MLT Method Validation Procedure & Protocol
The MLT method must be validated before it will be applied when testing a product for resistance to bacteria in order to ensure that the product has no microbial inhibitory…
Depyrogenating Tunnel – Qualification Protocol (PQ)
Performance Qualification Protocol for sterilizing and depyrogenating tunnel Dry Powder Injection Production area. Qualification (PQ) of Sterilizing and Depyrogenating Tunnel 1.0 Objective: The purpose of this protocol is to provide…
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…
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