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Labcompliance News, January 2003

Jan. 25 2003

Waning Letter confirms: "If it is not documented it's a rumor"

Documentation is most important when working in an regulated environment. We have heard it many times and it has been communicated in compliance seminars: "If something is not documented, the FDA considers this as not being done at all,"' or "If it is not documented, it is a rumor". We never have seen this as clear as in a warning letter to a manufacturer of API's in China. The statement in the warning letter is: "There are no documented investigations of process deviations or out of specifications (OOS) laboratory results. •During the inspection, our investigation requested
to see investigations of process deviations and out of specification laboratory results. She was informed that these investigations are conducted but not documented". This was not accepted, So the recommendation is to document whatever is required by the FDA. The warning letters can be downloaded from the Usersclub site (W-102). To see extracts and for ordering the Usersclub, click here

Jan. 7, 2003

Pharmaceutical GMP’s for the 21st Century: FDA’s New Initiative on Drug Product Quality

On November 4 the director of FDA's Center for Drug Evaluation and Research, Janet Woodcock, gave a presentation entitled Pharmaceutical GMP’s for the 21st Century”, FDA’s New Initiative on Drug Product Quality. Janet Woodcock gave an overview on what is the initiative is about, on the background , major themes/principles , immediate steps, longer term projects , and what the FDA hopes to accomplish. Themes and principles of the new initiative include risk based orientation, science based regulations and integrated quality system orientation. Immediate steps are expected to take six months and include scientific workshops with key stake holders and to shift the lead on part 11 to CDER.

Jan. 7, 2003

18 Additional Warning Letters/Inspectional Reports (483's) in the Usersclub Section

18 FDA Warning Letters/Inspectional reports (483's) have been added to the Labcompliance Users Club section (W-083 to W 101). Some are most recent and all are related to GLP, GCP or cGMP in laboratories or manufacturing. Cited deviations include: equipment not tested for all parameters, no boundary testing, potential cause for non-compliance not evaluated, insufficient personnel with adequate training, inadequate statistical analysis, inadequate retrospective validation of networked computer systems, inadequate software version control, code review not complete, no structural and functional design, inadequate record maintenance, code lacked annotations, code included 'dead' and unused code, failure to maintain records of calibration checks and inspections of automatic equipment, no testing of detector linearity, no testing of accuracy of temperature settings for column heater and detector, inadequate calibration procedure for GC's and GC headspace unit, API manufacturing not in compliance with CGMP, no documented qualification of vendors, no audit of contract laboratories, no reporting of changes in research activities, no reporting to the FDA of any unanticipated problems, no maintenance of meeting minutes, inadequate management responsibility, no procedures for management reviews, no procedures for corrective and preventive actions, no audit trail, inadequate password protection, deleting electronic records. Some deviations are related to 21 CFR Part 11. Warning letters can be downloaded from the Usersclub site. To see extracts and for ordering the Usersclub, click here

Jan. 6, 2003

Automated Balance with Part 11 Support

According to information from Labtronics Inc the NEXXIS BDS is a balance automation solution and data management system that provides secure and documented control over balance applications and balance data management. 21 CFR Part 11 compliance, control of the SOP process, automated data collection and automated data reporting make NEXXIS BDS ideally suited for laboratories concerned with regulatory compliance and ensuring the integrity of their SOPs.

Jan. 6, 2003

FDA Update on Part 11

At the RAPS Annual Conference from October 6-9 FDA's Associate Director for Regulatory Policy, Office of Compliance at FDA's Center for Biologics Evaluation&Research, Jennifer Thomas gave an update on part 11. After some comments on basic requirements Jennifer Thomas went into details on FDA guidance documents. Towards the end she talked about content and three goals of FDA's initiative on Pharmaceutical cGMPs for the 21st century and it's impact on part 11. A task force has been formed "To ensure Part 11 policy will be risk- and science-based" which is in line with the cGMP initiative.