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Deviation investigation guidelines in the pharmaceutical industry

GMPSOP

In the five years between 2019 and 2023, the FDA issued the following warning letters, closely related to ineffective deviation investigation. Adulterated Pharmaceuticals: 396 warnings iii. FDA Warning Letters for various deviations - 2019 to 2023 240 SOPs, 197 GMP Manuals, 64 Templates, 30 Training modules, 167 Forms.

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What are the elements of quality control process in pharmaceuticals

GMPSOP

– Record or capture all generated raw data directly, promptly, and legibly. – Use traceable data sheets or sequentially numbered notebooks. – Date and sign or initial data entries on the day of entry. Pharmaceutical manufacturers must integrate the key functions of the quality control process.