Quality Assurance (QA) is all about safeguarding the patient’s well-being, by assuring that operations associated with the production of a medicinal product are of a standard that ensures that the patient’s expectations of safety and efficacy are met. In practice, it is about checking the small print and making sure that what has been declared to have happened, did in fact happen in the manner detailed in the record and produced consistent results.
The scope of QA has steadily increased and today it cuts across all areas – development, quality control, production and distribution. The principles of current Good Manufacturing Practice (cGMP) have been extended to clinical trials operation (Good Clinical Practice) and safety and toxicology studies (Good Laboratory Practice). QA requirements are also extending ever further down the supply chain from active ingredients to excipients and intermediates.
It is a constantly moving target as standards are updated and increasingly couched in terms such as ‘using appropriate methods’, ‘to the extent possible’ and ‘state-of-the-art techniques’. In the past couple of years, the industry has seen new USP chapters drafted on metal impurities; the EU FMD directive introduced requiring oversight of the supply chain; while the growth in biologicals has also led to a raft of new quality issues.
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