On 4 June 2008, the ICH adopted the Step-4 version of the Guideline ICH Q10 "Pharmaceutical Quality System", and now it has also made the document available to the public. With this, the guideline is now harmonised in Europe, the US and Japan. The authorities in the 3 regions, i.e. the EMEA/European Commission in Europe, the FDA in the USA and MHLW in Japan, are now required to include this regulation in their respective legislative/ordinance procedures.

In Europe, this can e.g. be done in the form of Annex 21 to the EC GMP Guide or by means of changes to the text of Part 1 and Part 2 of the Guide. In this way, the implementation of ICH Q9 "Quality Risk Management" was e.g. realised.

If you have a look at the changes in comparison with the Step-2 version (see our GMP News of 31 May 2007), you will see several more concrete formulations, which will have to be taken into account during establishment.

The version that has now been adopted contains a stronger emphasis of the three guidelines ICH Q8 "Pharmaceutical Development" (includes among other things Quality by Design), Q9 "Quality Risk Management" and the now published final version of Q10. It is stressed that one will only be able to achieve the aims of a new "quality paradigm" by implementing these three ICH guidelines.

What is new in the Step-4 version is Annex 2 with an illustration explaining the model once more. A surprising feature of the image is the possibility to read into it that GMP is not yet necessary during development. However, this is certainly not intended.

Apart from the emphasis on local GMP requirements, which have to be seen in connection with ICH Q10, above all the part on outsourcing (Chapter 2.7) has been elaborated in much more detail. The guideline makes it clear that, in case of outsourcing, the quality system already has to begin with the selection of potential partners. This is something that many companies may not yet have implemented within the framework of supplier/contract manufacturer qualification. What is also interesting is the requirement to define responsibilities and to establish a structured communication process. The companies will also have to check in how far monitoring of the outsourced activities has been established in compliance with Q10.

The final Guideline ICH Q10 is obviously also a reaction to the current discussions about the global supply chains, which every enterprise has implemented today, and to the resulting (control) problems. This becomes clear among others in points 2.8 and 4.2, which deal with the complexity in case of company takeovers. It was conspicuous that in those cases in which considerable GMP problems were identified quite recently, in the previous months/years, one or even several changes of ownership of the concerned site had occurred.


The Guideline ICH Q10 "Pharmaceutical Quality System" can be found here.

We have created a comparison of the Step-3 and Step-4 version for you in which you can track the changes in detail. This comparative document can be found here.

Author:
Oliver Schmidt
On behalf of the European Compliance Academy (ECA)