How to validate a pharmaceutical process - Ostrove, Steve (London, UK : Elsevier, 2016)
Risk AssessmentProcess Parameters; Setting Process Limits; Next Steps; Notes; 8 The Process Validation Protocol-PPQ; Introduction; Setting Protocol Test Ranges; Preparing the Protocol; Executing the Protocol; Sampling Plans; Recording the Results; The Validation Report; Notes; 9 Dealing With Deviations; The Investigation; Notes; IV: Stage III-Continued Process Verification; 10 Stage III-Collection and Evaluating Production Data; General Approach; Legacy Products; Stage III-Continued Process Verification (CPV); Statistical Process Control and Control Charts; Notes; V: Other Related Activities.
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Includes index.
Mode of access: Internet
Keywords: Pharmaceutical industry -- Management; Production engineering; BUSINESS & ECONOMICS -- Industries -- General; Pharmaceutical industry -- Management; Production engineering; Electronic books