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Stability testing of active pharmaceutical ingredients and finished pharmaceutical products

2021-12-30T21:36:05+00:00

Guidelines For Stability of Active Pharmaceutical Ingredient Part-1 Active pharmaceutical ingredient a General b Stress testing c Selection of batches d Container-closure system e Specification f Testing frequency g Storage conditions h Stability commitments i Evaluation j Statements and labelling k Ongoing stability studies General Information on the stability of the API is an integral part of the systematic approach to stability evaluation. Potential attributes to be studied during stability testing of an API are listed in the examples of testing parameters. The selection of potential attributes and time points to be tested should be justified. The retest period or shelf [...]

Stability testing of active pharmaceutical ingredients and finished pharmaceutical products2021-12-30T21:36:05+00:00

General guidance on hold time studies

2021-12-30T21:41:31+00:00

Introduction and background Manufacturers should ensure that the products that they manufacture are safe, effective and of the quality required for their intended use. Systems should be in place to ensure that pharmaceutical products are produced according to validated processes and to defined procedures. Manufacturing processes should be shown to be capable of consistently manufacturing pharmaceutical products that are of the required quality and that comply with their specifications. Good manufacturing practices (GMP) require that arrangements should be made to ensure that the dispensed raw materials and packaging materials, intermediate products, bulk and finished products are stored under appropriate [...]

General guidance on hold time studies2021-12-30T21:41:31+00:00
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