RMM: In-Depth Focus 2014

• Rapid microbiological methods and the regulatory environment
  Michael J. Miller, Microbiology Consultants, LLC
  Rapid microbiological methods (RMM) continue to gain acceptance within our industry and a number of companies have already realised significant gains in detection sensitivity, automation, throughput, time-to-result and return on investment (ROI) when they have replaced their classical methods with these alternative technologies. Multinational firms have also obtained regulatory approvals for the routine use of RMMs, when appropriate, from authorities such as the U.S. FDA, EMA and Japanese PMDA. When a company desires to implement a RMM, it is advisable that all stakeholders initially understand and then subsequently utilise the policies and submission tools offered by global regulators with respect to validation. For these reasons, it is worthwhile to review the expectations from the two largest authorities in this arena, the FDA and the EMA…
• Online Water Bioburden Analyzers: The path to implementation and lessons learned
  Online Water Bioburden Analyzer Workgroup Members: Deborah Gessell-Lee (Baxter), Oliver Gordon (Novartis), Joe Johnston (Fresenius), Neil Lewis (Procter & Gamble), Jeanne Mateffy (Amgen), Jeffrey W. Weber (Pfizer)
  Commercially available continuous water monitors are a recent advancement in the arsenal of tools used to understand and control the microbial content of pharmaceutical water. In January 2013, six representatives from major pharmaceutical/healthcare companies joined the online water bioburden working group to provide shared guidance and user feedback intended for the development and implementation of Online Water Bioburden Analyzers (OWBAs). This workgroup merged a collective of experiences that were focused on the assessment and implementation of various rapid microbiological methods (RMM) and process analytical technologies (PAT). The primary goal of this workgroup is to provide guidance regarding the development of OWBA systems that would be broadly accepted by both the industry and the regulatory bodies. Previous workgroup outputs included three key documents used to engage instrument vendors and provide a framework for OWBA development: a user requirements specification (URS), a test protocol, and a business benefits proposal. Desired attributes and required system design inputs were incorporated into the URS document. Guidance on verification and performance tests used to demonstrate system capability and operation were provided in a test protocol. The third output of the OWBA workgroup highlighted the financial benefits of OWBA implementation…
• RMM Roundtable
  Moderator: James L. Drinkwater, Head of Aseptic Processing Technologies and GMP Compliance, F Ziel
  With contributions from Tim Russell (Product Specialist – Contamination Control, TSI), David Jones (Director of Technical Services, Rapid Micro Biosystems), Ulrich Herber (Senior European Product Manager EMD, Charles River), Rich Quashne (WW Product Manager – Industrial Microbiology, BD)