Transcript External Quality Control Program of Official Drug Quality Control

EXTERNAL QUALITY CONTROL PROGRAM
OF OFFICIAL DRUG QUALITY CONTROL
LABORATORIES (EQCP)
PROGRAMA DE CONTROL EXTERNO DE CALIDAD
DE LABORATORIOS OFICIALES DE C.C. DE MEDICAMENTOS
(PCEC)
José M. Parisi
PAHO/WHO
March 2-4, 2005

The External Quality Control Program (EQCP) is a PAHO/WHO
technical cooperation activity carried out in collaboration with the
United States Pharmacopeia (USP) with the participation of the
Official Drug Quality Control Laboratories of PAHO Member States.
EQCP
PAHO + USP + Official Drug Q.C. Laboratories
• to optimize testing capacity and reporting
• to evaluate the quality of drugs used in priority programs
• to identify the areas that require technical cooperation
• to develop the concept of Reference QC Laboratories
throughout the region
Objectives
Strengthening the performance in quality control tests
Increase communication and exchange of information;
Harmonize methodologies to facilitate the
acceptance/recognition among countries of
the validity of the results obtained.
The EQCP is composed of three Phases
PHASE I Diagnostic study of the laboratories
PHASE II Performance evaluation
PHASE III Training of human resources
Phase I: Diagnostic study of the Official Drug QC Lab.
A questionnaire and site visit.
To date Phase I includes two Stages
Stage 1: (2001/02) 18 laboratories from 16 countries from South America,
Central America, and Mexico.
Stage 2 : (2003/04) 5 laboratories from the Caribbean (Cuba, Dominican Rep,
Jamaica, Guyana) and Bolivia.
Main results:






100% have high-performance liquid chromatography (HPLC)
24% have sufficient staff to implement the Good Lab. Practices (GLP)
95% have equipment for dissolution tests
43% are self-financed
29% have Operational Manuals as required by ISO norms
24% have adequate buildings to implement the GLP
Phase II: Performance evaluation

Objective: to evaluate the performance of the laboratories testing methodology
and reporting.

Criteria: as USP evaluation of performance:
a)
b)
c)
d)

weighing-in
precision
equipment
reproducibility
d) errors standard relative
e) data report and interpretation
f) limitations of the monograph and
familiarity with the USP methods
Results: the laboratories were classified in three groups:
Group 1: Laboratories with a level of performance considered Excellent.
Group 2: Laboratories with a level of performance considered Good, but
do not execute some of the tests, or may have minimal errors to be
corrected with appropriate training of their staff.
Group 3: Laboratories with a level of performance considered Poor.
Phase II Tests of External Control Testing through the
shipment of samples and corresponding standards.
Stage
Laboratories
participants
Countries
Group 1
Group 2
Group 3
Sample
1ª (2001)
17
15
8 (47 %)
8 (47 %)
1 (6 %)
2ª (2001)
18
16
4 (22 %)
8(44.5%)
3ª (2002)
17
15
6 (35 %)
6 (33.5
%)
6 (35 %)
Acetil
salicylic
acid;
ibuprofen
Acetaminofen
4ª (2003)
21
19
11 (52.4%)
5ª (2004)
21
19
---
5 (23.8
%)
---
5 (30 %)
Streptomycin
sterile
powder for
injection
5 (23.8 %)
Aciclovir
---
Zidovudine
Phase III: Training of human resources.
Implementation of workshops and seminars on GLP in Countries that
according to the results need more assistance (to date it includes 4 stages).
Stage
Date
Place Participants
Region
Countries
Products
8 (COR,
CUB,
DOR,
ELS,
GUA,
HON,
NIC,
PAN)
7 (BOL,
BRA,
ECU,
GUY,
PER,
SUR,
VEN)
5 (BOL,
ECU,
PAR,
PER,
PAN)
9 (COR,
CUB,
DOR,
ELS,
GUA,
HON,
MEX,
NIC,
PAN)
Antiretroviral
(Zidovudina)
1º
July
GUA
Training
14-17
workshop (2003)
12
Centro América
y países del
Caribe
hispanohablante
2º
Nov.
Training
17-21
workshop (2003)
ECU
16
Amazonic
countries
(Ravreda-Ami
Program)
3º
Oct.
BOL
Training
19-22
workshop (2004)
10
Amazonic
countries
(Ravreda
Program)
4º
Nov.
PAN
Training
16-19
workshop (2004)
16
Central
America, Mexico
and the
Caribbean
Spanish speaker
countries
Antimalaric
(Quinina
sulfate)
Antimalarics
(Artesunate
and
Mefloquine)
Antiretrovirales
(Zidovudine
and
Lamivudine)
PROPOSAL
(to request)
To the National Drug Reg. Authorities: Support to the Official Drug QC Lab.
• to continue to participate in the EQCP
• to involve appropriate personnel in the training activities
• to establish the network of Official Drug QC Lab. and designate a coordinator
To USP
•
•
that it continue to contribute technical and financial support to the EQCP
through an annual plan of operation
to generate standardized protocols of analysis and common reports
To the pharmaceutical industry and to the Universities
•
To promote the updating and training of analysts in the industry and
university educators in analytical techniques, for supporting future
development of training workshops and improving the quality of the drugs
produced.
PROPOSAL
TO REQUEST
To the PANDRH: To establish a Working Group on Good Laboratory Practice
(WG/GLP) with the objective of:
•
•
•
•
To monitor the EQCP
To define the Procedures of the EQCP
To prepare educational materials on GLP and a plan of implementation
That the WG/GLP presents a report on GLP application in the region.