Current Status of PANDRH Good Manufacturing Practices Working Group
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DIA 2nd Latin American Regulatory Conference Mexico City November 18-20, 2009
Current Status of PANDRH Good Manufacturing Practices Workin...
DIA 2nd Latin American Regulatory Conference Mexico City November 18-20, 2009
Current Status of PANDRH Good Manufacturing Practices Working Group Justina A. Molzon, MS Pharm, JD Associate Director for International Programs Center for Drug Evaluation and Research US Food and Drug Administration The views expressed in this presentation are those of the author and do not necessarily represent the views of the U.S. Food and Drug Administration
Pan American Network for Drug Regulatory Harmonization Buenos Aires, Argentina 17–19 November 2008
• V Conference of the Pan American Network for Drug Regulatory Harmonization (PANDRH) • Information and p propositions p of 9 working groups presented for consideration
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PANDRH V Conference Working Group Reports 1. Bioequivalence and Bioavailability 1 2. Vaccines 3. Medicines Promotion 4. Pharmacovigilance 5. Drug Counterfeiting 6. Good Manufacturing Practices 7. Good Laboratory Practices 8. Good Clinical Practices 9. Registration Requirements
Current Members USA: Molzon Justina: Coordinator ARG: Rodolfo Monchetto BRA: Suzana Machado Marcelo Vogler de Moraes MEX: Sonia Zamudio Alonso CHI: Magdalena Reyes GUT: Norma de Pinto CAN: Louise Jodoin VEN: Elsa Castejón FIFARMA: Anthony Ventura ALIFAR: Marisela Benaim Resource Persons: Millie Barber/ Arlene Badillo
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GMP Working Group Meetings • March 3-4, 2002—Caracas • April 24-26, 2002 III Pan American Conference on Drug Regulatory Harmonization Washington, D.C • May 5-7 2003—Mexico City • May 5-7, 2004—Antigua, Guatemala • Aug 30-Sept 1, 2004—Dominican Republic • March 2-4, 2005 IV Pan American Conference on Drug Regulatory Harmonization Harmonization--Dominican Dominican Republic • July 20-22, 2005—Washington DC • March 3-5, 2006—Rockville, MD
Work Plan III Pan American Conference on Drug Regulatory Harmonization Washington, D.C April 24-26, 2002
• • • • •
Working Group meeting Training program design Implementation of training programs Mechanism for monitoring GMP implementation Identify y GMP standards under development p in other Forums (WHO and ICH) • Consider mechanisms for joint inspections
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IV Pan American Conference on Drug Regulatory Harmonization Dominican Republic 2-4 March 2005 • Adopted the document: Guideline for Verification of Good Manufacturing Practices for the Pharmaceutical Industry • WG to follow up on the adoption and evaluation of incorporating the Guideline for Verification of GMP in national regulations of the countries, and adoption of the Guideline by the subregional working groups • WG to t prepare a reportt on activities ti iti associated i t d with ith training programs and advisory services and to present at the next Pan American Conference on Drug Regulatory Harmonization
Proposals to the Conference
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Decision Tree for Implementing the Guideline for GMP Inspections •
The WG created a decision tree to promote the development of a national plan towards implementation of the Guideline for Verification of Good Manufacturing Practices for the Pharmaceutical Industry • The decision tree would help national regulators and also the pharmaceutical industry since they will also be implementing the Guideline for Verification of GMP • The proposed Decision Tree includes – Quality Assurance – Critical Supporting System – Validation and facilities
Adoption of ICH Q7 • The WG GMP proposes the adoption of the ICHQ7 (Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients) as a Guideline for GMPs for APIs in the Americas • The Secretariat reviewed the Spanish versions of Q-7 created by ANMAT and FDA • A final draft was created and posted on the PANDRH web page for public comment • The final version is presented to the Conference for adoption
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Mutual Recognition of GMP Inspections • PANDRH should promote harmonized procedures and information exchange among countries of the Americas • A common guideline, educational opportunities and participation in joint inspections are essential for mutual recognition • Ultimate goal is to build trust among NRA to promote efficient use of resources • The WG proposes that the Conference explore mechanisms to promote mutual recognition
Code of Ethics • The WG GMP developed a model code of ethics • It can be used by an Agency as a whole or only p of GMP for inspectors • It can be adopted or adapted by national agencies but the ideal is to have a Code of Ethics for the Region • It covers requirements of good conduct, behavior, communications with the industry, loyalty to the agency, anti-discrimination policy, development and conflict of interest • A final draft was posted on the PANDRH web page for public comment • Presented to the Conference for adoption
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Requests of the Secretariat • Establish a Q&A box when implementing the p for the Guidelines for GMP Inspection pharmaceutical industry and the decision tree for implementation of the guidelines. • Monitor process of the progress in implementing the guidelines and decision tree • Send the most recent Code of Ethics for Inspectors to member countries for i l implementation t ti • Investigate training programs for high-level inspectors
