Quality Risk Management Tools
The purpose of this Annex is to provide a general overview of and references for some of the primary tools that might be used in quality risk management by industry and regulators. The references are included as an aid to gain more knowledge and detail about the particular tool. This is not an exhaustive list. It is important to note that no one tool or set of tools is applicable [...]
Stability testing of active pharmaceutical ingredients and finished pharmaceutical products
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 [...]
General guidance on hold time studies
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 [...]
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