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Labcompliance News, September 2001

Sept 1, 2001

The Future State of Computer Validation

Regulatory requirements for computer validation are changing. What is good today may not be enough any more tomorrow. Therefore it is important not only to keep up-to-date with current trends but also to look into the future.

Nine world experts wrote an article in Pharmaceutical Technology with the attempt to look at the future state of computer validation principles based on the current events and trends in regulations, business practices, and technology. This crystal-ball approach will prepare the industry for the future by establishing a current-state best-practice foundation of computer validation principles as well as improving computer validation practices.

Authors are: Rory Budihandojo (Head of R&D IT Quality and Testing, Centre of Expertise at GlaxoSmithKline), Paul D'Eramo (former FDA employee, now Executive Director at Johnson&Johnson), David J. Bergeson (former FDA employee, now senior compliance consultant at KMI), Ludwig Huber, PhD, author of two validation books), Orlando Lopez (Senior consultant at McNeil Consumer Healthcare, a J&J company), Arthur Perez (Associate director at Novartis Pharmaceuticals), David Selby, PhD, is a managing partner at Selby Hope International, also known as the 'father of GAMP'. Guy Wingate, PhD, (Head of GMS Global Computer Validation at GlaxoSmithKline. Michael Wyrick (Director of IT Consulting Services at KMI, a division of Parexel International LLC.)

Sept 1, 2001

EU GMP Annex 15 on Validation and Qualification in Operation

The Final Version of Annex 15 to the EU Guide to Good Manufacturing Practice is coming into operation in September 2001. This Annex describes the principles of qualification and validation which are applicable to the manufacture of medicinal products. It has sections on planning for validation, documentation, DQ, IQ, OQ and PQ, process validation, cleaning validation, revalidation and change control. The planning for validation requires a validation master plan or an equivalent document (an example for a validation master plan is available from the Labcompliance book shop).

Sept 6, 2001

Update with Q&A's from FDA's Christine Nelson on Part 11

At a conference on June 29, 2001, Christine Nelson from the US FDA gave an update on part11. She talked about the purpose of Part 11, other electronic records/signatures regulations and current and future FDA guidance documents. She also gave four recommendations on what the industry can do. At the end she answered most frequently asked questions. One of them was whether paper print-outs can be a substitute of e-records. An other one was if there is a deadline on when the FDA will not accept signatures on paper any more. User club members can download the presentation, for preview and ordering users club membership, click here