Not only China and India are in the focus of the US FDA when it comes to GMP non-compliance. Recently the FDA has released warning letters for cGMP violations identified in Scotland, the Netherlands and Switzerland.
According to RAPS, the CFDA (Chinese Food and Drug Administration) has released a draft guidance on drug data management practices. The paper is addressed to manufacturers, developers and distributors of pharmaceutical products and aims at an accurate, timely and traceable recording of data.
The European Directorate for the Quality of Medicines and Healthcare (EDQM) announced a new agreement with Japanese authorities. The intention is to share more information on the outcome of GMP inspections of manufacturing sites of active pharmaceutical ingredients (APIs) that are of interest to both Europe and Japan.
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.