Quality of medicines questions and answers These questions and answers address a number of questions that have been brought to the attention of theJoint Committee for Medicinal Products for Human Use / Committee for Medicinal Products for Veterinary Use Quality Working Party(QWP) by marketing-...
general text 5.1.1: methods of preparation of sterile products states that, “wherever possible, a process in which the product is sterilised in its final container (terminal sterilisation) is chosen,” and that, “if terminal sterilisation is not possible, filtration through a bacteria-retentive ...
Quality of medicines questions and answers: Part 1: Active Substance - Active-substance-master-file procedure Can a mixture of an active substance with an excipient be submitted through an active-substance-master-file (ASMF) procedure? H+V August 2007. No. A mixture of an active substance ...
1.1 The process of finding new lead medicines 4 1.2 A drug discovery framework 6 2. Technology transfer and the climate of change 11 2.1 Innovation and research 11 2.2 Method transfer 14 3. Quality systems structure and a maximum quality environment 15 ...
Surprisingly, incorrect answers to simple questions about the system were frequently given by the informed pharmacists. Certain aspects of substandard storage conditions existed, in varying degrees, in significant percentages of pharmacies regardless of the pharmacists' qualifications, experience, or awareness...
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FDA - Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations: Questions and Answers 2nd October 2024 This guidance provides information for sponsors, clinical investigators, institutional review boards, contract research organizations, and other interested parties on the us...
1. FDA, Data Integrity and Compliance With Drug CGMP: Questions and Answers Guidance for Industry (December 2018). 2. FDA, CFR Part 11, Electronic Records; Electronic Signatures - Scope and Application (September 2003). 3. MHRA, ‘GXP’ Data Integrity Guidance and Definitions (March 2018). ...
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