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News & Press: Regulatory Updates

PHSS May Regulatory Update: GDP - Qual of Suppliers; UK Government response ; Data integrity of CGMP

04 May 2016   (0 Comments)
Posted by: Tamsin Marshall
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PHSS May Regulatory Update 2016

 

This month reported issues have come from the USFDA, UK MHRA, Indian and WHO regulatory authorities. Once again problems concerning sterility assurance have been noted by USFDA in a compounding pharmacy and in this case the company has refused to cease production or recall potentially affected products.

Europe

  • GDP and GMP
  • GDP - Qualification of suppliers- the 3 steps needed to assure supply chain integrity
  • UK Government response to the consultation on statutory fees for producers of e-cigarette products

USA 

 

  • Safety considerations for product design to minimize medication errors
  • Comparability protocols for human drugs and biologics
  • Assay development and validation for immunogenicity testing of therapeutic protein products
  • Contents of a complete submission for the evaluation of proprietary names
  • Data integrity and compliance with CGMP
  • FDA alerts health care professionals not to use sterile products from Pharmakon Pharmaceuticals, Inc., Noblesville, Indiana
  • Pharmaceutical distribution supply chain pilot projects; request for information
  • Facility definition under section 503B of the FD&C Act
  • Prescription requirement under section 503A of the FD&C Act
  • Hospital and health system compounding
  • FDA approves a second bio-similar

International

India

  • Proposal to replace gelatine in capsules
  • Guidelines on similar biologics

WHO

  • Prequalification of QC labs. for use by UN agencies – proposal for change

Products

  • MHRA letter to the editor of the Sunday Post in response to article on faulty equipment’

Documents

  • Annex 16 (QP certification) - Q&A 

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