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Labcompliance News, April 2003

April 16, 2002

FDA Releases Draft Guidance: PET Drug Products - Current Good Manufacturing Practice (CGMP)

This draft guidance is intended to help PET drug producers better understand FDA's thinking concerning compliance with the preliminary draft proposed CGMP regulations if they were to become final after notice and comment rulemaking. The guidance addresses resources, procedures, and documentation for PET drug centers, large and small. In some cases, the guidance provides practical examples of methods or procedures that PET centers could use to comply with possible CGMP requirements. In developing this draft guidance, FDA has taken into consideration relevant issues, concerns, and questions raised at the public meetings held with professional associations, producers of PET drug products, and other interested parties.
The guidance has sections on Laboratory controls, stability testing and computer controls and makes reference to 21 CFR Part 11: Corrections to electronic records should be recorded according to Part 11 (21 CFR Part11: Electronic Records; Electronic Signatures).

April 16, 2002

Major Revision of the Labcompliance Glossary

Understanding terminology is most important for validation and compliance. Labcompliance has updated it's glossary with more than 50% new content. Terms related to networking have been as well as some of the new terms used in FDA's most recent guidance documents. With this the Labcompliance glossary probably is the most extensive of it's kind in the industry. We also have added a link from the Labcompliance entry side to the glossary for easy access. To access the glossary, click here.

April 16, 2002

CITAC Publication on Traceability

The Co-operation in International Traceability in Analytical Chemistry (CITAC) has published a paper entitled 'Traceability in Chemical Measurement'. The paper discusses the importance of traceability for accurate analytical measurements and for mutual recognition of test results. Furthermore, the paper has paragraphs on Merits and Added Value of Traceability for Laboratories and Customers, Technical Elements of Traceability, Traceability of Values Carried by Reference Materials and References.