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Labcompliance News, September 2007

September 27, 2007


PIC/S Releases New Versions of GMP Guides

On September 1, 2007, the Pharmaceutical Inspection Convention Scheme (PIC/S) released new guides for GMP. They contents  and structure are more close to the corresponding EU guides. However, there are also still some differences. For example, the Position of a Qualified Person as defined in the EU guide is still called Authorized Person.

September 17 2007

Recent FDA Inspection Findings Related to Part 11 and Computer Systems

About two years after FDA's release of 21 CFR Part 11 the FDA started to enforce the regulation. This was in 1999. Between 1999 and 2002 the FDA reported many deviations to the regulations in 483's, EIR's and Warning Letters but also through conference presentations of FDA officials. With the promotion of the the new approach in 2003 the FDA stopped enforcing Part 11 and requirements for computer systems but resumed in 2004 and thereafter with highest density in 2006 and 2007. Most deviations have not been referenced directly to Part 11 but to predicate rule requirements. In some cases the FDA also gave advice to specific questions related to Part 11. Labcompliance has published excerpts of 16 FDA inspection reports (483's, warning letters, EIR's) from inspections between 2004 and 2007. Labcompliance has also developed a Part 11 Compliance Package that helps to avoid deviations reports according to current and future Part 11 requirements.

September 27, 2007

EU GMP Annex 2 “Manufacture of Biological Products” available for comments

Annex 2 of the EU GMP Guide has been revised as a consequence of the restructuring of the GMP Guide and the introduction of GMP for active substances used as starting materials. Further revision was necessary due to an increase of breadth of biological products. In addition, with the agreement on the new regulation on advanced therapies the Commission is asked to draw up specific GMP guidelines for advanced therapy medicinal products, including gene therapy, somatic cell therapy medicinal products and tissue engineered products as defined in the regulation.

September 27, 2007

EMEA Answers Questions Related to Harmonized Test Methods in Microbiology

Questions and Answers are related to PH. EUR. Chapters 2.6.12, 2.6.13 AND 5.1.4:  Examples are "How should industry apply the harmonized chapters of Ph. Eur. 2.6.12 Microbiological harmonization of non-sterile products – Microbial enumeration tests?" or "Should industry demonstrate the suitability of the harmonized methods for every registered product?". Questions and answers are available on EMEA"s Quality Working Party (QWP) website.

September 17, 2007

New Part 11 Tutorial

The new Part 11 Tutorial should help to to get a good understanding on basic requirements and FDA's new approach for Part 11. The tutorial includes includes

  • A primer with basic information and recommendations for implementation
  • Expert advice on selected topics
  • Links to warning letters, 483's and/or establishment inspection reports
  • Literature references
  • Links to other websites

September 17, 2007

85 SOPs from Labcompliance 

Labcompliance now offers 85 model SOPs for regulated industry. They can be used as a starting point for further customization, they save time and can increase confidence for inspections. They are available in PDF format or in Microsoft word with hyperlinks for easy customization. For a list with titles and ordering, click here.