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Annex 6 WHO good manufacturing practices for sterile

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10 common GMP challenges facing maintenance

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1 Annex 1 Manufacture of Sterile Medicinal Products

125 3 Pharmaceutical Quality System PQS 126 The manufacture of sterile medicinal products is a complex activity that requires 127 additional controls and measures to ensure the quality of products manufactured 128 Accordingly the manufacturer s Pharmaceutical Quality System PQS should encompass

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16 05 2022 · Good Manufacturing Practices A basic principle of GMP is that quality cannot be tested into a batch of product but must be built into each batch of product during all stages of the manufacturing process It is designed to minimize the risks involved in any pharmaceutical production that cannot be eliminated through testing the final product 6

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QA encompasses all of the arrangements made to ensure that pharmaceutical products meet the quality required for their intended use Although QA is not specified in all GMP documents the WHO GMP guidelines ref 27 present the principles of QA are to ensure that GMP and other regulatory codes GLP Good Laboratory Practice

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