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Labcompliance News, November 2007

November 13, 2007

GAMP® Good Practice Guide: Electronic Data Archiving

This Guide provides a rational and scalable approach to electronic data archiving through the development of an archiving strategy. The implementation of such a strategy should assist organizations to achieve and maintain regulatory compliance, and to more effectively manage electronic records over the long term.
Labcompliance has conduced an audio seminar "Cost Effective Electronic Archiving for FDA Compliance". The seminar has been recorded and is available on CD with all Q&As and 10+ Best Practices.

November 15, 2007

FDA Advices on Investigating OOS Test Results

Edwin Rivera, Chief Investigations and Preapproval Compliance Branch at CDER US FDA gave a very detailed presentation at the 31st international GMP conference in Athens, Georgia. He started with on overview of FDA inspection findings over the last year This information included top 10 CGMP deviations, top 5 citations and top 3 laboratory and production deviations. He continued the presentation with a brief overview on the history and scope of FDA's final OOS guidance. Then he explained FDA's expectations for laboratory and full investigations. The presentation has 55 slides and gives very detailed advice. For example, Mr. Rivera made it clear that QCU should provide oversight of laboratory investigations. He also gave examples when averaging tests results is acceptable. The presentation is included in the reference material of the Labcompliance audio seminar: Managing OOS, failure investigations and CAPA.

November 19, 2007

Canadian Digital Information Strategy Published

Long term archiving and retrieval of digital data is a concern worldwide for industry but also for public organizations. Therefore industry and public organizations develop guidelines and strategies. A recent example is the Digital Information Strategy published by the Canadian Library and Archives organization. The strategy focuses on preservation of the information but also on maximizing access and use. The document is quite interesting, since we have not seen any country with such a broad national program, and its reference list is both useful and up-to-date. To download the 63 pages paper, click here. Labcompliance has conduced an audio seminar "Cost Effective Electronic Archiving for FDA Compliance". The seminar has been recorded and is available on CD with all Q&As and 10+ Best Practices.

November 19, 2007

The Method Validation Tutorial is Back

The popular Method Validation Tutorial has been updated and is now available for Labcompliance visitors. It should help to get a good understanding on USP, ICH, EMEA  and FDA requirements and strategies for initial validation, for transferring methods and for verification of compendial methods.  The tutorial includes

  • A primer with basic information and recommendations for implementation.
  • Expert advice on selected topics
  • Links to warning letters, 483's and/or establishment inspection reports
  • Literature references
  • Links to other websites

November 20, 2007

New EMEA Guideline for Stability Testing

The Committee for Medical Products for Veterinary Use (CVMP) has published a draft guideline on "Stability Testing of Existing Active Substances and Related Finished Products". deadline for comments is April 30, 2008. The earlier version of the guideline EMEA/CVMP/846/99 was revised to be brought in line with the requirements of the Note for Guidance on Stability Testing of New Veterinary Drug Substances and Medicinal Products (EMEA/CVMP/VICH/899/99-Rev.1). As a consequence, the relative humidity at storage under intermediate conditions, i.e. presently 30°C ± 2°C/60%RH ± 5%RH, will be changed to 30°C ± 2°C/65%RH ± 5%RH. Within the EU, data from studies generated using the new conditions are accepted immediately. Furthermore, data from studies where the relative humidity has been changed from 60%RH to 65%RH during the study to meet the new requirements will also be accepted under the condition that the respective storage conditions and the date of the change are clearly documented and stated in the application file. It is recommended that all marketing authorization applications contain data from complete studies at the intermediate storage condition 30°C ± 2°C/65%RH ± 5%RH, if applicable, by <3 years after final adoption of the revised guideline>.
The draft guideline is available for download on the EMEA website.

November 20, 2007

FDA Warning Letter Issued for Incomplete GLP Study Report

 FDA regulators inspected the GLP facility between on Dec 6-22, 2006 as part of FDA's Bioresearch Monitoring Program and found practices that did not conform with U.S. FDA requirements Violations included: failure of the study director to assure that all experimental data were accurately recorded and verified and to document the reason for any change in the entries, for example, the study director failed to assure that dosing were accurately recorded to confirm that study animals received protocol-specified doses of the vehicle. In addition QAU failed to assure that reported results in the final study report accurately reflected the raw data. Furthermore, the company was cited for failing  to identify the test and control articles with appropriate characteristics in the final report and to adequately test, calibrate, and/or standardize all equipment used the generation, measurement and assessment of data. The Warning Letter can be downloaded from the Labcompliance Usersclub. (Scroll down to 193). Non members can preview excerpts.

November 20, 2007

Article on MHRA Inspection Findings

This article published by the Pharmaceutical Journal (PJ) reports the nature and frequency of serious deficiencies in compliance with Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP) found on regulatory inspections by the Medicines and Healthcare products Regulatory Agency (MHRA) during the year 2004–05. It covers industrial manufacturing and distribution sites in the UK, manufacturing sites in third countries and sites where the NHS is the license holder. Data for the years 1996–97, 1998–99 and 2001–02 were published previously. The paper also reviews reports of defective medicines received by the MHRA’s Defective Medicines Report Centre (DMRC) and drug alerts issued in 2005 to support recalls issued by the relevant importers, manufacturers and marketing authorization holders. The article is not new but reading the data is interesting. Data from 2006-07 are not available yet. As of Nov 2007 the article is available on the PJ website. Copyright resides with the publisher.

November 20, 2007

API Manufacturer Cited for Incomplete Batch Records and Poor Laboratory Practices

The inspections from April 207 revealed significant deviations from U.S. Current Good Manufacturing Practice (CGMP) in the manufacture of Active Pharmaceutical Ingredients (API). Deviations have been: Incomplete batch records, insufficient documentation of method validation, and inadequate documentation of laboratory equipment calibration. For example, batch production records did not include complete information relating to the production and control of each API batch, method validation documentation did not include appropriate data to verify that the analytical method produced accurate and reliable data, production equipment was not adequately cleaned and was not maintained in a good state of repair and laboratory equipment calibration was not adequately documented.

The letter also stated that any future shipments of APIs manufactured at the company's Kun Tai Road site (Old Site) will be denied entry into the United States. The letter further stated the the ICH CGMP Guidance "Q7A Good Manufacturing Practice Guidance of Active Pharmaceutical Ingredients" describes current good manufacturing practice (CGMP) for manufacturing of APIs. Although the ICH CGMP Guidance does not impose requirements, FDA considers its recommendations, as well as alternatives intended to accomplish the same goals and provide an equivalent level of quality assurance, in determining whether a firm's APIs have been manufactured, processed, packed, and held according to current good manufacturing practice. The Warning Letter can be downloaded from the Labcompliance Usersclub (Scroll down to 193). Non members can preview excerpts