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Labcompliance News, August 2003

August 22, 2003

Electronic Records and Signatures in Europe

The question frequently comes up if European countries are working on a regulation or guideline equivalent to part 11.Most close to part 11 is Annex 11 of the EU/EC GMP directive: Computerized Systems. It has 19 paragraphs with requirements for validation, limited and authorized access to systems and data, recording of attempts to access unauthorized persons, identification of operators by the computer, data integrity and for qualification of personnel.

August 18, 2003

Warning Letters will Speak Louder Than Ever

FDA Warning letters and 483 inspectional observations will be more consistent and predictable around the world. More dialog between the field and the centers and review of the warning letters by the centers will help a lot. This was a conclusion of a discussion around this topic with David Horowitz, Director of CDER's Office of Compliance and Douglas Ellsworth, Director of the FDA's New Jersey District Office at the CDER Life Conference. However, David Horowitz also said: "Warning letters will speak louder than ever now because when industry receives a warning letter they will know that it is not just the view of a particular investigator of a particular district or even of a particular region".

August 16, 2003

FDA Compliance Officer Emphasizes the Importance of Validation Master Plans

In a presentation on June 2nd the importance of a validation master plan has been emphasized by FDA's John Dietrick, a compliance officer in the Center's Division of Manufacturing and product quality. "Without a Validation Master Plan, there may be no direction and little likelihood of success" he said. "It is a tool for planning and documentation and is required by EU as spelled out in Annex 15 of the EU (EC) GMP directive". To get more information on the presentation and on contents of a Validation Master plan, click here.

August 8, 2003

'Advice' on Using Spreadsheets from FDA Inspection Reports

Spreadsheets are frequently used in regulated environments, for example batch releases in pharmaceutical manufacturing can be based on spreadsheet calculations. You can learn from Inspection Reports what FDA's expectations are to demonstrate data integrity and accuracy.