Friday 10 September 2021

ICH Q12 meets FDA acceptance


The US Food and Drug Administration (FDA) has adopted the final ICH Q12 Guideline for post-approval change management. This now becomes cGMP.


Currently, ICH Q12 is in the implementation phase across other ICH regions, including the EU.


ICH Q12 aims to produce a standardised approach by defining the categorisation of post-approval of:


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


There is lots of detail about how, why and when process parameters can be adjusted etc., in relation to original validation.


The guideline expands on the relationship between Regulatory Assessment and GMP Inspection.


The guideline also defines how established conditions are identified as well as what information can be designated as supportive information that would not require a regulatory submission, if changed.


ICH Q12 “Technical and regulatory considerations for pharmaceutical product lifecycle management”:


Posted by Dr. Tim Sandle, Pharmaceutical Microbiology Resources (

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