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20 Apr

Posted at 15:32h in Blog

Revision of PIC/S GMP Guide (PE 009-15)

The PIC/S GMP Guide to Good Manufacturing Practice (GMP) for Medicinal Products has been revised to include a new Annex 2A and 2B:

  • Annex 2A: Manufacture of Advanced Therapy Medicinal Products for Human Use (ATMP); and
  • Annex 2B: Manufacture of Biological Medicinal Substances and Products for Human Use

Annex 2A provides PIC/S GMP requirements for ATMP – it is not a standalone document but it enables reasonable harmonisation with the standalone ATMP Guidelines published by the European Commission.  Annex 2B had very minor revisions and continues to harmonise with the EU Annex 2 for human use biological medicinal substances and products.

The revised GMP Guide (PE 009-15), with the new Annex 2A and 2B, will enter into force on 1 May 2021. All non-EEA Participating Authorities of PIC/S and Applicants have been invited to transpose the revised Chapters of the PIC/S GMP Guide into their own GMP Guides.

For the original document, please see link below.

SCARICA ALLEGATO: PE_009_14_GMP_Guide_xAnnexes_.pdf

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14 Apr

Posted at 14:51h in Blog

Q3C(R8) Adoption of Part VI of Q3C(R8) (PDEs for 2-MTHF, CPME, TBA) by the Regulatory Members of the ICH Assembly under Step 4

The ICH Q3C(R8) Residual Solvents guideline has been updated and Permitted Daily Exposure (PDE) values have been added for the following substances:

  • 2-methyltetrahydrofuran (50 mg/day)
  • Cyclopentyl methyl ether (15 mg/day)
  • Tertiary butyl alcohol (35 mg/day)

These values has been developed by the appropriate ICH Expert Working Group (EWG) based on the toxicity details.

On March 25, 2020, ICH had already published the document open for public consultation (Step 2). The proposed values were then adopted as final and included in the final draft of the document (step 4). This will allow for adoption by the regulatory parties of ICH regions, in accordance with the ICH Process (step 5), concluding the review.

For the original document, please see link below.

SCARICA ALLEGATO: ICH_Q3C-R8_Guideline_Step4_2021_0422_1.pdf

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