Harmonisation of GMP inspections within ASEAN Flashcards
1
Q
What is MRA?
A
Mutual recognition agreements
2
Q
Benefits of ASEAN MRA on GMP inspection
A
- Avoid duplication of GMP audits within ASEAN
- Save time, resources and costs for regulators and industry
- Facilitate trade in medicinal products across ASEAN
- Quicker access of medicinal products by ASEAN patients
- Harmonising ASEAN inspection system to that of PIC/S
- Increased attractiveness of ASEAN to investors from larger economies
3
Q
Developments beyond AEC 2015
A
- Increase number of ASEAN LIS
- Train ASEAN inspectors
- Expand scope of ASEAN sectoral MRA
4
Q
What makes up the audit checklist for LIS
A
11 components, 78 indicators
- legislative and regulatory requirements and scope
- regulatory directives and policies
- GMP standards
- Inspection resources
- Inspection procedures
- Inspection performance standards
- Enforcement powers and procedures
- Alert and crisis systems
- Analytical capability
- Surveillance programmes
- Quality management systems
