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News & Press: Regulatory Updates

PHSS Sept 2016 Reg Update:PIC/s Data integrity Guidance; DMRC Rep ; Insanitary Cond at comp fac.

21 September 2016   (0 Comments)
Posted by: Tamsin Marshall
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PHSS September 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,USA,PIC/S and WHO regulatory authorities.
The topics covered in this edition of the “Update” include:

 

Europe

  • Data integrity Q&A

    DMRC Reporting – Do’s and Don’ts

USA

 

  • Insanitary Conditions at Compounding Facilities
  • Regulatory classification of pharmaceutical co-crystals.
  • ANDA Submissions – Refuse to receive for lack of justification of impurity limits.
  • Foreign and domestic establishment registration and listing for human drugs
  • Change in hard gelatin capsule shell supplier


International
PIC/S

  • PIC/S Inspectorates’ Academy (PIA) is up and running.
  • Good practices for data management and integrity in regulated GMP/GDP environments
  • Thai FDA joins PIC/S

WHO

  • WHO general guidance on variations to multisource pharmaceutical products


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