Now online: Draft ICH Q12

The long awaited and highly discussed ICH Q12 draft Step 2b Guideline including its Annexes is now available online on the ICH website.

ICH states that the document entitled Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management "is proposed to provide guidance on a 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".

The topic was endorsed by the ICH Steering Committee in September 2014 and the new guideline is intended to complement the existing ICH Q8 to Q11 Guidelines. During the elaboration of the draft guideline there has been some discussion about the term "established conditions" (these also apply for analytical methods). Therefore, a statement has been introduced that in certain ICH regions, the current ICH Q12 guideline is not fully compatible with the established legal framework (e.g. the EU "Variations Guideline") with regard to the use of explicit Established Conditions ('EC') and with the Product Lifecycle Management ('PLCM') as outlined in this guideline. ICH says that "these concepts will, however, be considered when the legal frameworks will be reviewed and, in the interim, to the extent possible under the existing regulation in these ICH regions".

According to the draft document the use of the following harmonized ICH Q12 regulatory tools and enablers with associated guiding principles, as described in this guideline, will enhance the management of post-approval changes, and transparency between industry and regulatory authorities, leading to innovation and continual improvement:

  • Categorization of Post-Approval CMC Changes (the MAH (marketing authorization holder) may propose reporting categories for changes to ECs based on risk and knowledge gained through enhanced pharmaceutical development),
  • Established Conditions (ECs) (for example appropriate control strategy),
  • Post-Approval Change Management Protocol (PACMP) (provides predictability regarding planning for future changes to ECs),
  • Product Lifecycle Management (PLCM) (The PLCM document is a summary that transparently conveys to the regulatory authority how the MAH plans to manage post-approval CMC changes),
  • Pharmaceutical Quality System (PQS) and Change Management (all changes to an approved product are managed through a firm’s Pharmaceutical Quality System; changes to ECs must also be reported to the regulatory authority),
  • Relationship Between Regulatory Assessment and Inspection (collaboration and communication between assessors and GMP-inspectors are necessary for the implementation of this guideline),
  • Post-Approval Changes for Marketed Products (the guideline proposes approaches to facilitate post-approval changes to marketed products without the need for regulatory review and approval prior to implementation of certain CMC changes).

Furthermore, the guideline describes how ECs are identified as well as what information can be designated as supportive information that would not require a regulatory submission, if changed. Guidance is included for managing revisions of the ECs over a product’s lifecycle

Additionally, a glossary and two appendices are included in the core document. The appendices describe 

  • CTD sections that contain ECs,
  • Principles of Change Management (including Knowledge and Risk Management).

The three annexes to the ICH Q12 core document provide illustrative examples for

  • ECs (chemical and biological products),
  • PACMPs (examples for an alternative manufacturing site for a small molecule drug substance and manufacturing site transfers of biotech drug substances),
  • PLCM-Documents (e.g. summary of product control strategy): Example for a solid dosage form tablet (small molecule) (a similar example is also provided in EMA´s Guideline on Manufacture of the finished dosage form which will enter into effect on February 14, 2018).

It is expected that ICH Q12 would not be implemented before the end of 2018, as this document will be opened to review and comment over 12 month. But please refer to the official Q12 accordeon for each Regulatory region's commenting period.

The Q12 draft core Guideline and Q12 Annexes are available for download on the ICH Quality Guideline page.

Save the date: The ECA will organize a conference on ICH Q12 in Berlin, Germany, from 13-14 November 2018 with speakers from the ICH Q12 Expert panel. Use the opportunity for discussion and for directly providing your comments! More information will be available on the ECA website soon.

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