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Available Guidelines
104 matches
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Chapter 1: Pharmaceutical Quality System
PublishedThe holder of a Manufacturing Authorisation must manufacture medicinal products so as to ensure that they are fit for their intended use, comply with the requirements of the Marketing Authorisation or Clinical Trial Authorisation, as appropriate and do not place patients at risk due to inadequate safety, quality or efficacy.
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Chapter 2: Personnel
PublishedThe correct manufacture of medicinal products relies upon people. For this reason there must be sufficient qualified personnel to carry out all the tasks which are the responsibility of the manufacturer. Individual responsibilities should be clearly understood by the individuals and recorded. All personnel should be aware of the principles of Good Manufacturing Practice that affect them and receive initial and continuing training, including hygiene instructions, relevant to their needs.
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This document comprises individual Recommendations on four topics relating to Equipment Qualification and Process Validation in pharmaceutical manufacture, as follows: the Validation Master Plan, Installation and Operational Qualification, Non-Sterile Process Validation and Cleaning Validation by PIC/S.
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This Annex deals with the manufacture of active substance gases and with the manufacture of medicinal gases.
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