M.

Pharm Pharmaceutical Analysis

1st Semester
MPA103T: Pharmaceutical Validation
Lceture-1 Validation: scope and importance
Dr. Bhupinder Kumar
Associate Professor
ISF College of Pharmacy, MOGA
06-11-2020 ISF College of Pharmacy, MOGA [email protected] 1
CONTENTS

• Quality control vs Quality assurance

• Introduction and definitions
• Importance of validation
• Phases of validation
• Documentation
• References
• Questions

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 Quality assurance vs Quality control
Quality assurance Quality control
• Assures that the right production • Ensures that the product will match
process is performed in the right manner the requisite standard
• Preventing from defects • Identifying the defects (Corrective
measure)
• Takes place at the time of development • Takes place after the final product is
of the product produced.
• Emphasis on the customer • Emphasis on standards
• Focusing on process • Focusing on product
• Protects the product from defects • Detects and sort out the defects in
• Quality is created during the designing the product
phase • Quality is created at the control stage.
• Verification • Validation
• QA is the process of managing for • QC is used to verify the quality of the
quality output
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Definitions

Validation
The documented action of proving, in accordance
with the principles of GMP, that any procedure,
process, equipment, material, activity or system
actually leads to the expected results.

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 Qualification
• Action of proving that any premises, systems and items of
equipment work correctly and actually lead to the expected
results.

• A system must be qualified to operate in a validated process.

(Validation usually incorporates the concept of qualification)

Qualification versus validation, e.g. you qualify an autoclave,

whereas you validate a sterilization process

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 Principle

• Qualification and Validation: Essential part of

GMP
• Manufacturer has to identify what qualification
and validation work is required.
• Provides proof that critical aspects of work are
controlled and provide documented evidence.
• Key elements of qualification and validation
defined and documented: Policy and approach.

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 Importance of validation
1. Assurance of quality
2. Time bound
3. Process optimization
4. Reduction of quality cost
5. Nominal mix-ups, and bottle necks
6. Minimal batch failures, improved efficiently and
productivity
7. Reduction in rejections
8. Increased output
9. Avoidance of capital expenditures

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 Importance of validation

10. Fewer complaints about process related failures

11. Reduced testing in process and in finished good
12. More rapid and reliable start-up of new equipment
13. Easier scale-up form development work
14. Easier maintenance of equipment
15. Improved employee awareness of processes
16. More rapid automation
17. Government regulation (Compliance with validation
requirements is necessary for obtaining approval to
manufacture and to introduce new products)

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Phases in process validation
The activities relating to validation studies may be classified into
three phases:
Phase 1- Pre-validation phase or the qualification phase, which
covers all activities relating to product research and
development, formulation, pilot batch studies, scale-up studies,
transfer of technology to commercial scale batches, establishing
stability conditions, storage and handling of in-process and
finished dosage forms, equipment qualification, installation
qualification, master production documents, operational
qualification, process capability.

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 Phases in process validation

Phase 2- Process validation phase (Process

Qualification phase) designed to verify that all
established limits of the critical process parameters are
valid and that satisfactory products can be produced
even under the “worst case” conditions.

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 Phases in process validation

Phase 3- Validation maintenance phase requiring

frequent review of all process related documents,
including validation audit reports to assure that there
have been no changes, deviations, failures,
modifications to the production process, and that all
SOPs have been followed, including change control
procedures.

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 Planning for validation

• The key elements of a validation program should be

clearly defined and documented in a validation
master plan (VMP) or equivalent documents.
• The VMP should be a summary document, which is
brief, concise and clear.

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 Planning…..
The VMP should contain data on at least the following:
1. Validation policy.
2. Organizational structure of validation activities.
3. Summary of facilities, systems, equipment and processes to be
validated.
4. Documentation format: The format to be used for protocols
and reports.
5. Planning and scheduling.
6. Change control.
7. Reference to existing document.
8. In case of large projects, it may be necessary to create separate
validation master plans.
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 Documentation
• A written protocol should be established that specifies how
qualification and validation will be conducted.
• The protocol should be reviewed and approved.
• The protocol should specify critical steps and acceptance
criteria.
• A report that cross-references the qualification and/or
validation protocol should be prepared, summarizing the
results obtained, commenting on any deviations observed,
and drawing the necessary conclusions, including
recommending changes necessary to correct deficiencies.

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 Documentation…

• Any changes to the plan as defined in the protocol

should be documented with appropriate
justification.
• After completion of a satisfactory qualification, a
format release for the next step in qualification and
validation should be made as a written
authorization.

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References
• F. J. Carleton and J. P. Agalloco, “Validation of pharmaceutical
processes, sterile products” 3rd Ed. 2007, Informa Helathcare, N.Y.
• European Commission Enterprise Directorate General Single
market, regulatory environment, industries under vertical
legislation Pharmaceuticals and Cosmetics Brussels, July 2001. EU
Guide to Good Manufacturing Practice, Qualification and
validation.
• https://www.who.int/medicines/areas/quality_safety/quality_as
surance/validation-without_appendices_2016_05_17.pdf
• https://www.who.int/medicines/areas/quality_safety/quality_as
surance/SupplementaryGMPValidationTRS937Annex4.pdf?ua=1

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 Questions
1. Define validation.
2. Define qualification.
3. Why to validate any instrument or process?
4. What are advantages of validation?
5. How to plan a validation for any process?
6. What is documentation process for validation?

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 THANKS
For Further Detail/SUGGESTIONS Please Contact
ISF COLLEGE OF PHARMACY
(An Autonomous College)
NAAC Accredited “A” Grade College
GT Road, Ghal Kalan, Moga- 142001 (Pb.)
E- mail: [email protected]
Website: www.isfcp.org

06-11-2020 ISF College of Pharmacy, MOGA