Quality assurance & quality control in pharma industry

1. A
Presentation
On
Presented To: Presented By:
Dr. Harish Dureja Vikas yadav
M.D.University Rohtak
Department of Pharmaceutical Science
2016-2017

3. Aspect of quality management
Quality management :- In the drug industry at large, quality
management is usually defined as the aspect of management function
that determines and implements the “Quality policy” the overall
intention and direction of an organization regarding quality, as formally
expressed and authorized by top management.
The basic elements of quality management are:-
Quality Assurance:- It is the sum total of the organized
arrangements with the objective of ensuring that products will be of the
quality for their intended use.
Quality control:- Is that part of GMP concerned with sampling,
specification & testing, documentation & release procedures which
ensure that the necessary & relevant tests are performed & the product
is released for use only after ascertaining its quality.

5. QA and QC

7. Quality Approaches :-
ISO quality standard:- ISO 9000 is a series of international standards for
quality management.
 ISO 9000 – Quality management and quality assurance standards – guidelines
for selection and use.
 ISO 9001 – Quality systems – model for quality assurance in design ,
development, production, installment and servicing.
 ISO 9002 – Quality systems – model for quality assurance in production ,
installation and servicing.
 ISO 9003 – Quality systems – model for quality assurance in final inspection
and testing.
 ISO 9004 – Quality management and quality system elements – guidelines for
quality management planning, implementation and performance improvements.

9. Objective of quality management:-
1. Provide high quality drug product to patient and prescriber.
2. Prevent and reduce the number of recalls defective product.
3. Harmonise the cGMP to the extent possible with other widely used
quality management system like ISO 9000 etc.
4. To handle many types of changes to facilities, equipment and
processes without the need for regulatory submission.
5. To help in getting quality by design.

10. Principle in quality management:-
1. Customer focus : - Organization depend on their customers and
therefore they should understand and meet the current and future
customer needs and strive to exceed customer expectations.
2. Leadership:- Leaders establish unity of purpose and direction of an
organization. They create and maintain a micro environment in which
people can become fully involved to achieve organization‘s objectives.
3. Involvement of people:- People at all levels are the essence of an
organization and their full involvement enables their abilities to be utilized
for the organization’s benefit.
4. Process approach:- A desired effect is realized more efficiently when
related resources and activities are managed as a process.
5. System approach to management:- Identifying, understanding and
managing a system of interrelated processes for a given objective
improves the organization’s efficiency and effectiveness.

11. 6. Continual improvement:- Continual improvement should be a
permanent objective of the organization.
7. Decision making:- Effective decisions are based on the permanent
objective organization .
8. Mutual beneficial supplier relationship:- An organization and its
suppliers are interdependent and a mutually beneficial relationship
increases their ability to create value.
9. Quality:- Every pharmaceutical product must meet 4 attributes namely
identity, strength, safety and purity to achieve the desired effectiveness of the
product
10. Quality by design and product development:- Quality by design
means designing and developing the pharmaceutical products during
products development stage to achieve the desired characterization in their
product.

13. 11. Risk management and risk assessment:- Risk management guides us
in establishing specification and process parameter(any type of discrepancy
investigation)
12. Corrective and preventive action:- cGMP concept which focuses on
investigation and correcting discrepancies and attempting to prevent
recurrence.
13. Quality unit:- It includes quality control and quality assurance.

14. Six System Inspection Model :- The FDA drug manufacturing
inspection compliance program is a system based and consist of
evolution of following Six quality system:-
 Production
 Facilities and Equipment
 Material
 Packaging and labeling
 Laboratory control
 Overall Quality system

15. Other quality activities:-
1. Personnel:- The performance of any department depends upon
personnel, facilities, equipment etc. quality control department must
have sufficient number of suitably qualified people.

16. 2.Equipment:- Lab depend upon many thing like personnel facilities,
equipment, chemical etc. All the equipment is calibrated and with their
SOP.

17. 3. Sampling:- Sampling is a procedure for collecting a sample and
sample means a small part or quality intended to show what the
‘Whole’ is like. It show the quality of product.
Sampling plans:- It is of two type
1. Attributes plan:- Random sample is taken from the lot and each
unit is classified or defective.
2. Variable plan:- A sample is taken and measurement of specified
quality characteristics is made on each unit.

18. 4. Testing:- After the materials have been sampled the next activity is to
test the material using ‘Standard Test Method’ against the approved
material specification.
Pre test part
Testing part
Post testing part

19. 5. Reference and Working Standard:- Reference Std are most pure
substances of a given molecules and it is used for comparing the
purity of a sample being analyzed.
6. Retained sample:- A sample should be retained from each batch
produced in the industry this sample should be retained for at least 1
year after the expiry of the product and should be equivalent to
minimum to full analysis requirement ( except for test for sterility).
7. Production review and release of finished product:- Before a
finished product is released for sale or distribution the complete
productions control records must be reviewed and assured satisfaction
about the entire process of production and control.
8. Batch numbering:- The identity is one of the major component in
it. Hence batch numbering become one of the major issues.

20. 9. Stability studies:- Stability studies of the finished pharmaceutical is an
important activity under the quality system. Document showing the shelf life
of products being manufactured are based on stability studies carried out is
demanded by FDA auditor.
10. Self inspection and Quality Audits:-
1. Internal quality audit or self inspection:- It is a powerful tool for any
business to measure the efficiency and effectiveness of the quality
management system.
2. External Audit :- These audits are carried out by a company on its
vendors or sub contractor.
3. Regulatory Audit:- These audit are carried out by regulatory bodies
against relevant regulation for the manufacture and supply of pharmaceutical
product.

21. 11. Authorized Person:- A person appointed by the manufacturer and
distribution of drug product.
12. Documentation and Formats:- A quality manual is a
documented quality system procedures intended for the overall
planning and administration of activities which impacts quality within
an organization. A quality manual should cover all the applicable
elements of the quality system standards required for an organization .