| Finding and resolving the source of product defects is an obvious concern for the industry. Philip Payne at RSSL Pharma reviews the important techniques
The pharmaceutical industry has an impressive track record of producing products to a consistently high standard. However, even with the best systems in place, an unforeseen event during manufacture or distribution can easily result in the quality of the end product being compromised, with potentially serious consequences for all concerned should the product reach the marketplace. Hence, whenever a defect is detected, be it during routine quality control checks or when the product is returned with a complaint, it’s vital to conduct a full investigation. In the short-term, it is essential to find out the nature of the problem and its likely consequences, and to decide what needs to happen next. Longer-term, the investigation might show how the defect or contamination arose, and how it can be prevented from recurring.
Almost by definition product crisis incidents, they do point to their sheer random nature, and the fact that they occurs without warning and often at the most inconvenient times. But regardless of whether an incident occurs inside normal working hours, or over a weekend, what is needed is a multidisciplinary analytical service, capable of turning out at any time to provide rapid answers to the crucial questions surrounding any incident. Armed with these answers, product managers can then determine the most appropriate course of action – perhaps to withhold a batch, to recall a product, or to take no further action over a ‘problem’ that the test results have shown to be risk-free and isolated.
OUT OF SPECIFICATION
The majority of emergency investigations are initiated after routine testing yields an out of specification (OOS) result. Whether the initial test was carried out in the manufacturer’s own laboratories or at a contract laboratory, the same need arises to understand how and why the product has ‘failed’ its routine test. |
