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Labcompliance News, November 2006

November 15, 2006

November 15, 2006 New FDA Guidance: Quality Systems Approach to Pharmaceutical Current Good Manufacturing Practice Regulations

This guidance as released in September 27, 2006 replaces the draft guidance with the same title from September 2004. This guidance is intended to help manufacturers implementing modern quality systems and risk management approaches to meet the requirements of the Agency's current good manufacturing practice (CGMP) regulations (2l CFR parts 210 and 211). The guidance describes a comprehensive quality systems (QS) model, highlighting the model's consistency with the CGMP regulatory requirements for manufacturing human and veterinary drugs, including biological drug products. The guidance also explains how manufacturers implementing such quality systems can be in full compliance with parts 210 and 211. This long awaited guidance is very important because the quality system is the only one that is always investigated during FDA inspections and most deviations in FDA warning letters are related to quality systems. For guidance on how to implement the new guide, click here. .

November 15, 2006

28 New Documents in the Labcompliance UsersClub

We have added 28 new documents to the Labcompliance UsersClub. They include 11 SOPs, 5 checklists/ templates/examples, FDA presentations and guidance documents and 11 FDA warning letters/483's related to GMP/GLP or GCP. User club members can instantly download the new additions. To see the list and ordering the users club, click here, and scroll down to 'new additions'. With these additions, the UsersClub has more than 350 documents ready for download.

November 15, 2006

New FDA Draft Guidance: Drug Interaction Studies — Study Design, Data Analysis, and
Implications for Dosing and Labeling

The guidance has been released as draft and provides recommendations for sponsors of new drug applications (NDAs) and biologics license applications (BLAs) for therapeutic biologics who are performing in vitro and in vivo drug metabolism, drug transport, and drug-drug interaction studies. The guidance reflects the Agency’s current view that the metabolism of an investigational new drug should be defined during drug development and that its interactions with other drugs should be explored as part of an adequate assessment of its safety and effectiveness. For drug-drug interactions, the approaches considered in the guidance are offered with the understanding that the relevance of a particular study depends on the characteristics and proposed indication of the drug under development.

November 15, 2006

Contract Testing Laboratory not Audited, FDA Warning Letter Says

Contract laboratories should be audited on a regular basis. According to a recent warning letter, a repackager and distributor of APIs failed to conduct audits of contract laboratories that perform testing-of-incoming APIs. The letter cited other deviations, for example: failure to validate the authenticity of suppliers COAs, reserve samples not retained, equivalency of container closure system not documented, failure to demonstrate adequacy of re-test, failure to include on the certificate of analysis the name and address of the laboratory that performed the analysis, and failure to document that air-handling filters are changed. The Warning Letter can be downloaded from the Labcompliance Users Club. Non members can preview excerpts. In a new seminar you can learn everything about auditing laboratories for internal audits, for auditing contract laboratories or just in preparation for FDA inspections. For information, click here.

November 15, 2006

Citizen Petition to Increase FDA Inspections of Foreign Drug Manufacturers

The Bulk Pharmaceutical Task Force (BPFT) of the Synthetic Chemical Manufacturer's Association (SOCMA) submitted the petition to request that the FDA take specific actions designed to allow it to better manage the risks to public health associated with the use of drugs manufactured or processed at foreign facilities. As background information the petition states that nearly half of all drugs marketed in the United States are produced or manufactured in foreign facilities, but that the vast majority of FDA inspections occur domestically. The petition also states that even though as much as 80% of API's used by U.S. manufacturers to produce prescription drugs, the Agency inspects foreign API suppliers of drug products infrequently, if at all. The petition specifically has three key recommendations:
Ranking foreign and domestic drug manufacturing firms together according to FDA's risk based approach to inspections
Listing "foreign facility" as a significant risk factor for purposes of its risk based approach and
Implementing a program of monitoring the impurity profiles of imported over-the-counter (OTC) drugs for patters that create the appearance of underlying problems with current good manufacturing practices (cGMP), so that FDA may refuse under 21 U.S.C. §381 (a) to products that appear adulterated

November 15, 2006

EMEA Guideline for Test Procedures and and Acceptance Criteria for Herbal Medicinal Products Effective

On October 1, 2006, the EMEA Guideline on Specifications: Test Procedures and Acceptance Criteria for Herbal Substances, Herbal preparations and Herbal Medicinal Products/Traditional Herbal Medicinal Products became effective. The document provides general principles on the setting and justification, to the extent possible, of a uniform set of specifications for herbal substances/preparations and herbal medicinal products to support applications for marketing authorization or registration according to Directive 2001/82/EC and Directive 2001/83/EC. Existing herbal medicinal products on the market will not be affected by this guideline, with the exception of traditional herbal medicinal products for human use that were already on the market on the entry into force of Directive 2004/24/EC (30 April 2004. The guideline makes it clear that the quality of a medicinal product is independent of its traditional use, therefore all general principles of quality also apply to traditional herbal medicinal products for human use.