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Validation & Qualification - Coggle Diagram
Validation & Qualification
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Validate (process/procedures)
reduce variables in manufacturing process
evidence consistently produces product meeting predefined specifications & quality attributes
Qualify (things)
ensure it operates as expected & within known tolerances
meets predefined acceptance criteria
confirm item is fit for intended use
Process
define & verify proven acceptance ranges (PAR) that product will meet specifications
Sequence
Commissioning -> Qualification -> Validation
Qualification doesn't constitute process validation
Required Documentation
Validated Master Plan
A high-level, living document that defines the company’s overall validation strategy
Provides guidance for validation and qualification activities across the site or project
Reviewed and updated at least annually
Most critical element: schedule for validation, qualification, revalidation, and re-qualification
Qualification & Validation Protocols
Qualification & Validation Reports
SOPs
Change Control Procedure
Validation
Process validation
any upstream/downstream operation step parameters
Analytical method validation
used by QC labs
Cleaning validation
Computer systems validation
Process Validation
Prospective validation
performed before distribution of new product/made using revised manufacturing process
includes in-process & final product testing per validation protocols
validation report must be completed & approved before product release
Concurrent validation
performed when validation is incomplete before routine production
conducted alongside each production batch
product released on lot-by-lot basis
used for existing/insufficiently validated products or low-volume/infrequent production
Retrospective validation
validation of existing product already in distribution using historial data
based on past production, testing & control records
require sufficient batches to show process consistecy & stbaility
no new testing/execution
not acceptable if:
product composition, operating procedures, equipment
Process Validation Program
Number of validation runs depends on process complexity or extent of change
Prospective & concurrent validation:
Usually 3 consecutive successful batches (or more if needed)
retrospective validation
Review data from 10–30 consecutive batches to assess process consistency
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must be periodically reviews to confirm they remain in validated state
revalidation not required if:
no significant changes made
quality reviews show consistent compliance with specificaition
Stages of Qualification
Design Qualification
based on Design specification
Installation Qualification
Operational Qualification
based on Functional requirement specification
Performance Qualification
based on User requirement Specification
Computer System Validation (CSV)
verify documentation of computer system
ensure system is performing as per documentation