Basic Concept of Process Validation

=>> Calibration, verification and maintenance of process equipment.
=>> Prequalification or revalidation.
=>> Establishing specifications and performance characteristics.
=>> Selection of methods, process and equipment to ensure the product meets specifications.
=>> Qualification or validation of process and equipment.
=>> Testing the final product, using validated analytical methods, in orderto meet specifications.
=>> Challenging, auditing, monitoring or sampling the recognised critical key steps of the process.

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.

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.

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.

At this stage the Validation Team also assures that there have been no changes/deviations that should have resulted in requalification and revalidation.

Share This Post

Related Articles

© 2024 Pharmaceuticals Index. All rights reserved.