Basics of Process Validation

1. Process Validation
Shreekant Vader

2. WHAT IS
VALIDATION
Establishing Documented evidence
Providing high degree of assurance that a
Specific process or equipment, will continuously produce a
product or result
Meeting its predetermined specifications and quality attributes
Validation is a key process for effective Quality Assurance (QA)
QA = QC (Quality Control) + GMP (Good Manufacturing
Practice)
Quality Control (QC) is incomplete without coordination of
Production.

3. WHAT IS
VERIFICATION
Confirmation by Examination
and
Provision of objective
evidence
That the specific requirements
have been fulfilled.

4. Objectives of
Validation
Form basis for written procedures for Production Process and
Control (PPC)
PPC designed to assure that the
products meet Criteria (SISPQ)
Safety
Integrity
Strength
Purity
Quality
To Determine that Process Consistently Performs as intended by
repeatedly running the system on it’s intended schedules.
Reporting all relevant and information data.
Results must demonstrate that the process meets pre-
determined specifications under normal conditions

5. Objectives of
Validation
To Determine that Process
Consistently Performs as intended by
repeatedly running the system on it’s
intended schedules.
Reporting all relevant and information
data.
Results must demonstrate that the
process meets pre-determined
specifications under normal conditions

6. Types of
Validation
1. Prospective
Validation
Validation done
during
Product
Development
Stage
New
Manufacturing
Process
Proactive
approach of
Documenting the
Design,
Specification
Performances
before the system
is operational
Input resources are selected
and clearly defined.

7. Types of
Validation
2. Concurrent
Validation
Validation carried out during
Production
Extensive testing &
monitoring ensure desired
quality of product is met

8. Types of
Validation
3. Revalidation
Revalidation is
carried out
Change in Process
Negative trend in
Quality
Modification in
Product
Revalidation are
two types
Periodic
Revalidation
Revalidation for
known Changes
Frequency of Revalidation can
be determined using risk-based
approach

9. Phases of
Validation
Design Qualification
(DQ)
Documented evidence of Design
of Product or Manufacturing
Facilities
Installation Qualification
(IQ):
Documented evidence that
equipment is installed and
operating properly.
Operational Qualification
(OQ)
Document evidence that every
product or manufacturing process
is in target operating range.
Performance
Qualification (PQ):
Documented evidence that
processes operates as expected
under routine production
conditions.
Maintenance Qualification
(MQ)
Documented evidence that,
preventive maintenance is being
carried out.

10. Validation
Protocol
(Document
stating how
Validation will be
conducted)
General Document
Objective
Background/ Pre-validation
Activities
Summary of Design
Technology Transfer from R&D
In Process Testing & Controls
Any Pre-validations
List of Equipments & their Qualification status
Facilities Qualification
Process Flow Chart
Manufacturing Process Narrative
List of critical processing parameters and critical excipients
Sampling, tests and specifications.
Acceptance Criteria.

11. Process of
Validation
Pre-Validation Activities
Validation Protocol Preparation
Validation Protocol (Review & Approval)
Protocol Execution
Data Analysis
Validation Report & Sign Off
Re-Validation

12. Process Validation
User Needs