Pharma

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 to every situation in which a quality risk management procedure is used. I.1 Basic risk management facilitation methods: Some of the simple techniques that are commonly used to structure risk management [...]

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 [...]