Docket Management
Docket: 03N-0059 - Pharmaceutical Current Good Manufacturing Practices for the 21st Century: A Risk-Based Approach
Comment Number: EC -9

Accepted - Volume 1

Comment Record
Commentor Mr. Dennis Tajiri Date/Time 2003-03-06 17:52:41
Organization Mr. Dennis Tajiri
Category Individual

Comments for FDA General
1. General Comments Dennis, Thanks for your message. Unfortunately, the agency is backing away from part 11 safeguards, and meaningful regulation of the industry, in general. See the attached documents. I encourage you to send your comments to the indicated docket. You might also want to attend an April workshop and let FDAers hear your views: P. Motise -----Original Message----- From: Dennis T. Tajiri [] Sent: Thursday, March 06, 2003 2:48 PM To: Cc: Subject: Greetings Paul, I've been working in Part 11 Computer Validation as a contractor for the past several years. I worked at Genentech, AMGen, and Bayer as a full time employee and have put the big block buster products into the clinic and have designed the production facilities. Namely, Tissue Plasminogen Activator (Genentech), Erythropoietin (AMGen), and recombinant Factor VIII (Bayer). I have experience with Process Control, PC based databases, and Analytical Instrumentation validation. I am one of the few with the skill set. I learned the fundamentals by performing Part 11 Assessments for Biotech and Big Pharma. My clients have included but not limited to: Scios, Aviron (now MedImmune), Matrix Pharma, B. Braun Medical, Wyeth, AHP, NicePak, Novartis, Immunex (now AMGen) Rhode Island, PowderJect, Bayer, Merck, Avecia, Genzyme, Pharmacia/Pfizer, Schering Plough, and Abgenix. I have a unique perspective in this field because I have seen and evaluated work from not only other contractors but also Equipment vendors with the so called canned validation packages. I can see your concern to simplify the guidelines but I get the sense that some companies may interpret this as a loosening up the stringency of validating certain systems. I've performed Risk Assessments as well and can see the need to prioritize systems based on this analysis. I have to say the industry is all over the board on level of compliance. Contractors are also raising the bar and maybe over interpreting the guidelines by taking a conservative approach. I have done this as well to prevent criticism of not performing a functional test that I felt was critical. The other observation is the lack of preparation of User Requirements and Functional Specs and use of FAT and SATs in the software design and code review. Its getting to the point where we as consultants are getting pushed into a corner by the Clients needing to get their production facilities online. I have been working with Software development companies on the use of new state of the art Part 11 Compliant document management and Wrapper technologies. There are developments that can literally revolutionize the industry. Its been hard to convince clients without cost justification of using this new technology. We've been able to work with forward thinking companies but I believe you can be instrumental in the adoption of new software solutions. I would like to also propose a set of guidelines for minimally required software tests for system categories: 1. BAS 2. DCS/SCADAs 3. Process PLCs 4. Analytical Instrumentation 5. OTS 6. Custom Configurable Software 7. Custom Scripting or program development (eg., Java or other Client/Server based software) You can reply to my email or feel free to contact me by cell phone and we can discuss this in greater detail. Thank you for your consideration in this matter. Dennis T. Tajiri 707-803-2071 cell phone

EC -9