[Stability Testing related News – vol.6]

◆ Draft Guideline ICH Q3D for Elemental Impurities published(06-Aug-13 ECA)

The ICH Q3D Guideline on Elemental Impurities has just been published.
This Guideline will have a major impact on both the pharmaceutical and the API industry and companies now have to make efforts to be prepared for the new provisions of the guideline.

◆ WHO revises GMP Guide regarding the Principles of GMP(14-Aug-13 ECA)

In July the WHO has published a revised version of their Guideline “Good Manufacturing Practices for Pharmaceutical Products: Main Principles” for comment.
Following sections have been changed in this draft:
1. Pharmaceutical quality system (formerly “quality assurance”)
2. Good Manufacturing Practices for pharmaceutical products
7. Contract production and analysis
17. Good practices in quality control

◆ New FDA Guidance on the Finalization of several FDA Draft Guidances(14-Aug-13 ECA)

On 7. August 2013 the US FDA published a notice in the federal register entitled: Retrospective Review of Draft Guidance Documents Issued Before 2010; Withdrawal of Guidances.
CDER has reviewed many draft guidances published before 2010. As a result of this review, FDA identified 23 draft guidances for withdrawal.
One of them is“Manufacturing, Processing, or Holding Active Pharmaceutical Ingredients”?issued April 1998.

◆ CEPs are becoming more transparent(17-Jul-13 ECA)

A release recently published by the EDQM states that starting on 15 July 2013 all revised or newly issued CEPs will comprise detailed information on operations involved in the manufacture and testing of the API – as, e.g., facilities in which intermediates were manufactured or in which milling or sterilisation steps were conducted. The CEP will also list quality control labs and facilities for in-process controls. For CEPs issued before 15 July 2013 the manufacturers are asked to forward this information to their customers.
The background for this extension of CEPs are the regulations of the recently revised EU “Guideline on Active Substance Master File Procedure”; CHMP/QWP/227/02 Rev 3/Corr”, which requires exactly this detailed information for the ASMF (see our GMP News from 19 June 2013). To ensure the CEP procedure’s consistency with the ASMF procedure the EDQM has taken over these requirements. They are by the way only applicable to CEPs describing the API’s purity. CEPs on TSE are not affected.

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