[Stability Testing related News – vol.9]

◆ Implementation of the ASEAN Guideline on Stability Study for Drug Product (10-Sep-13 HSA)

With the adoption of version 6.0 of the ASEAN Guideline on Stability Study for Drug Product at the 20th ACCSQ-PPWG, the implementation of this guideline is timely, especially with the implementation of the ASEAN Variation Guideline.

Since implementation of the ASEAN stability guideline has taken a 2-phase approach from 1 January 2009, the impact associated with full implementation of version 6.0 of this guideline has been minimised.

Implementation of the ASEAN stability guideline is proposed for 1 April 2014, in line with the 1st phase of the implementation of the ASEAN Variation Guideline as described above.

There will be an additional 6-month grace period, if needed. Thus, full implementation of the ASEAN Guideline on Stability Study for Drug Product will be 1 October 2014.

For access to version 6.0 of the ASEAN stability guideline, you may find the document here on the HSA website.


◆ Summary of the new EU GMP Chapters and Annexes (15-Jan-14 ECA)

The last year was an interesting year for those who have to have an eye on GMP regulations in the European Union. The EU GMP Guide is under constant revision. Here is an overview:

On 16 February 2014, the new Chapter 2 Personnel will become effective. The basic principles of chapter 2 have been unchanged; however a few new topics have been introduced like for example a more important role of Senior Management. The new chapter accommodates the trend in pharmaceutical industry to move more and more quality related tasks to a quality assurance department. In the old version, which will now be replaced, a lot of quality related responsibilities were assigned only to the Head of Quality Control and the Head of Production. Now, additionally and depending on the size and organisational structure of a company, a “separate Head of Quality Assurance or Head of the Quality Unit may be appointed”. In this case, some of the responsibilities can be shared with the Head of Quality Control and Head of Production.


◆ Implementation of Good Distribution Practices: Explanatory Notes from MHRA (15-Jan-14 ECA)

The Medicines and Healthcare products Regulatory Agency (MHRA) has published a document to clarify the interpretation of the new EU Good Distribution Practice (GDP) Guideline. The document should be read alongside with the GDP Guide for better understanding.

The MHRA has made concrete statements to this point: “Temperature should be recorded in degrees Celsius. Any temperature monitoring equipment should have a resolution of 0.1degree Celsius (C) and the calibrated accuracy of the equipment should be +/- 0.5 C for cold stores, refrigerators and controlled temperature environments. For temperate areas, a calibration accuracy of +/- 1.0 C is acceptable.”


◆ FDA: more Inspections in 2014 (29-Jan-14 ECA)

U.S. President Barack Obama has signed the budget for the fiscal 2014 for U.S. Government agencies. With their new budget, The U.S Food and Drug Administration FDA will be able to increase drug plant inspections worldwide and especially in China. The FDA has been given the money which was needed to fund necessary operations. And it seems they got what they requested. In their request, FDA asked for budget to “perform additional foreign inspections in China, focusing on facilities that produce drugs and drug ingredients …”. “FDA will also conduct training with Chinese drug authorities to enhance their ability to regulate pharmaceutical products exported to the United States”.


◆ Electronic Submission of Marketing Authorisation Dossiers (29-Jan-14 ECA)

“How and to whom shall I submit my dossier?” – this question is No 28 of EMA’s Q&A document on procedural issues in the context of the centralised procedure (“Pre-authorisation Procedural Advice for Users of the Centralised Procedure“; EMA/339324/2007). The answer to this question was updated in December 2013 and describes the approach to the submission of a dossier in the electronical format in the context of the centralised procedure (since the 1st of January 2010, all paper submissions have been rejected). The answer contains references to documents and Guidelines which have been also recently updated.

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