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FDA has officially endorsed the ICH Q12 guideline for post-approval change management

The guideline ICH Q12 “Technical and regulatory considerations for pharmaceutical product lifecycle management”, provide a globally agreed framework to facilitate the management of post-approval chemistry, manufacturing, and controls (CMC) changes in a more predictable and efficient manner across the product lifecycle.

This guideline establishes a harmonized approach to defining which elements in an application are considered necessary to ensure product quality (Established Conditions for Manufacturing and Control” – ECs) and therefore would require regulatory submission if changed after approval.

ICH Q12 Core Guideline

defines the concepts of:

• Post-Approval CMC (chemistry, manufacturing, and controls) changes,
• Established Conditions(ECs),
• Post-Approval Change Management Protocols(PACMPs),
• Product Lifecycle Management (PLCM)

ICH Q12 Annexes

FDA also published the Annexes to ICH Q12 which contains illustrative examples describing how to use the principles in the guidance as a framework for managing postapproval changes.

Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management Guidance for Industry

Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management Annex

ICH Q12: Implementation Considerations for FDA-Regulated Products

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.

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.