Medicines and Health Technologies
Esta página ha sido archivada y ya no es actualizada.
The PANDRH Technical Working Groups system was switched in 2015 to a project based approach in prioritized areas-the following is historical information...
PANDRH Working Groups consist of groups of experts in areas that have been identified as priorities for drug regulatory harmonization. Members are selected by the steering committee and confirmed by the regulatory authorities of the respective countries. Whenever possible, working groups have at least one representative from each of the five sub-regional blocs of the Americas.
Academics and other experts can be members of the working groups. Each group's main objectives include the implementation of diagnostic studies in order to identify the differences among the countries regarding the implementation of international standards and to define the necessary strategies for technical cooperation, analyze international guidelines, and prepare harmonized proposals in their areas to be considered during the conference for implementation in the region. PANDRH rules and regulations (available only in Spanish) have a specific chapter on Working Groups operation; also available: the member list of the technical working groups (2010).
La misión del grupo de trabajo de vacunas es la de promover la armonización de la reglamentación farmacéutica para las vacunas con vista a garantizar su calidad, seguridad y eficacia, generando mecanismos mas eficientes que contribuyan a su disponibilidad para los países de las Américas.
Biotechnological products are medicines produced from animal cell substrates and microbial cultures. Constitutes proteins obtained by the recombinant DNA technique expressed in animal tissues or in microbial life forms, including products obtained through the monoclonal antibody technique 1. The World Health Organization also uses biotherapeutic products name to refer to biotechnological products.
Mission, purpose and documents.
Mission: Develop and strengthen Pharmacovigilance through regulatory harmonization activities and proposals that promote the safety and rational use of drugs as a necessary component of public health policies in the Americas.
Mission: To promote and harmonize criteria for medicines promotion as a contribution to the rational use, within the scope of health policies in the Americas.
Mission, Objectives and Documents.
Presents Mission, objectives and documents.
Since its creation in 1999, the GT / CFM has focused on the formulation of proposals for the development of policies and strategies for implementation by countries, development and promotion of training programs for process optimization of inspection and capacity building/ investigation; and promoting the exchange of information.
This Working Group on Good Laboratory Practice (WG/GLP) was created in June 2005 by recommendation of the Fourth Pan American Conference for Drug Regulatory Harmonization (PARF Network) of PAHO. The formation of this group was based on the excellent work and results obtained up until that time by the external quality control program (PCEC).
The PCEC measures the performance of the official laboratories for control of medicines in the region and sends them blind samples for analysis. The results are evaluated by the United States Pharmacopeia (USP). The medicines controlled to date have been in the PAHO programs on antimalarial drugs, anti-tuberculosis drugs, and HIV/AIDS drugs. The PCEC works under the direction of PAHO/WHO. It has technical assistance and financial support from the USP.
The working group held its first meeting in the city of Panama (1-3 June 2005). At this time, the group was established and defined its mission, objectives, and a 2-year work plan.
Strengthen the performance of the official laboratories for control of medicines (LOCM) in the countries of the Region of the Americas through implementation of Good Laboratory Practice, in order to guarantee the quality of the laboratory test results and facilitate mutual recognition of the results.
- Support implementation of GLP in the LOCM
- Preparation and dissemination of educational material for implementation of the WHO GLP (2002)
- Preparation of a training and continuing education plan
- Technical support for countries that accept the commitment to implement GLP
- Establishment of a LOCM network
- Formalization of PCEC
- Harmonization of reports on results
- Preparation of a proposal to structure the network
Members of the Working Group on Good Laboratory Practice
Main Members: MERCOSUR: Sigrid Mathison, Uruguay; ANDEAN COMMUNITY:Ofelia Villalba, Perú; SICA: Nilka Guerrero, Panama; CARICOM: Lucette Cargill, Jamaica; USP: Damian Cairatti, United States; FIFARMA: Thomas Schultz, United States; Mara Gloria Olate, Chile (Main Coordinator).
Alternate Members: MERCOSUR: Olga Gruc, Argentina; ANDEAN COMMUNITY: Cecilia Garnica, Bolivia; SICA: Ana Lara Sterling, Cuba; CARICOM: Mrs. C. Alvarez, Trinidad and Tobago.
Secretariat (PAHO/WHO): José M. Parisi, Washington, D.C.
The work plan included the definition and planning of tasks, the assignment of responsibilities, and a time line for:
Interpreting and applying the standard (WHO Report 36)
Preparing educational modules and workshops
Executing courses on GLP
Executing education and training workshops
Preparing the self-evaluation guide on GLP
Implementing the self-evaluation guide on QCL
Evaluating materials provided by USP
Preparing sample program for PCEC
Preparing documents for the formalization of PCEC
Preparing documents for structuring the QCL network
Preparing forms for the harmonization of reports and results
Meetings and Activities
Results of the activities of the Working Group on GLP
A. Documents prepared
- pdf Red PARF Documento Técnico No. 2. OMS Serie de Informes Técnicos, No. 902, 2002. Informe 36, Anexo 3. Buenas prácticas para Laboratorios Nacionales de Control Farmacéutico . (2010) 137 p. (Spanish, English and Portuguese)
- pdf Red PARF Documento Técnico No. 3. Guía de autoevaluación de buenas prácticas para Laboratorios Nacionales de Control Farmacéutico . (2010) 71 p. (Spanish, English and Portuguese)
pdf Red PARF Documento Técnico No. 4. Estudio sobre las condiciones actuales de los Laboratorios Oficiales de Control de Calidad de Medicamentos (LOCM) en América Latina y el Caribe. (2010) 45 p. (Spanish, English and Portuguese)
pdf Red PARF Documento Técnico No. 6. Documento de Autoevaluación de Buenas Prácticas de Laboratorio (BPL) (2011) 113 p. (Spanish, English and Portuguese)
Background: The Pan American Network for Pharmaceutical Harmonization (PANDRH Network), through the Technical Working Group on GLP (WG/GLP), developed a proposal for a course on good practices for national pharmaceutical control laboratories. This course has been implemented in several countries of the Region. It will be presented at the Fifth Pan American Conference on Drug Regulatory Harmonization to be held in 2008.
- Promote use of the WHO recommendations for GLP: Report 36, Annex 3 (Technical Report Series 902, 2002).
- Improve the performance of the quality control laboratories.
- Circulate and promote use and correct implementation of the Self-Evaluation Guide on GLP of the PANDRH Network.
- Increase the communication and exchange of information between the official quality control laboratory, local manufacturers of medicines, and the academic sector.
- Update the knowledge of the staff members of the Ministries of Public Health and the academic sector with regard to the latest WHO recommendations on GLP.
a) Anexo 1 Prácticas adecuadas de fabricación de productos farmacéuticos
b) Informe 32 Anexo 5. (25.89 kB)
c) Apéndice 2 del Informe 32 (14.2 kB)
d) WHO Technical Report 834 (in English)(1.46 MB)
e) Anexo 5 Directrices para las pruebas (56.68 kB)
f) Annex 5 Guidelines for stability testing (in English) (117.77 kB)
g) Anexo 6 del Informe 34 (61.81 kB)
h) WHO Technical Report Series 885 (in English) (7.01 MB)
i) Anexo 3 Informe 35 Directrices generales (50.63 kB)
j) Annex 6. Good manufacturing practices (in English) (137.73 kB)
k) Introduction (512.47 kB)
l) Annex 4.Good Manufacturing Practices for pahrameceutical products (in English) (18.65 kB)
m) WHO Technical Report Series 929 (in English)(965.48 kB)
n) WHO Technical Report Series 937 (in English) (1.97 MB)
ñ) Guía de verificación de buenas prácticas de manufactura (538.24 kB)
Workshops and solutions (in Spanish)
Constant table (in Spanish)
Workshop: Validation vitamin D3, instructions (23.49 kB)
Workshop: Validation vitamin D3, data processing (106.05 kB)
Formulas for validation of test methods (62.53 kB)
Worksheet: Dissolution (29.77 kB)
Worksheet: Dose uniformity- UV (59.5 kB)
Worksheet: Water determination by Karl Fisher (24.82 kB)
Workshop: Audit non-conformoties (22.78 kB)
Workshop: Verification visit (12.65 kB)
Workshop: Audit plan (31.15 kB)
Solutions for the workshops (in Spanish)
Presentations (in Spanish)
a) Introducción (68.45 kB)
b) Parámetros de calidad (506.43 kB)
c) Módulo de comparación ISO 17025 y BPL de OMS (2.02 MB)
d) Módulo de gestión e infraestructura (1.04 MB)
e) Módulo muestreo (1.35 MB)
f) Módulo metrología (487.08 kB)
g) Módulo procedimientos de trabajo (444.5 kB)
h) Orden de servicio (63.78 kB)
i) Hoja de trabajo. Valoración e identidad HPLC (84.07 kB)
j) Informe de análisis (168.45 kB)
k) Módulo materiales y acondicionamiento (901.38 kB)
l) Módulo validación de métodos microbiológicos (241.03 kB)
m) Módulo validación de métodos fisicoquímicos (965.48 kB)
n) Módulo seguridad (1.83 MB)
ñ) Módulo de seguridad - Ficha de datos
o) Módulo auditorías de calidad (303.87 kB)
p) Módulo Capítulo 12 BPF Control de calidad para la industria (252.37 kB)
4. Courses given
The team of instructors for each course consists of three professionals, a combination of university professors and professionals from pharmaceutical quality control laboratories. There are two basic criteria that should be met in all cases. All of the courses should have at least one facilitator from the university (teaching experience) and a facilitator from an official laboratory (practical experience). It is recommended that the facilitators should be from different countries, since this enriches the discussion of the subjects. They are usually from three different countries. In all cases, it is stressed that they should be from at least TWO different countries. A professional from the United States Pharmacopeia (USP) is also available to explain the proper use of the USP-NF and present a DVD on a commonly used technique (e.g., TLC, HPLC). The group of facilitators includes: Ruben Szyszkowsky (Universidad de Buenos Aires, Argentina); Catalina Massa (Universidad de Córdoba, Argentina); Rosalba Alzate (Universidad de Antioquia, Medellín, Colombia); Carlos Saldarriaga Alzate (Universidad de Antioquia, Medellín, Colombia); Milagros Real Pérez (National Center for Quality Control, INS, Peru); Fredy Rafael Mostacero Rodríguez (National Center for Quality Control, INS, Peru); Antonio Hernández Cardoso (United States Pharmacopeia); José M. Parisi (PAHO/WHO)
Self-Evaluation Implementation Guide, Education and training workshops
C- Self- Evaluation Guide
The Objective of the guide is to train the laboratory staff on application of the guide and observe the performance of the laboratory. The expected results are to know the laboratory's situation in terms of compliance with the recommendations of WHO Report 36, Annex 3.
D - Education and training workshops
The WG/GLP has supported the activity conducted by the PAHO external quality control program (PCEC) since 2003 with technical assistance from the staff of the QCL and USP.
Improve the performance of the official control laboratories (QCL) by educating and training staff on the laboratory test procedures and techniques commonly used in the quality control of medicines. The workshops were related to:
High-performance liquid chromatography (HPLC), dissolution test for conventional release medicines, microbiological control and bacterial endotoxin assay, Limulus test (LAL)
E. Results of the activities of the Working Group on GLP. Additional activities on strengthening of human resources
Additional training has been provided based on the main activities of the Working Group:
1. Replication of the GLP course in Chile, organized by the University of Chile with the participation of two facilitators from the WG (28 Nov-2 Dec 2006): 81 participants, primarily students in the final year of chemistry and pharmacy studies and students preparing their thesis. The industry and the health authority (ISP) also participated.
2. One week of training (23-27 Oct 2006) at the National Institute of Health (INS) of Lima, Peru for five staff members from the Dominican Republic on: physical-chemical assays, IR, SGC documentation, SGC management requirements, aspects of SGC management.
3. Training in Nicaragua (June 2007) for 1 staff member from the IEA of Panama and 1 staff member from the national health laboratory (LNS) of Peru in international workshops on HPLC and dissolution.
4. HPLC workshop in the LNS of Guatemala (February 2007) with the participation of 10 professionals (6 from Guatemala, 2 from Dominican Republic, 2 from Nicaragua). The facilitators were Yariela M. de Noriega (Panama) and Nancy Calvo Plaza (Peru).
5. Training of professionals in microbiological analyses: specific tests for bacterial endotoxins and antibiotic potency: DOR (in ARG), ECU, and BOL (in PER), COR and HON (in PAN).
6. Training of professionals in physicochemical tests (high-performance liquid chromatography, dissolution, other): quality control of Mebendazole in ARG for JAM, TRT, ECU, NIC, GUT, and PAR (2nd semester 2011).
7. Training of auditors in GLP, with professionals from USP: 1 from URU, 3 from PER.
8. Audits of Quality Management System for ISO 17025/ WHO prequalification (verification of compliance with GLP in accordance with 44th Report, Annex 1 of WHO, implementing the Self-evaluation Guide).
-Audited Laboratories (10): Dr. Defilló (DOR), CCSS (COR), LAYAFA (COR), LCQF (HON), LNS (GUT), INVIMA (COL), IEA (PAN), CRDTL (JAM), INCQS (BRA), FUNED (BRA)
-Auditors (7): Julia Chu Cayatopa, Milagros Real Pérez, Juan Ortíz Bernaola, Fredy Mostacero, Ofelia Villalba, Mónica Hirschhorn, Rosalba Alzate
9. Endorsement of the request for WHO prequalification: FUNED, INCQS, CRDTL.
10. Support for performance monitoring programs:
a) PCEC (PAHO-USP): 9th stage MEBENDAZOLE
b) Interlaboratories of the CNCC (PER): Sterility, microbial limit
bacterial endotoxins (LAL), antibiotic potency
Meetings and activities
F. Results of the activities of the Working Group on GLP. Meetings of the Working Group on Good Laboratory Practice
The Working Group on Good laboratory Practices meets twice a year to define, plan, implement, follow-up, and analyze the results of the different activities established at its work meetings. The subjects considered at each meeting are summarized in the respective reports prepared by the Secretariat. To date the following meetings have been held:
Nine Meeting. Through Elluminate. December 12, 2011
2nd Virtual Meeting Network of Official Medicines Control Laboratories
Click here to listen to the recorded session.
Eight meeting. Through Elluminate. April 6, 2011
Seventh Meeting. Lima, Perú. July 20-22, 2010
Sixth meeting. Brazil. November 23-25, 2007
Fifth meeting. Guatemala. May 30- June 1, 2007
Fourth meeting. Bolivia. November 3-4, 2006
Third meeting. Dominican Republic. March 6-10, 2006
Second meeting. Peru. November 29- December 2, 2005
First meeting. Panama. June 1-3 , 2005
Fifth Meeting of the Working Group on Good Laboratory Practices (WG/GLP) and the Course on Good Practice for Pharmaceutical Control Laboratories. The members of the Working Group (PAHO) are: (standing from left to right) Milagros Real Pérez and Rosario Vega Huanca, INS/Peru; Carlos Saldarriaga Alzate, Universidad de Antioquia/ Colombia; José María Parisi, PAHO/Washington (Secretariat); María Gloria Olate, ISP/Chile (Coordinator); Silvana Vaz de Melo Mattos, ANVISA/Brazil; Nilka M. Guerrero R, IEA/Panama; Lucette Cargill, CRDTL/Jamaica.
Contents: Bioequivalence Working Group´s Mission, objectives, background, recommendations, educational activities, working papers, and information resources.