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Labcompliance News, July 2003

July 29,2003

Final Part 11 Guidance Most Likely to be Released on August 20

The final version of the new part 11 guidance on scope and applications will most likely be released on August 20, 2003. The guide was announced for end of June and then July. We do not believe that the delay was because of many changes. We still believe the final guidance will be very similar to the draft version from February 20. A thorough interpretation on what the new guidance means in practice has been described by Winter&Huber in a publication from BioPharm.

July 3,2003

New Publication: GMP Implementation for Near Infrared Spectrophotometry

The authors used ICH, USP, EP and ASTM method validation guidelines in combination with standard computer hardware and software qualification/validation guidelines to pave the way for GMP roll out and implementation of Near Infrared Spectrophotometry.

July 3,2003

Question and Answers on Active Pharmaceutical Ingredients

Since the release of the ICH Guidance on Active Pharmaceutical Ingredients there have been many questions about practical implementation. Questions have been around responsibilities of QA, e.g., does the quality unit have to approve laboratory procedures, cGMP certification of API manufacturers, rejection procedures of API's, when does a material become an API, do methods for testing raw materials have to be validated and so on. The PDA has developed a list of Q&A that came up during ICH related PDA training sessions. The answers are not intended to be regulatory policy nor do they reflect the position or opinion of individual companies, countries or government agency. The Q&As can be downloaded from the PDA website.

July 3,2003

Canadian Therapeutics Good Directorate Updates Guidance on Risk Classification

The guidance on risk classification has been updated in April. A product has been defined ass critical if one or more of the following criteria apply:

  • narrow therapeutic window
  • high toxicity
  • sterile product
  • biological drug
  • complex manufacturing process.

Over-the-counter products, low dosage vitamins and minerals are not considered critical even when their manufacturing processes are complex. Most valuable are three Appendices with examples of critical, major and other observations The Guidance is available from the TGD website.

July 3,2003

Note for Guidance on Validation of Non-Standard Processes

The European Committee for Proprietary Medicinal Products has published draft Annex II to Note for Guidance (NfG) on Process Validation - Non-Standard processes. The NfG defines four categories on non-standard processes.