The FDA provides an electronic reading room on its website that provides access to a great deal of useful information, including copies of Warning Letters issued by the FDA. Reviewing these letters can be useful because they provide insight into the inspection techniques and concerns of FDA inspectors. Additionally, they can be used to perform gap analyses of the processes used at your company in preparation for an FDA inspection. This article provides a summary of the review conducted for Warning Letters issued between 2000 and 2010 for products that are aseptically filled and for manufacturing processes identified as non-sterile.
Employee training in a pharmaceutical company almost always includes instilling a 'healthy fear' of regulatory agency inspections. Most, if not all, countries have established governmental agencies that are responsible for the safety and efficacy of the medicines manufactured, sold and distributed within their country. These agencies typically have the legal authority to go into production facilities to assess various aspects of the manufacturing and distribution facility. As such, employees learn that the company's viability is dependent upon successfully passing these inspections.1The notification that a regulatory inspector is planning a visit to a company site can trigger concern regarding the expected outcome and frantic activities often take place in preparation. Since the implementation of the FDA's Systems Based inspection programme, however, it has become more difficult to successfully prepare for an inspection.
Originally, the Systems Based Inspection guide was introduced by the FDA as a pilot programme.2 The method for evaluation entailed a portion of the FDA's regional offices using the programme for a 6-month trial period in 2001. The results were successful and the FDA officially implemented the programme in 2002 as the Compliance Program Guidance Manual for FDA Staff: Drug Manufacturing Inspections (Program 7356.002).2
Prior to the implementation of this guidance, companies prepared for inspections by thoroughly reviewing and assessing products with upcoming pre-approval inspections because these products tended to be the focus of the inspection. Under the new guidance, however, the FDA reviews companies in a systematic approach, which makes it more difficult to prepare. One valuable way to prepare for an inspection is to look at the FDA's inspection findings from other companies to determine which types of observations are also issues at your company.
For this study, the FDA's website was searched to review the Warning Letters issued between 2000 and mid-2010. The searches were limited to those referencing aseptic processing or non-sterile processing, and the data were summarised.2,3
Warning Letter review