![]() ![]() Processes and requirements for equipment validation were created, and legal right of inspection was explicitly given to the agency. This incident helped to define sterility assurance in an operational way. Together, these factors resulted in a sterilization cycle that did not assure that all vials in the autoclave were sterilized thus, some doses were safe, while others led to sepsis in patients who received them. The chain of events that compromised the safety of the drug product included inadequate maintenance, inadequate understanding of autoclave operation, and regular deviations from the written production instructions (often as an attempt to compensate for equipment malfunction). ![]() The Clothier inquiry, which examined the causes and contributing factors, identified several violations of what we now consider basic good manufacturing practice (GMP). An unwritten change to autoclave operation, communicated orally between operators, resulted in dextrose intravenous solutions that were not uniformly sterile. ![]() The 1972 Devonport, UK, incident resulted in at least five deaths when drug products designed to be sterile became contaminated and recipients developed infections. So, too, with the issue of drug safety and drug quality. It is a truism that it takes a disaster to happen for people, and especially regulators, to wake up and review the accepted way of doing things. ![]()
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