Wickham Micro is pleased to announce the publication of its latest editorial piece on the topic of pharmaceutical method development and validation, featured by Manufacturing Chemist Pharma in their July / August edition.
If the abstract below is of interest, please visit the Manufacturing Chemist Pharma website or contact us directly to request the full article.
Abstract
As analytical methods provide data crucial to ensure consumer health and safety, their validation is highly scrutinised. Dr. Joanna Greenhough, R&D Scientist, Wickham Laboratories, outlines the best practices in validating methods used in pharmaceutical product testing.
Any analytical method applied to a pharmaceutical product under current Good Manufacturing Practices (cGMPs) requires validation. The methods used to produce data supporting the production of pharmaceuticals or regulatory filings (with FDA for example) need to be validated prior to use.
Validated analytical methods support a drug’s characterisation, quality control and manufacturing batch records. This analytical test method validation provides a documented process demonstrating that the test procedure is suitable for its intended purpose, provides evidence of the method’s performance and ensures quality and reliability of results...
