There has been a tremendous increase in field alert reports, recalls have increased dramatically, and drug shortages due to component problems, delays, and capacity issues (quality) are increasing as well. Industry itself is ultimately responsible for quality, of course. But while some plants are improving facilities, modernizing control platforms and process technologies, and rolling out quality-by-design (QbD) programs, the facts do not support the idea that there has been real improvement. Industry’s position is “all the FDA cares about is compliance to GMPs [good manufacturing practices]. You don’t care about quality.” GMPs do matter and, at least in theory, quality is covered in the GMPs. But the agency is thinking that compliance may have become such a focus that drug makers are not sufficiently concentrating on quality—quality of the process, the batch, the packaging, and the distribution. This lack of focus on quality has resulted in recalls, drug shortages, and other impacts on consumers. To address this issue, FDA has now established an Office of Pharmaceutical Quality to improve the agency’s scrutiny of brand-name, generic, and over-the-counter drugs, and is calling on industry to offer up metrics to prioritize field investigations. This presentation gives the context for the quality metrics, discusses the draft guidance issued for comment by the FDA and gives the results of FDA and industry discussions to date. Click here to read more or Buy Now

Analysis of investigation reports reveal that human error is one of the top root causes for deviations, discrepancies and quality incidents in pharmaceutical manufacturing. And when you examine the CAPA’s that are developed from these, retraining and rewrite of SOP is top the list. Yet on further re-examination, you find that these problems keep resurfacing again and again. Put in another way, the CAPA’s are ineffective. Does it mean that the CAPA’s were wrong or is it pointing to another problem? Namely, that the investigation did not pinpoint the root cause of or most probable contributing factors to the problem. Most often “human error” is not really the problem but a symptom of a system or facility or operation that is not designed to be run by humans. Humans do contribute to problems but more often than not, because what we are asking them to do is not designed with humans in mind. So a true CAPA should be developed to solve the problems with the system, facility and operation rather than focus on remediation of people. This requires investigations to focus on getting to the real root cause and contributing factors. Click here to read more, or Buy Now

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