Regulation and Compliance Q&A: Preparing for Inspections

Q. Inspections by FDA are on the rise. How can one best prepare?

A: FDA inspections will continue to rise, particularly after recently passed user-fee bills in the House and Senate come together and a final law is enacted. The law will better enable FDA to meet the challenges of globalization, promote innovation, mitigate product shortage situations and, through harmonization and direct action, extend inspectional coverage to the global regulated industries.

David Elder

In July 2011, FDA published a roadmap for addressing the challenges of globalization. The "Pathway to Global Product Safety and Quality" is based on four core building blocks: with a global coalition of regulators, build and strengthen the product safety net around the world; develop a global data-information system; expand intelligence gathering and use, focused on risk analytics and modernized IT; leverage and prioritize resources based on risk.

Bolstered by impending legislation, the agency's roadmap becomes feasible. In the years ahead, the worldwide industry should expect to see: improved consistency among regulatory inspections; inspections that are well-informed by global issues affecting product quality, safety, or efficacy; enhanced recognition and reliance upon the regulatory inspections conducted by recognized health authorities, which may reduce the total number of regulatory inspections at any one site but also increase the impact of each inspection.

Regardless of which health authority conducts the inspection, the preparation for, and management of, the inspection process is quite similar. Whether it's a surveillance, pre-approval, or for-cause inspection, regulatory inspections are crucial activities that affect business success on several levels. PAREXEL advocates the following steps for inspection preparation and management:

1. Establish and maintain systems that ensure sustained compliance with applicable laws and regulations. No amount of inspection-specific preparation or training will ensure success if the elements that the health authority inspector will assess do not comply with laws and regulations. Senior managers would be well advised to fully understand and embrace International Conference on Harmonization Q10 Pharmaceutical Quality System guideline.

2. Understand the rules that govern inspections. To avoid confusion, anxiety, and some procedural missteps, company personnel should understand the rules under which health authorities must operate. Generally, health authorities have the right to enter premises during normal operating hours, review and copy records (including raw data) relating to legal and regulatory requirements, interview company personnel regarding such records and operations, and collect samples. Health authorities should conduct regulatory inspections in a reasonable and professional manner and provide feedback on findings during the inspection and more formally at the conclusion of the inspection. Company officials should leverage these sessions to obtain understanding, seek clarification, and correct facts.

3. Establish procedural systems to manage the health authority's presence on site. Develop an SOP that includes such elements as: who to notify when a health authority arrives on site, who will serve as the primary liaison for the company (and a back-up), what will be the process for prompt retrieval of requested records, how will requests and issues be communicated to key personnel within the company, who will attend the feedback sessions, and what is the company policy regarding photographs and affidavits.

4. Train staff to understand the inspection process, with emphasis on how to effectively answer questions. Key personnel will always be interviewed during an inspection. Managers and subject matter experts should be prepared to address inquiries but health authorities could easily ask questions of line employees about responsibilities, training, and governing procedures. Understanding and preparing for the inspection will better enable employees to answer questions effectively and truthfully, and reduce their anxiety.

5. Practice: Conduct mock inspections to rehearse systems and assess employee readiness. Mock inspections can familiarize employees with the process and may serve to identify compliance issues that need to be addressed before an inspection takes place. Exercise the inspection management system regularly and the inspection itself will inevitably deliver better outcomes.