1. General information
2. Objective
3. Background/Prevalidation Activities
Summary of development and tech transfer (from R&D or another
site) activities to justify in-process testing and controls; any
previous validations.
4. List of equipment and their qualification status
5. Facilities qualification
6. Process flow chart
7. Manufacturing procedure narrative
8. List of critical processing parameters and critical excipients
9. Sampling, tests and specifications
10. Acceptance criteria
Reference to: Stability protocol/packages, protocol change provisions
(i.e., procedures to handle any deviations), plans for a biobatch comparison
(formula, process, specifications)
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Validation of the Autoclave is classified into the following 1.0 OQ – Operational Qualification 2.0 PQ – Performance Qualification The valid... -
K. Dashora, D. Singh, Swarnlata Saraf and S. Saraf *. Institute of Pharmacy, Pt.RavishankarShuklaUniversity, Raipur 492 010. *Author for ...
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2.0 Scope: Final visual inspection is performed manually by human operators. Prior to being qualified as an inspector, each in...
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