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.