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ICH published a Final Concept Paper for a new ICH Q12 Guideline

  • 25 February 2015
  • change management, chemistry, CMC, continual improvement, control, ICH Q12, knowledge management, lifecycle management, management of post-approval CMC changes, manufacturing, prospective change management,
Recently, ICH published a Final Concept Paper for a new ICH Q12 Guideline entitled “Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management”. There is currently a lack of a harmonised approach on technical and regulatory considerations for product lifecycle management. While the concepts in ICH Q8, Q9, Q10 and Q11 provide opportunities for a
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