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Labcompliance News, March 2006

March 7, 2006

"GC and HPLC Qualification SOPs Should be Uniform" FDA Inspection Report Says.

It is difficult to justify why instruments in the same category, e.g., HPLCs, follow different qualification protocols. However, this frequently happens, when instruments are qualified by instrument suppliers with different proprietary protocols. A recommendation about this was made in an FDA inspection report: "The firm does not have a written procedure that includes requirements for the performance verification of HPLC and GC systems. They do not have specific directions. "During the inspection, the firm did not provide an SOP for the performance verification of the HPLC and GC systems. Actually, they are contracting services for the verification of those systems, and then they are adopting contractor's SOP. Each of them has different SOPs, which includes different types of tests that does not compare. The firm should establish a procedure to assure uniformity providing specific directions. The inspection report further noted: "The balance used to weigh more than 20 mg did not comply with the USP 0.1% requirement for balance measurement uncertainty" and Documentation of the GC system calibration performed by an outside contractor is incomplete. It does not include the following information: acceptance criteria and instrument identification. The 16 page inspection report can be downloaded from the Labcompliance Users Club. Non members can preview excerpts. . Recommendations for FDA compliant equipment qualification can be found in the USP draft chapter "Analytical Instrument Qualification". To learn more about this chapter, click here.

March 7, 2006

FDA Releases Updated Draft Guidance on Impurities in New Veterinary Medicinal Products

The document provides guidance to registration applicants on the content and qualification of impurities in new veterinary medicinal products produced from chemically synthesized new veterinary drug substances not previously registered in a country, region, or member state. The guidance addresses only those impurities in new veterinary medicinal products classified as degradation products of the new veterinary drug substance or reaction products of the new veterinary drug substance with an excipient and/or immediate container closure system. According to the guidance, the registration applicant is expected to summarize the degradation products observed during manufacture and/or stability studies of the new veterinary medicinal product.

March 7, 2006

FDA Releases Final Guidance for GMP Inspection Dispute Resolution

FDA has released the final guidance for industry entitled ``Formal Dispute Resolution: Scientific and Technical Issues
Related to Pharmaceutical CGMP.'' The guidance was developed as part of the FDA initiative ``Pharmaceutical CGMPs for the 21st Century: A Risk-Based Approach,'' which was announced in August 2002. The initiative focuses on FDA's current CGMP program and covers the manufacture of veterinary and human drugs, including human biological drug products. The guidance describes a formal, two-tiered dispute resolution process intended to resolve disputes of scientific and technical issues relating to current good manufacturing practice (CGMP) that arise during FDA inspections of pharmaceutical manufacturers. According to the guidance, inspectors are expected, during inspections of manufacturers, to make every reasonable effort to discuss observations relating to manufacturing quality as they are observed, or on a daily basis to minimize surprise, errors, and misunderstandings when a Form FDA 483 is issued. At the conclusion of an inspection, investigators will normally meet with the manufacturer's management to again discuss observations and solicit views and additional relevant information

March 7, 2006

Lack of Complete Records of Modification Modifications Cited in FDA Warning Letter

The FDA expects modifications to an established method to follow a documented change control procedure and changes be recorded. This was confirmed through an FDA warning letter to a drug manufacturing operation. According to the letter the company failed "To maintain complete records of any modification of an established method employed in testing, including the reason for the modification and data to verify that the modification produced test results at least as accurate and reliable for that material being tested as the established method." The company also failed "To establish and follow validated sampling and testing procedures of in process materials and drug products". The Warning Letter can be downloaded from the Labcompliance Users Club. Non members can preview excerpts.  Recommendations for FDA compliant equipment qualification can be found in the USP draft chapter "Analytical Instrument Qualification". To learn more about FDA compliant method validation and change control, click here.