This document discusses quality assurance in the pharmaceutical industry. It defines quality assurance as the planned activities to provide confidence that a product or service will meet requirements. The basic principles of QA are that quality must be designed into the product and cannot be inspected in afterwards. Key components of a QA system include following GMP, having written production and control procedures, managing materials and processes, inspecting finished products, conducting self-inspections, and having top management responsibility.

1. Quality Assurance

2. Contents
• Introduction
• Quality Assurance
 Introduction
 Definitions
 Basic Principles of QA
 Characteristics of QA
 Components of QA

3. Quality Assurance
• Quality assurance is a wide ranging concept
covering all matters that individually and
collectively influence the quality of product.
• It is the arrangements made with the object of
ensuring that pharmaceutical products are of the
quality required for the intended use.
• Assurance of product quality is derived from
careful attention of factors including selection of
quality parts and materials, adequate product
and process design, control of the process, and
in-process and end-product testing.

4. Definitions
 According to WHO (World Health Organization):
“QA is the activity of providing evidence needed to establish
confidence among all concerned that quality related
activities are being performed effectively.”
 According to ISO 9000:
“All those planned and systematic activities implemented to
provide adequate confidence that an entity will fulfill
requirements for quality.”

5. Definitions
“Quality Assurance is verifying that quality control
procedures are being followed to provide confidence
that a product or service will satisfy client
requirements”. (Edwards and Kelcey)
 “Quality Assurance is a comprehensive written
plan and activities that documents the progress of a
project design for example from initial planning
through final plans”.

6. Basic Principles of QA
• Quality, safety and effectiveness must be
designed and built into the product.
• Quality cannot be inspected or tested into the
finished product.
• Each step of manufacturing process must be
controlled to maximize the probability that
the finished product meets all quality design
specifications.

7. Characteristics of Quality
• Identity
• Strength
• Safety
• Purity
• Efficacy

8. Identity
• The regulatory authorities consider
identity as the product identity. i.e.
the unique identity of a given
product, which primarily relates to
the name and content of the product.
• Product identity may be referred to
as:
– Name of the Product,
– Type of formulation
– Name of quantity of API in a unit dose

9. Identity
Who
When
where
How
What
Who

10. Strength
• Regulatory authorities consider this
mainly to the strength of the
pharmaceutical unit dose as claimed
on label.
• Ex: “each tablet contains 500mg of
Paracetamol”
• What was assay/ potency of API?
• Does each unit dose contain the
claimed amount?
• Does each primary pack contains
claimed units?
• Does each secondary / tertiary pack
contains desired primary / secondary
packs in it?

11. Safety
• The regulatory authorities refer it to
the safety of ultimate user or patient.
• What happen? And what should
happen? When pharmaceutical
product consumed by patient.
– First, he gets no desired effect
– Second, he gets partial desired effect.
– Third, he gets undesired, unexpected
effects. (i.e. unknown side effects).
– Fourth, he get expected undesired
effects. (i.e. known side effects).
– Fifth, he gets desired effects

12. Purity
• The product is free from
any cross contamination.
• A contaminant in this case
may be defined as the
presence of any undesired
/unexpected material in
the product.

13. Efficacy
• Any product which meets the above four
characteristics will have the desired
therapeutic efficacy of product.

14. Components of QA
• Pharmaceutical products are
designed and developed in a way
that takes account of the
requirement of GMP, GLP, GVP,
GCP etc.

15. Components of QA
• Production and control operations are clearly
specified in a written form and GMP requirements
are adopted.
• Managerial responsibilities are clearly described.

16. Components of QA
• Arrangements are made for manufacture, supply and
use of correct starting and packaging materials.
• All necessary controls on starting materials,
intermediate products and bulk products and other
in process controls, calibrations and validation are
carried out.

17. Components of QA
• The finished products is correctly processed
and checked according to defined procedures.

18. Components of QA
• Pharmaceutical products are not sold or
supplied before authorized person certified
that each production batch has been
produced and controlled accordance with
requirement.

19. Components of QA
• Self inspection or quality audit that regularly
appraise the Q. A. system.

20. Components of QA
• Production environment and service to
production operations are monitored.
• Deviations are adequately recorded,
investigated and responded.

21. RESPONSIBILITIES OF QA
In particular the top management is responsible
for:
• Providing leadership
• Structure the organization.
• Build quality systems to meet the requirements.
• Establishment policies, objectives and plans.
• Review the system.