The hunt is well underway for medicines to combat COVID-19, but it will be longer for vaccines, which protect the body against the disease, than it will for drug treatments, which fight infection once a person has fallen ill.
New Jersey-based biopharma intelligence firm Ozmosi has launched GlobalClinicalTrialsData.com, with the ambition to provide information on almost all clinical trials around the world through a single platform.
The primary objective of process validation is to provide assurance that the process consistently delivers product of acceptable quality. FDA recommends that manufacturers adopt a product lifecycle approach to process validation. Recommendations for implementing this approach are delineated in the FDA’s 2011 guidance on process validation. nnOpportunities and challenges in implementing the product lifecycle approach are discussed in this article. Case studies on the application of this approach to cell culture, centrifugation, chromatography, and other biopharmaceutical unit operations will be presented in subsequent parts of this series. nnBackgroundnFDA first published guidance on process validation in 1987 (1). Nearly a quarter of a century later, FDA issued new guidance on the subject entitled Process Validation: General Principles and Practices (the 2011 guidance) (2). The driver for revising the 1987 guidance was articulated by a senior policy advisor at FDA: “Poor quality of drugs on the market, evidenced by recalls, complaints, and other indicators, from supposedly ‘validated’ processes, pointed to a lack of process understanding and adequate process control” (3).nnThe 2011 guidance is consistent with the basic principles of process validation articulated in the 1987 guidance and cGMP regulations enunciated in 21nCode of Federal Regulations (CFR) Parts 210 and 211 (4). It conveys FDA’s thinking on process validation based on more than 25 years of experience and regulatory oversight, and the Pharmaceutical cGMPs for the 21st Century Initiative (5). The 2011 guidance promotes a product lifecycle approach to process validation; it also provides recommendations for concurrent release of process performance qualification (PPQ) lots, documentation, and analytical methodologies.