In-Plant Training

at

Drug International LTD. Unit-0

Presented by,
Sabia Islam
Alamin Hossain
Ok
Department of Pharmacy
Khwaja Yunus Ali University

DURATION OF TRAINING: 30 Days (From 03 Mar

Introduction
Company Name: Drug International Limited.
Drug International Limited was incorporated under the Registrar of Joint Stock Companies in 1974 as a
Private Limited Company. The company commenced formulation and production in 1983 and emerged as a
pioneer in Bangladesh for adding a state of the art oral solid dosage plant.
Honorable founder chairman: Dr. M. M. Amjad Hussain (October 1, 1925 to September 11, 2012)
Achievements:
● GMP certificate from Food and Drug Authority, Ghana.
● ISO certificate.
● GMP certificate from Pharmacy Board of Sierra Leone.
● NAFDAC certificate.
● Exported above 20 countries all over the world.

Factory Location: 252, Tongi Industrial Area , Tongi,

Gazipur, Bangladesh.
Corporate Setup: Private Limited Company.
Massage From Managing Director

M A Haider Hussain
Managing Director
Present Managing Director, younger son of Dr. M. M. Amjad Hussain. Prior to becoming Managing Director, he
was Director Marketing of Drug International Limited. He was also elected Chairman of Khwaja Yunus Ali
Medical College & Hospital, Khwaja Yunus Ali Medical College. He is also Managing Director of ATI Limited,
ATI Ceramics Limited and Harnest Label Industries. Governing Body Member of Khwaja Yunus Ali University
and KYAMCH Nursing Institute.
 Contents
QC
● Quality Control
● Steps in Quality Control
● Responsibilities of QC
Department
● Component of QC.
● Testing parameter of QC
● Major QC Instrument
 Quality
Assurance
 Quality Assurance
Quality assurance is the sum total of the organized arrangements made with the object of ensuring
that products will be of the quality required by their intended use.

Function of QA:
a) To ensure quality of the product.
b) To generate and maintain SOP.
c) Perform and monitor the validation and calibration activity
d) To handle product recall/mock recall
e) To perform training session for officers and workers.
f) To handle deviation and CAPA
g) To handle market complain.
h) To ensure IPQC check.
Quality Assurance Work With

In Process Quality
Control

Raw Materials
Quality Control

Quality Control

Finished Products
Quality Assurance
Quality Control

Quality Compliance

Packaging Materials
Quality Control
Quality Control
Quality control covers all measures taken, including the
Setting of specifications, sampling, testing and analytical
clearance to ensure that raw materials, packaging materials
and finished pharmaceutical products conform with
established specifications for identity, strength, purity and
Other characteristics.

QC=Testing + Assessment
 Devising the
control over raw
materials : The Fixing
quality of Maintaining
standards Maintaining
finished products quality of
is determined and records.
equipment.
mainly by the specification.
quality of raw
materials.
 Efficacy: Quality:
In digital marketing ,efficacy refers to Quality is the totality of features and
whether or not something produces the characteristics of a product or service that
desired effect. For example “ we need to bear on its ability to satisfy stated or
test the efficacy of these lead generation implied needs.
ads.’’

Quality Control

Compliance:
Safety:
Compliance refers to the act of responding
“Freedom from danger ,injury or favorably to an explicit or implicit request
damage .Reducing danger or harm.” offered by others.
Components of Quality Control

Maintainin
Batch
Analysis of g reports
Inspection
QC Lab. Finished Sampling. Records. and
and
Product. document
Sampling.
s.
 Some Important Term of Quality Control

● Sample: A portion of a material collected according to a defined

sampling procedure. The size of any sample should be sufficient to
allow all anticipated test procedure to be carried out.

● Sampling: The process of taking a small portion from a batch for

test and analysis.

● Validation: All the methods used by QC say for sampling,

testing and other activities must be validated.Validation of
testing method is particularly very important.
Calibration: Calibration is done to ensure that the system is ready
to use for any analysis it was just an instrument performance
check.

Batch Record: The batch record is a product quality control

document that collects all the data and information to make
regulated products. Batch records record materials, equipment,
data, labels and during production of product.
Log book: All companies are required to keep a log book for the
chronological documentation of equipment related events such as
validation and qualification work, calibration, equipment cleaning
preventive maintenance and repair unexpected deviations for
manufacturing equipment, apparatus etc.
● SOP: Standard Operating Procedures (SOP) define the essential steps, their
sequence, and the precautions necessary to formally repeat a quality
performance.

● STP: STP is standard test procedure -This acronym is generally given when
the test method are product specific.

● Verification: Verification is based on checking and testing the product or

process against the established standards and specifications.

● Drug Potency: It is a measure of drug activity measured in terms of

amount of drug required to produce an effect

● Drug Purity: It is the absence of unwanted substance like impurity &

contamination.
 Methods Used For Quality Control

Various tests and procedures for analysis including finding and determining impurities.

In the quantitative analysis, depending upon the characteristics of drugs and its
formulation various analytical methods are followed

This includes:-
1.Qualitative Analysis: It include determine of Product labels,Packaging materials etc.

2.Quantitative Analysis: It include the separation technique like

chromatographic(HPLC,TLC etc.)
Many types of test like etc. variation, uniformity test done by
Quantitative analysis.
 Some Testing Parameters of QC

Raw materials testing parameters: Finished product testing parameters

Identification Appearance

Melting point
Individual weight
PH
Average weight
Assay
Uniformity of
Dissolution weight

Viscosity Weight variation

Disintegration
Mechanism of HPLC
Instrument used in quality
control department
( Analytical Lab):
1. Electric balance
2. Dissolution Tester
3. FTIRs
4. pH meter
5. Karl Fisher Titrator
6. LOD Machine
7. Coulometric Karl Fisher Titrator
8. IEC
9. Moisture analyzer
10.Muffle Furnaces MUF
11.GC
12.HPLC
13.Particle Size Analyzer
14.Sieve Analyzer
15.UV- visible Spectrophotometer
16.Viscometer
HPLC Both quantitative & qualitative analysis can be done.
GC-MS
 Separates chemical mixture of volatile substance (the GC
component) & identifies the components at a molecular
level(the MS component)
 Some QC Instruments Names, Manufacturer & Country of Origin

1.HPLC(High Performance Liquid Chromatography)

Manufacturer: Agilent Technologies

Origin: Germany
Function: Measurement of durg Potency

2.GC(Gas Chromatography)
Manufacturer: Agilent Technologies
Origin: USA
Function: Separate the chemical
Component of a mixture.
3.UV-Spectrophotometer
Manufacturer: Agilent Technologies
Origin: Germany
Function: Use identification & Determination

4.FTIR Spectrophotometer
Manufacturer: Agilent Technologies
Origin: Malaysia
Function:Measurement of Infrared radiation
with matter.
7.Moisture Analyzer
Manufacturer: Mettler Toledo
Origin: China
Function:Measure moisture content
of the sample

8.Analytical Balance
Manufacturer: OHAUS
Origin: China
Function:Measure sample,STD & raw
materials
9.Dissolution Test Apparatus
Manufacturer: Copley Scientific
Origin: China
Function: Measure the amount of drug release per unit
10.Melting Point Apparatus/Meter
Manufacturer: Paradise Scientific Company
Origin: Germany
Function: Measure the melting point of the
sample
11.Sonicator Bath
Manufacturer: GT Sonic
Origin: China
Function: Use proper mixing of the sample
12.PH Meter
Manufacturer: Mettler Toledo
Origin: China
Function:Measure & Adjust water,Buffer & Mobile
phase pH

13.Conductivity Meter
Manufacturer: Seven Compact
Origin: China
Function:Measure conductivity in
water & sample solution.