Samples are retained to fulfil two purposes; Reference sample A sample of a batch of starting material, packaging material or finished product which is stored for the purpose of being analysed should the need arise during the shelf life of the batch concerned. Where stability permits, reference samples from critical intermediate stages or intermediates,…
Navigating through the complexities of ICH guidelines can be daunting for pharmaceutical professionals. Here’s a distilled comparison to clarify how these standards apply across different stages of drug development: ICH Q3A & Q3B: Focus on organic and degradation impurities in new drug substances and products, emphasizing safe limits and identification protocols. ICH Q3C:…
Parametric Release (Real Time Release Testing) A system of release that gives the assurance that the product is of the intended quality based on information collected during the manufacturing process and on the compliance with specific GMP requirements related to Parametric Release. PURPOSE The purpose of the document is to…
Reagents are an integral part of any laboratory and as such play a vital role in ensuring the validity of analytical results. Reagents must be suitable for the intended use. Consideration should be given to the accompanying documentation and appropriate physico-chemical or biological critical quality attributes for the intended purpose/s. In the laboratory,…
Does cGMP regulations require three successful process validation batches before a new active pharmaceutical ingredient (API) or a finished drug product is released for distribution? No. Neither the cGMP regulations nor FDA policy specifies a minimum number of batches to validate a manufacturing process. The current FDA guidance on APIs (see ICHQ7) also…
How does FDA interpret the regulations (21CFR part 211) regarding the establishment of expiry dating for chemicals, reagents, solutions, and solvents? Laboratory “reagents, and standard solutions,” as referenced in the CGMP regulations at 21 CFR 211.194, includes laboratory chemicals such as solvents (including mobile phases), dry chemicals (salts, primary standards, etc.), and solutions (#buffers,…
Is parametric release an appropriate control strategy for sterile drug products that are not terminally sterilized? No. Parametric release is only appropriate for terminally sterilized drug products. Although both terminally sterilized and aseptically processed drug product batches are required to meet the sterility test requirement (see 21 CFR 211.167(a)) before release to the market,…
Skip or Periodic Testing Periodic or skip testing is the performance of specified tests at release on pre-selected batches and / or at predetermined intervals, rather than on a batch-to-batch basis with the understanding that those batches not being tested still must meet all acceptance criteria established for that product. This represents a less…
