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News & Press: Regulatory Updates

PHSS Mar 2017 Regulatory Update : Annex 16 QP cer & batch rel FAQ; FDA Ban on Powder

09 March 2017   (0 Comments)
Posted by: Tamsin Marshall
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PHSS March Regulatory Update 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 MHRA and the USA regulatory authorities plus PIC/S. If you are involved in ATMP manufacture then the very strongly worded PIC/S letter to the European Commission will be of particular interest.

The topics covered in this edition of the “Update” include

Europe

  • Annex 16 QP certification and batch release – FAQ – part 1
  • API supply chains blog – Part 2
  • Medregs Blog
  • GMP Inspectorate compliance management escalation processes
  • Exports and customs procedures
  • New Orange and Green Guides 2017 

USA

  • Q11 Development and Manufacture of Drug Substances Q&A

  • Planned new & revised draft guidances CDER is planning for calendar year 2017

  • FDA Ban on Powdered Medical Gloves

International

PIC/s

  • Strong stance on European Commission's proposed stand-alone ATMP GMP Guidelines

Products

  • Sterility concerns – cephalosporin APIs made by Antibioticos Do Brasil LTDA

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