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stdClass Object ( [id] => 1049 [title] => Working Group on Good Laboratory Practices - Page 5 Meetings and activities [alias] => grupo-trabajo-buenas-practicas-laboratorio [title_alias] => Grupo de Trabajo de Buenas Prácticas de Laboratorio [introtext] =>

El PCEC mide el desempeño de los Laboratorios Oficiales de Control de Medicamentos de la región, enviándoles muestras ciegas para su análisis cuyos resultados son evaluados por la Farmacopea Norteamericana (USP).

[fulltext] =>

Backgroung

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.

Mission 

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.

Objectives

1.  Support implementation of GLP in the LOCM

1.1 Preparation and dissemination of educational material for implementation of the WHO GLP (2002)

1.2 Preparation of a training and continuing education plan

1.3 Technical support for countries that accept the commitment to implement GLP

2. Establishment of a LOCM network

2.1 Formalization of PCEC

2.2  Harmonization of reports on results

2.3 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.


Work Plan

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


Results of the activities of the Working Group on GLP

A.  Documents prepared 

B. Course on Good laboratory practices(GLP) for the Official Laboratories for Control of Medicines (LOCM)

1. 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.

2. Objectives

  • 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.

3. Educational Materials

Documents:

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)

icon Table of GLP courses conducted by country and the number of professionals trained by August 2008 (54.24 kB) (Spanish) 


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 known the laboratory’s situation in terms of compliance with the recommendations of WHO Report 36, Annex 3.

iconTable on implementation of the self-evaluation guide. DF - 16.6 kB) 

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.

  • Objectives

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)

icon Implementation table(16.46 kB) 


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

c)  WHO

 


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

Documents

icon Agenda 9ª Meeting- Good Laboratory Practices (GT- BPL) (34.34 kB)

icon Activities developed by GT/BPL during 2011 (639.5 kB)

icon VI PANDRH Conference. Working Group Good Laboratory Practices (7.11 MB)

icon WHO Good Practices For Pharmaceutical Microbiology Laboratories (631 kB)

Click here to listen to the recorded session.  

      • Eight meeting. Through Elluminate. April 6, 2011

icon PANDRH Network WG/GLP. Report of the Eight Meeting. Through Elluminate. April 6 2011 (39.67 kB) (Spanish version) 

      • Seventh Meeting. Lima, Perú. July 20-22, 2010

        icon Red PARF - GT- BPL- Report of the Seventh Meeting. Perú. July 20-22, 2010  (60.51 kB) (Spanish version)

      • Sixth meeting. Brazil. November 23-25, 2007

icon PANDRH Network WG/GLP. Report of the Sixth Meeting. Brazil. November 23-25  2007 (53 kB) (Spanish version)

      • Fifth meeting. Guatemala. May 30- June 1, 2007

icon PANDRH Network WG/GLP. Report of the Fifth Meeting. Guatemala. May 30- June 1 2007 (205.94 kB) (Spanish version)

      • Fourth meeting. Bolivia. November 3-4, 2006

icon PANDRH Network WG/GLP: Report of the Fourth Meeting. Bolivia.  November 3-4 2006(86.35 kB)

      • Third meeting. Dominican Republic. March 6-10, 2006

icon PANDRH Network WG/GLP: Report of the Third Meeting. Dominican Republic. March 6-10 2006 (53.15 kB)

      •  Second meeting. Peru. November 29- December 2, 2005

icon PANDRH Network WG/GLP: Report of the Second Meeting. Peru. November 29- December 2 2005 (70,95 kB)

      • First meeting. Panama. June  1-3 , 2005

icon PANDRH Network WG/GLP: Report of the First Meeting. Panama. June 1-3 2005 (62.34 kB)

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.

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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

Documents

icon Agenda 9ª Meeting- Good Laboratory Practices (GT- BPL) (34.34 kB)

icon Activities developed by GT/BPL during 2011 (639.5 kB)

icon VI PANDRH Conference. Working Group Good Laboratory Practices (7.11 MB)

icon WHO Good Practices For Pharmaceutical Microbiology Laboratories (631 kB)

Click here to listen to the recorded session.  

      • Eight meeting. Through Elluminate. April 6, 2011

icon PANDRH Network WG/GLP. Report of the Eight Meeting. Through Elluminate. April 6 2011 (39.67 kB) (Spanish version) 

      • Seventh Meeting. Lima, Perú. July 20-22, 2010

        icon Red PARF - GT- BPL- Report of the Seventh Meeting. Perú. July 20-22, 2010  (60.51 kB) (Spanish version)

      • Sixth meeting. Brazil. November 23-25, 2007

icon PANDRH Network WG/GLP. Report of the Sixth Meeting. Brazil. November 23-25  2007 (53 kB) (Spanish version)

      • Fifth meeting. Guatemala. May 30- June 1, 2007

icon PANDRH Network WG/GLP. Report of the Fifth Meeting. Guatemala. May 30- June 1 2007 (205.94 kB) (Spanish version)

      • Fourth meeting. Bolivia. November 3-4, 2006

icon PANDRH Network WG/GLP: Report of the Fourth Meeting. Bolivia.  November 3-4 2006(86.35 kB)

      • Third meeting. Dominican Republic. March 6-10, 2006

icon PANDRH Network WG/GLP: Report of the Third Meeting. Dominican Republic. March 6-10 2006 (53.15 kB)

      •  Second meeting. Peru. November 29- December 2, 2005

icon PANDRH Network WG/GLP: Report of the Second Meeting. Peru. November 29- December 2 2005 (70,95 kB)

      • First meeting. Panama. June  1-3 , 2005

icon PANDRH Network WG/GLP: Report of the First Meeting. Panama. June 1-3 2005 (62.34 kB)

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.



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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

Documents

icon Agenda 9ª Meeting- Good Laboratory Practices (GT- BPL) (34.34 kB)

icon Activities developed by GT/BPL during 2011 (639.5 kB)

icon VI PANDRH Conference. Working Group Good Laboratory Practices (7.11 MB)

icon WHO Good Practices For Pharmaceutical Microbiology Laboratories (631 kB)

Click here to listen to the recorded session.  

      • Eight meeting. Through Elluminate. April 6, 2011

icon PANDRH Network WG/GLP. Report of the Eight Meeting. Through Elluminate. April 6 2011 (39.67 kB) (Spanish version) 

      • Seventh Meeting. Lima, Perú. July 20-22, 2010

        icon Red PARF - GT- BPL- Report of the Seventh Meeting. Perú. July 20-22, 2010  (60.51 kB) (Spanish version)

      • Sixth meeting. Brazil. November 23-25, 2007

icon PANDRH Network WG/GLP. Report of the Sixth Meeting. Brazil. November 23-25  2007 (53 kB) (Spanish version)

      • Fifth meeting. Guatemala. May 30- June 1, 2007

icon PANDRH Network WG/GLP. Report of the Fifth Meeting. Guatemala. May 30- June 1 2007 (205.94 kB) (Spanish version)

      • Fourth meeting. Bolivia. November 3-4, 2006

icon PANDRH Network WG/GLP: Report of the Fourth Meeting. Bolivia.  November 3-4 2006(86.35 kB)

      • Third meeting. Dominican Republic. March 6-10, 2006

icon PANDRH Network WG/GLP: Report of the Third Meeting. Dominican Republic. March 6-10 2006 (53.15 kB)

      •  Second meeting. Peru. November 29- December 2, 2005

icon PANDRH Network WG/GLP: Report of the Second Meeting. Peru. November 29- December 2 2005 (70,95 kB)

      • First meeting. Panama. June  1-3 , 2005

icon PANDRH Network WG/GLP: Report of the First Meeting. Panama. June 1-3 2005 (62.34 kB)

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.



Last Updated on Tuesday, 13 December 2011 06:32
 

 

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