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GMP for Advanced Therapy Medicinal Products (ATMPs) (Part II) and hospital exemption (HE)

  • 14 February 2018
  • advanced therapy medicinal product, aseptic manufacturing, ATMP, biosafety, clinical trials authorisation, CTA, data integrity, decentralized manufacturing, GMO, GMP, HE, hospital exemption, IMP, investigational medicinal product, MAH, manufacturer, manufacturing, manufacturing platform, marketing authorisation, marketing authorisation holder, operating theatre, process validation, risk assessment, sponsor, unmet medical needs,
  On 22 November 2017, the European Commission (EC) has adopted and published Guidelines on Good Manufacturing Practice specific to Advanced Therapy Medicinal Products, one of the initiatives of the Action Plan for ATMPs launched in October 2017 to foster the development of ATMPs. Advanced Therapy Medicinal Products (ATMPs) manufacturers should comply with these Guidelines
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Pharmaceutical industry Brexit preparedness and its legal consequences for MAH

  • 13 November 2017
  • API, batch release, Brexit, CMDh, CMDv, CP, DCP, EC, EMA, finished product, GMP, impact, import, legal consequences, MA, MAH, manufacture, marketing authorisation, marketing authorisation holder, medicinal products, MRP, notice, QPPV, RMS, site, transfer, UK's withdrawal, variation,
On 2 May 2017, the European Commission and EMA published a Notice to marketing authorisation holders of centrally authorised medicinal products for human and veterinary use, stating: “The United Kingdom submitted on 29 March 2017 the notification of its intention to withdraw from the Union pursuant to Article 50 of the Treaty on European Union.
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Is the risk of GMP dis-harmonisation in the field of ATMPs (Advanced Therapy Medicinal Products) real?

  • 12 May 2017
  • advanced therapy medicinal product, ATMP, GMP, harmonisation, IMP, investigational medicinal product, PIC/S,
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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GMP and MAHs

  • 13 October 2016
  • 2019/6, EU, GMP, MAH, marketing authorisation holder, regulation,
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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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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On 12 October 2015, the European Commission published revised version of Annex 16: Certification by a Qualified Person and Batch Release of the EU GMP Guide. The new annex will become effective on 15 April 2016. General principles Revised version of the annex states that: The ultimate responsibility for the performance of a medicinal product over its
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Revision of the EU GMP Guide – Annex 17 (Part I)

  • 14 October 2015
  • Annex 17, GMP, parametric release, PAT, pharmaceutical development, 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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On 30 March 2015, the European Commission published revised version of Annex 15: Qualification and Validation of the EU GMP Guide. The new annex will become effective on 1 October 2015. Comparing to current version of the annex, extensive changes have been made in some areas. Particularly, it relates to Process Validation and Cleaning Validation.
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On 28 March 2014, the European Commission published revised version of Chapter 6: Quality Control of the EU GMP Guide. The new chapter came into force on 1 October 2014. Special attention should be given to current point iv. of section 6.7 and section 6.9 relating to OOS and OOT results and also to newly
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On 13 August 2014, the European Commission published revised version of Chapter 8: Complaints, Quality Defects and Product Recalls of the EU GMP Guide. The new chapter will become effective on 1 March 2015. Extensive changes have been made to this chapter and in practice, it has been revised completely. The principle: “In order to
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