Types and Merits

1. A seminar on
PHARMACEUTICAL VALIDATION
Presented by-
Shubham N. Gharat
1st YR M.pharm
Department of
Pharmaceutics
Guided by-
Supriya Sandhan
Mam
M.V.P. College of Pharmacy Nashik

2. Content:
Introduction
Scope of validation
Merits of validation
Types of validation

3. INTRODUCTION
• Validation means Rectification or Confirmation.
• The Concept of Validation first proposed by FDA officials in
1978.
• It was only in FDA Compliance Program entitled 'Drug
Process Control' in June 1978.
• On March 29 , 1983 draft guideline on General Principle of
Process Validation made available and finalize in May 1987.

4. • A documented program , which provide a high
degree of assurance that a specific process will
consistently produce a product meeting its pre-
determined specifications and quality attributes.
• Now regulatory authority over world wide started
considering process validation as one of the
compliance point in their inspection.
• Its not prescribed by regulatory authority.
• Validation is key process for effective Quality
Assurance.

5. GMP Validation
XYZ Company
Business Profits Prestige
Customer
Satisfaction
Customer

6. Scope Of Validation:
 Analytical test method
 Instrument calibration
 Raw material and packing material
 Equipment
 Facilities
 Manufacturing
 Product design
 Cleaning

7. Merits Of Validation:
 Reduction of quality cost
 Process Optimization
 Assurance of quality
 Safety
 Customer satisfaction

8. Types Of Validation:
• Process Validation
• Equipment Validation
• Cleaning Validation
• Validation of analytical method

9. Process Validation:
• Process Validation is a documented program which provide a
high degree of assurance that a specific process will
consistently produce a product , meeting its pre-determined
specifications and quality attributes.
• It only start when complete qualification program of facilities
and equipment is over.
• Validation consider in following situation:
a. Totally new process
b. New equipment
c. Processes & Equipment which have been altered
d. Processes where the end product test is poor and unreliable
indicator of product quality.

11. Types of Process Validation:
i. Prospective Validation
ii. Concurrent Validation
iii. Re-validation Validation
iv. Retrospective Validation

12. Prospective Validation
• Prospective Validation means validation , Which is done
during product development.
• When we develop a new manufacturing process it'll give us
desire results , in routine processing.
• Input resources are selected & clearly specified.
E.g. Material specifications , Equipment and process
parameter and operating condition also level of training of
people can defined.

13. • In this inputs and operating parameters decided &
recorded then this output studied & specification of
the output is defined and shown by repeated
experiments that they are consistent.
E.g. Every aspect from laboratory scale to
commercial scale is documented and recorded.

14. Concurrent Validation
• Concurrent Validation is the validation , which is
carried out during production.
• When after 3 commercial batches are taken and the
process is handed over to the manufacturing
personnel the verification of the process parameter
still goes on batch to batch & studied if
change/deviation observed.
• In this In process quality control decided and
monitored (I.P.Q.C)
• Normally 3 batches recorded.

15. • If initial development batches and the commercial
production batches use same type of equipment then
revalidation of whole process during commercial
manufacturing may not be required.
• In this only I.P.Q.C tests may only be enough.
• I.P.Q.C. test should be carried out for every batch to see
that the process is moving in expected direction.
• This data useful during Retrospective Validation.

16. Re-validation
• Change of formulae, equipment, procedures or quality of raw
materials.
• A change in equipment doing the same process but by different
principal will require revalidation.
• Major changes to Process parameters.
• Changes to facilities and installations.
• On appearance of negative quality bond.

17. Retrospective Validation
• It means establishing document evidence that the
process has perform satisfactorily and consistently over
time , based on analysis and review of historical data .
• The source of such data is Production & QA/QC record.
• Retrospective validation allowed when the formulation
procedure & equipment have not been altered.

18. Equipment Validation:
• Equipment Validation is to provide high degree of
evidence that the equipment and process confirm to
standard.
• EV consist following steps:
a. User requirement specification
b. Preparation of Design qualification and its certificate
(DQ)
c. Installation qualification (IQ)
d. Operational qualification (OQ)
e. Performance qualification (PQ)

19. Cleaning Validation:
Definition:
A process of attaining and documenting sufficient evidence to
give reasonable assurance, given the current state of Science and
Technology, that the cleaning process under consideration does,
and / or will do, what it purports to do.
Objective:
To minimize cross contamination
To determine efficiency of cleaning process
To do troubleshooting in case problem identified in cleaning
process & give suggestions to improve the process.

20. Source of Contamination:
 Cross contamination of one product to another
 Product contamination by foreign material
 Microbial contamination
Cleaning Method:
 Manual cleaning method
 Semi automated procedure
 Fully automated procedure

21. Factor Influencing Cleaning Validation
• Product
• Equipment
• Facilities
• Cleaning methods
• Cleaning agents
• Sampling
• Testing, limits and acceptance criteria

23. Validation of analytical method:
• Accuracy
• Precision
• Specificity
• Limit of detection
• Limit of Quantitation
• Linearity
• Range
• Ruggedness
• Robustness

24. Conclusion:
In new drug and development, before drug approval the
sponsors are required to demonstrate its effectiveness
and safety for target patient population - To provide an
accurate and reliable assessment pharmaceutical
validation i.e. assay validation play important role.
Its not unnecessarily burdensome regulatory
requirement.
Apart from all the consistency and reliability of a
validation process to produce is the very important for
an industry.

31. Reference:
M. A. Potdar, Pharmaceutical Validation. In: Rachna
offsests, editor. Pharmaceutical Quality Assurance, 3rd ed.
Pune: Nirali Prakashan; 2013. p. 8.1-44
Nandhakumar L., Dharmamoorty G., Rameshkumar S.
and Chandrasekaran S. (2011). An overview of
pharmaceutical validation: Quality Assurance view point.
IJRPC 1(4), 1003-14
Retrieved from:
http://www.ijrpc.com/files/000032.pdf
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