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…
Grounding Requirement for Equipment and Building
Guideline (SOP) for grounding static equipment and building, but it is not applicable to transportation equipment, except when equipment is used in the loading or unloading of flammable material. The…
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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