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....
SOP FOR LEAK TEST

SOP FOR LEAK TEST

Objective: To describe the Procedure for Performing a leak test during packing Scope: This SOP applies to the Production and QA departments. Responsibility:  Production and IPQA Personnel shall be responsible for Performing the leak test.  Head Quality Assurance shall...

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