6TH PARF NETWORK CONFERENCE 6-8 JULY 2011 WORK GROUP GOOD LABORATORY PRACTICES Coordinator : QF. Maria Gloria Olate ANAMED ( National Drug Agency ) Public Health Institute of Chile

Background The GT/BPL was created in June 2005, with representatives from all of the subregions in the Americas at the request of the External Quality Control Program that was developing OPS with USP (Andean Countries, CARICOM, SICA, MERCOSUR, NAFTA, Pharmaceutical Industrial and USP). MISSION To strengthen the performance of official medication control laboratories (LOCMs) in the countries in the Americas region, through the implementation of Good Laboratory Practices (BPLs) to guarantee the quality of the analytical results and facilitate mutual recognition among countries. OBJECTIVES 1.- Support the implementation of the BPLs in the LOCMs 2.- Promote the establishment of a LOCM Network

BPL WORK GROUP MeetingsCountryDate 1ªPanamaJun ªPeruNov ªDominican RepublicMar ªBoliviaNov ªGuatemalaMay ªBRAZILNov ªPeru ( guests from Arg, Bol, Bra, Col, Chi, Jam, Pan, Uru, USA, Peru) 32 participants Jul ª Virtual ILLUMINATE 35 connections among LOCM’s and OPS Offices (Arg, Bra, Chi, Col, Cub, Cor Dor, Ecu, Gut, Hon, Pan, Par, Per, Uru, USP Structuring an LOCM Network for Latin America and the Caribbean April 2011

ACHIEVEMENTS REACHED 1.- Countries with the BPL course taken (Report 36, Annex 3, OMS; for national control laboratories) Dominican R. Chile Honduras Venezuela Costa Rica Brazil Peru El Salvador Uruguay Argentina Colombia Jamaica Paraguay Nicaragua Bolivia Guatemala Ecuador Panama Cuba Mexico : under way Total : 19 Professionals trained: 742 (Official Sector, Universities, Pharmaceutical industry, others) LOCM Professionals : 261

This document was prepared by the GT and its main objective is to orient the personnel of official laboratories to perform a self-evaluation of their quality control system in relation to the BLP/OMS’s, allowing them to obtain diagnostics. This is a common work tool in the countries of the Region, promoting the unification of criteria in the self-inspections of official laboratories. Self-evaluated laboratories: Self-evaluation document, based on Technical Report No. 36, Annex 3/OMS (BPL in effect through 2010)

3 : Training workshops Since 2005 the GT/BPL has continued to support the training activities in analytical techniques and procedures frequently used in drug quality control The activities are assisted technically by the LOCM and USP staff To date numerous workshops related to: High-resolution liquid chromatography ( HPLC ) Physical chemical parameters Dissolution tests, for conventional release medications Microbiological control and bacteria endotoxin test ( LAL ) SGC Documentation and management aspects PANAMA COSTA RICA NICARAGUA HONDURAS GUATEMALA JAMAICA GUYANA BOLIVIA ECUADOR PERU BRAZIL DOMINICAN R.

4: Technical documents published, PARF Network 1. PARF Network Technical Document Nº 2, OMS Technical Report Series No. 902, Report 36, Annex 3, Good Clinical Practices for National Pharmaceutical Control Laboratories, version in Spanish, English, and Portuguese ( 2010 ) 2. PARF Network Technical Document Nº 3, Good Practices Self-Evaluation Guide for National Pharmaceutical Control Laboratories, version in Spanish, English, and Portuguese ( 2010 ) 3 PARF Network Technical Document No. 4. Study on the current conditions of Official Medication Control Laboratories (LOCM’s) in Latin America and the Caribbean,, version in Spanish, English, and Portuguese (2010) 45 p. 4. PARF Network Technical Document No. 6. Good Laboratory Practices Self- Evaluation (BPL) version in Spanish, English, and Portuguese (2011) 113 p. 5. PARF Network Technical Document No. 9. Good OMS Practices for Pharmaceutical Quality Control Laboratories (Portuguese) (2011) Good Pharmaceutical Quality Control Laboratories, version in Spanish (2011) In the process of being included on the OMS’s website. Link for the publications on the website: Link for the GT/BPL activities and educational material on courses and workshops in BPL:

5.- LOCM’s Prequalified by OMS (Sep 2010) as United Nations reference laboratories (GT/BPL and USP) CONCAMYT (Official Medication Quality and Toxicology Quality Control Laboratory ) BOLIVIA CCCM ( Official Medication Quality Control Laboratory ) URUGUAY CNCC ( Official Laboratory National Quality Control Center )PERU

WORK PLAN ACTIVITIES BPL Course (Rep 36/Rep 44 - OMS)CompletedMexico On request Workshops in microbiology, antibiotic potency) DOR, ECU, BOL, COR, HONGUTPAR Workshops in Physiochemistry ( HPLC, Dissolution) 2 nd half, in ARG for: TRT, ECU, NIC, GUT GUT, PARSUR, TRT Workshops Uncertainty in medicines and the validation of analytical methodologies 2 LOCM de COR (performed) HON( performed) COL, DOR, BOL, GUT, CHI, ARG BRA, ECU, PAN, VEN,NIC, PAR NIC, CUB, PER, GUY, TRT, JAM Audits of the SGC for ISO 17025/ OMS prequalification (verification of compliance with BPL Rep 44, Annex 1 OMS with implementation of the self- evaluation document Audited: GUT, COL, DOR, HON, COR (LAYAFA, CCSS), PAN, JAM, BRA (INCQS FUNED) To be audited: CHI, DOR, GUTOn request Support on OMS prequalification applications FUNED, INCQS, CRDTL, GUT, DOR, PAN, COR CHI On request

WORK PLAN ACTIVITIES Support for performance improvement programs PCEC( OPS/USP ) CNCC Inter-laboratory (PER) sterility, LAL, antibiotic potency OMS (EDQM) 9 th phase PCEC: Mebendazol To be defined Training of BPL auditorsURU, PER, USAOn request Update study on the current conditions of the LOCM’s and issue technical document GT/LOCM ( Caribe y America Central) GT/LOCM (America del Sur) GT/LOCM (Final document) Virtual meetings ( elluminate)GT/Red LOCM (Apr 2011) GT/BPL (Sep 2011) 1 GT/BPL 1 GT/Red LOCM 1 GT/BPL 1 GT/Red LOCM Harmonization Analytical Worksheets biological tests GT/BPL ( bacterial endotoxins) GT/BPL (Antibiotic potency) GT/BPL (sterility) Consolidate the structuring of the LOCM Network, through an operating document (focal points, OPS, GT offices, others) GT/LOCM Gather information GT/LOCM Consolidate the structure of the LOCM Network GT/LOCM Prepare document

Members of the GT/BPL ANDEAN COUNTRIES Maria Gloria Olate CHILE (Full) Coordinator Ofelia Villalba PERU (Full) (Alternate Coordinator) SICA Nilka Guerrero PANAMA (Full) Ana Lara Sterling CUBA (alternate) CARICOM Lucette Cargill JAMAICA (Full) Cheryl Scott-Alvarez TRT ( alternate) MERCOSUR Sigrid Mathison URUGUAY ( Full) Olga Gruc ARGENTINA (alternate) USP Damian Cairatti USA (Full) BRAZIL Eduardo Chavez BRAZIL (INCQS) Francisco Gerlandio BRAZIL FIFARMA Thomas Schultz USA (Full) OPS SECRETARY Jose Maria Parisi USA

FACILITATORS Rosalba Alzate, Univ. de Antioquia, Colombia Carlos Saldarriaga, Univ. de Antioquia, Colombia Rubén Szyszkowsky. Univ. de B.Aires, Argentina Catalina Massa, Univ. de Córdoba, Argentina Gabriela Velázquez, INAME, Argentina Matías Gómez, INAME, Argentina Milagros Real Pérez, INS, Peru Rosario Vega Huanca, INS, Peru Julia Chu Cayatopa, INS, Peru Juan Ortiz Bernaola, INS, Peru Fredy Mostacero, INS, Peru Nancy Calvo, INS, Peru Adrián Barojas, USP Antonio Hernández Cardoso, USP Ángela Alfonso Manso, CIDEM, Cuba Maydelin Blanco, CECMED, Cuba Yariela de Noriega, I EA, Univ.de Panama Mónica Hirschhorn, CCCM, Uruguay

Copihues National Flower of Chile