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Labcompliance News, December 2005

December 28, 2005

Labcompliance in 2005

2005 was an other great year for Labcompliance and website visitors: new products, new services, and significantly increasing number of visitors were just a few highlights. We delivered 19 Audio seminars with far over 1000 attendees, we launched three new compliance packages Part 11, Internet/Intranet and Computer System Validation. We also updated the Network Quality Package. The Labcompliance Usersclub now includes more than 300 documents for instant downloads and the Newsletter with the free Document of the Month enjoys more than 10,000 subscribers. We are looking forward to 2006 with more new products. The first one will be the Laboratory Compliance Package with more than 30 SOPs for Analytical Laboratories. It will be announced in the January newsletter. We thank our customers and other visitors of our website for continual support.

December 28, 2005

'Missing Computer System Audits' and 'No Review of Computer Audit Trail Cited in FDA 483

FDA regulators inspected a generic pharmaceutical manufacturer between May 2nd and July 1st, 2005, and found practices that did not conform with U.S. requirements. Deviations have been documented in a 12 item inspectional observation (483). According to the report the company failed to review computer audit trails and to conduct audits of the of the data acquisition system used to run the HPLC instruments during analysis of drugs. Furthermore, the FDA noticed that laboratory records did not include complete data from all tests, examinations and assay necessary to assure compliance with established specifications and standards, e.g., OOS data, chromatograms, and sample weighs. The report further stated that manufacturing investigations into rejected batches of drugs did not include an evaluation of the validated manufacturing process. The 483 form inspectional observation can be downloaded from the Labcompliance Usersclub. Non members can preview excerpts. To learn more about electronic audit trails, click here.

December 28, 2005

Recent CGMP Presentations by FDA Professional

Nicholas Bugay, FDA's Deputy Director of CDER's Division of Manufacturing & Products Quality Office of Compliance gave an interesting presentation on cGMP at FDA's cGMP China training. The training was part of FDA's China training program and was organized at the Ying Jie Convention Center Beijing of the University Beijing on Dec 5-7, 2005. The presentation is entitled "CGMP in the USA" and gives a very good overview on basics of GMP. Mr. Buhay covered topics like: Overview of CGMP Requirements, Legal bases for CGMP, CGMP legal principles, CGMP implementation tools, CGMP resources and integrity of records and data. 

December 28, 2005

European Guidelines for Electronic Records

There is no direct equivalent for 21 CFR Part 11 in Europe. Requirements for electronic record compliance can be found in Annex 11 of the EU GMP, in the APV interpretation guide and in the PIC/S good practices guide on using computers in GxP environments. Annex 11 includes 19 paragraphs with requirements for personnel, validation during development and use, audit trail, built-in checks for correct entry of data, authorized and limited access to the system, verification of manual data entry, automated identification and recording of operators, procedures for change control, back-up and protection of data, contingency planning, disaster recovery, automated detection of errors, qualification of 3rd party service providers and release of batches by a 'Qualified Person'. Most detailed information can be found in the good practices guide from the pharmaceutical inspection convention scheme (PIC/S). The document has been written by inspectors as guideline for inspections. It also includes a six page inspection checklist and is quite useful for the industry in preparation for internal and external audits/inspections.

December 28, 2005

FDA Human Drug CGMP Notes

The Human Drug CGMP Notes is no longer being published. It was published from 1993-2003 as a periodic memo for FDA personnel intended to enhance field and headquarters communications on CGMP issues in a timely manner. The Notes was issued by the Division of Manufacturing and Product Quality, Office of Compliance, Center for Drug Evaluation and Research, U.S. FDA. Editions published during 2001 to 2003 were distributed internally and only made publicly available by a Freedom of Information Act request. In the meantime FDA has created the web site Questions and Answers on Current Good Manufacturing Practices (cGMP) for Drugs for posting answers to questions about the CGMP regulations, statute, and related guidance. The format for these "Questions and Answers" is similar to the Notes and now includes participation by the other drug product centers in FDA, the Center for Veterinary Medicine and the Center for Biologics Evaluation and Research. Each answer is approved for posting in accordance with the good guidance practices regulations at 21 CFR 10.115