Compliance Update from CBER’s Malarkey: From Sterility Testing to Rapid Methods

At the annual GMP by the Sea event in Tampa this week, Mary Malarkey, Director of CBER’s Office of Compliance and Biologics Quality, updated the audience on her office’s current preoccupations and pursuits. She covered several key topics:

• Sterility Testing Proposed Rule 21 CFR 610.12: The new rule, Malarkey noted, would eliminate the need to submit supplements under 21 CFR 610.9 for alternate sterility test methods. The objectives of the new rule are to improve innovation and flexibility for manufacturers. It would eliminate the requirement for sterility testing of most bulk material, and instead generally require sterility testing of each lot of each biological product’s final container material.
• Guidance Update: Malarkey discussed the following guidance documents of note: “Guidance for Industry: Potency Tests for Cellular and Gene Therapy Products,” issued January 2011;“Guidance for Industry on Process Validation; General Principles and Practices,” issued January 2011; Continued implementation of the guidance for submission of BLAs for cord blood, with October 2011 as end of two-year period for submission of BLAs and/or INDs; and Final Guidance for cord blood INDs, issued on July 29, 2011.
• Rapid Microbiological Methods: Malarkey made note of the fact that CBER’s own Laboratory Quality System has been accredited (for 13 testing methods) under ISO/IEC 17025 standards. A key reason for the accreditation was to ensure that CBER is up to date with alternate and rapid microbiological methods that the industry is using, and that FDA must also use these methods to, for example, accelerate product screening during pandemics.
• Electronic Gateway Expansion: CBER developed an Electronic Gateway for submission of H1N1 lot release protocols, and worked with the individual manufacturers to further expedite the lot release process. It is now expanding this program into other areas.
• Bioresearch Monitoring. The thrust of Malarkey’s comments related to CBER’s stepped up random surveillance of clinical trial facilities, to better ensure the safe and ethical treatment of patients. Surveillance activities will focus on those facilities with high concentrations of at-risk patients (i.e., children and the elderly).