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News & Press: Regulatory Updates

PHSS Oct 2016 Regulatory Update: Reverse osmosis and biofilms and control strategies; USP tablet bre

11 October 2016   (0 Comments)
Posted by: Tamsin Marshall
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PHSS October Regulatory Update 2016

During the last 4 weeks there have been a number of developments in the regulation of the pharmaceutical industry. This month reported issues have come from the EU and USA regulatory authorities.
The topics covered in this edition of the “Update” include:

 

Europe

  • Q&A on production of water for injections by non-distillation methods – reverse osmosis and biofilms and control strategies
  • Responses to the public consultation on EU GMP, revised Annex 17 (Real Time Release testing)
  • Concept of ‘similar medicinal product’ in the context of the orphan legislation: adaptation to technical progress (concept paper)
  • Study on the regulation of advanced therapies in selected jurisdictions
  • MHRA undergoes an external inspection
  • Wider access to MHRA conferences

USA

  • Self-Identification of Generic Drug Facilities, Sites, and Organizations
  • USP general chapter prospectus: tablet breaking force <1217>
  • Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients Guidance for Industry


Documents

  • Current Status of GDP Implementation and the Role of the RP - an Overview

Products

  •  Pharmaceutics International Inc., US: Supply of non-critical medicines to EU to be stopped due to manufacturing failings

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