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…
Regulatory Audit : Preparation & Handling
Standard Operating Procedure (SOP) / Guideline for Preparation and Handling of Regulatory Audit (FDA Inspection) in Pharmaceutical Drug Manufacturing Plant. Handling of Regulatory Audit (FDA Inspection) 1.0 PURPOSE The purpose…
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