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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K. Dashora, D. Singh, Swarnlata Saraf and S. Saraf *. Institute of Pharmacy, Pt.RavishankarShuklaUniversity, Raipur 492 010. *Author for ...
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