A. Kodash, A. V. Basevich, T. Bitkina, E. Smirnova, I. Kaukhova
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Audit of the Production of Sterile Medicines for Compliance with the Requirements of the Draft EU GMP Annex 1 with Risk Analysis
The role of the PIC/S organization in the pharmaceutical industry was noted, the main aspects and place of inspection activities in the production of medicines were determined, the general classification of incompliances, as well as the main methods and tools for risk assessment were
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