Quality Metrics – New FDA Guideline
The term “Quality Metrics” means all those indicators that give an idea of the collective quality characteristics of a certain production site. The number of rejected batches per year compared…
Dietary Supplements Recall Guideline
Guideline / SOP for Handling procedure to recall the Dietary Supplements from supply warehouse or market in case of a market complaint or defective product supplied in the market. Recall…
Reprocess Rework of API and Drug Product
Guidance (SOP) about the procedure and documentation of reprocess and rework during Active Pharmaceutical Ingredient (API), excipients, and Drug Product in Pharmaceuticals. Guideline for Reprocess / Rework of API &…
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