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Labcompliance News, September 2005

September 15, 2005

New FDA Draft Guidance: ANDAs - Impurities in Drug Products

This new guidance provides recommendations on what chemistry, manufacturing and controls (CMC) information sponsors should include regarding the reporting, identification, and qualification of impurities that are classified as degradation products in drug products when submitting original abbreviated new drug applications (ANDAs) or ANDA supplements for changes that may affect the quantitative or qualitative degradation product profile. The guidance also provides recommendations for establishing acceptance criteria for degradation products (specifically, degradation products of the active ingredient or reaction products of the active ingredient with an excipient(s) and/or immediate container/closure system) in generic drug products.

September 15, 2005

30 New Documents in the Labcompliance Users Club

We have added 30 new documents to the Labcompliance users club. They include nine SOPs, six checklists/ templates, two reference papers, two FDA presentations and 14 FDA warning letters/483's. User club members can instantly download the new additions.. To see the list and ordering the users club, click here.

September 15, 2005

New Edition of ISO/IEC 17025 Standard Released

ISO/IEC has just published a new version of the standard: General Requirements for the Competence of Testing and Calibration Laboratories. The standard, first published in 1999, has been acknowledged as the international benchmark for approving the competence of the testing and calibration laboratories that play a vital role in trade, in product development and manufacturing, and in protection of the consumer. The new standard does not suggest changes to the technical requirements. The modifications relate mainly to the management requirements in order to harmonize with the quality management standard ISO 9001:2000. Accreditation bodies will allow laboratories up to two years to implement the new standard.

September 15, 2005

Root Causes for GMP Violations Must be Identified, FDA Says

A May 2-16 FDA inspection revealed a number of QS violations, including failures to establish complaint handling procedures and to establish a policy of overall intentions and direction with respect to quality. A warning letter was sent to the company in June. In the letter the agency gives recommendations for root cause identification, corrective and preventive action plans. FDA also informed the company about consequences if deviations can not be promptly corrected: "You are responsible for investigating and determining the causes of the violations identified by the FDA. You also must promptly initiate permanent corrective and preventive action of your quality system. Failure to promptly correct these deviations may result in regulatory action being initiated by the FDA without further notice. These actions include, but are not limited to, seizure, injunction, and/or civil penalties. Also, no requests for Certificates to Foreign Governments will be approved until the violations related to the subject devices have been corrected". The warning letter can be downloaded from the Labcompliance Usersclub. Non members can preview excerpts.

September 15, 2005

Inadequate Corrective and Preventive Actions Draws FDA Warning Letter

According to the warning letter, the company failed to establish and maintain an adequate corrective and preventive action procedure which ensures identification of actions needed to correct and prevent the recurrence of nonconforming product and other quality problems. Other violations included to validate changes to your manufacturing processes, Failure to validate your manufacturing process and failure to establish adequate management controls to ensure that an effective quality system has been established and maintained. FDA added that "he violations included in this Warning Letter and discussed above concern significant deficiencies across all of your quality systems, including corrective and preventive actions (CAPA's), that warrant your immediate attention to assure that an effective quality system is in place. The warning letter can be downloaded from the Labcompliance Usersclub. Non members can preview excerpts.