Concept of Deviation

Departure from an approved procedure, instruction, or documented procedure is called deviation. A deviation should be properly documented and handled. A deviation can occur during the manufacturing, testing, storage, or distribution of pharmaceuticals. Deviations most...

Hold Time Study in Pharmaceutical Manufacturing

Hold Time Study in Pharmaceutical Manufacturing: We know that the quality, safety, and efficacy of the medicine we produce are paramount. The pharmaceutical industry should develop a system in place to ensure the above such that the products we produce are of quality....

Handling of Biological indicators

1.0 OBJECTIVE The objective of this Standard Operating Procedure (SOP) is to establish a consistent and controlled process for the procurement, storage, handling, and disposal of biological indicators used for the qualification and monitoring of sterilization...

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