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Labcompliance News, November 2005

November 25, 2005

FDA Draft Guidance on Electronic Drug Recalls

In this new guidance the FDA encourages to use modern communication technologies for conveying important safety information, The guidance is intended to describe the Food and Drug Administration's current thinking regarding the format and methods of dissemination and distribution of product information using electronic communication, including voluntary recall communications for FDA regulated products and/or important drug safety information. The FDA recognizes that electronic communication such as e-mail can significantly shorten the time between an event and the public's knowledge of the event. "We will consider e-mail and other electronic communication methods, such as fax or text messaging, to be appropriate, provided they accomplish the same objective (i.e. effective risk communication) of traditional delivery communications.", the guidance states. Unfortunately the guidance has no further details on how to achieve the same objective of traditional communication. It refers to the Part 11 guidance on Scope and Applications to decide which controls to put in place. The new Internet Quality and Compliance Package from Labcompliance gives a basic technical understanding for using Internet and e-mails to communicate regulated information. It also includes SOPs, checklists and examples for convenient implementation.

November 25, 2005

The FDA Continues to Enforce Part 11 Deviations

After silence for almost three years now the FDA seems to continue to look after part 11 related requirements and writes deviation reports. A new example is a 483 from an inspection in August/September 2005. The company received several 483 observations on their e-records system. Observations are related to inadequate validation, missing records and employee accountability for electronic records. Other observations have been: electronic records do not meet signature manifestation requirements to ensure that they are trustworthy, reliable and generally equivalent to paper records, and electronic records do not meet retention requirements.

November 25, 2005

Part 11 Update

Labcompliance has been informed by several sources, that the new revision of part 11 most likely will not be released in 2005 as originally indicated by FDA officials. New target time frame is more like Q1/2006. It seems that the content is very much defined but it just takes time to get approval from all related FDA offices. From all information we got it looks like the new Part will be modeled around the FDA Part 11 guidance on scope and applications complemented by some strong industry inputs, for example. They include: Extent risk based approach to all part 11 requirements and allow more flexibility to implement the requirements, for example, electronic audit trail should not be the only possibility to demonstrate a file's integrity, if more convenient tools could also do it. In addition, we expect that enforcement for legacy systems will be replaced by the risk assessment approach: "Base your decision on a justified and documented risk assessment". Now it is a good time to either start your Part 11 implementation program or adjust your existing program to FDA's new approach. The new Part 11 Compliance package is ideal to get a good understanding on basic requirements and FDA's new approach, and it also comes with 20+ documents for easy implementation. For more information and ordering, click here.

November 25, 2005

New ICH Guideline: Data Elements and Standards for Drug Dictionaries M5

In the past regulators in the ICH regions and observer countries have established their own procedures and applications with standards that differ in data format, content, language and applied terminology (e.g. terminology used for active ingredients, routes of administration, pharmaceutical dose forms). This makes it difficult to exchange medicinal product information between regulators and industry in a structured and efficient way and to ensure data consistency and to evaluate and compare medicinal product-related information across the ICH regions due to the lack of harmonized definitions of terminologies and data sets. For the pharmaceutical industry, this means major administrative burdens and duplication of efforts requiring substantial human and financial resources to comply with and handle different regional requirements. The objectives of this new guideline are to address the issues by developing harmonized standards that build on the processes currently established in the three ICH regions and the observer countries and to support the population of existing systems/applications with fully reliable regulatory medicinal product information. The guideline refers to approved medicinal products.

November 25, 2005

New Publication on Compliance and Procedural Training

"Not following procedures" is one of the most frequently cited deviations in FDA warning letters and 483 observations. One of the reasons is lack of adequate training. This new article written by Mike Stark gives recommendations for structured compliance training with focus on procedures.

November 25, 2005

85 Item 483 Observation for Pharmaceutical Manufacturer

FDA regulators inspected the pharmaceutical company between December 28, 2004 and January 24, 2005, and found practices in the laboratory control, production and labeling systems that did not conform with U.S. requirements. According to the 483, the company failed to routinely calibrate equipment according to a written program and to review batch records by QC, Furthermore conductivity meters were not calibrated to an NIST traceable device and there was no reference in the analytical method to a recognized standard method, The company also failed to review current SOPs by QC and there was no diagram of the water system. The 483 can be downloaded from the Labcompliance Usersclub. Non members can preview excerpts.