QUALITY ASSURANCE AND QUALITY

MANAGEMENT CONCEPTS

1
Miss. Arpita Jena
Assistant Professor
Shree Devi College of Pharmacy, Mangalore
2 CONTENTS

 INTRODUCTION

 QUALITY MANAGEMENT SYSTEMS

 QUALITY ASSURANCE

 QUALITY CONTROL

 cGMP (GOOD MANUFACTURING PRACTICES)

3 INTRODUCTION

Quality – According to ISO “The totality of features and Characteristics of product or

service that bear on its ability to satisfy stated/implied needs.
4 QUALITY MANAGEMENT SYSTEM

 A quality management system (QMS) is defined as a formalized system that

documents processes, procedures, and responsibilities for achieving quality
policies and objectives.
 A QMS helps coordinate and direct an organization’s activities to meet customer
and regulatory requirements and improve its effectiveness and efficiency on a
continuous basis.
5 ELEMENTS OF QUALITY MANAGEMENT
SYSTEM
 A quality management system typically consists of four facets:
1. QUALITY PLANNING: Process of translating quality policy into processes, procedures,
and introduces to achieve measurable objectives and requirements.
2. QUALITY ASSURANCE: Planned and methodical activities executed as part of a quality
system to provide confidence that process, product or service requirements for quality
are being satisfied.
3. QUALITY CONTROL: Act of monitoring, appraising, and correcting a process, product, or
service to ensure requirements for quality are being satisfied.
4. QUALITY IMPROVEMENT: Process of analysing performance and taking methodical,
systemic actions to improve it.
6 PURPOSES OF QUALITY
MANAGEMENT SYSTEMS
 Improving processes
 Reducing waste
 Lowering costs
 Facilitating and identify training opportunities
 Engaging staff
 Setting organization- wide direction
7 QUALITY ASSURANCE

DEFINITION OF QUALITY ASSURANCE –

 By WHO: “Quality assurance is a wide ranging concept covering all matters that
individually or collectively influence the quality of product. The totality of the
arrangement made with the objective of ensuring that pharmaceutical products are
of the quality required for their intended use and QA also includes GMP and other
factors such as product design and development.
 By ISO 9000: “QA is a part of Quality Management focused on providing
confidence that quality requirements will be fulfilled.
8 CONCEPT OF QUALITY ASSURANCE

Quality Assurance
 QA is a set of activities for ensuring quality in the process by which the products
are developed.
 QA is a managerial tool.
 QA aims to prevent defects with a focus on process used to make the product.
 The goal of QA is to improve development and test processes so that defects do
not arise when the product is being developed.
9
Quality Assurance system should ensure that
 Medicinal products are designed and developed in a way that takes account of the
requirements of Good manufacturing Practice.
 Production and control operations are clearly specified and Good Manufacturing
Practice adopted.
 Managerial responsibilities are clearly specified.
 Arrangements are made for the manufacture, supply and use of the correct starting
and packaging materials.
 All necessary controls on intermediate products and any other process controls and
validations are carried out.
 The finished product is correctly processed and checked, according to the defined
procedures.
10

 Medicinal products are not sold or supplied before an authorized person has
certified that each production batch has been produced and controlled in
accordance with the requirements of the marketing authorization and any other
regulations relevant to the production, control and release of medicinal products.
 Satisfactory arrangements exist to ensure, as far as possible, that the medicinal
products are stored, distributed and subsequently handled so that quality is
maintained throughout their shelf life.
 There is a procedure for self-inspection and/or quality audit, which regularly
appraises the effectiveness and applicability of the quality assurance system.
11

Responsibilities of Q.A Department

 QA department is responsible for ensuring that the quality policies adopted by a
company are followed to meet quality requirements.
 To identify and prepare the necessary SOP’s related to the control of quality.
 QA department ensures that the product meets all the applicable specifications
and that it was manufactured according to the standards of GMP.
 QA also holds responsibility for quality monitoring or audit.
 QA functions to assess operations continually and to advise and guide them
towards full compliance with all applicable internal and external regulations.
12 QUALITY CONTROL

DEFINITION OF QUALITY CONTROL-

 By WHO: “Q.C is a part of GMP which is concerned with sampling, specification,
testing with the organization, documentation and release procedures which ensure
that the necessary and relevant tests are actually carried out and that materials are
neither released for use, nor products released for sale or supply, until their quality
has been found satisfactory”.
13 CONCEPT OF QUALITY CONTROL

Quality Control
 QC is a set of activities for ensuring quality in products, the activities focus on
identifying defects in actual product produced.
 QC is a corrective tool.
 QC aims to identify defects in finished products and the also to identify defects
after a product is developed and before it is released.
 QC works by finding and eliminating sources of quality problems through tools and
equipment's so to meet customer’s requirement.
14

 There should be Adequate facilities, trained personnel and approved procedures

are available for sampling, inspecting and testing Raw materials, packaging
materials, intermediate products, bulk, and finished products, and where
appropriate for monitoring intermediate products, bulk, and finished products, and
where appropriate for monitoring environmental conditions for GMP purposes.
 Samples of starting materials, packaging materials, intermediate products, bulk
products and finished products should be taken by personnel according to the
methods approved by Quality Control.
 Test methods should be validated.
15

 Records should be made, manually and/or by recording instruments, which

demonstrate that all the required sampling, inspecting and testing procedures were
actually carried out. Any deviations are fully recorded and investigated.
 The finished products containing active ingredients should comply with the
qualitative and quantitative composition of the marketing authorization and should
be of the purity required, and should be enclosed within their proper containers
and correctly labelled.
 All the Records containing results of inspection and that testing of materials,
intermediate, bulk and finished products should be formally assessed against
procedures.
16

 Product assessment should includes a review and evaluation of relevant

production documentation and an assessment of deviations from specified
procedures.
 No batch of product should be released for sale or supply prior to certification by
an authorized person that it is in accordance with the requirements of the relevant
authorizations.
 Sufficient reference samples of starting materials and products should be retained
to permit future examination of the product if necessary and that the product is
retained in its final pack unless exceptionally large packs are produced.
17

Responsibilities of Q.C Department

 QC is responsible for the day-to-day control of quality within the company.
 QC department is responsible for analytical testing of incoming raw materials and
inspection of packaging components, including labelling.
 To conduct in-process testing when required, perform environmental monitoring,
and inspect operations for compliance.
 They also conduct the required tests on finished dosage form.
 QC plays a major role in the selection of qualified vendors from raw materials are
purchased.
18

 The environmental areas for manufacturing of various dosage forms are tested
and inspected by QC department.
 Maintenance of all documents related to Q.C department.
19 GMP (GOOD MANUFACTURING
PRACTICES)
DEFINITION OF GMP
BY WHO: “GMP is that part of Quality Assurance, which ensures that products are
consistently produced and controlled to the quality standards appropriate for their
intended use and the legal requirements. GMP is thus concerned with both production
and Quality control parameters”.
 CONCEPT OF GMP
20
 GMP guidelines represent minimal standards that are necessary conditions for
marketing authorization, drugs are considered to be adulterated, if GMP’s are not met.
 It comprise strong recommendations on quality management, personnel, production
facilities and equipment's, documentation and records, production and in-process
controls, packaging and labelling, storage and distribution, laboratory controls,
validation, complaints and recalls.
 It helps in implementing modern quality systems and risk management approaches to
meet the requirements of quality products to ensure their intended use.
 It ensures that quality is build into the organization and the processes and operations
in the manufacture of the products should be carried out strictly.
 The guideline serves as a basic minimum requirement for both local and foreign
pharmaceutical companies to be authorized for import products. It is also a reference
and guidance tool to the Authority for GMP inspection and licensing of establishments.
21 GMP REQUIREMENTS

 All manufacturing processes are clearly defined, systematically reviewed and

should be capable of consistently manufacturing medicinal products of the required
quality and complying with their specifications and/or marketing authorization.
 Critical steps of manufacturing processes and significant changes to the process
are validated.
 All necessary facilities for GMP are provided including.
 1. Appropriately qualified and trained personnel.
22

2. Adequate premises and space.

3. Suitable equipment and services.

4. Correct materials, containers and labels.

5. Approved procedures and instructions.

 6. Instructions and procedures are written in an instructional form in clear and
23 unambiguous language, specifically applicable to the facilities provided.

7.Operators are trained to carry out procedures

correctly.

8. Records are made, manually and/or by recording instruments,

during manufacture. Any significant deviations are fully recorded
and investigated.

9. Records of manufacture including distribution which enable

the complete history of a batch to be traced are retained in a
comprehensible and accessible form.
 10. The distribution of the products minimizes any risk to
their quality.
24

11. A system is available to recall any batch of product, from sale or supply.

12. Complaints about marketed products are examined, the causes of

quality defects investigated and appropriate measures taken in respect of
the defective products and to prevent re-occurrence.
 2. Building and facilities 4. Sanitation and
25 Hygiene

3. Equipment
1. Personnel
5. Control of components,
Drug product containers
and closures
11. Reports and
records GMP COVERS
(Documentation)
6. Production and Process
10. Returned and controls
Salvaged drug
products 8. Holding and
distribution

9. Laboratory 7. Packaging and

controls Labelling controls
26 PERSONNEL
 There must be sufficient qualified personnel to carry out all the tasks which are the
responsibility of the manufacturer.
 Individual responsibilities should be clearly understood by the individuals and recorded.
 All personnel should be aware of the principles of GMP that affect them and receive
training, including hygiene instructions.
 The manufacturer should have an adequate number of personnel with the necessary
qualifications and practical experience. The responsibilities placed on any one individual
should not be so extensive as to present any risk to quality.
27

 The manufacturer must have an organization chart. People in responsible

positions should have specific duties recorded in written job descriptions and
adequate authority to carry out their responsibilities. There should be no gaps or
unexplained overlaps in the responsibilities of those personnel concerned with the
application of GMP.
 Key Personnel includes the head of production, the head of Quality Control, and
the head of engineering and if at least one of this persons is not responsible for the
release of products the authorized person(s) designated for the purpose (Quality
Assurance Head).
 The heads of production and Quality Control must be independent from each
other.
28 BUILDING AND FACILITIES
 Buildings should be of suitable size, construction location to facilitate cleaning,
maintenance, and proper operations.
 Space should be adequate for the orderly place of equipment and materials to prevent
mix-ups.
 The movement of components and product through the building must be designed to
prevent contamination.
 Operations should be performed within specifically defined areas having adequate
control systems and to prevent contamination or mix-ups.
 Holding rejected materials and storage of in-process materials released components,
drug product containers, closures and labelling.
 Manufacturing and processing operations.
 Packaging and labelling operations.
  Quarantine storage before release of drug products.
29
 Storage of drug products after release.
 Aseptic processing
 Floors, walls, and ceilings of smooth, hard surfaces that is easily cleanable.
 Temperature and humidity control.
 An air supply filtered through High Efficiency Particulate air (HEPA) filters under positive pressure
regardless of whether flow, laminar or non-laminar.
 A system for monitoring environmental conditions, a system for cleaning and disinfecting the room
and equipment to produce aseptic conditions.
 A system for maintaining any equipment used to control the aseptic conditions.
 Heating, ventilation, and air conditioning (HVAC).
 Adequate ventilation is required in all areas.
 Sewage, trash, and other refuse in and from the building and immediate premises must be
disposed of in a safe and sanitary manner.
30

EQUIPMENTS

 Equipments should be of appropriate design, adequate size, and suitably located

to facilitate operations for its intended use and for cleaning and maintenance.
 Equipments, should be constructed so that surfaces that contact components, in-
process materials, or drug products should not be reactive.
 Any substance required for operation such as lubricants or coolants shall not come
into contact with drug products, containers and so on.
 Equipment and utensils should be cleaned, maintained, and sanitized at
appropriate intervals to prevent malfunctions or contamination that would alter the
drug product beyond the official requirements.
 Written procedures must be established and followed for cleaning and
maintenance of equipment and utensils used in the processing of a drug product.
31 SANITATION AND HYGIENE

 A high level of sanitation and hygiene should be practiced in every aspect of the
manufacture of pharmaceutical products.
 Sanitation and hygiene covers personnel, premises, equipment and apparatus,
production materials and containers, products for cleaning and disinfection, and
anything that could become a source of contamination to the product.
 Potential sources of contamination should be eliminated through an integrated
comprehensive program of sanitation and hygiene.
 The layout and design of premises must aim to minimize the risk of errors and permit
effective cleaning and maintenance in order to avoid cross-contamination and
facilitate cleaning.
 A high level of personal hygiene should be followed and observed by all those
concerned with manufacturing processes. In particular, personnel should be
instructed to wash their hands before entering production areas. Signs to this effect
should be posted and instructions observed.
32 CONTROL OF COMPONENTS, DRUG
PRODUCTS CONTAINERS AND CLOSURES
 1. General requirements.
 2. Receipt & storage of untested components, drug product containers and
closures.
 3. Testing and approval or rejection of components, drug product containers and
closures.
 4. Use of approved components, drug product containers, and closures.
 5. Retesting of approved components, drug product containers, and closures.
 6. Rejected components, drug product containers, and closures.
 7. Drug product containers and closures.
33

 All containers and closures intended for use shall comply with the pharmacopoeial
requirements. Suitable validated test methods, sample sizes, specifications,
cleaning procedure and sterilization procedure, wherever indicated, shall be strictly
followed to ensure that these are not reactive, additive, absorptive, or leach to an
extent that significantly affects the quality or purity of the drug. No second hand or
used containers and closures shall be used.
34
PRODUCTION AND PROCESS
CONTROLS
 Written procedures for production and process control must be written and followed.
These procedures should be designed to assure that the drug products have the
identity, strength, quality and purity they are represented to possess.
 All actions must be documented at the time of performance. Any deviations from the
written procedures must be recorded and justified.
 The batch must be formulated with the intent to provide not less than 100% of the
labeled amount of active ingredient.
 Weighing, measuring, or subdividing operations for all components must be adequately
supervised.
 Actual yield and percentage of theoretical yield should be determined at the completion
of each appropriate phase of manufacturing, processing, packaging or holding.
35 PACKAGING AND LABELING
CONTROLS
 Materials examination and usage criteria.
 Labeling issuance.
 Packaging and labeling operations.
 Tamper-evident packaging requirements for over-the-counter (OTC) human drug
products.
 Drug product inspection.
 Expiration dating.
36 HOLDING AND DISTRIBUTION

 Warehousing procedures.
 Distribution procedures.
  Prior to distribution or dispatch of given batch of a drug, it shall be ensure that the
37 batch has been duly tested, approved and released by the quality control
personnel. Pre-dispatch inspection shall be performed on each consignment on a
random basis to ensure that only the correct goods are dispatched. Detailed
instructions for warehousing and stocking of Large Volume Parenteral, if stocked,
shall be in existence and shall be complied with after the batch is released for
distribution. Periodic audits of warehousing practices followed at distribution
centres shall be carried out and records thereof shall be maintained. Standard
Operating Procedures shall be developed for warehousing of products.
38 LABORATORY CONTROLS

 General requirements
 Testing and release for distribution
 Stability testing
 Special testing requirements
 Reserve samples
 Animals used in testing components
39 RETURNED AND SALVAGED DRUG
PRODUTCS
 1. Returned drug products
 2. Drug product salvaging
• Adequate areas shall be designed to allow sufficient and orderly warehousing of
returned or recalled products.
• Segregation shall be provided for the storage of rejected, recalled or returned
materials or products.
40 REPORTS AND RECORDS
(DOCUMENTATION)
 1. General requirements
 2. Equipment cleaning and use log
 3. Component, drug product container, closure, and labeling records
 4. Master production and control records
 5. Batch production and control records
 6. Production record review
 7. Laboratory records
 8. Distribution records
 9. Complaint files
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