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FDA has published “Quality Metrics Technical Conformance Guide”

  • 30 September 2016
Recently, FDA has published a new technical specifications document entitled Quality Metrics Technical Conformance Guide. This Guide supplements and serves as the technical reference for implementation of the draft FDA guidance for industry on Request for Quality Metrics and additionally provides recommendations about submission of information that will support the FDA’s calculation of quality metrics.
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GMP for ATMPs (Advanced Therapy Medicinal Products) (Part I)

  • 15 September 2016
  • advanced therapy medicinal product, aseptic manufacturing, ATMP, clinical trials authorisation, CTA, data integrity, GMO, GMP, IMP, investigational medicinal product, MAH, manufacturer, manufacturing, marketing authorisation, marketing authorisation holder, process validation, risk assessment, sponsor,
On 28 June 2016, the European Commission (EC) released for 3 months consultation (till 26 September 2016) the draft Guidelines on Good Manufacturing Practice for Advanced Therapy Medicinal Products. Article 5 of Regulation No 1394/2007 of the European Parliament and of the Council on advanced therapy medicinal products and amending Directive 2001/83/EC states: The Commission
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