The ICH has published the final version of the Q&A document to the ICH Q7 Guideline: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients. The document was prepared by the Q7 Implementation Working Group in order to clarify uncertainties related to the interpretation of some sections.
As previously announced by the ICH, new training material to ICH documents will be published and updated on the ICH website on a regularly basis. The intention behind this supporting service is to facilitate the implementation of ICH Guidelines by resolving uncertainties which have arisen during the application of the guideline.
The WHO has published the final versions of the
Both documents were released as part of the Technical Report Series 992, which was published by the WHO Expert Committee on Specifications for Pharmaceutical Preparations in May 2015.
The EMA has released a concept paper on new guidance for importers of medicinal products. GMP/GDP Inspectors Working Group agreed to draft a specific guidance for import authorisation holders. This document most likely would take the form of a new annex (Annex 21). The deadline for comments is 29 August 2015.
The ICH Steering Committee (SC) will meet in Fukuoka, Japan from 6 to 11 June to discuss ongoing harmonisation activities. One item on the agenda is the development of the ICH Q12 Guideline on Lifecycle Management.
The IPEC Federation (International Pharmaceutical Excipients Council) has published a three-page position paper concerning the risk-based approach of the EU Guidelines following the principles of Quality Risk Management according to ICH Q9. The IPEC-paper applies to the community regulated under the EU Risk Assessment Guidelines.
The European Commission has published the responses to the public consultation on the revision of Annex 15: Qualification and Validation.
For many years now, discussions have been ongoing as to whether it is possible to include non-distillation technologies as a method for the production of Water for Injections (WFI). Following a number of consultations with its stakeholders, the Ph. Eur. is proposing a revision of the monograph for Water for Injections (0169) to take into account current manufacturing practices which use methods other than distillation to produce water of injectable quality. The draft of the monograph foresees production of WFI also by reverse osmosis, which may be single-pass or double-pass, coupled with other suitable techniques such as deionisation and/or ultrafiltration.
As announced on the website of the Pharmaceutical Inspection Co-operation Scheme (PIC/S), the PIC/S Committee, by written procedure, has adopted the revision of Annex 15 of the PIC/S GMP Guide. The document will enter into force on 1 October 2015, simultaneously to the EU revision of Annex 15.
The currently valid version of the EU GMP Guide Annex 15 “Qualification and Validation” from 2001 will finally be replaced by 1 October 2015. This is when the now published revised Version of Annex 15 will enter into force. An update was more than necessary. Not only the new principles of ICH Q8, Q9, Q10 and Q11 constituted a new regulatory environment but also a continuous updating of Chapters of Part I of the EU GMP Guide or Annex 11 (computerised systems). Another important document to be mentioned in connection with the new Annex 15 is the EMA guidance on process validation. The changes now reflect the changed regulatory requirements and the latest state of technology in the pharmaceutical industry.