QAS-001 - Quality Operations Procedures for Pharmaceutical, API, and Biotechnology - page 134

SOP No. QAS-001.00 Effective date: mm/dd/yyyy
Approved by:
20.5.2.4 Process validation
The QA manager or designate shall prepare the PV protocol. Existing products (processes) shall be
validated by the retrospective approach where possible; for further details, refer to the correspond-
ing SOP.
New processes shall be validated by the prospective approach where possible. Otherwise data
should be reviewed after the manufacture of three batches.
20.6 Protocol aPProval
Protocols must be approved prior to gathering any data or carrying out any test.
20.7 execution of Protocol
Once the protocol is approved, the validation program will proceed as per the procedure outlined in
the protocol.
20.8 revalidation
Is most often utilized to validate changes in equipment, packaging, formulation, operating proce-
dure, or the process that could impact the product or product effectiveness or when the occurrence
of a problem is identified in the product or process. This is evaluated/revalidated and corrective
actions are taken to rectify on the critical system. For revalidation, the same procedure as for valida-
tion is followed. For further details of revalidation, refer to the corresponding SOP QAS-000.
20.9 sign-off reQuirement/aPProval
The completed protocols must be reviewed for completeness, accuracy and acceptance of the results
and signed off by the QA manager as a minimum.
20.10 validation documents
The plant QA involved in validation activities shall establish and maintain a central validation docu-
ment filing system.
These files shall be kept under the control of the QA manager.
These files may include such items as validation protocols, QC testing reports, calibration
records, flow diagrams, validation reports, and so on.
20.11 reason for revision
First time issued for your company, affiliates, and contract manufacturers.