What Are the Most Common GMP Deficiencies Found by FDA?  
​[Posted on: Thursday, April 20, 2017]

The regulators publish lists of common deficiencies to create awareness about the kind of concerns raised by auditors in a given period. Such lists are useful to understand the common areas of error and may help reduce those findings in future at other organizations. Few weeks back, MHRA, the regulators in the UK, published common findings in GMP audits conducted by its auditors. This list is almost identical to that released by FDA and EMA earlier in the year. The most common deficiencies found at GMP sites were in the Quality Systems and documentation. In the quality systems, auditors frequently found lack of SOPs, lax QA oversight, deficient CAPA practices, inadequate training, and inappropriate QC testing. Documentation errors were related to reports being incomplete, documents being inappropriately controlled, created and destroyed. These issues are not new. For the last 8-10 years for which such trends are available, the similar quality system and documentation issues have dominated. So, does it mean that the industry is not paying attention, or are the regulators being very picky? As the industry expands across national boundaries, there are several new players who need to learn the tools of the trade. Also, cultural nuances affect the risk assessment and mitigation practices followed at manufacturers. FDA’s auditors in India recently published a blog about building a culture of quality in India, as many deficiencies were linked to the perception of risk by the manufacturers who did not appreciate that several regulatory requirements are based on experience and are expected to be followed by the book. For examples, organizations frequently do not initiate CAPA events appropriately, and close the CAPA events in a timely fashion. Similarly, training of personnel is frequently deficient and SOPs are not followed or partially followed. The lists do not tell individual stories about specific manufacturers but provide an interesting overall perspective of the status of the industry. The list of findings can help self-assessment to assure that such problems do not exist at your organization. The list also provides multitude of examples of practices that the auditors objected to that can be used for training and troubleshooting.