n October 2004, both the Pharmaceuticals Process Analyzer Roundtable (PPAR) and its older brother the Pharmaceuticals Automation Roundtable (PAR) held their respective annual gatherings. These roundtable sessions are designed to facilitate sharing of non-proprietary practices and techniques in these two disciplines within the pharmaceuticals/biotech manufacturing community.
The fourth PPAR meeting was hosted by Genentech in South San Francisco (Oct 12-14). Twelve manufacturers (split 50-50 between traditional pharma and biotech) as well as the two leading research consortia for process analysis were represented among the thirty (30) attendees.
About half of the attendees participated in an extensive tour of a Genentech bioprocess synthesis (fermentation) and separation (process chromatography) facility. Special attention was devoted to the use of on-stream analyzers and analytical data in these operations.
The participants met for two full days of discussion on topics including:
Â· Formalized Vendor Auditing Procedures
Â· European and Other Overseas PAT Filing Procedures
Â· Review of FDA’s PAT Guidance Document
Â· Dealing with Research Data in the Implementation of PAT
Â· Organizational Structures for PAT
A teleconference was also held with Chris Watts and Ali Afnan of FDA CDER’s PATRIOT Team. CDER’s progress in training inspector’s was reviewed as well as their intention to invite European and Japanese regulators to participate in the next round of PATRIOT training courses.
The results of a benchmarking survey (12 companies participated) were also discussed. The survey covered 13 organizational questions (e.g., size of PAT effort number of professionals?), 12 manufacturing questions (e.g., where is PAT currently used?) and 9 research questions (e.g., barriers to the use of PAT in R&D?).
Amgen and Pfizer are potential hosts for the 2005 PPAR session.
A week later (Oct 17-19), twenty-one (21) process automation specialists, representing thirteen pharmaceuticals and biotech manufacturers, met at GlaxoSmithKline’s research campus in Research Triangle Park, NC. This was the 10th Pharmaceuticals Automation Roundtable session in a format that began in 1994.
Discussion topics included:
Â· Automation Professional Certification
Â· Process Sensors to MES Integration
Â· Equipment Control in a Recipe Environment
Â· Organizational Approaches and Assessment
Â· Computer Validation
Â· Batch Reporting Software Assessment
Â· Validated vs. Non-validated Data/Controllers for Building Automation
Under Computer Validation, an FDA training course was described that had been developed by Schering Plough and Johnson & Johnson. In March 2004, 50 FDA Inspectors took this course which is directly concerned with computers used for manufacturing automation not LIMS, MES, ERP or similar uses. At least three of the companies represented at the Roundtable had had automation-specific FDA investigations.
The roundtable concluded with a visit to Bayer’s Clayton, NC Biological Products site. Important life saving pharmaceutical products derived from human blood plasma are produced at this site. Roundtable members toured the new Immune Globulin (brand name: Gamunex) facility. Automation is used throughout the process to support the highest standards of product safety combined with optimum manufacturing efficiency.
Biogen Idec is a possible host for the 2005 PAR meeting.
Terrence K. McMahon, McMahon Technology Associates, 135 Fort Lee Road, Leonia, NJ 07605: Tel: 201-585-2050; Fax: 201-585-1968; Mcmahontec135@aol.com.