Validation Standard Operating Procedures: A Step by Step Guide for Achieving Compliance in the Pharmaceutical, Medical Device, and Biotech Industries
Book Description
Ideal for pharmaceutical, medical device, and biotechnology industries, Validation Standard Operating Procedures guides design engineers, manufacturing personnel, researchers, and quality control professionals in validating processes needed for non-aseptic and aseptic pharmaceutical production. This second edition provides 131 ready-to-use master validation procedures, template protocols, and reports. With 14 exclusive environmental performance evaluations, it features 57 new protocols on such topics as sterility assurance, media fill guidelines, and environmental control. It also includes a CD-ROM with a template of customizable validation standard operating procedures.
Book Info
(St. Lucie Press) Outline provides information managers need to establish functions, acceptance criteria, and validation procedures in compliance with FDA guidelines. Includes directions for translating GMP requirements into action and describes how to establish test functions and prevent defects. CD contains 74 template procedures.
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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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