Quality rules in active pharmaceutical ingredients manufacture american edition 5 pack 9781574911398 medicine health science books amazoncom. Active pharmaceutical ingredients apis are important compounds that are used in the manufacture of pharmaceutical drug products apis are biologically active and intended for the treatment of diseases the quality of the api plays a vital role in the quality of a drug product quality should be built in by design. Container components and active pharmaceutical ingredients excipi ents and solvents used in a variety of dosage forms the quality of the packaging of pharmaceutical products plays a very important role in the quality of such products it must protect against all adverse external influences that can alter the properties of the product eg moisture light oxygen and tem perature . Good manufacturing practice for active pharmaceutical ingredients table of contents section title 1 introduction 11 objective 12 regulatory applicability 13 scope 2 quality management 21 principles 22 responsibilities of the quality units 23 responsibility for production activities 24 internal audits self inspection. In many who guidelines the following definition for an active pharmaceutical ingredient api in the singular is found under the glossary for instance it appears three times in the recently published who technical report series no 961 active pharmaceutical ingredient api any substance or combination of substances used in a finished pharmaceutical product fpp intended to furnish
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