

analysis, assess and reduce the corresponding risk to an acceptable level

 To identify and assess potential exposure to chemical, physical and biological

stressors utilizing qualitative and / or quantitative evaluation

 To ensure continuous development of EHS standards

 To maintain good relation on EHS issues with neighbors, authorities, customers

and suppliers

15
 The main functions of the EHS department are:

 Waste Management

 Fire Fighting

 Training on earthquake

 Health Check ups

Waste Management

One of the main functions of EHS is waste management. As this is a pharmaceutical plant

there are various forms of toxic wastes produced every day and if they are passed onto

the nature without any treatment this will lead to serious consequences. The wastes can

be categorized as:

1. Non- chemical solid waste

This type of waste can include the packaging materials, the API containers, the vials,

glass containers, plastic containers, papers and so on. They are passed to Prism

Bangladesh Foundation for incineration. Some of the containers which are not

contaminated can also be recycled.

2. Chemical waste

Managing chemical wastes are more challenging than the solid one. Again, they can be

categorized as Flammable and Inflammable Chemical. Under flammable waste there can

be liquid, solid and gaseous wastes. Gaseous wastes are managed through GHS.

The liquid chemical wastes are treated through Biological ETP (Effluent Plant

Treatment) and exposed to the environment.

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This is called as biological ETP because here bacteria are being used for equalizing the

chemicals.

Fire Fighting

Another important function of EHS is to train on fire-fighting issues. There should be fire

fighters who have at least 6 years of experience. Every employee is trained on what to do

if there is a fire occurrence. The fire-fighting aids are checked on regular intervals and

employees are trained on what to do if there is a fire breakout, where to assemble, how to

avoid the smoke and call out rolls to find out of there is a missing person.

Training on Earthquake

Employees are trained on what to do if there is an earthquake and how to evacuate

themselves in this kind of situations.

Health Check-ups

 Employees are tested to ensure they do not carry any contagious disease

 A physician is assigned in the for-emergency situations

 First aid facilities are ensured

 For ensuring safety employees are provided with PPEs

 Employees are being trained on good ergonomics

Warehouse

17
Warehouse is the place where materials for the production are stored for further use and

distributor. Warehouse management deals with the reception, storage, and movement of

goods, usually finished goods, to intermediate storage locations or to the end customer.

The Labaid Pharmaceuticals Ltd has warehouse where raw, packaging, and finished

products are stored with great care. The objective of warehouse management is to help in

the optimal cost of timely order fulfillment by managing resources economically. This

warehouse has different units. They are as follows-

 General Warehouse Unit

Raw materials, finished goods, primary packaging materials are stored in warehouse with

required temperature, humidity, and other specifications. They have different units.

 Quarantine area: After receiving of raw materials, they are stored first in the

quarantine area to manage them properly and systemically. Then Q.C. sampling

and checking is approved and then shifted to the main storage area. A balance

weights the raw materials. Temperature is maintained between (15-25) o C.

 Sampling area: Sampling process involves taking a small portion from a lot for

subsequent testing to provide an effective check on the quality of the product or

substances being processed. This consists of sampling booths where the

temperature and humidity are strictly maintained, and the sampling is done by QC

officer.

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  Main storage area: Specific raw materials are stored in specific mentioned area

with proper documentation. According to plan and recovery maintenance, the raw

materials are supplied to the production area for required batch size.

 Released area: Here raw & packaging materials are stored; those only passed the

tests performed by QC and QC provides released tag. The purpose of released

area is to store the approved materials in different conditions as specified by the

manufacture

 Rejected area: Rejected materials are stored here those failed the tests performed

by QC and QC provides rejected tag and the local raw materials are returned to

the suppliers. It is located at a corner of the warehouse where entry is strictly

restricted.

 Finished product area: Finished products that are ready to release in the market

are stored until delivery.

 Area for narcotics and controlled drugs: There are other specific area in the

warehouse for narcotics and controlled drugs.

 Routine works done by Warehouse department

Only authorized person can enter the premises. After the arrival of materials, the

concerned authorities of the warehouse check the invoice and physically inspect and

receive them by storing in the quarantine area. The actual received quantity of materials

are listed into the logbook entry. Warehouse authority will inform the QC for sampling

and after doing sampling and analyzing, QC will send the report to the QA. QA will give

passed tag for qualified ones and rejected tag if the material fails to pass QC test on each

19
& individual container or box. Only the released materials are dispensed and distributed

as per requisition of production department following respective SOP.

Sampling rule-

For Active Ingredients, all containers are sampled

For excipients and packaging, √𝑁+1 (N= no. of containers)

If N<10, then all are sampled.

 Storage Condition
Storage condition is highly maintained in the warehouse. Temperature is maintained by

24 hours online monitoring system and data loggers. There are five types of storage

condition maintained in the warehouse.

I. (2 to 8)0C – Cold room

II. (8 to 15)0C – Cool room

III. (15 to 25)0C – Controlled temperature

IV. (15 to 25)0C + (45-65) % RH – Controlled room

V. (-20 to -25)0C - Refrigerator

 Working Procedure of Warehouse

Purchased materials are received

Keep record and send GRN (Goods Receive Note) with pass level about the
materials to QC

QC collects sample
Perform test and provide approval or rejected tag

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 ↓

If QC tests are passed, then supply the material to the concerned department

according to product order sheet

After packaging of finished products, QA provides not released yellow tag

to the products and stored in the outer portion of the warehouse

All types of tests are performed by QC

QC fixes Green Approved tag if tests are passed

Approved products are distributed to depots throughout the country in first

in first out process

Keep the record

 Central Warehouse Unit

Here secondary packaging materials are stored that does not come into direct contact with

the product. It is the outer part of the primary package system.

 Chephaosporin Warehouse Unit

Cephalosporin has its own warehouse to prevent cross contamination.

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Product Development Department

Product Development Department is the process by which a company works to obtain

new knowledge that it might use to create new technology, products, services, or systems

that it will either use or sell. The PD is the core of any pharmaceutical industry. The PD

department deals with both new product formulation and re-formulation of the existing

products. Labaid Pharmaceuticals Ltd. has well equipped research and development

department ever in Bangladesh containing a group of competent and hardworking

personnel. PD is key to success for any pharmaceutical company and Labaid

Pharmaceuticals Ltd. has given top priority in building and strengthening our capabilities

to excel in formulating technologically complex products. The PD team develops a wide

range of generic products including difficult to copy formulations in defined specialty

areas.

Functions of Product Development Department

i. Troubleshooting of existing product

ii. Modification of existing product

iii. Prepare BMR, BPR and process validation protocol

iv. Prepare Master formula

v. Preparation of recipe

vi. Packaging material development

vii. Quality parameter

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Work Procedure of PD

Receive product proposal from PMD department

Technical feasibility study of factory

Approval of the product proposal if technically feasible

Identification of class of drug

↓
What dosage form to be prepared

Supply chain are requested to send trial sample

If compendial, assay of sample according to USP, BP or in case of INN

assay sample according to certificate of analysis of supplier

Standard testing procedure (STP) development both for compendial or INN

Certificate of analysis

Trial batch preparation

↓

Sample evaluation feedback from PMD cost data sheet preparation for
costing

23
 ↓

Formula and product specification preparation

Packaging material specification preparation

Pilot batch preparation

Accelerated stability study

Shelf -life declaration

BMR and BPR preparation for process validation

Final product brief

Master formula completion

After adjusting batch manufacturing report (BMR), specific batches are prepared for

optimization purpose. Then as a part of prospective validation 3 more batches are

prepared. After that the product is ready for commercial production.

PD department in Labaid Pharmaceuticals Limited is divided into two parts:

1. Analytical unit

2. Formulation unit

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 1. Analytical Unit

According to ICH guideline Analytical Unit depends on the following parameters for

validation method development-

- Specificity

- Range

- Decision

- Linearity

- Accuracy

- Detection limit

- Precision

- Standard deviation (SD)

- System stability testing

- Quantification limit

Several analytical machines are used for analysis:

 HPLC (SHIMADZU, JAPAN)

 FTIR (SHIMADZU, JAPAN)

 Dissolution tester (Electrolab, India)

 Disintegration tester (Electrolab, India)

 Hardness tester (ERWEKA, Germany)

 Moister Analyzer (Mettler Toledo, Switzerland)

 Balances (Mettler Toledo, Switzerland)

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 2. Formulation Unit

Areas available in functional machines are:

✓ Tablet compression machine

✓ Coating machine

✓ Granulation, drying and milling machine

✓ Fluid bed Dryer

✓ Blending machine

✓ Sheer mixture

✓ Stability study chambers

Formulation unit runs production of batches after getting COA (Certificate of

Analysis).

 Trial Batch

PD department manufactures trial batch for pre-formulation study.

 Pilot Batch

After approval of the product, PD department manufactures two consecutive batches in

the production area.

 Validation Batch

PD checks up to 3 batches of production. This is called validation batch.

26
  Stability Testing

Another part of PD is Stability Chamber. The products are kept in the stability chamber

and tests are performed at first after one month then after 3 months and then after 6

months. If after 6 months the degradation of the product is less than 5% in 6 months then

the shelf life is 24 months is determined.

Stability test is done for the following purposes-

✓ To determine the expiry period.

✓ To determine the packaging mode.

Products of pilot batches prescribed in three separated stability chambers of three

different specific conditions. These are:

✓ Room temperature and pressure Condition (Real Time study): 25±2°C and 60±5

% relative humidity.

✓ Long Term Study: 30±2°C, 65 ±5% Relative humidity.

✓ Accelerated Study: 40 ±2°C, 75±5% Relative humidity.

 Stability Parameters

Certain parameters should be followed in stability testing of Tablets/Capsules. Such as:

- Hardness

- Thickness

- Disintegration time

- Dissolution

27
 - Assay/Potency

- Impurity

 Climate Zone

To store a drug in suitable storage conditions and to export drugs to foreign countries, the

knowledge of climate zone is very important fact. According to ICH (International

Conference on Harmonization), the whole world is divided into five following climate

zones on the basis of environmental conditions:

Climatic Zone Temperature Relative Humidity

Zone I 21ºC ± 2ºC 45% ± 5%

Zone II 25ºC ± 2ºC 60% ± 5%

Zone III 30ºC ± 2ºC 35% ± 5%

Zone IVa 30ºC ± 2ºC 65% ± 5%

Zone IVb 30ºC ± 2ºC 75% ± 5%

Bangladesh is in the Zone IVa. So, the environmental factors must be considered to

ensure proper storage of drugs.

28
Quality Management System (QMS)

Quality operation in pharmaceuticals is a term that deals with the quality of dosage form

that can give the expected therapeutic effects and maintenance of the quality starting

from raw materials to the finished products which patient receives. This department

basically is responsible for the quality of raw materials (RM), packaging materials (PM),

finished goods and rest of the others sectors that are included in manufacturing program.

Serving quality product to the respective user is the main responsibility of this

department. According to guidelines, steps are taken to ensure the requirements and

desired quality.

The Quality unit in Labaid Pharmaceuticals Limited is as per WHO guideline, consists of

Quality Assurance and Quality Council, which are working independently. The Quality

Assurance department consists of Quality Control and Quality Compliance. Quality

assurance and Quality Control are a wide ranging of concept which covers all matters

individually or collectively influence the quality of a product. It is the sum total of the

organized arrangements made with the object of ensuring that medicinal products are of

the quality required for their intended use.

Quality Control

Quality control is a part of Quality Assurance (QA). Quality control (QC) is a procedure

or set of procedures intended to ensure the production of a perfect product by a series of

measures requiring an organized effort by the entire company to prevent or eliminate

errors at every stage in production.

29
Labaid Pharmaceuticals Limited has its own QC department. Personnel work here by

following SOP to control the quality of products.

Responsibilities that QC meets:

 Assessment, approval or rejection of all materials, such as, active

substances, excipients, intermediates and finished products, primary

and secondary packaging materials

 Analytical methods development

 Calibration and standardization of laboratory equipment

 Stability testing

 Microbiological testing

 In process analysis

 Water and effluent and secondary standard

 Batch documentation

 Documentation and routine analysis

 Auditing compliance to the quality system

Labaid Pharmaceuticals Limited have the following sectors in a QC department:

 General Unit

 Microbiology Department

 Cephalosporin Unit

Quality control has two wings:

 Analytical Section

 Instrumental section

30
  Analytical Section

1. Raw Material Analysis

The raw materials are tested for appearance, identity, potency, purity, etc. to check

whether the material meets the specification. If the material meets specification, passed

labels are issued in the QC department and attached to the batch of containers from which

sampling has been done.

Tests parameters for raw materials are given below:

 Appearance

 Melting point

 Solubility

 Bulk density

 Identification

 Loss on Drying

 Sulphated Ash

 pH

 Heavy metal

 Retention Sample of raw material

 Assay

 Purity

 Optical rotation

2. Finished Product Analysis

31
After sampling, various parameters of the bulk and finished products are tested to check

whether they meet the specification or not. If these products are found to meet the

specification, then they are labelled as passed and are released for the next process.

Tests parameters for bulk and finished product analysis are given below:

 Appearance

 Weight variation

 Average Weight

 Identification

 Dissolution

 pH

 Assay

3. Packaging Material Analysis

Packaging materials are tested for Length, Width, Thickness, Height, GSM, Thickness of

polyethylene film lacquer, Identification test of foil, PVC & PVDC, Density of PVC &

PVDC, Appearance, text, and Design, etc.

Test parameters for packaging materials are given below:

Primary packaging materials Secondary packaging

materials
Text Code Number

Thickness Text

Moisture Alignment

Light Leaflet Check

32
 Resistance Foreign Letter Check

 Instrumental Section

Equipment available at QC laboratory:

Serial Instrument Manufacturer Purpose

No:

1 HPLC Binary SHIMADZU, Japan Qualitative and Quantitative

Gradient System
analysis
2 HPLC Quaternary Agilent, Germany Qualitative and Quantitative
Gradient System analysis
3 HPLC Quaternary SHIMADZU, Japan Qualitative and Quantitative
Gradient System analysis
4. UV-1800
SHIMADZU, Japan Quantitative determination
spectrophotometer

5. FTIR Determination of functional group

SHIMADZU, Japan
Spectrophotometer

6. Polarimeter Rudolph Research analytical Check polarity of optical

(USA) substances
7. Refractometer Rudolph Research analytical Check RI
(USA)
8. Melting point BUCHI (Switzerland) To detect melting point
Apparatus

9. Digital Viscometer Brookfield (USA) To measure the viscosity of a

fluid
10. Centrifugation Thermo Scientific (USA) Centrifuge Solution
Machine

33
11. Vortex machine Fisher Scientific (UK) Mixing solutions uniformly

12. Conductivity Meter Mettler Toledo (Switzerland) To test conductivity

13. pH meter Mettler Toledo (Switzerland) To check pH

14. Magnetic Stirrer Hot Scilogex (USA) To agitate the liquid for speeding
Plate up the reaction
15. Dissolution tester Electrolab (India) To determine% of API in blood

16. Fume Hood Esco (USA) To limit exposure to hazardous or

toxic fumes, vapors or dusts
17. Orbital Shaker Stuart (UK) To mix substances

18. Water Bath Clifton (UK) To heat samples

19. Electromagnetic Electrolab (India) To separate and determine

Sieve Shaker particle size
20. Tap Density tester Electrolab (India) To measure tap density of
powder
21. UV lamp Viewing Ultra- Violet Productions Chromatographic Analysis
Cabinet Ltd.

(UK)
22. Muffle Furnace Carbolite (UK) To check loss on drying

23. Oven (108L) MEMMERT Drying

24. Oven (256L) MEMMERT Drying

26. Vacuum oven MEMMERT Drying glassware

27. Karl Fisher Auto Mettler Toledo (Switzerland) To determine trace amount of
Titrator water in samples
28. Potentiometer Rudolph Research analytical Auto titration
(USA)
29. Ultrasonic Bath Clifton (UK) Mixing Solutions

30. Analytical Balance Mettler Toledo (Switzerland) Weighting

34
 31. Total Organic SHIMADZU, Japan Determines the amount of carbon
Carbon Analyzer in water sample
32. Semi-micro Balance Mettler Toledo (Switzerland) Weighting

33. Atomic Absorption Perkin Elmer (USA) Qualitative and Quantitative

Spectrophotometer analysis

HPLC

High-performance liquid chromatography or high-pressure liquid chromatography

(HPLC) is a chromatographic method that is used to separate a mixture of compounds to

separate compounds that are dissolved in solution. Its main function in analytical

chemistry is to identify, quantify or purify the individual components of the mixture.

UV

Ultraviolet (UV) light is electromagnetic radiation with a wavelength shorter than that of

visible light, but longer than X-rays, in the range 10 nm to 400 nm, and energies from

3eV to 124eV. It is so named because the spectrum consists of electromagnetic waves

with frequencies higher than those that humans identify as the color violet.

Fourier Transform Infrared (FTIR) Spectroscopy

It is a measurement technique that allows one to record infrared spectra. Infrared light is

guided through an interferometer and then through the sample (or vice versa). A moving

mirror inside the apparatus alters the distribution of infrared light that passes through the

interferometer. The signal directly recorded, called an "interferogram", represents light

output as a function of mirror position. A data-processing technique called Fourier

transform turns this raw data into the desired result (the sample's spectrum): Light output

35
as a function of infrared wavelength (or equivalently, wavenumber). As described above,

the sample's spectrum is always compared to a reference.

Polarimeter

It is a scientific instrument used to measure the angle of rotation caused by passing

polarized light through an optically active substance. Some chemical substances are

optically active and polarized (aka unidirectional) light will rotate either to the left

(counter clockwise) or right (clockwise) when passed through these substances. The

amount by which the light is rotated is known as the angle of rotation.

Dissolution Tester

In the pharmaceutical industry, drug dissolution testing is routinely used to provide

critical in vitro drug release information for both quality control purposes, i.e., to assess

batch-to-batch consistency of solid oral dosage forms such as tablets, and drug

development, i.e., to predict in vivo drug release profiles.

In vitro drug dissolution data generated from dissolution testing experiments can be

related to in vivo pharmacokinetic data by means of in vitro-in vivo correlations (IVIVC).

A well- established predictive IVIVC model can be very helpful for drug formulation

design and post- approval manufacturing change.

Karl Fisher Titration

36
It is a classic titration method in analytical chemistry that uses coulometer or volumetric

titration to determine trace amounts of water in a sample.

 Microbiology Department

Microbiology division of QC performs microbiological tests. A microbiological test

determines the potency of products as well as the presence or absence of microbes in

products.

Functions of Microbiology Department

 Microbial count- Water, raw materials, bulk samples, finished products, packing

containers.

 LAL test/sterility test- Water, raw materials, parenteral products, other sterile

products.

 Environmental study- All manufacturing &filling area including aseptic filling

room.

 Validation- Steam &dry heat sterilizer, oven & cleaned equipment.

 Personnel hygiene area- Aseptic production area operators.

 Bio-Assay- Antibiotic raw materials &finished products.

Microbial Tests
37
  Microbial limit test of raw materials and finished products-

 Total aerobic bacterial and fungal count

 Detection of pathogens like E. coli, Salmonella sp, aeruginosa. Staphylococcus,

Pseudomonas

 Microbial assay of raw materials and finished products

 Environmental monitoring

 Test for water

 Bioassay.

Microbiology Department Instruments

Instrument name Origin Purpose

Laminar Air Flow ESCO (Singapore) To make contamination free

work environment

Block Heater Wifsphirm (Korea) To incubate sample

Autoclave Delama (Italy) Sterilization

Air Borne particle Count Lighthouse (USA) Count particles

Incubator MEMMERT (Germany) To grow and storage for

bacterial, fungal culture

Colony Counter Stuart (USA) To count bacterial and

fungal colony

Microscope Olympus (Japan) To identify and visualize

micro-organisms

Air Sampler SAS Super (Italy) To force air onto its

collection medium

38
Membrane Filter Unit PALL Corporation (China) Separate contaminants from

sample

Quality Assurance (QA)

Quality assurance (QA) is any systematic process of determining whether a product or

service meets specified requirements to increase customer confidence and a company's

credibility. This department covers all aspects that could have an impact on the quality of

prescribed pharmaceutical products. A pharmaceutical product must satisfy certain

standards to claim its quality. The main characteristics of any drug, in dosage form are-

safety, potency, Efficiency, stability, Acceptance, regulatory compliance. To produce

quality drug product, quality must be ensured in:

 Every step in the production

 In maintaining environment

 Personnel

 Equipment

 Operating procedure

For this QA establishes and maintains set requirements for developing or manufacturing

reliable products while also improving work processes and efficiency. QA applies for

both drug substances (APIs) and medicinal products, and includes current Good

Manufacturing Practices (cGMPs) and Good Laboratory Practice (GLP) as well as any

necessary analytical testing and stability studies. Additionally, it applies to clinical trials

39
operations (Good Clinical Practice - GCP) and safety/toxicology studies (Good

Laboratory Practice - GLP).

Quality Assurance Department is a very organized department in Labaid Pharmaceuticals

Limited, which successfully ensures the quality of the products up to the end user.

QA= Product development + Quality Compliance + Quality Control + Validation

It exercises all the activities from designing, developing, production, installation,

servicing to documentation. It needs the regulation of the quality of raw materials,

assemblies, products, components, servicing related to production and inspection Process.

Objective of Quality Assurance

 Ensuring proper warehousing practices of finished products

 Manufacturing process and critical process check

 Process monitoring and process controls

 Batch record review

 Final release of drug products for distribution

 Out of specification event investigations

 Internal Quality audits and quality review

 Reprocessing of non-confirming products and returned goods

In Labaid Pharmaceuticals Limited, Quality Assurance (Quality Compliance) Department

has two wings:

a. Quality Management System

b. Floor management

40
Quality Management System

The most important task of the quality assurance department is documentation. The aim

of documentation is to record important information with evidence. GMP requires that

complete and accurate records of all raw packaging materials, finished product, BMR,

BPR have to be maintained for any forcing back of any time. The following documents

are maintained:

 BMR (Batch manufacturing record)

 BPR (Batch packaging record)

 SOP (Standard Operating Procedure)

 APQR (Annual Product Quality Review)

 Coated tablet inspection sheet

 Leak test record sheet

 Packaging order sheet

 Tablet / capsule inspection sheet

 Weight / volume inspection sheet

 Retention sample quality

 Production sheet order

Functions of Quality Management System

 Deviation Management

 Change control

 Market complains

 Document control

 SOP management

41
  Art work

 Risk assessment

 Internal audit

 Archiving

 Document destruction

 Calibration Management

 Commercial Stability

 Self-inspection

 Reprocess Rework Management

 CAPA

 Qualification

 Process Validation

Validation

Validation is the most recognized and important parameter of GMPs. It is the process of

establishing documentary evidence demonstrating that a procedure, process, or activity

carried out in testing and then production maintains the desired level of compliance at all

stages. The goal of the validation is to ensure that quality is built into the system at every

step, and not just tested for at the end, as such validation activities will commonly include

training on production material and operating procedures, training of people involved and

monitoring of the system whilst in production.

In Pharma Industry it is very important apart from final testing and compliance of product

with standard that the process adapted to produce itself must assure that process will

consistently produce the expected results.

42
Here the desired results are established in terms of specifications for outcome of the

process. Qualification of systems and equipment is therefore a part of process of

validation. It is a requirement of food and drug, pharmaceutical regulating agencies like

FDA's good manufacturing practices guidelines.

Since a wide variety of procedures, processes, and activities need to be validated, the

field of validation is divided into a number of subsections including the following:

 Equipment validation

 Facilities validation

 HVAC system validation

 Cleaning validation

 Process Validation

Functions of Floor Management

 Assuring GMP

 In process check

 Document issue and release

 Batch document Compliance and Release

 Cleanliness

 Good Documentation Practice

 Logbook management

 Sampling

 Sample retention (The sample of cover batch is preserved in the archive

rooms for reviewing product quality if any complain comes from any

source. These samples are called retention samples)

43
In Process Check (IPC)

In Labaid Pharmaceuticals Limited’s QA section, following parameters are checked:

- Weight variation (Mettler Toledo, Switzerland)

- Friability (Electrolab, India)

- Moister Content (Mettler Toledo, Switzerland)

- Hardness (ERWEKA, Germany)

- Leak test (Electrolab, India) – Rhodamine Bromide is used for leak test

- Disintegration time (Electrolab, India)

In Process Quality Assurance (IPQA) Functions

 Functions in the Warehouse

Visual inspection of raw material and

packaging materials

Sampling of raw and packaging material

for test

Release of raw and packaging material

 Functions in the Dispensing Area

a. Monitoring the dispensing process

b. Providing attachment of dispensing cards to materials

c. Checking drum weight, product name etc.

44
  Functions in the Solid Department

a. In manufacturing area: -

 Granulation area:

- Detecting machine cleanliness and room condition

- Permitting line clearance

- Checking LOD for granules

 Compression Area

-Detecting machine cleanliness and room condition

-Permitting line clearance

-Initially some tablets are compressed to check general description, weight,

hardness, thickness, friability, disintegration, dissolution time and relevant

parameters.

-In case of capsule initially some capsules are tilled to check weight.

b. In Quarantine Area

The tablets and capsules are released in the packaging area on the basis of QC report.

II. Secondary Area

 Functions in the packaging area:

✓ Bottle fitness & height testing

✓ Leak test of packaging

✓ Labeling of stripper, inner & outer cartoons

✓ Manufacturing date, expiry date & batch no. checking

45
 ✓ Inner and shipping cartoon checking at regular time interval

Production

Production Unit of Labaid Pharmaceuticals can be divided as the following:

1. Solid Dosage Unit

2. Cephalosporin Unit

3. Sterile Unit

4. Liquid and KDF Unit

Solid Dosage Unit

The overall atmospheric conditions inside this unit are well maintained. The conditions

may vary according to the products that are being manufactured. Important parameters

maintained within the solid manufacturing area:

 Temperature: Below 25℃

 Relative Humidity: Below 65%

 Pressure: 5-10 Pa

Batch Manufacturing Number (BMR)

Batch Manufacturing Record (BMR) is the necessary quality and GMP documentation

for tracing the complete cycle of manufacture of a batch or lot.

Contents of BMR:

46
  Name of products, batch size and shelf life

 Manufacturing formula

 Dispensing records

 Manufacturing process

 Granulation

 Blending

 Compression

 Coating

Process Order (PO)

PO is a key element of order fulfilment associated with the delivery of raw and packaging

material.

Contents of PO:

 Product name

 Name and quantity of APIs and Excipients

 Batch or Lot number

Two types of products are being manufactured inside the solid dosage unit:

 Tablets- Coated or Uncoated

 Solid Filled Capsules

 Tablet Manufacturing

Tablets are solid pharmaceutical dosage preparations which contain one or more active

pharmaceutical ingredients (API).

47
Both coated and uncoated tablets are produced here in solid dosage unit. Tablets of

various strengths are manufactured here.

Tablet Manufacturing Process

Dispensing

Granulation

Blending

Compression

Coating

Packaging

Dispensing

At first, the raw materials are received through the primary hatch from the material

management department. When the material management department receives requisition

for raw materials they weigh and send the raw materials through the primary hatch and

48
stored in unweighted material room. The unused raw materials are sent back to the

warehouse through the same primary hatch and labelled as “Under Issue”.

After the raw materials are received, they are taken to the dispensing booth and dispensed

under laminar air flow. The conditions of the laminar air flow are also being controlled

and no products will be dispensed under it unless it is calibrated and cleaned after

dispensing the previous product. There are three types of filter in dispensing booth which

are: pre- filter, intermediate filter and HAPA filter. Dispensing room condition (humidity

and temperature) is maintained though it varies product to product.

Figure: Dispensing Booth

Parameters that are checked in dispensing room are as follows:

identification, appearance, product code, lot number, potency, quarantine

label, approval label, expiration date, manufacturing date.

There are two dispensing booths in solid dosage form of Labaid Pharma

49
  One for weighing under 60 kgs

 Another for weighing above 5 kgs

 Granulation

Three types of granulation methods are followed:

1. Wet granulation

2. Dry granulation

3. Direct Compression

Wet Granulation Method

Weighing of active ingredient as well as excipients

Dry mixing

Wet mixing (in case of wet granulation) by addition of de-

mineralized (DM) water or Maize starch pastes in Rapid Mixer

Granulator (RMG) for a certain time

Period specified in the Batch Manufacturing Record (BMR)

Milling in the cone mill

Initial Phase drying in Fluid Bed Dryer (FBD)

50
 ↓

Milling in the Multi mill

Sieving in the Vibratory shifter according to the required particle size/

granule size

Granules of desired size ready for blending

↓

Compression

Dry Granulation Method

Weighing & sieving API & Diluents

Mixing API & Diluents

Slugging or Pre-compression

Milling

Lubrication

Compression

51
Direct Compression Method

API + Excipients+ Super Disintegrants

↓
Blending
↓
Compression

 Compression

Compression is the process where appropriate volume of granules in die cavity is

compressed between upper & lower punch to consolidate material into single solid matrix

which is finally ejected from die cavity as tablet.

Compression parameters:

 Embossing

 Shape

 Weight

 Hardness

 Thickness

 Friability

 Disintegration

In the compression machines for tablet manufacturing, hoppers are used for holding and

feeding granulation to be compressed. Each station in compression machine contains one

52
upper punch and one lower punch. Dies that determine the size and the shape of the tablet

are placed between the upper punch and lower punch. Feed frame helps to move the

granules from hopper into the dies. Pressure is applied in order to form an intact tablet by

consolidating the materials and is subsequently ejected from the die cavity.

Tablet Compression Process

Granules (Previously made)

Transfer of granules in the hopper of tablet press machine manually

Rising of upper punch and dropping of lower punch

Filling of die cavity through filomatic fit frame

Removal of extra granules by scrape off - plate compression to produce tablet

Rising of both upper and lower punches to certain extent

Ejection of tablet with the help of take- out plate

Tablet of desired shape and size come out

Remove dust by de- duster

53
 ↓

Check by metal detector

Collect tablet and send for coating/packaging

Figure: Tablet Compressing Machine

Parameters which are considered during compression

 RPM

 Machine Speed

 Hardness and Thickness

 Friability

 Uniformity of Weight

Common problem of tablet compression process:

54
  Capping

 Lamination

 Chipping

 Picking and sticking

 Bridging in the dye

 Mottling

 Weight variation

 Hardness variation

 Double impression

 Coating

Tablet coating can be described as a process of applying an edible paint on

the surface of a pharmaceutical dosage form to achieve specific benefits such

as masking the unpleasant taste & odor of the drug, improving the

appearance, aiding in identification of the product, providing special

characteristics of drug release (e.g., enteric coating) etc.

Coating Process

Coating material dispense

↓
Weight Check
↓

Preparation of coating solution (aqueous and non-aqueous)

Filtering through 80 mesh (need for only non-aqueous solution) Tablet into coating pan

55
 ↓

Pre-heating at 750C and temperature 550C

Spray by 3 spray guns through 3 spray nozzles at 800C at 12-13m 3/min inlet air pressure
for 2 hours
↓

Set the drum rotation at 3.5-6.5rpm

Drying at 65-750C for 20 mins at 3 rpm

Check LOD >3%

Cooling at 25-350C temperature for 20 mins at 3 rpm

Unload and send for packaging

Coating Parameters

 Inlet air temperature

 Exhaust air temperature

 Pan speed

 Atomizing pressure

 Spray rate

 Gun to tablet bed distance

Common problem of tablet coating process:

 Sticking

56
  Broken tablet

 Peeling effect

 Color variation

 Edge chipping

 Logo bridging

 Logo infilling

 Twinning

 Capsule Manufacturing

According to the USP, “capsules are solid dosage forms in which the drug is enclosed in

either a hard or soft, soluble container or „shell‟ of a suitable form of gelatin.” Mainly

hard gelatin capsules are produced here. Capsule shells are imported and ready granules

are used for capsule filling.

Capsule Manufacturing Process

Empty capsule shells are inserted in one hopper and pellets/ powders are inserted in

another hopper

Cap and body of the capsule are segmented

Pellets and powders are filled within the capsules shell

Cap and body of the capsules are closed

Filled capsules are discharged for de-dusting/polishing

57
 ↓

Elimination of faulty capsules

 Packaging
Packaging area is divided in two units:

 Primary packaging area

 Secondary packaging area

 Primary packaging area: Here the primary packaging of a product is performed

with primary packaging materials, which includes aluminium foil, PVC, PVDC.

 Secondary packaging area: Here secondary packaging of a product is performed

with secondary packaging material which includes shipper cartoon, fiber fold

outer, printed paper, liner, packaging record cartoon and printed cartoon.

Blister Packaging

Blister pack is a term for several types of pre-formed plastic packaging used for small

consumer goods, foods, and for pharmaceuticals. Blister packs are useful for protecting

products against external factors, such as humidity and contamination for extended

periods of time. Opaque blisters also protect light-sensitive products against UV rays.

Common Procedure of Blister Packaging for Alu- Alu Blistering

Aluminium-PVC/PVDC bottom foil from roller

Forming station 110-140/1500C temperature is required for Pocket formation

58
 ↓

Aluminium top foil from another roll

Sealing of both foils in sealing station by heat at a190-230 0C

Cooling by a lower cooling plate at 15-200C

Embossing the expiry date and batch no. on blister

Perforation if required (making perforated divided section in blister)

Cutting the blister

Release for secondary packaging

59
 Figure: Blister Machine

Blistering Parameters
 Appearance

 Shape

 Cutting

 Pocket

 Sharpness

 Batch number

 Expiration date

Machines Used in Solid Dosage Production

Machine Name Manufacturer and Origin

Rapid Mixer Granulator (RMG) N.R. industries, Thailand

(60Kg)

Fluid Bed Dryer (60Kg) N.R. industries, Thailand

Double –Cone blende r(60Kg) N.R. industries, Thailand

Compression Machine Sejong, South Korea

Coating Machine N.R. industries, Thailand

Encapsulation Machine Sejong, South Korea

Blister Machine Honga, South Korea

60
  Sterile

Parenteral products or injections are sterile, pyrogen free preparations intended to be

administered parentally. The term Parenteral has been derived from the Greek wards

„Para‟ &„Enteron‟ mean outside of the intestine i.e., it denotes the route of administration

other than the oral route. The Parenteral refers to the injectable routes of administration.

Besides water for injection (WFI) is also prepared.

At first, by using washing machines ampules are washed then pass through the dynamic

pass box to the filling machine. Water for injection pass through a tunnel towards the

infinite zone, sterilization zone and cooling zone.

The basic procedure for sterile injectable is:

Warehouse

Pass-box

Dispensing

Manufacturing

Filtration

61
 ↓

Filling and Sealing

Autoclave

Crimping

Inspection

Packaging

Warehouse

Products of Sterile Unit

Injection

PFS (Powder for suspension)

Cleanroom Classes

A room which the concentration of airborne particles is controlled, and which is

constructed and used in a manner to minimize the introduction, generation, and retention

of particles inside the room and in which other relevant parameters, e.g., temperature,

humidity, and pressure, are controlled as necessary.

The liquid sterile area has five zones-

62
  Class A

 Class B

 Class C

 Class D

 Class E

Class A

 Its main application is for aseptic processing.

 It works in compliance with EU Grade A clean room class.

 Aseptic sampling and dispensing of sterile starting material are done in

this zone.

Class B

 Supportive work for aseptic processing is done in this zone.

 It works in compliance with EU Grade B cleanroom class.

 Final compartments of gowning rooms, filling room and

area are attached to this zone.

Class C

 Less critical processing steps are carried out in this zone.

 It works in compliance with EU Grade C cleanroom class.

 Sampling and dispensing of raw materials are done in this zone.

 In this zone, bulk solutions are prepared for sterile products to be filtered

and terminally sterilized and vials are washed.

Class D

 Supportive work is done in this zone.

63
  It works in compliance with EU Grade D cleanroom class.

 Preparation and washing of primary packaging materials, dress changing

are done in this zone.

Class E

Unclassified area such as corridors.

Cleanroom Classification Chart:

Machines Used in Sterile Unit

Name Manufacturer Capacity

Autoclave ZIBRUS, Germany 700L

Vertical Ultrasonic Washing Tofflon, China 150 vials/min

64
Machine
Drying Dehydrogenation Tofflon, China
Tunnel
Vial Filling and Rubber CVC, Taiwan 100 vials/min
Stoppering Machine
Vial Cap Sealing Machine Tofflon, China
Filter Integrity Tester Sartorius, Germany
Vial Inspection Machine CVC, Taiwan
Vial Labeling Machine CVC, Taiwan
Balance Mettler Toledo, Switzerland Maximum 120gm

Autoclave

An autoclave is used to sterilize surgical equipment, laboratory instruments,

pharmaceutical items, and other materials. It can sterilize solids, liquids, hollows, and

instruments of various shapes and sizes. Autoclaves vary in size, shape, and functionality.

A very basic autoclave is like a pressure cooker; both use the power of steam to kill

bacteria, spores and germs resistant to boiling water and powerful detergents.

Function of autoclave: An autoclave is a pressure chamber used to carry out industrial

and scientific processes requiring elevated temperature and pressure in relation to

ambient. Autoclaves are used in medical applications to perform sterilization in sterile

area.

 Liquid and KDF (Kidney Dialysis Fluid)

Syrup Manufacturing Process

65
 Sugar Grading & sieving Process (Machine – Vibratory Sifter)

Sugar Transfer in the sugar melting vessel (Machine – Vacuum Transfer System)

Sugar Melting Process by Sugar and mixed with and heated in sugar melting

vessel so sugar is malted (Machine –Sugar Melting Vessel)

Melted Sugar to be filtered for removing impurity of solid particles and transfer the

manufacturing vessel (M/c. Basket Filter and Transfer Pump)

Syrup manufacturing by adding drugs & ingredient in malted sugar and mixed by

stirrer and highspeed homogenizer with heating. Also, the material re circulated in the

vessel after that readiness of syrup it will be cooled by cooling system (Machine –Syrup

Manufacturing Vessel)

Cooled syrup will be transfer through inline homogenizer and filter press for

homogenize mixing and filtered up to 5 microns size in storage tank.

(M/c Inline Homogenizer & Filter Press)

The syrup is storage in the storage vessel and when transfer to the filling machine

that time mixed by stirrer. (Machine –Storage Tank)

66
 ↓

Syrup transfer to float tank of filling machine by transfer Pump system

(Machine – Transfer Pump)
↓

Liquid syrup will be packed in bottle by filling & sealing & packing line machinery

Automatic washing of all vessel and Tank by CIP system (Machine –CIP/ WIP System)

KDF (Kidney Dialysis Fluid)

While healthy kidneys have several functions in the body, the most well-known job is to

produce urine. When kidney function goes below 10% to 15% kidneys are no longer able

to filter the blood and make urine. This causes toxins to build up in the body along with

excess fluid. Fortunately, we live in a time when there are treatments and medicines that

can replace the functions of the kidneys and keep the body alive. One type of renal

replacement therapy — meaning a treatment that replaces kidney function — is

hemodialysis. Hemodialysis is a therapy that filters waste, removes extra fluid and

balances electrolytes (sodium, potassium, bicarbonate, chloride, calcium, magnesium and

phosphate).

Machines used in liquid and KDF Manufacturing

Name Manufacturer Capacity

Liquid manufacturing The United Engineering 500L (Pre-mixing vessel)

machine Company, India 2000L (Manufacturing
vessel)
2000L (Storage Vessel)

67
Conveyer belt The United Engineering
Company, India
HIBRO Washing machine The United Engineering 24 nozzels
Company, India
KDF ManufacturingMachine MOM Industries, 500L (Pre-mixing vessel)
Bangladesh 2000L (Manufacturing
vessel)
2000L (Storage Vessel)

Engineering

Labiad pharmaceutical Limited has a complete and sound Engineering department for

supporting the frequent production. Production environment is provided by the

engineering department. The manufacturing of various products requires cleanliness,

machine in order, different type of water supply, the controls of air, ventilation of the

company, control of the temperature, control of the RH, test of the new machine,

repairing machines etc. are most important concern for the pharmaceutical industry. All

of those are maintained by the engineering department. Therefore, Engineering

department is the supporting department of the industry which is responsible for design,

setup, qualification, validation of required machines and equipment aimed for facilitating

the manufacturing of quality product, identification of critical steps and relevant

monitoring of machines and equipment.

Functions of Engineering Department

Function of engineering department in pharmaceutical industry mainly divided into two

parts. The section maintains continuous supply of electricity, gas steam and also HVAC

system.
68
  Project
It can be a new project or project extension where engineers work in a pharmaceutical.

Heavy machineries for production and full set up for controlled environment in a

production and storage area is set up and installed by engineering department. HVAC

system, boiler, water purifier, compressed air system etc. are installed by the engineering

department. Moreover, required extension after completing a project is also done by the

engineering department. The process follows as-

URS (User Required Specifications) Checking market availability Purchase

Installation Handed over to Maintenance department after qualification check

 Power Supply

LABAID Pharmaceutical Ltd. has its own complete power supply plant, which is

considered as the heart of the factory. They do not use PDB electricity. This power plant

is divided into two sections Low Tension (LT) &High Tension (HT). About 4000 kW

power is produced from LT sector & 1950 kW power is produced from HT sector.

 Maintenance or Utility Service

The utility operation is based on electricity, gas, steam and compressed air system. Along

with set up and installation maintenance of the existing system is also done by the

engineering department. The function of this section is to separate the utilities and

services in the plant. They also perform the proper preventive maintenance functions to

run the existing facility to ensure maximum output. The machines and services handled

by this section are divided into two parts.

69
 1. Process equipment: This includes machineries that are used in the production

department

2. Utility: The wings of this sections are listed below-

 HVAC system

 Central Vacuum System

 Compressed Air

 Electricity Boiler

 Nitrogen Gas

 Potable/ drinking water and Purified water

 Hot Water

 Cold Water

Compressed Air System

Compressed air is provided by compression unit (up to 8 atm). Compressed air required

for the purposes below without having impact on product quality-

 Driving portable tools

 Driving machinery

 Transmitting control signals

 Actuating pneumatic control devices

Terminal filters are also used before the user points of the machines where the products

come in direct contact with the compressed air.

 Chiller System (Central AC)

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This system is involved in the production of chilled water. It is supplied through pipe at

5oC to produce air conditioning system. Some components are evaporator, condenser,

compressor etc.

 Boiler

A boiler is a closed vessel in which fluid (generally water) is heated and produce steam at

1100oC. Steam produced by the boiler is supplied to the whole pharmaceutical plant as

per requirement as the steam temperature is very high and free from contaminants.

 HVAC System

The simultaneous control of various parameters of air to the specific limit as required for

the manufacturing of quality medicine is known as air conditioning. The main objective

of HVAC system is to maintain a constant temperature and a constant humidity (RH) in

the production area. HVAC system is required for-

 To maintain specified temperature

 To maintain specific relative humidity

 To remove dust particle from production area

 To maintain proper airflow to the rooms to prevent cross contamination

 To prevent microbial contamination in some area by maintaining particle size

within the tolerance range

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  Water Treatment Plant

In Labaid pharmaceuticals, raw water is treated in different stages to meet criteria

specified for various applications. Process water should meet USP pacification for

purified water. Besides soft water is used for boiler feed water and generator cooling

tower. Potable water is used for drinking, sanitary, washing applications etc.

 Purified Water

Purified water is prepared here. Purified Water is actually all minerals removed water.

Purified Water is heated →Pure Steam →Condensed→ Water for Injection

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Scope of Improvement

Labaid Pharmaceuticals is one of the best pharmaceutical in this country. However,

following points can be considered as a part of improvement:

 It would be great if the training period could extend beyond 3 weeks.

 It would be great for us if we could spend a longer time in each of the

departments separately.

Conclusion

Labaid Pharmaceuticals Limited believes that pharmaceutical business is built solely on

the blocks of trust by ensuring quality and it takes perseverance for a pharmaceutical

business entity to earn the trust of the people. Many global best practices are being

cultured in the everyday activity of Labaid Pharmaceuticals which are contributing in a

big way to shape up its future & earning people’s trust. Labaid presented us an

opportunity to develop skills and knowledge about pharmaceutical industries and its

working and maintaining procedure from experienced and professional individuals. We

received the most cordial treatment in every department that we visited. We are thankful

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to the authority for giving us this chance to flourish our knowledge. The last two weeks

were a great experience being in-plant trainee at Labaid Pharmaceuticals Limited

Finally, we would like to give hearty thanks to Labaid Pharmaceuticals Limited and our

gratitude goes to its all personnel.

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