COBBLESTONE, a Division of The Center for Professional Advancement (CfPA) training

The purpose of a regulatory inspection is to ensure that your facility is in compliance with FDA rules and regulations. Investigators want to know that product was manufactured appropriately and that the current Good Manufacturing Practices are up to FDA standard. An inspection can be very intimidating to all involved, but it is vital if you want an inspection that results in a satisfactory report. Many times, the arrival of a Regulatory Investigator is a daunting experience for some. This is why it is important to learn how to properly alert key members that an investigator has arrived, the proper protocol for setting up the Inspection room and any associated war rooms that will support the inspection, and how to manage requests from the investigators in a timely and accurate manner. This preparation minimizes stress and disorder during the inspections.

In the FDA’s Guide to Sterilization Process Controls, the FDA stated five (5) key inspectional objectives which are used by the agency during routine inspections of sterilization and sterility assurance processes. One of the key areas of concern pertains to the production and process control subsystem (including sterilization process controls) which requires that manufacturers of products must manufacture products that meet defined specifications. Developing processes that are adequate to produce medical devices or other products that requires a defined Sterility Assurance Level (SAL) requirements, testing specifications, validating or fully verifying the results of those processes, including monitoring and controlling the processes are all steps that help assure that the result of the manufactured products meet the defined specifications.

For products that claim a desired Sterility Assurance Level (SAL), proof of a defined SAL (specification) is achieved through the product’s sterilization and sterility assurance controls. Compliance Observations cited each year by the FDA on Form 483s that relates to Sterilization and Sterility Assurance processes shows that there are deficiencies associated with these key processes that are critical to a product’s sterility including inappropriately qualified and trained personnel required as key staff to implement a fully compliant sterilization process.