Title: Pan American Network for Drug Regulatory Harmonization 2nd Steering Committee Meeting March 2324, 20
1III 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
2Pan 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
3GMP 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
4GMP 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
5Report 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
6The 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.
7FDA/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
8SURVEY 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
9ASSESSMENT 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
10GMP 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
11FDA 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
12FDA 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
13Pan American Network for Drug Regulatory
Harmonization2nd Steering Committee
MeetingOrlando, FloridaMarch 23-24, 2001
14EDUCATIONAL 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
15Report 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
16Working 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.
17Mission 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.
18Objectives 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
19Objective 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
-
20Objective 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
-
21Objective 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.
22Objective 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
-
23WG/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.
24Muchas graciasMuito obrigadoMerci