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Water for Pharmaceutical Purposes

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According to pharmabiz.com the WHO expressed strong interest in setting up a centre of excellence (CoE) in regulatory science at the Indian Gujarat FDCA’s (Food and Drug Control Administration) office. This will be the first Asia-Pacific-CoE of the WHO. If things go as planned, all the financial and technical support will be given by the WHO while the state government of Gujarat will provide infrastructural support within the FDCA’s building.


According to the Chinese regulatory authority CFDA, China and the United States agreed to further enhance cooperation in the field of food safety, joint actions against online sales of counterfeit drugs, drug and medical device registration approval and clinical trial, as well as dialogue on cosmetics supervision, in order to protect the health of the public.


In 2014, the European Medicines Agency (EMA) published a Qualified Person (QP) declaration template together with a guidance document. This template provides a basis for demonstrating compliance of the API-manufacture with the current GMP requirements and a relevant knowledge of the supply chain. However, the past year has shown that there are still uncertainties and open questions.


In October 2015, a PIC/S Committee meeting took place in Nusa Dua (Indonesia). 30 out of 46 PIC/S Participating Authorities attended the meeting.

Here are some of the Meeting highlights in short:


Chapter 1231– Water for Pharmaceutical Purposes (USP 38) – from the US-American Pharmacopeia is currently under revision due to a conclusion of the former Pharmaceutical Waters Expert Committee and public comments suggesting a more user-friendly version of the chapter. The overall intent and purpose of the chapter remained unchanged.


Five Indian manufacturing facilities from both, Sandoz and Dr. Reddy’s, received warning letters from the US Food and Drug Administration (FDA) for serious data integrity violations.


The government of France has proposed a new labelling claim to the European Commission – a pictogram – indicating that the manufacturing operations of excipients, the manufacturing of the active substance, its production or packaging were carried out within the territory of the European Union or Member States of the European Free Trade Association (EFTA).


Professor Guido Rasi took office as Executive Director of the European Medicines Agency (EMA) on 16 November 2015. He had already held this position from 2011 - 2014 before he had to step down due to a formal error in the selection procedure.


The International Council for Harmonisation (ICH), formerly the International Conference on Harmonisation (ICH) held the inaugural meetings of its new Assembly [and Management Committee] on 23 October 2015.


Already discussed at a WHO-meeting in April 2014, the WHO has now published a 35-pages draft to the Guideline for Good Data and Record Management Practices.


The U.S. FDA (CDER, CBER, CDRH) has published a draft guidance on the "Selection of the Appropriate Package Type Terms and Recommendations for Labeling Injectable Medical Products Packaged in Multiple-Dose, Single-Dose, and Single-Patient-Use Containers for Human Use".


China Food and Drug Administration (CFDA) has published four new guidelines explaining its approach to on-site inspection for medical device good manufacturing practices. The documents are intended to strengthen the supervision and management of medical device manufacturing and to offer guidance to regulatory departments during on-site inspections or when evaluating inspection results. The main document covers an overall approach, while the other three focus on in-vitro diagnostics, sterile and implantable medical devices.


This month the British MHRA (Medicines and Healthcare products Regulatory Agency) signed a Memorandum of Understanding (MOU) with CDSCO (Central Drug Standard Control Organisation), its counterpart in India. This comes as no surprise, considering that nearly 25% of UK medicines are made in India.


A new version of Annex 16 of the EU GMP Guide "Certification by a Qualified Person and Batch Release" has been published by the European Commission. This version will become operational on 15 April 2016.


During a consultation on data management, bioequivalence, GMP and medicines inspection held by the WHO in 2015, a revision of the Supplementary Guidelines on Good Manufacturing Practices for Heating, Ventilation and Air-conditioning Systems for Non-sterile Pharmaceutical Dosage Forms was discussed with the inspectors.

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