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Labcompliance News, December 2001

Dec 13, 2001

PhRMA Sends Response to FDA's Part 11 Guidance

The Pharmaceutical Research and Manufacturers of America (PhRMA) has sent a letter in response to FDA's proposed guidance on the scope and implementation of 21 CFR Part 11. The letter suggests that companies should achieve compliance for high priority systems within five years. Medium and low risk systems should be implemented based on availability of commercial software and on the position of individual systems in their overall lifecycle. 

Dec 3, 2001

FDA Releases Final API Guidance

On Sept 24 the FDA released the International Conference on Harmonization (ICH) Q7A guidance for the production and control of active pharmaceutical ingredients (APIs). The guidance covers OTC drugs and clinical supplies but no veterinary products. The guidance is intended to replace FDA's own guidance on API GMPs from 1998.

Dec 3, 2001

Inadequate Spreadsheet Validation Cited in a Warning Letter

FDA's Warning Letters get more and more specific. While in the past we saw citations like "Software not validated" a warning letter from July reads: Failure to have an adequate validation procedure for computerized spreadsheets used for in-process and finished product analytical calculations. Spreadsheet Validation is deficient in that only a small range of values are being used to challenge computerized spreadsheet mathematical calculations" (W-063). Labcompliance user club members can pre-study keywords and extracts and download warning letters. To preview extracts and ordering users club membership, click here. Members can also find SOP's for validation of spreadsheet calculations and Marcos in the section computer validation.
Other new warning letters on the users club site list deviations regarding missing or inadequate corrective and preventive action procedures, missing non conformity evaluation, process validation (W-062) and missing or inadequate collection of representative samples of components for testing and examination (W-061).

Dec 3, 2001

Article on Qualification of Equipment and Computerized Systems

Written by Ludwig Huber, Published in Pharmaceutical Canada. Using examples from an analytical laboratory, this paper guide users of equipment and computerized systems through the entire qualification process from DQ to IQ, OQ and PQ. It lists major steps and examples of each qualification phase. Main focus is on setting specifications and testing. User club members can download the paper.