Pan American Network for Drug Regulatory Harmonization 2nd Steering Committee Meeting March 2324, 20

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III Pan American Conference on Drug Regulatory
Harmonization Washington DC 24-26 April
2002 The Pan American Network for Drug
Regulatory Harmonizations GMP Working
Group Justina A. Molzon M.S. Pharm.
J.D. Associate Director for International
Programs Center for Drug Evaluation and
Research US Food and Drug Administration
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Pan American Network for Drug Regulatory
Harmonization Work Plan 2000 - 2001

• Priorities Approved by the Steering Committee
• FirstUrgent Issues
• Good Manufacturing Practices
• Bioequivalence
• GCP
• Counterfeit
• SecondImportant Issues
• Classification
• Drug Regulatory Agency
• Third Recommended Issues
• Pharmacopoeia

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GMP WORKING GROUPWORKPLAN

• Training program design
• Implementation of training programs
• Mechanism for monitoring GMP implementation
• Identify standard under development in other
  Forum (ICH) (Consultation GMP)
• Joint inspection/observation (sharing documents)
• Working Group meeting

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GMP WORKING GROUPTEAM MEMBERSCOORDINATOR
FDA/USA

• Contact Person Justina Molzon
• ALIFAR Miguel Maito
• Argentina Carlos Chiale
• Brazil Antonio Bezerra
• Canada France Dansereau
• FIFARMA Cindy Marín
• Guatemala Esmeralda Villagran

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Report on Educational Activities

• The WG/GMP presents to the III Conference this
  report on the educational activities that are
  being developed in this area.
• Please refer to your background materials for
  details

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The Second Pan American Conference on Drug
Regulatory HarmonizationWashington D.C. 2-5
November 1999Recommendations on GMPs

• The training program for GMPs that the FDA
  proposes to carry out with the UPR and PAHO/WHO
  should be institutionalized
• The program should rely on contributions from
  government and industry in the interested
  countries include distance learning and take
  advantage of the installed capacity of the Region.

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FDA/UPR GMP Efforts

• The UPR initiative is a proactive response to
  numerous requests for GMP training
• Due to decreasing FDA resources it is difficult
  to meet these requests
• UPR an ideal bridge to enable FDA to respond to
  hemispheric requests for training
• Located in a US territory
• Pharmacy curriculum in Spanish
• Would provide FDA outreach capability

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SURVEY ON GMP

• To progress the topic a survey concerning
  pharmaceutical GMP training was developed and
  sent to Latin American Regulators
• Responses from 12 countries
• Used to prepare for a meeting of interested
  parties to the pharmaceutical activities under
  the FDA and University of Puerto Rico Partnership
• Latin American regulators invited to attend

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ASSESSMENT OF GMP TRAINING NEEDSSan Juan Puerto
RicoApril 5 2000

• Followed 1st meeting of PANDRH Steering Committee
  meeting April 3-4 2000
• Steering Committee members invited
• Met with UPR and FDA staff to assess the GMP
  training needs in the Americas
• Over 30 participants from 8 countries
• Survey responses facilitated discussion
• Focused discussion on GMP training topics

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GMP CURRICULUM DEVELOPMENT

• Based on the lecture break down it was
  determined that there should be an emphasis on
  Quality Assurance/Quality Control
• A series of 18 lectures proposed
• Matched with FDA Basic Drug School lectures for
  materials
• THEN--FDA decided to initiate a pilot program on
  system based inspections
• Curriculum changed to reflect new approach

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FDA SYSTEMS-BASED cGMP INSPECTION PROGRAM

• Old inspection protocol is problems-based with
  investigators examining shortcomings in cGMP and
  attempting to determine their causes.
• New systems-based approach is solutions-based and
  assesses the strength of the systems put in place
  by manufacturers to prevent and resolve
  difficulties

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FDA SYSTEMS-BASED cGMP INSPECTION PROGRAM

• More efficient use of resources
• More cGMP inspections in less time
• Coverage of 2 or more systems with mandatory
  coverage of Quality System
• Inspect minimum number of systems to provide
  basis for overall CGMP decision
• Concept adapted to UPR GMP training program as it
  represents state of the art

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Pan American Network for Drug Regulatory
Harmonization2nd Steering Committee
MeetingOrlando FloridaMarch 23-24 2001
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EDUCATIONAL ACTIVITIES UPR GMP TRAINING PROGRAM

• Training program offered Summer 2001
• May 29-June 2 2001 (FDAgtUPR)
• June 18-22 2001 (UPRgtFDA)
• Held at the University of Puerto Rico
• 20-25 participants 2-3 per country
• 5 day program taught in Spanish
• Lectures and case studies for interaction
• Laboratory exercises and site visit
• Simulated inspection using systems approach
• Next course June 24-28 2002

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Report on Educational ActivitiesPAHO Training

• National workshops of GMP based on educational
  models developed by WHO
• Based on WHO report 32 in GMP
• Caribbean countries--April 2000
• Modules translated into Spanish
• Being implemented in all LA countries
• 8 seminars to date
• Completed in all LA countries by August 2002
• See backgrounder for specifics

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Working Group/GMP Meeting 13-4 March
2002Caracas Venezuela

• The WG/GMP
• Defined the Mission
• Determined the Objectives of the Group
• Developed a Working Plan for the Group
• Discussed the Indicators that will be used to
  evaluate the accomplishment of the Ojectives.

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Mission of Working Group

• To promote the knowledge and implementation of
  GMPs as a strategy for improving the quality of
  medications in the countries of the Americas.

• Promover el conocimiento y la implementacion de
  las Buenas Practicas de manufactura como una
  estrategia para el mejorammientode la calidead de
  los medicamentios en los paises de las americas.

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Objectives of Working GroupPRIORITIZATION

• 1. Education on GMP
• 2. Harmonized guidelines for
• inspection reports
• 3. Monitor implementation of GMP
• 4. Support to drug regulatory authorities
  strengthening GMP

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Objective Number 1

• To promote the democratization of the knowledge
  in GMP through coordinated activities of
  dissemination training and specialization
  directed toward the health authorities the
  industrial sector the academic sector and other
  sectors that are identified as basic for the
  implementation of the GMP.
• Please refer to Plan of Action and Indicators

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Objective Number 2

• To obtain a Harmonized Guideline or questionnaire
  for inspection in order to confirm compliance
  with GMP for the countries of the Americas being
  based on Report 32 of WHO.
• Please refer to Plan of Action and Indicators

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Objective Number 3

• Monitoring GMP inspections.
• Plan of Action
• To establish as minimum requirements for GMP
  Report 32 of WHO
• Obtain the commitment to adopt as the standard of
  the regulatory agencies
• To monitor the utilization of the standard (GMP
  report 32 WHO) by country.
• To monitor the progress of the industry in the
  degree of implementation of the GMP based on the
  data obtained in the audit qualification system.

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Objective Number 4

• To raise the level of awareness and to support
  the regulatory authorities in order to assume the
  leadership in each country of the implementation
  and monitoring of the GMP.
• Please refer to Plan of Action and Indicators

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WG/GMP Proposal

• The Working Group on GMP requests the Conference
  to coment on the document considering the
  technical political and economic feasibility of
  implementing the proposed Working Plan.

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Muchas graciasMuito obrigadoMerci

• Thank you