Almost one year ago, on 15 September 2015, the European Commission published a comprehensive draft version of Annex 17: Real Time Release Testing (we reported). The seven-page document was open for public consultation until December 2015. All in all 12 responses were received which have now been published on the Commission's website.
As previously announced, the International Council on Harmonization (ICH) has now published the additional two training modules to ICH Q3D Elemental Impurities on its website. The modules 8 (case studies) and 9 (FAQs) are part of a comprehensive training programme prepared by the ICH Implementation Working Group (our news of March 2016).
According to pharmabiz.com, the Indian Central Drug Standards Control Organization (CDSCO) is planning to recruit 500 more drug inspectors by the end of 2017. Up to now 147 inspectors have already been trained to enhance inspections of manufacturing units in line with current Good Manufacturing Practices (cGMP).
On 8 August 2016, the U.S. Food and Drug Administration (FDA) updated the list of new and revised draft guidances CDER is planning to publish until the end of this year.
EMA has added the topic of Data Integrity to its list of Q&As regarding the overall area of EU-GMP.
The EMA has just published a draft for a questions and answers paper on production of water for injections (WFI) by non-distillation methods. The Ph.Eur. monograph for WFI was revised to include, in addition to distillation, reverse osmosis (RO) coupled with suitable techniques, for the production of WFI.
From 4 to 8 July 2016, the MHRA hosted the following events in Manchester (UK): PIC/S Committee meeting, PIC/S Executive Bureau meeting, and PIC/S Annual Seminar.
WHO has recently issued a 21-page draft document “Guidelines on Validation” which covers the main principles of validation and qualification. The guidelines are not intended to be prescriptive in specific validation requirements but focus on the overall concept of validation. The principles may be considered useful in its application in the manufacture and control of starting materials and finished pharmaceutical products (FPPs) as well as other areas. Validation of specific processes and systems, e. g. sterile product manufacture, are beyond the scope of the guideline.
FDA has published an 11-page draft guidance on elemental impurities that provides recommendations regarding their control in human drug products marketed in the United States. The draft document is set up in consistence with ICH Q3D, published in August 2015 by the ICH (International Council for Harmonisation). The FDA draft guidance intends to help manufacturers to comply with ICH and United Pharmacopeial Convention (USP) standards.
The International Council for Harmonisation (ICH) met in Lisbon, Portugal in June 2016. Two new members were accepted and 14 new observers welcomed.
Two pharmaceutical industry bodies were accepted as new Members:
- The International Generics and Biosimilars Association (IGBA)
- The World Self-Medication Industry (WSMI).
The FDA has issued a 10-page technical specifications document providing recommendations on the submission of data to support quality metrics as part of the process validation lifecycle and pharmaceutical quality system assessment. The guide serves as the technical reference for implementation of the draft FDA guidance “Request for Quality Metrics” that was published in July 2015 and can be seen as a supplement.
Almost one year after publishing the draft, the WHO has now issued the final version of the Guideline to “Good Data and Record Management Practices”. The document is part of the Technical Report Series No. 996, 2016 and is therein listed as Annex 5.
With the U.K. voting to leave the EU, the speculation about a new headquarter for the European Medicines Agency EMA have started. The London-based EMA approves medicines for all EU countries. With a full-time staff of around 750, it is the largest EU body in Britain.