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The New USP <1231>
Water for Pharmaceutical Purposes

a detailed Overview


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4. The New USP <1231>: Water for Pharmaceutical Purposes
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News about GMP/cGMP


On 9 February 2016 the European Commission published the Delegated Regulation 2016/161 in its Official Journal. The document sets out the details of obligatory “safety features” for the packaging of medicinal products for human use.


Counterfeit drugs are a major threat to public health. Current efforts to guard against counterfeit medicines often focus on serialization of the secondary packaging which - while providing a substantial improvement in patient safety - does not allow tracing of the individual unit.


The U.S. Food and Drug Administration (FDA) published the yearly list of new and revised draft guidances, CDER is planning to publish in 2016. A total of 102 planned guidance documents are set out. There are a couple of carry overs from 2015, e. g. documents on the drug supply chain security act, on biosimilars or two guidances in the field of GMP.


The WHO has listed a revised guideline WHO GMP for Biological Products which was adopted by the 66th Meeting of the WHO Expert Committee on Biological Standardization. The document is proposed to be published in its final editorial form in the next WHO Technical Report Series.


On 1 January 2016, the Pharmacy and Poisons Board of Hong Kong SAR (PPBHK) as well as the Agency for Medicinal Products and Medical Devices of Croatia (HALMED) became the 47th and 48th PIC/S Participating Authorities.


According to the ICH, the Australian Therapeutic Goods Administration (TGA) has become the latest ICH Observer. In this position the TGA is now allowed to attend ICH Assembly meetings and to participate in ICH activities.


EMA has published the work plan of the GMP/GDP Inspectors Working Group for 2016. The plan covers the different tasks of the group, e.g. harmonisation of inspections, mutual recognition agreements (MRAs) (maintenance, extension of scope) and GMP/GDP topics.

Two issues stand out from the usual subjects: European inspectors see the need for guidance on data integrity and on the implementation of cross-contamination risk management in shared manufacturing facilities for industry as well as for inspectorates.


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.

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