QUALITY ASSURANCE

INTENDENT LEARNING OUTCOME

Upon completion of this lecture session, you will be able to:
Define Quality Assurance (QA)
Discuss about the objective of QA
Describe activities of QA
Compare QA and QC

INTRODUCTION
 Quality assurance is a wide-ranging concept covering all
matters that individually or collectively influence the quality
of a product.
 “Planned and systematic activities implemented within the
quality system that can be demonstrated to provide confidence
that a product or service will fulfill requirements for quality” QC
 Object of ensuring that pharmaceutical products are of the
quality required for their intended use.
QA = QC + GMP /Other Quality Systems

OBJECTIVE OF QA
1) Managing good manufacturing practices (GMP)including
2) Managing good laboratory practices (GLP)
3) Managing a safety programme
4) Assuring the quality of raw materials
5) Assuring the quality and traceability of finished product
6) Evaluating plant environment
7) Developing an HACCP plan

QA ACTIVITES
1. Technology transfer 4. Assuring quality of products
2. Validation 5. Quality improvement plans
3. Documentation

1) TECHNOLOGY TRANSFER
1. Receipt of product design documents from research centre
2. Receipt of the trial-and-error data and its final evaluation
3. Distribution of documents received from research centre
4. Checking and approval of documents generated based on research centre documents i.e. batch
manufacturing record
5. Scale-up and validation of product
2) VALIDATION
1) Preparation of Validation Master plan for facility/equipment's/process Utility, Cleaning and all the
sections of the validation
2) Approval of protocol for validation of facility/ equipment/product/ process/Utility
3) Team member for execution of validation of facility/equipment / product/ process
4) Final approval of the facility/ equipment/product/ process/Utility validation
 3) DOCUMENTATION
Type of documents
1. Standard operating procedures 3. Results
2. Protocols of tests 4. Reports

1. Controlled distribution and archiving of documents

2. Control of changes made by proper change control procedure
3. Approval of all documents

4) ASSURING QUALITY OF PRODUCTS

1. CGMP training 6. Critical sampling
2. SOP compliance 7. Record verification
3. Audit of facility for compliance 8. Release of batch for marketing
4. Line clearance 9. Investigation of market complaints
5. In-process counter checks

5) QUALITY IMPROVEMENT PLAN

Feedback received from the compliance team
Customer complaint history
Proposals for corrective and preventive actions
Annual Products review
Trend analysis of various quality parameters for products, environment and water
Review of the Deviations, Change Controls, Out of Specifications and Failures.

QUALITY CONTROL
Component of a QA program
Procedure control
QC process involves checking all the operational procedures to make certain they are performed correctly
The QC chemists must ensure that they meet standards at all times
Quality Assurance Quality Control

SUMMARY
Quality Assurance (QA)
Objective of QA
Activities of QA
QA and QC
 QUALITY CONTROL
INTENDENT LEARNING OUTCOME
o Upon completion of this lecture session, you will be able to:
o Define Quality control
o Discuss about the importance of QC
o Describe about objective of QC
o Explain the steps in QC
o State advantageous of QC

INTRODUCTION
o Quality Control is the part of Good Manufacturing Process.
o It is concerned with sampling, specifications and testing and with the organization, documentation and
release procedures which ensure that the necessary and relevant tests are actually carried out.
o The materials are neither released for use, nor products are used for sale & supply until their quality
has been satisfactory.
o QC is a set of activities for ensuring quality in products.
o The activities focus on identifying defects in the actual products produced.
o QC is a corrective tool
o The purpose of this operations to produce medications of superior efficacy, safety and elegance, and to
provide assurance to the physician, the pharmacist and the consumer.

IMPORTANCE OF QC
 The pharmaceutical environment today is changing quickly due to globalization, increased
competition, cost constraints, demands for efficiency, development of international regulation, supply
chain complexity, and product/process complexity.
 In this fast-changing environment, the people and companies that learn to adapt will prosper.
 Produce zero-defect products
 The quality, efficacy and safety attributes of products must be ensured.

OBJECTIVES OF QUALITY CONTROL

1) Establishment of quality standard
2) Locating quality deviations
3) Evaluating methods and processes of production
4) Quick sale of quality goods

COMPONENTS OF QUALITY CONTROL

QC Lab Retained sample
Analysis of finished product Sampling
Validation Records
Batch inspection and sampling
 QC LAB
o Chemical testing lab
o Instrumental analysis lab
o Microbiology and Toxicology lab
o Provision for retained samples and stability samples
o Documentation Room
o Relevant Books
o SOPs
o Trained Personnel

SAMPLING
 Approved method for sampling
 Well trained personnel and sampling tools
 Records maintenance of all sampling
 Checklist for every stage
 Sops divided into – before, during and after
 Sampling Sops for RM/FM/IM
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

RECORDS
o Records must be made demonstrating that all the required sampling, inspecting, testing procedures
have been actually carried out and that any deviation have been recorded and investigated.
o Recording is the primary basis of any pharmaceutical activity and hence all regulations insist on
recording of each and every activity carried out.
o This helps in tracing the history of a batch produced; this may be required in future if any
investigation is to be made.
FINISHED PRODUCT
The finished product must contain ingredients complying with qualitative and quantitative composition of
the product described in the marketing authorization, the ingredients must be of required purity, in their
proper containers and correctly labeled.

BATCH INSPECTION AND SAMPLING

 RETAINED SAMPLE
Sufficient samples of starting materials and products should be retained to permit further examination of
the product if necessary; the retained samples must be kept in the final pack unless the pack is
exceptionally large.

STEPS IN QUALITY CONTROL

1. Devising the control over raw materials
2. Fixing standards and specifications
3. Exercising control over production operations
4. Locating inspection points
5. Maintaining quality of equipment
6. Maintaining records
 ADVANTAGES OF QUALITY CONTROL
o Improvement of the quality of production and reduction in the production cost.
o Uniformity in the production and supply of standard quality goods to consumers.
o Offering full return of the price paid by the consumers and giving convenience and satisfaction to
consumers.
o Reduction in spoiled production and rejection from consumers and dealers.
o Promotion of exports due to superior and standard quality production.
o Reduction in inspection cost.
o Making products popular in market.

SUMMARY
1. Quality control 4. Steps in QC
2. Importance of QC 5. Components of QC
3. Objective of QC 6. State advantageous of QC