Details about the qualification and validation in the pharmaceutical analysis. Definitions, types and protocols of the qualification and validation

1. QUALIFICATION AND
VALIDATION
K. Archana
M.Pharm (Analysis)

2. Definition
 The technology transfer is a critical step in the
life cycle of any pharmaceutical product that
involves many steps.
 USFDA validation guidance issued in 2011
specified three major stages of process validation
that must be satisfied to consider the process
validated.
 “Qualification is defined as action of providing
that equipment or system are properly installed,
work correctly and actually lead to expected
results.”

3. Qualification
Installation
qualification
Operational
qualification
Process
qualification
Performance
qualification
• Together qualification assures consistency of manufacturing.
• Critical process parameters are recorded and analyzed to ensure critical quality
attributes.
• In process qualification the process design is evaluated to determine if the
process is capable of reproducing commercial manufacturing.
• Well trained staff, thorough records helps the ongoing protection from process
faults and quick recovery.
• Process qualification vital component is process qualification protocol(PPQ).
• PPQ is important for maintain production standards with in the organization.

4.  The protocol includes:
 Facility, Utilities
 Equipment, Personnel
 Manufacturing process
 Control protocols and monitoring software
 Validation master plan
 GMP risk analysis
 Validation protocol,
 Validation analysis
 Summary of deviation and issues.

5. VALIDATION
 Validation of a process ensures production of drugs with
reproducible quality.
 Validation is an ongoing activity that covers the development,
operation and maintenance.
 Validation was first proposed by two FDA officials named Ted
byers and Bud Loftus in 1970 to improve the quality of
pharmaceuticals.
 Initially it was process controlled but quickly associated to
applied processes such as environmental control, media fill,
equipment sanitization and purified water production.
 Regulation of raw materials, production procedures, testing of
final product.
 Validation protocol must be followed, maintained up to date by
trained personnel and inspected regularly.

6. Reasons for validation
 Quality assurance: Quality cannot be assured daily by
quality control testing.
 Validation checks the accuracy and reliability of the
system or a process to meet definite criteria.
 A successful validation provides high assurance.
 Economics: Decrease in sampling and testing
procedures on successful validation. This leads to cost
saving benefits.
 Compliance: For compliance cGMP’s validation is
necessary and essential.

7. Phases of validation
 Pre validation qualification: occurs during R&D
 Pilot plant studies, small batches, scale up studies
 Attention must be paid to the details including material handling, storage
procedures, finished product review, equipment installation and verification,
distribution of final product.
 Process validation phase:
 Through out the manufacturing process
 Decreases the mistakes and recalls.
 Trained personnel to follow protocols and SOP’S
 All materials to be handled from the staring point to end point of the
production in the same manner.
 Validation Maintenance phase:
 Maintenance phase is when the process is running smoothly and consistently
at the same time.
 No know problems, but review of SOP’S and changes to be documented.
 Audit and audit reports to be maintained, refreshing training to the personnel
with the news specifications.

13. Process validation

14. Types of process validation

16. Validation documentation
 Change control: The need for action that would ensure and document that
the system is maintained in a validated state.
 Validation master plan: Summarized document that describes the whole
project including quality aspects of the project.
 Validation protocol: VMP is ready protocol will be developed.
 General information
 Objective
 Prevalidation activities
 List of equipment and qualification
 Facilities qualification
 Flow charts
 Manufacturing procedure narrative
 Critical processing parameters
 Sampling tests
 Acceptance criteria

17. Approved Regulatory agencies
EU: Chapter 4 guidelines that
require transfer protocols,
policies, procedures
Chapter 6: testing methods in
transfer technology
Chapter 7: Written content,
documents
FDA: Technology transfer
“Quality Agreements”
Required details of starting
materials, procedures,
protocols etc from starting
point to end point
WHO: Published guidelines in
2011.

19. THANK YOU