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 availableto the public. With this, the guideline is now harmonised in Europe, the US andJapan. The authorities in the 3 regions, i.e. the EMEA/European Commission inEurope, the FDA in the USA and MHLW in Japan, are now required to include thisregulation 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 orby 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 ourGMP News of 31 May 2007), you will see several more concrete formulations, whichwill have to be taken into account during establishment.
The version that has now been adopted contains a stronger emphasis of the threeguidelines ICH Q8 "Pharmaceutical Development" (includes among other thingsQuality by Design), Q9 "Quality Risk Management" and the now published finalversion of Q10. It is stressed that one will only be able to achieve the aims ofa new "quality paradigm" by implementing these three ICH guidelines.
What is new in the Step-4 version is Annex 2 with an illustration explaining themodel once more. A surprising feature of the image is the possibility to readinto it that GMP is not yet necessary during development. However, this iscertainly not intended.
Apart from the emphasis on local GMP requirements, which haveto 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 itclear that, in case of outsourcing, the quality system already has to begin withthe selection of potential partners. This is something that many companies maynot yet have implemented within the framework of supplier/contract manufacturerqualification. What is also interesting is the requirement to defineresponsibilities and to establish a structured communication process. Thecompanies will also have to check in how far monitoring of the outsourcedactivities has been established in compliance with Q10.
The final Guideline ICH Q10 is obviously also a reaction to the currentdiscussions about the global supply chains, which every enterprise hasimplemented today, and to the resulting (control) problems. This becomes clearamong others in points 2.8 and 4.2, which deal with the complexity in case ofcompany takeovers. It was conspicuous that in those cases in which considerableGMP problems were identified quite recently, in the previous months/years, oneor even several changes of ownership of the concerned site had occurred.
The Guideline ICH Q10 "Pharmaceutical Quality System" can be found here.
On behalf of the European Compliance Academy (ECA)