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PHSS June 2016 Regulatory Update: EU GMP Q&A, MHRA Blog, • MaPP - Applying ICH Q8(R2), Q9, and Q10 P

14 June 2016   (0 Comments)
Posted by: Tamsin Marshall
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PHSS June Regulatory Update 2016


In 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, PIC/S USA  and WHO regulatory authorities.


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



  • Improving safety of first-in -human clinical trials
  • EU GMP Q&A – data required for sterilisation processes of primary packaging materials subsequently used in an aseptic manufacturing process.
  • Eudralex Volume 3 Sterilisation of the medicinal product, active substance, excipient and primary container.
  • Implementation plan for the introduction of the safety features on the packaging of centrally authorised medicinal products for human use
  • New EP general chapter on host-cell protein assays
  • Survey on Microbiological control of tissues
  • MHRA Blog


  • Review of Grouped Product Quality Supplements
  • MaPP - Applying ICH Q8(R2), Q9, and Q10 Principles to Chemistry, Manufacturing, and Controls Review



  • PIC/S Seminar, Manchester (July 2016)
  • PIC/S - PDA API (Q7) Training Puerto Rico (US) August 2016


  • Technical Report Series, No. 996
  • Supplementary guidelines on GMP for HVAC systems for non-sterile pharmaceutical dosage forms QAS/15.639/rev.1


  • Proposed reduction of use in animals of “last resort antibiotic” colistin to manage risk of resistance


  • Can regulators influence the affordability of medicines?
  • Guide to information on human medicines evaluated by EMA




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