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.

Table 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)

 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