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...
“USP Glass Types: Standards for Pharma Packaging”

“USP Glass Types: Standards for Pharma Packaging”

Types of Glass containers Used for sterile Products Glass containers are used for packing injectable Products in the form of vials, ampoules, etc. And the selection of glass is essential. Only approved glass materials need to be used, as all products have different...

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