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Labcompliance News, June 2009

Harmonization Steps Move Forward in Yokohama, Japan

The International Conference on Harmonisation (ICH) Steering Committee and its expert working groups met in Yokohama from June 6 - 11, 2009. A significant milestone was achieved with the finalization of the revision of the M3 Guideline "Non-clinical Safety Studies for the Conduct of Human Clinical Trials and for Marketing Authorizations". The new M3 Guideline promotes more rapid discovery and development of innovative medicines, by reducing the reliance on animals required in drug development studies. These efforts continue ICH's commitment to the 3Rs (Reduction, Refinement and Replacement) of animal testing. Progress was made on the harmonization of pharmacopoeial texts in the three regions, which will reduce testing requirements for the industry.

FDA Data Standards Council Launched New Website

The FDA Data Standards Council coordinates the evaluation, development, maintenance, and adoption of health and regulatory data standards to ensure that common data standards are used throughout the agency. The new site has links to other FDA sites with specific information on data standards for selected applications, for example, Structured Product Labeling, Regulated Product Submission, Stability Data Standard and others.

New FDA Guidance on Regulatory Submissions in Electronic Format

The Food and Drug Administration announced in a Federal Register notice of June 1, 2009, the availability of a guidance for industry entitled ‘‘Providing Regulatory Submissions in Electronic Format—Drug Establishment Registration and Drug Listing.’’ This guidance document is designed to assist industry (e.g., manufacturers, repackers, and relabelers) with the electronic submission of drug establishment registration and drug listing information. Specifically, the document provides guidance to industry on the types of information to include for purposes of drug establishment registration and drug listing and on how to prepare and submit the information in an electronic format that FDA can process, review, and archive. The guidance can be downloaded from the FDA Website

New FDA Guidance on Research or Radioactive Drugs

The Food and Drug Administration announced in a Federal Register notice of June 3, 2009, the availability of a draft guidance for industry and researchers entitled ‘‘The Radioactive Drug Research Committee: Human Research Without An Investigational New Drug
Application. This draft guidance provides information to those using radioactive drugs for certain research purposes to help determine whether research studies may be conducted under an FDA-approved radioactive drug research committee, or whether research studies must be conducted under an investigational new drug application(IND). It also offers answers to frequently asked questions on conducting research with radioactive drugs, and provides information on the membership, functions, and reporting requirements of a radioactive drug research committee approved by FDA. The guidance can be downloaded from the FDA website

"Failure Investigation not Extended Outside the Lab " Cited in FDA Warning Letter

FDA requires for OOS failure investigations to determine if corrective and preventive actions are necessary. The root cause of the OOS result should be determined, if necessary, outside the laboratory. This became obvious in a warning letter to an API manufacturer. The letter reads: "Failure of your investigations of out-of-specification results to determine if corrections or preventive actions are needed. Your firm failed to continue its investigation of the OOS results outside of the laboratory in order to determine the cause of the results." Furthermore the FDA letter recommends "Any OOS result obtained should be investigated and documented according to a procedure. This procedure should include analysis of the data, assessment of the extent and cause of the problem, allocation of the tasks for corrective actions, and conclusions." The warning letter can be downloaded from the Labcompliance Usersclub. Non members can preview excerpts (scroll down to 209).  To learn everything about FDA compliant handling of failure investigations, Out-of-specification and Out-of-trend test results, attend the upcoming audio seminar

New Primer on Analytical Instrument Qualification and System Validation for Free

Agilent Technologies offers a 67 page primer on Analytical Instrument Qualification and Laboratory Computer System Validation. This primer written by Dr. Ludwig Huber, guides analysts, laboratory managers, quality assurance managers and IT and validation professionals through instrument qualification and system validation at minimal extra cost.  Special focus is placed on getting a good understanding of and implementing USP chapter <1058>. After an introduction to the chapter’s approach for instrument qualification and system validation, this primer will lead you through individual qualification phases and give recommendations for implementation. For more information and ordering the free printed primer , click here

Free Document of the Month

As a 'Thank You' for our visitors Labcompliance offers every month one document for free. This month's document is the SOP: Validation of Spreadsheet Applications (for example; Excel Spreadsheets). To download your free copy, go to the Computer System Validation Package website.  Scroll down and click on the corresponding ICON on the left (offer expires on July 12, 2009). Labcompliance offers more than 100 SOPs that help to comply with FDA and ISO 17025 compliance. For titles and ordering, click here.

New Audio Seminar Schedule

Managing Out of Trend Results in Pharmaceutical Manufacturing and Quality Control
Comply with the FDA and international guidances
Recorded, available with all reference material at any time

Understanding and Implementing ISO 17025
Requirements, Strategies and Tool Kits for Laboratory Accreditation
Recorded, available with all reference material at any time

Successful FDA Inspections
Preparation - Conduct - Follow Up
Recorded, available with all reference material at any time

New or Updated Sites

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