Guideline on Post Approval Change Management of Pharmaceutical Manufacturing Process [Guidance for Industry]

The document provides comprehensive guidelines for managing post-approval changes in pharmaceutical manufacturing, emphasizing regulatory compliance and quality assurance. It outlines the following key aspects:

Types of Changes and Categories

• Changes are classified based on their potential impact on product quality:
  • Annual Report (AR): For changes with minimal impact on quality.
  • Immediate Report (IR): For changes requiring prompt notification.
  • Cmin/Cmaj: For minor and major changes affecting product quality.

Applicable Regulations and Guidelines

– References include the Regulations for Safety of Pharmaceuticals, ICH guidelines, and WHO guidelines, ensuring alignment with international standards.

Key Requirements

• Change Management Conditions:
  • Categorization of changes based on their impact on product quality and safety.
• Required Documentation:
  • Data requirements include impurity profiles, stability data, batch analysis, and process validation results.
• Process Validation:
  • Emphasis on ensuring that drug products consistently meet predefined specifications and quality attributes.

Submission and Reporting Procedures

• Annual Reports:
  • Details for changes that do not affect product quality.
  • Includes the timeline for submission and the required format.

Immediate Reports and Cmin/Cmaj Changes:

• Specific documentation and procedures based on the nature and significance of the change.

This guidance ensures that pharmaceutical manufacturers maintain product quality and regulatory compliance while managing post-approval changes effectively.

Region: South Korea

Source: https://www.mfds.go.kr/brd/m_218/view.do?seq=33618&srchFr=&srchTo=&srchWord=&srchTp=&itm_seq_1=0&itm_seq_2=0&multi_itm_seq=0&company_cd=&company_nm=&page=1