Validated analytical methods for registered in-process and final
product testing
Raw materials meet specifications; Drug substance is validated and
fully characterized; at least 2 separate lots from vendor
Facilities and equipment are qualified and calibration and PM
programs are in place
Key process variables are identified and their operating ranges have
been established
Finalized master batch record
Relevant SOPs are in place and training is completed on equipment
operation, manufacturing instructions, and sampling strategy.
Quality Systems such as deviations, change control, site Quality
Review Committee are in place
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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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