EU guidelines A number of EU guidelines have been proposed for adoption or non-adoption by the TGA. These are now open for comment until 19 August 2013. The guidelines in question are listed below: Guideline on quality aspects on the isolation of candidate influenza vaccine viruses in cell culture. Guideline on the requirements for quality documentation…
Why is this required? In line with the new European Falsified Medicines Directive, all active substances imported into the EU must now be accompanied by a written confirmation from the competent authority of the exporting country which confirms that the standards of GMP and control of the manufacturing plant are equivalent to those in the…
The impact of recent changes to the “Internationally harmonised requirements for Batch Certification”? The European Union (EU) has reformed the rules for importing active pharmaceutical ingredients into the EU for medicinal products for human use. As of 2 January 2013, all imported active substances must have been manufactured in compliance with standards of good manufacturing…
On December 12 and 13, 2012, the MHRA held its annual GMP Symposium. I was able to attend this event and have captured some of the major themes within this blog. December 12 – Good Manufacturing Practices Update MHRA Future Directions The UK’s MHRA has recently confirmed its short-term areas of criticality. These include: Product…
This concept paper addresses the need to update Annex 17 (Parametric release) of the EU GMP Guide. At the time the original guideline was adopted (January 2002), the main foreseen application area was sterility testing, with a particular focus on the release of terminally sterilised medicinal products. Since then, there have been significant changes in…
Annex 15 qualification and validation was originally published in September 2001, and since then there have been significant changes in the GMP environment with the incorporation of ICH Q9 and Q10. In addition, the Quality Working Party (QWP) is in the process of updating its guideline on Process Validation, and there has been advancement in…
Chapter 7 “Contract Manufacture and Analysis” will be re-titled as “Outsourced Activities” from the 31st of January 2013. The revision will provide further clarification and guidance on “any activity covered by the GMP guide that is outsourced”, rather than just “contract manufacture and analysis”, as per the previous version. This update also aligns the context…
As of the 31st of January 2013, Chapter 1 will come into operation titled as “Pharmaceutical Quality System” in order to align with the concepts and terminologies described in the ICH Q10. The current version of Chapter 1 describes “Quality Management” and how it incorporates Good Manufacturing Practice (GMP). The new revision further clarifies that…
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