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Labcompliance News, April 2005

April 07, 2005

Network Compliance with Sarbanes-Oxley, E-Sign Act, HIPAA and Part 11

Several Federal laws and regulations mandate to put controls and measures on networks to ensure security and data integrity. Examples are 21 CFR Part 11, Sarbanes-Oxly Act, the E-sign Act and HIPAA in the U.S. and the European (EU) Data Protection Directive and Electronic Signature Directive in Europe. With this new legislation network qualification and compliance become a much more recognizable issue at higher levels of management. However currently there is no official guideline and the situation is similar to what happened with computer validation in the early 90's and with general part 11 issues from 2000 to 2003. Until there will be an industry wide accepted approach companies either waste valuable resources because doing too much or take a risk to fail inspections because not doing enough or doing it wrong. A new audio seminar presented by Dr. Ludwig Huber will help. After an introduction on regulatory requirements the seminar will focus on economic strategies for compliance. During the seminar attendees will get detailed step by step instructions on how to qualify network infrastructure. After the seminar an extensive list of reference material like SOPs, templates and examples will be available to help immediate and cost effective implementation. For more information click here.

April 07, 2005

FDA Issues Draft Guidance on Immunotoxicity Studies

Evaluation of potential adverse effects of human pharmaceuticals on the immune system should be incorporated into standard drug development. Toxicity to the immune system encompasses a variety of adverse effects. Under the auspices of the International Conference on Harmonisation (ICH). The FDA has developed a guideline that provides 1) recommendations on non-clinical testing approaches to identify compounds which have the potential to be immunosuppressive, and 2) guidance on weight-of-evidence decision making approach for immunotoxicity testing. The guidance is focused on providing recommendations on testing for immunosuppression induced by low molecular weight drugs (non-biologicals). The guideline applies to new pharmaceuticals intended for use in humans, as well as to marketed drug products.

April 07, 2005

Commission of the European Union Proposes Changes to EU GMP Guides

There is a series of proposed or adopted changes that have been published recently by the Commission of the European Union relating to the EU GMP guide, for example: Sub-Chapter 3.6 on dedicated facilities and Annex 14, defining requirements for medicinal products derived from human blood or plasma.

April 07, 2005

FDA Warning Letter Report 2004 Published

Every year, CONCEPT HEIDELBERG publishes the FDA Warning Letter Report. In a comprehensive analysis, the focal points of FDA inspections are identified. 18 out of the 33 warning letters concerning Part 211 cite deficiencies in the field of "Equipment cleaning and maintenance" (this is the title of § 211.67), up from eight of 46 in the previous year. Thus, this paragraph ranks second in the top ten list of most frequent warning letter citations - just behind § 211.100 (Written procedures; deviations), which is mentioned in 19 warning letters.

April 07, 2005

New Article on Validating Automated Systems

The article written by George Koroneos gives a good up-date on validation of automated systems. The article includes many quotes from industry experts and emphasizes the importance of a validation master plan, contributions of the vendor for IQ/OQ and risk based validation.

April 07, 2005

Failure to Extend Failure Investigations to Other Batches Draws FDA Warning Letter

"Failure to thoroughly investigate a rejected batch and to evaluate other batches of the same drug product and other drug products that may have been associated with the specific failure or discrepancy" and "Failure to follow established laboratory control procedures". have been two citations from a warning letter. The FDA also found that the company failed to follow established Standard Operating Procedures regarding the handling of written and oral drug product quality complaints. Furthermore, the company was cited for failing to follow written procedures for Annual Product Reviews. The letter further states that "We will review the implementation and the adequacy of your cGMP corrective actions during our next inspection of your firm". The warning letter can be downloaded from the Labcompliance Usersclub. Non members can preview excerpts. To learn how to avoid OOS, handle failures investigations and manage corrective actions, click here.