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News & Press: Regulatory Updates

PHSS Regulatory Update April 2012

28 November 2013  
Posted by: Tamsin Marshall
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PHSS Regulatory Update April 2012

INTRODUCTION

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 ,USA, Health Canada and PIC/S Regulatory Authorities. It is worth noting that there are again topics from both sides of the Atlantic on supply chain security and particularly that in the EU there seems to be some dis-harmony in the way that the regulators and industry propose that it should be achieved / its main focus for finished packs. The regulator emphasizing the need for the patient to be able to personally confirm authenticity of the medicine.

The topics covered in this edition of the "Update” include:

Europe
  • Draft guideline on Process Validation
  • Guideline on Real Time Release Testing
  • EDQM progresses with e-TACT
  • Reference standards - online webinar
  • Changes to inhaled product monographs - BP Draft Policy Document
USA
  • Medical devices -voluntarily submission of audit reports to FDA
  • FDA initiative to combat drug shortages – 6 months on
  • RxTEC Supply Chain Security Model
  • Counterfeit drugs / supply chain integrity.
International
  • PIC/S Aide Memoire Quality Risk Management

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