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Good Manufacturing Practices
Introduction, requirements and impact on your organization

Recorded

 

How to Comply with International GMP Regulations and Guidelines
Recorded

 

Understanding and Implementing ISO 17025
Requirements, Strategies and Tool Kits for Laboratory Accreditation
July 23, 2009

 

Successful FDA Inspections
Preparation - Conduct - Follow Up
July 30, 2009

 

Auditing Laboratories for FDA and ISO 17025 Compliance
Preparation - conduct - follow up - documentation
Recorded 

 

Primer

SOPS

Checklist

200+ FDA Warning Letters, keyword search, by topics, for instant download.

 

South East Asia Moving to Harmonized GMP Inspections

On April 10, 2009, all 10 member countries of the Association of Southeast Asian Nations (ASEAN) have signed a Mutual Recognition Agreement (MRA) to harmonize GMP inspections. Member states are obliged to establish inspection services for conducting GMP audits and issuing Reports/Certificates. Also, each member state is obliged to accept and recognize GMP certificates/Reports issued by listed inspection services of another member state. GMP certificates are issued in accordance to the PIC/S GMP Inspection Framework. This also means, drug companies marketing products in all ASEAN member countries should implement PIC/S GMP guidelines. While Singapore and Malaysia are already PIC/S members, PIC/S GMP compliance is not easy for some countries For example, it is estimated that currently only 5% of the drug industry in the Philippines complies with international GMP regulations. 

About the ASEAN Inspection Task Force

  • Taskforce on GMP inspections formed 2005
  • Singapore and Malaysia, already member countries, are Chair and Co--Chair of the  taskforce
  • Goal: Work towards an ASEAN sectoral MRA on GMP inspections
  • Meetings in 2005 (Singapore), 2006 (Hanoi and Jakarta), 2007 (Kuala Lumpur), 2008 (Vientianne, Brunei), 2009 (Manila)

10 Member countries of the Association of Southeast Asian Nations (ASEAN).

 

Scope, Obligations and Deferral of Implementation and  of the MRA

  • Scope: includes Medicinal Products in Finished Dosage Forms, excludes APIs and Biopharmaceuticals
  • Structural Obligations: Member States obliged to have Inspection Services for conducting GMP audits and issuing Reports/Certificates in accordance to PIC/S GMP Inspection Framework
  • Recognition Obligations: Member States obliged to accept and recognize GMP certificates/Reports issued by listed inspection services of another member state
  • Deferral of implementation: Any member state that whishes to defer recognition of GMP certificate issued by a Listed Inspection service shall notify ASEAN Sec-General in writing within three months from date of signing of MRA (July 9, 2009). ASEAN countries concerned shall also notify ASEAN Sec-General that it will implement sectoral MRA by Jan 1, 2011.
  • Signed on April 10, 2009, in Pattaya, Thailand, by Economic ministers of all 10 ASEAN member states notify member countries to notify Secretary-general of ASEAN in writing by July 9, 2009

Benefits of MRA for Regulators and Industry

  • Avoids duplication of GMP Audits within member countries
  • Saves time, resources & costs for regulators and industry
  • Facilitates trade in medicinal products across ASEAN
  • Quicker access of medicinal products by ASEAN patients
  • Increased competitiveness of ASIA viz-a-viz India, China & other bigger industrialized countries.

Post Signing Action Plan

Establish checklist for implementation of the MRA

  • Develop FAQ on Implementation
  • Develop Terms of Reference (TOR) and Operating & funding Mechanism for Panel of Experts
  • Organize 2 technical workshops and one dialogue session

Presentation from the Task Force Chairman

Sia Chong Hock, Chairman of the ASEAN MRA taskforce on GMP Inspection for Medical Products gave a presentation at the ISPE conference in Singapore on June 1, 2009 about the history, status and further plans of the MRA. The presentation includes a checklist with coordinators and proposed due dates for further implementation. The presentation can be downloaded from the Labcompliance Usersclub. For information and registration to the Usersclub, click here