Biomedical Engineering Reference
In-Depth Information
SOP No. QAS-021.00 Effective date: mm/dd/yyyy
Approved by:
40.1 PurPose
The present document describes the guidelines that will be applied to the operational qualification
of pharmaceutical utilities and equipments.
40.2 resPonsibility
It is the responsibility of ABC Pharmaceutical Company's plant managers, QA manager, engineers,
and validation team members (QA, QC, production, packaging, stores, maintenance, and water
treatment plant) to follow the procedure as a guideline.
The QA officer will draft the initial protocol with cGMP requirements embedded in it. The
protocols will be sent to the concerned engineers/members as appropriate for technical checks.
The amended protocols will then be sent back to the QA officer for finalization. The finalized
protocols will be signed off by the reviewers. The protocol will be authorized by the QA
director.
The approved protocol will be executed under the supervision of plant managers/engineers/QA
managers and the QA officer.
40.3 Procedure
Some optional sections could be added, for example, a paragraph describing the test and measure
equipments used.
The content of the operational qualification is detailed hereunder.
40.3.1 d ocument d eScriPtion
This describes the operational qualification documents. This description includes
• Responsibility
• A paragraph stating the objective of the document (description of subject)
• A paragraph specifying the scope of the document, that is, the exhaustive list of the con-
cerned equipment(s), or categories of equipments (qualification scope)
• Any other observation
• Written by
• Veriied by
40.3.2 o Perational c heckS
This description includes
• Supplier-ixed set points (if required)
• Alarms and safety checks (if required)
• Analog transmission inputs (if required)
• Machine setting checks as per user manual
• Critical operating parameters
• Actual test runs of machine
• Any other check
• Conclusion
Search WWH ::




Custom Search