An open expert-advisory workshop on the topic «Water-treatment in pharmaceutical production in view of up-to-date regulatory requirements and trends» to be held on 8-9 November, 2018

Within the program of promoting implementation of the best practices in the Russian pharmaceutical industry, Federal State Institution «State Institute of Drugs and Good Practices» and Pharmstrategy, Ltd. will hold an open expert-advisory workshop on the topic «Water-treatment in pharmaceutical production in view of up-to-date regulatory requirements and trends».

Water-treatment in pharmaceutical production is one of the «critical» utilities, towards which proper design and operation are traditionally of close attention both for drug manufactures and supervising regulatory authorities. Non-compliance with GMP requirements in terms of water-treatment systems results in a high risk of obtaining water with excursions in quality parameters. In its turn, this directly leads down to deviations in quality parameters of the drug manufactured using such water. Quite often, major and critical non-conformities are identified in this area during GMP-inspections.

Over the last years, the regulatory environment in terms of the requirements for quality parameters and generation methods of pharmaceutical water has become more stringent. It’s worth noting the significance of such changes as:

• Revision of the effective version of the Ph.Eur. monograph «Water for Injections» (0169);
• Deletion of the Ph.Eur. monograph «Water, highly purified» (1927);
• Revision of the effective version of the EU «Guidance on Quality of Water for Pharmaceutical Use»;
• Approval of the Recommendations by the Board of the Eurasian Economic Commission as of 13 December, 2017 No. 31 «On Requirements for Water for Pharmaceutical Use in Drug Manufacture».

The above-mentioned new regulatory requirements implicate relevant changes in the approaches to organization and operation of water-treatment systems in pharmaceutical production.

At the workshop, the mentioned changes in regulations will be reviewed in detail, and the audience will get practical recommendations on their technical implementation. A special focus will be on consideration of practical cases of non-conformities frequently identified during GMP-inspection as applied to water-treatment systems, their qualification and operation, as well as to monitoring of water quality parameters.

The workshop will be held on 8-9 November, 2018.