1. OBJECTIVE
To lay
down a procedure for preparation, review, and approval of Performance
Qualification (PQ) and Re-Qualification (RQ) plan/ protocol, execution of the
qualification activity and post-execution approval of qualification report.
2. SCOPE
This
procedure is applicable to all performance / re-qualifications performed in
Pharma Ltd.
3. RESPONSIBILITY
3.1 Validation
Group:
3.1.1 Is
responsible for preparation of plan/ protocol. Also responsible for execution
of qualification activity as per the approved protocol, with required support
from cross functional groups (User, Engineering, QC).
3.2 Engineering
/ Instrumentation:
3.2.1 Is
responsible to review the protocol and support the qualification activity, wherever
applicable, and review the qualification data/ activity.
3.3 User
department:
3.3.1 User
is responsible to review the protocol, support the qualification activity,
wherever applicable, and review the qualification data/ activity.
3.4 Quality
Control:
3.4.1 Is
responsible to review the protocol, test the qualification samples and review
the report, wherever applicable.
3.5 Quality
Assurance:
3.5.1 QA designee is responsible to review
the plan/ protocol and report and verify the qualification activities, wherever
applicable.
3.6 Head-
QA:
3.6.1 Head-QA
is responsible to approve the protocol and report.
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