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Labcompliance News, August 2002

On-going Discussion About Durable Media as Criterion for Part 11 Record

Currently there are several discussions going on about the FDA moving away from the concept of 'durable media' as a criterion for electronic records. It came up with a statement of Paul Motise at the IVT ERES conference in Arlington in April 2002. The answer to the question: "Are EPROMS and EEPROMS considered to be storage media when they contain GLP, GMP, GCP related programs or data" was a clear "yes". Labcompliance has investigated the history of this question starting from statements in the part 11 preamble through FDA guidance documents and answers from FDA employees up to the most recent Q&A session. The article also includes references to recommendations from industry consultants.

FDA Warning on Laboratory Equipment, Records and Spreadsheet Applications

This warning letter from July 2002 went to an analytical laboratory of a college that performs testing for a drug manufacturing firm. Citations include missing or inadequate training documentation, missing validation of test methods, and inadequate calibration and maintenance of equipment. Towards the end of the Warning Letter the FDA also cited missing Part 11 functionality by design and missing functionality like security, password control, integrity, back-up and audit trail. Labcompliance user club members can pre-study keywords and extracts and download warning letters (select W-081). To preview extracts and ordering users club membership, click here .

Macro and Spreadsheet Quality Package Available from Labcompliance

The package has been designed to help developers and users of Macro programs and Spreadsheet applications to reduce errors and to comply with regulations, e.g., 21 CFR Part 11. The package includes a CD with an interactive video presentation that is an ideal training material. It also includes a primer as reference material and SOPs on 'Using Macros and Spreadsheets in a Regulated Environment', 'Validation of Macros and Other Software Applications' and on 'Change Control'. Most important are Excel examples for a standard Spreadsheet application and a Macro with functions that are important for quality and compliance. It also includes validation documentation such as 21 Requirement Specifications, project schedule, test plan, test traceability matrix and 13 test protocols. Wit this information you can save days and weeks, you can reduce errors and you are well prepared for the next inspection. Click here to get more info on the package and and ordering.

New FDA Draft Guidance on Bioavailability and Bioequivalency

This guidance is intended to provide recommendations to sponsors and/or applicants planning to include bioavailability (BA) and bioequivalence (BE) information for orally administered drug products in investigational new drug applications (INDs), new drug applications (NDAs), abbreviated new drug applications (ANDAs), and their supplements. This guidance is a revision of the October 2000 guidance. This revised guidance changes recommendations regarding (1) study design and dissolution methods development, (2) comparisons of BA measures, (3) the definition of proportionality, and (4) waivers for bioequivalence studies. The guidance also makes other revisions for clarification.