Book Description
This book provides the tools to more easily achieve satisfactory inspections, new medical product approval, minimize non-conformance, reduce rework and rejected lots, and avoid recall lots by developing and managing a Master Validation Plan. The accompanying CD provides a template that can be customized to incorporate additional regulatory requirements specific to individual companies worldwide. Together, the book and CD contain everything required to develop and execute a successful Master Validation Plan based on FDA guidelines for the pharmaceutical industry, and allows the templates to be extended to diagnostic products, medical device, medical equipment, and biotech industry products.
Book Info
(St. Lucie Press) Provides a generic format for a Master Validation Plan using a pharmaceutical manufacturing site with sterile and non-sterile operations as the case facility. Provides a road map for validation to establish FDA requirements/procedures, validation programs, protocols, and resource planning and scheduling. DNLM: Drug Industry--standards.
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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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Validation of the Autoclave is classified into the following 1.0 OQ – Operational Qualification 2.0 PQ – Performance Qualification The valid... -
Cold storage is a relatively simple cold room that is commonly used to store material between 2[degrees] to 8[degrees]C. Such cold rooms a...
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