By Dr Ash Ramzan, founder and principal consultant, Woodley BioReg During a pharmaceutical product’s lifetime, it’s widely known and accepted that manufacturing processes will drift within their specified ranges — typically due to equipment wear-and-tear and operator variance. To maintain the ‘validated state’, diligent producers spend a lot of time and effort in ensuring validation and periodic re-validation of processes to ensure that any process drift is accounted for and controlled. The registration file — such as the Marketing Authorisation (MA) or Product Licence (PL) — may be considered as the equivalent to the manufacturing process, and from which parameters
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