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Is the risk of GMP dis-harmonisation in the field of ATMPs (Advanced Therapy Medicinal Products) real?

  • 12 мая 2017
  • ATMP, CTA, GMP, IMP, MAH, PIC/S, высокотехнологичные лекарственные средства, лекарственные препараты для клинических исследований, НПП,
The PIC/S Committee, which comprises representatives of PIC/S’ 49 Participating Authorities as well as representatives from Partner Organisations such as EMA, EDQM and WHO, expressed its unanimous concern at the European Commission’s proposed stand-alone Advanced Therapy Medicinal Products (ATMP) GMP Guidelines, which will not only lower GMP standards for ATMP at the risk of patients
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Первые клинические испытания на людях – FIH CTs (Part I)

  • 12 апреля 2017
  • 1 фаза, FIH, IMP, замена, интегрированный протокол клинического исследования, исследуемый препарат, концепция 3R, начальные клинические испытания, первые исследования на людях, первые клинические испытания на людях, снижение риска, сокращение, усовершенствование,
Clinical trials are essential for the development of medicines and without them patients cannot gain access to new potentially life-saving medicines. EU and international guidelines are in place to ensure that first-in-human clinical trials are conducted as safely as possible. EMA’s existing guideline, released in 2007, provides advice on first-in-human clinical trials, in particular on
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GMP and MAHs

  • 13 октября 2016
  • 2019/6, EU, GMP, MAH, regulation, владелец регистрационного удостоверения лекарственного препарата, держатель регистрационного удостоверения лекарственного препарата, НПП,
Update [18/11/2021] On 29 July 2021, the European Medicines Agency (EMA) published final version of Reflection paper on Good Manufacturing Practice and Marketing Authorisation Holders. This Reflection Paper is focussed on the GMP-related responsibilities that apply to Marketing Authorisation Holder (MAH) companies and it seeks to provide clarity as to what the various responsibilities are
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FDA has published “Quality Metrics Technical Conformance Guide”

  • 30 сентября 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 сентября 2016
  • ATMP, CTA, GMO, GMP, IMP, MAH, асептическое производство, валидация процесса, владелец регистрационного удостоверения лекарственного препарата, высокотехнологичные лекарственные средства, генетически модифицированный организм, ГМО, держатель регистрационного удостоверения лекарственного препарата, лекарственные препараты для клинических исследований, НПП, оценка риска, производитель, производство, регистрационное удостоверение лекарственного препарата, целостность данных,
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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EMA published Guideline on process validation (PV) for the manufacture of biotechnology-derived active substances and data to be provided in the regulatory submission

  • 18 июля 2016
On 29 April 2016, EMA published a new document entitled Guideline on process validation for the manufacture of biotechnology-derived active substances and data to be provided in the regulatory submission. The new guideline will become effective on 1 November 2016. It should be noted that the need to develop guidance on process validation of biotechnology
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EMA published a Draft guideline on the sterilisation of the medicinal product, active substance, excipient and primary container (Part I)

  • 29 июня 2016
  • API, GMP, SAL,
On 13 April 2016, EMA released for 6 months public consultation the Draft guideline on the sterilisation of the medicinal product, active substance, excipient and primary container. A new guidance is developed as a separate guidance document and will replace Decision trees for the selection of sterilisation methods (CPMP/QWP/054/98) and Decision trees for the selection
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Определение новой активной субстанции (NAS, New Active Substance) которое касается химических веществ

  • 1 марта 2016
On 19 January 2016, the European Medicines Agency published a new document entitled Reflection paper on the chemical structure and properties criteria to be considered for the evaluation of new active substance (NAS) status of chemical substances. This document is intended to reflect the current experience concerning the definition of a New Active Substance (NAS) in
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Пересмотр Руководства по GMP EC – Приложение 17 (Часть I)

  • 14 октября 2015
  • GMP, PAT, QbD, QRM, RTRT,
On 15 September 2015, the European Commission released for public consultation (until 11 December 2015) a draft revised version of Annex 17: Real Time Release Testing of the EU GMP Guide. Comparing to current version of this annex, an application of the concept, which under specific circumstances, and where authorised, allows batch release based on information
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