cGMP

FDA Warning Letter on cGMP Violations of US Based Compounding Facility
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FDA Warning Letter on cGMP Violations of US Based Compounding Facility

Byipharmacist

A Waring Letter (#659142) issued to a US based compounding facility for several serious cGMP violations, including:   Several other violations were listed for non-HEPA filtered air, lack of validation of aseptic processes, inadequate cleaning and disinfection, issues with facility design, inadequate environmental monitoring, lack of final product testing and an inadequate stability program.  …

cGMP Requirement for Pharmaceutical Manufacturing
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cGMP Requirement for Pharmaceutical Manufacturing

Byipharmacist

Production must follow all Principles of cGMP in order to get Quality defined by Regulatory Authorities.   As per EudraLex Volume 4: 1. Production should be performed and supervised by trained & qualified staff. All handling of materials and products, such as receipt and quarantine, sampling, storage, labelling, dispensing, processing, packaging and distribution should be…