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Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management

View Resource (HTM)

Category

Document

Published on CMKC

Abstract

Document highlights the product lifecycle and the various considerations for maintaining consistent quality through both shelf life and entire lifecycle.

Journal

ICH Q12

Type of publication

Document

Affiliations

  • International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH)

Article Classification

Guideline

Classification Areas

  • Regulatory

Tags

  1. Categorization of Post-Approval CMC Changes / Structured Approaches for Frequent CMC Post-Approval C
  2. Established Conditions (EC)
  3. Guideline
  4. Post-Approval Change Management Protocol (PACMP) / Change Management
  5. Product Lifecycle Management (PLCM) Document
  6. regulatory
  7. Relatinship between Regulatory Assessment and Inspection
  8. Stability Data Approaches to Support the Ebvaluation of CMC changes