Month: March 2023
FDA is hosting a webinar on Electronic Systems, Electronic Record, and Electronic Signatures on April 25, 2023. This is your opportunity to get information on FDA’s thinking regarding 21 CFR Part 11 and its application to electronic systems, records and…
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One of the many activities performed by GMP Consultants is Auditing. We average 10 – 12 audits / year. We have experts that are qualified to audit sterile and non-sterile drug manufacturers, APIs, packagers, labelers, testing laboratories, importers, distributors and…
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FDA has published Guidance “Q13 Continuous Manufacturing of Drug Substances and Drug Products“ on 1 March 2023 for Industry. The guidance describes scientific and regulatory considerations for the development, implementation, operation, and lifecycle management of continuous manufacturing (CM). Building on…
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