cGMP

FDA Warning Letter on cGMP Violations of Over-the-Counter Drug Manufacturer

FDA Warning Letter on cGMP Violations of Over-the-Counter Drug Manufacturer

Byipharmacist

A prominent manufacturer of over-the-counter drug products, was recently issued a detailed FDA warning letter (#663478) for a number of cGMP violations, including: Insufficient Verification of Component Identity The company failed to conduct necessary tests to confirm the identity of each component used in drug products, including high-risk components like glycerin and propylene glycol, which…

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…