The following was included in our July email newsletter.

There are many training sessions conducted each year by GMP Training Managers and company quality and compliance staff on “How to Manage an FDA Inspection”. Regularly, FDA inspection management is a “headliner” on the agendas of industry trade association meetings. And of course, there are numerous industry experts who consult and advise companies on how to manage FDA inspections as one of their key offerings.

Times are changing though. The FDA is adding a new, modern approach to its arsenal of approaches for conducting site inspections. This change is not a subtle change – it is a significant change.

Traditionally, FDA has conducted detailed, paper-based reviews. Requested documentation was presented to FDA by the company in hard-copy format. Timely retrieval and presentation of documentation and data by the company to the Investigator has been, and continues to be, a critical-to-quality attribute of a successful inspection.

To ensure timely and accurate presentation of documentation and data, many companies have developed an extensive “back room” process to retrieve and review documents requested by FDA prior to presentation in the front room. This process often includes a “pre-review” and “dress rehearsal” with the individuals presenting the documentation. A recent addition to back-room / front-room communications includes the use of computer-based tools (IM / chat / screen presentations) to enhance communications and document availability responsiveness.

The Live Review: New, Modern FDA Inspection Technique

Recently, I had the opportunity to participate first-hand in a different type of FDA inspection. Having directly managed (and saved) many, many critical FDA inspections, I know what to expect, and how to lead and manage the inspection process. However, when the detailed document reviews began, the traditional process of hard-copy record review was circumvented when the FDA Investigator requested a “live review” of the documents contained within the IT system deployed by the company to manage documentation for one of its core quality sub-systems. In this case, the Investigator was reviewing the complaint process. As part of the “Live Review”, the Investigator:

• Requested an electronic copy (on a memory stick) of the summary tables for the past x years of product quality complaints for “y” products; and
• Requested the ability to randomly select specific complaint documentation to review “live” on the company’s computer system.

What You Can Do

This new approach to FDA inspections is likely to occur with increasing frequency. Because of this, now more than ever, exceptional writing skills are essential for all levels of the Quality organization to ensure quality records and other compliance-implicated documents stand on their own – successfully – during a Live Review inspection. Because the Live Review inspection approach bypasses the traditional “managed approach” to FDA inspections, direct actions during the inspection to improve inspection outcomes are limited. There is little to no opportunity to “verbally augment” the written record during a Live Review inspection. Your compliance documents need to be written, reviewed and approved with this new, potential inspection approach top of mind.

During numerous client engagements, Compliance Architects® has identified that writing skills for compliance implicated documents are deficient. This lack of skills leads directly to poor inspection outcomes, since quality records are the source of FDA’s determination of a company’s compliance status. However, every company can take action to ensure your quality records meet FDA expectations, and provide a complete and thorough story of compliance for Investigators to review. To find out more about the problem of compliance writing, and how you can improve your FDA inspection outcomes, please visit our Writing for Compliance® website.

FDA’s new approach to inspecting quality system documents and quality records will, over time, substantially change the traditional company inspection management process, reducing the importance of the “back room” and creating more uncertainty during inspections. For additional insight into FDA’s Live Review inspection approach, download our white paper. To find out more about our experiences with this new approach, please contact me, Teresa Gorecki, at [email protected], or call me direct at 310-465-7285.

Teresa Gorecki
Practice Director
Compliance Architects LLC