GMP Consultants Inc.
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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GMP Consultants routinely conduct GAP Assessments for clients. They can be general GMP Assessments to ensure that the company meets regulatory GMP requirements or they can be specific assessments, on topics such as Data Integrity, Cleaning Validation, QMS, Analytical Services,…
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Many of us have been touched by Cancer—perhaps through a personal diagnosis—or by a family member, friend, or colleague diagnosed with the disease. The West Island Cancer Wellness Center (WICWC) is organizing an “Amazing Race” type event called “Challenge of…
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ICH has published a Revised Guideline on Quality Risk Management Q9(R1) on 18 January 2023. GMP Consultants can provide you with a word by word comparison of the 2005 vs 2023 documents. If you would like to purchase a copy…
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