With the first publication of a draft guideline on GMP for ATMP in 2016, we have been reporting several times about the two rounds of public consultations. You could also read about the subsequent developed document and stakeholder comments as well as about the following discussion with the PIC/s on the content of the document and on the suitability of such a stand alone document instead of an additional annex to the European GMP Guideline.
Now, on 22 November, the European Commission has adopted the "New Guidelines on Good Manufacturing Practice specific to Advanced Therapy Medicinal Products". As date for coming in operation the new document defines: "ATMP manufacturers should comply with these Guidelines no later than 22 May 2018".
At the beginning of the first chapter of the guideline, the "scope", the authors state that GMP is required for all medicinal products with a marketing authorisation and an equivalent quality standards for products made under hospital exemption. Additionally they point out that the development of such specified guidelines for ATMP are mandated by Article 5 of Regulation (EC) No 1394/20072 as well as by Article 63(1) of Regulation (EU) No 536/2014 for IMPD.
The new guideline includes requirements for ATMP with a marketing authorisation as well as for advanced therapy medicinal products that are being tested or used as reference in a clinical trial (i.e. advanced therapy investigational medicinal products).The document should be the main document for the definition of the GMP requirements for ATMP, so in the scope it states: " These Guidelines do not apply to medicinal products other than ATMPs. In turn, the detailed guidelines referred to in the second paragraph of Article 47 of Directive 2001/83/EC4 and Article 63(1) of Regulation (EU) No 536/2014 do not apply to ATMPs, unless specific reference thereto is made in these."
A look on the length of over 80 pages and on the table of content shows that the status as a stand alone guideline has made it necessary to include all important fields with relation to ATMPs which are normally covered for other medicinal products in the existing GMP guideline and its Annexes:
- Risk based approach
- Starting/Raw Materials
- Seed lot and call bank systems
- Qualification and Validation
- QP and batch release
- Quality Control
- Quality defects and recalls
- Automated production
In several bullet points of these chapters topics like hygiene aspects up to aseptic processing requirementts and finally batch release issues are covered. For the manufacturers of ATMP, it will now be the challenge to check whether the current established processes will be in accordance with the new guideline or whether some changes or additional activities will be necessary.
Being aware of these challenges the ECA Academy will organise a workshop on "GMP for ATMPs" in Berlin, Germany on 21 (and possibly 22) June 2018. The detailed programme will be published soon. If you are interested in learning more about the planned workshop please send an e-mail to W.Heimes at firstname.lastname@example.org.