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News & Press: Regulatory Updates

PHSS July 2017 Reg Update: GMP Short Notice and Unannounced Insp; Responsible Pers: requirements

03 July 2017   (0 Comments)
Posted by: Tamsin Marshall
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PHSS Regulatory Update July 2017

 

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, Swiss   and USA regulatory authorities.

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

 

Europe

  • First ever EU guidance on sterile manufacturing processes for veterinary stem cell medicines
  • GMP Short Notice and Unannounced Inspections
  • Use of freezers

USA

  • Updated form to submit Field Alert Reports (FARs) electronically
  • FDA Leads Effort to Create a Supply Chain Security Toolkit for Medical Products
  • ANDAs: pre-submission facility correspondence associated with priority submissions
  • CGMP  Medical Gases
  • Single Entity Injectable Drug Products –labeling
  • FDA’s Orphan Drug modernization plan
  • Frequently Asked Questions: Water for pharmaceutical and analytical purposes

International

Switzerland

  • Responsible Person: requirements – technical interpretation version 03E (Swissmedic)

Products

  • Contaminated steroid injections – CEO  given 9 years prison sentence
  • Regulators in EU, Japan and US take steps to facilitate development of new antibiotics

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