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2-4. WHO Sampling and Testing Programmes. Jitka Sabartova WHO Prequalification Programme: Priority Essential Medicines HSS/EMP/QSM.

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slide1

2-4

WHO Sampling and Testing Programmes

Jitka Sabartova

WHO Prequalification Programme: Priority Essential Medicines

HSS/EMP/QSM

Interregional Seminar for Quality Control Laboratories involved in WHO Prequalification Programme and/or participating in respective sampling and testing projects, Nairobi, Kenya, 23-25 September 2009

who prequalification programme monitoring of medicines quality
WHO Prequalification Programmemonitoring of medicines quality

Policy

To monitor quality of medicines procured by UN agencies/ prequalified products

To contribute to quality control of medicines, if requested by Member States

To contribute to capacity building by cooperation with NDRAs

Sampling and testing projects

A tool for fulfilling the policy

sampling and testing projects
Sampling and testing projects

Entry

information

Quality concerns,

complaints/defects,

signals, inspections

PQ procedures

Plan

+updates

Actions

Reports

Inspections

Assessment

PhV

Conduct

of projects

P1

P3

P2

planning of projects
Planning of projects

Entry information

Commitments

Signals

Evaluation,

discussion with experts, if needed

Draft plan

Discussion with experts

Action needed?

NO

End

YES

Plan

Urgent action?

NO

YES

Conduct of projects

conduct of a project 1
Conduct of a project (1)

Setting OBJECTIVES of the project

Drafting protocol, its commenting and approval

Selection of the testing laboratory/ies and sampling organizations

Agreements, incl. financial arrangements

Collection of samples

Storage and dispatch of samples

1

conduct of a project 2
Conduct of a project (2)

1

Receipt and check-in of samples

by the laboratory

Monitoring of quality of

labels and package inserts,

if required

Testing of samples

Report

Laboratory report

Evaluation of reported data and

discussion with involved parties

Conclusions and recommendations

Project report

Actions

project protocol 1
Project protocol (1)
  • Background information
  • Objectives (limitations)
  • Selection of countries and medicines
    • Procured volumes, existing regulation, stability of medicines
  • Selection of sample collection sites – cooperation with NDRAs
    • Levels of distribution, regions, transport and storage conditions
  • Instructions for sample collection - the more detailed the better
    • Definition of sample
    • Number of dosage units or multidose packages to be collected
    • Time period
    • Sample collection form (incl. monitoring storage conditions at collection sites)
    • Handling and storage of samples
    • Training of collectors
project protocol 2
Project protocol (2)
  • Selection of tests to be conducted
    • Closely related to the project objectives
    • In principle
      • Appearance
      • Identity and content of active ingredient/s, related substances
      • Uniformity of dosage units, dissolution/disintegration, pH
      • Sterility, bacterial endotoxins/ pyrogens
  • Selection of specifications
    • If products from more manufacturers collected – pharmacopoeial specs easier, but it has to be taken into account when making conclusions
    • Differences in pharmacopoeial monographs to be considered
      • Procaine Benzylpenicillin injection - PhInt spectrophotometry for total penicillins and titration for procain, no related substances; USP iodometric assay for antibiotics, no related substances; BP(Vet) HPLC for related substance and assay
    • Laboratory validated method
project protocol 3
Project protocol (3)
  • Content of the laboratory report
  • Monitoring of quality of labels and package inserts
    • Evaluation of the compliance with the national requirements
    • Assessment of quality and completeness of essential information in package inserts
  • Handling of results
    • Non-compliant results pre-discussed with the respective NDRA and manufacturer
    • All results provided to NDRAs involved in the project and discussed
    • Corrective actions recommended
    • Adoption of the relevant measures in the responsibility of the respective NDRA
    • Agreed outcomes and report from the project published
quality control laboratories used
Quality control laboratories used

Importance of reliability

WHO Prequalified laboratories used, if available

If not, laboratories for which the evidence of reliability is available

European OMCL network

Inspection report

who qcls prequalification procedure 1 september 2009
WHO QCLs Prequalification Procedure (1)September 2009

Prequalified QCLs:

  • South Africa, RIIP+CENQAM (2005)
  • Algeria, LNCPP (2005)
  • South Africa, Adcock Ingram (2007)
  • Morocco, LNCM (2008)
  • Kenya, NQCL (2008)
  • India, Vimta Labs (2008)
  • France, CHMP (2008)
  • Vietnam, NIDQC (2008)
  • Kenya, MEDS (2009)
  • Singapore, HSA (2009)
  • Singapore, TÜV (2009)
who pq capacity building
WHO-PQ Capacity building

Capacity building focuses on national QC laboratories

Organization of trainings

Trainings in Quality Assurance, Quality Control and Ph.Int. (2007)

Morocco, 44 participants from 16 Francophone countries (AFRO, EMRO), cooperation with EDQM and AFSSAPS

Tanzania, 46 participants from 23 Anglophone countries (AFRO, EMRO, PAHO/AMRO)

Training on rational sampling and testing in quality control of medicines (2009)

Nairobi, 48 participants from 22 countries (AFRO, EMRO, WPRO)

Participation in EDQM Quality Assurance training for OMCLs

2005, 5 participants from AFRO and EMRO; 2007, 12 participants from AFRO, EMRO and EURO

Technical assistance provided to 8 national medicines QC laboratories

Focus on implementation of quality system and microbiological testing, inventory audits

Organization of proficiency testing for national quality control laboratories

WHO External Quality Assurance Scheme - free of charge

survey of the quality of antiretroviral medicines circulating in selected african countries 1
Survey of the quality of antiretroviral medicines circulating in selected African countries (1)
  • Carried out in 2005, report published
    • http://www.who.int/prequal/info_general/documents/ARV_survey.pdf
  • 42 collection sites in 7 countries, cooperation with NDRAs
    • Cameroon, DR of Congo, Kenya, Nigeria, Tanzania, Uganda and Zambia
  • 394 samples of monocomponent products and FDCs
    • didanosine, efavirenz, lamivudine, nevirapine, stavudine, zidovudine
    • lamivudine/zidovudine, stavudine/lamivudine, stavudine/lamivudine/nevirapine
survey of the quality of antiretroviral medicines circulating in selected african countries 2
Survey of the quality of antiretroviral medicines circulating in selected African countries (2)
  • Testing in Swissmedic
    • Ph.Int., USP, Indian Pharmacopoeia, validated in-house Swissmedic methods
    • Appearance, identity and content of active ingredient/s, related substances, uniformity of mass, dissolution/disintegration, pH
  • Very low failure of 1.8%, no critical deficiencies
    • 1 sample higher API content, 1 sample failed to disintegrate in 30', 2 samples lower dissolution
  • Sampling limited to official procurement and treatment centres and capital cities
  • Positive effect of common efforts of NDRAs, WHO and others involved in prequalification and purchase policies
quality monitoring of medicines funded by unitaid 1
Quality monitoring of medicines funded by UNITAID (1)
  • Strengthening quality control in close cooperation with NDRAs
    • Evaluation of the quality of medicines close to patients
    • Evaluation of compliance with national requirements for information on external and primary packaging and in package inserts
    • Capacity building of NDRAs by involving them in organization of the project
  • Framework protocol supplemented by country specific sampling plans prepared by NDRAs
  • Pilot phase
    • Paediatric and second line ARVs + co-trimoxazole
    • Kenya, Tanzania, Uganda and Zambia
    • Samples collected mostly in treatment centres, throughout regions
    • 383 samples from 24 manufacturers
    • Majority of collected medicines registered in the country (for some information missing)
quality monitoring of medicines funded by unitaid 2
Quality monitoring of medicines funded by UNITAID (2)
  • Pilot phase - testing
    • Testing in MHRA (UK), AFSSAPS (France), NICPBP (China)
    • Tests performed
      • Appearance
      • Identity
      • Content of active ingredient/s
      • Related substances
      • Uniformity of mass
      • Dissolution
      • pH
    • Specifications
quality monitoring of medicines funded by unitaid 3
Quality monitoring of medicines funded by UNITAID (3)
  • Pilot phase - results
    • Non-compliance
      • 2 samples LAM+STA+NEV dispersible tablets collected in Zambia low stavudine content (83%)

(4 samples from the same batch OK, complaint to the manufacturer)

      • 1 sample Trimethoprim+Sulfamethoxazol collected in Kenya higher trimethoprim impurity
    • Problems solved
      • All Didanosine dispersible tablets samples (2 manufacturers) additional peaks in related substances test, placebo requested from manufacturers  peaks due to excipients
      • All Nevirapine oral suspension samples (2 manufacturers) additional peaks in related substances test, placebo requested from manufacturers  peaks due to excipients
      • All LAM+STA+NEV tablets showed low nevirapine dissolution when tested according to Indian Ph. Conditions, dissolution method requested from both manufacturers  compliant results
    • Majority of collected medicines WHO prequalified
quality survey of antimalarial medicines in selected african countries 1
Quality survey of antimalarial medicines in selected African countries (1)
  • ACTs (most sold and recommended by national guidelines), sulfadoxine-pyrimethamine, oral dosage forms
    • Artemether/lumefantrine, artesunate/amodiaquine (both co-blistered and FDCs), sulfadoxine/pyrimethamine, sulfamethoxypyrazine/pyrimethamine
  • Cameroon, Ethiopia, Ghana, Kenya, Nigeria, Tanzania
  • Collection of samples
    • At all levels of distribution chain (private and public) and informal market, throughout the countries
    • In cooperation of NDRAs with WHO country offices
    • 936 samples collected
  • Testing
    • Screening of all collected samples by Minilab
    • 305 samples then tested in RIIP, South Africa (296 samples) and USP laboratory, USA (9 samples)
quality survey of antimalarial medicines in selected african countries 5
Quality survey of antimalarial medicines in selected African countries (5)
  • Tests performed
    • Appearance
    • Identity and content of active ingredient/s
    • Artemether related substances
    • Uniformity of mass, dissolution, pH
  • Specifications
  • Results are currently evaluated
  • Assessment of quality of product information (Labelling and PIL)
quality survey of antituberculosis medicines 1
Quality survey of antituberculosis medicines (1)
  • First- and second-line anti-TB medicines to be collected close to patients
    • Rifampicin capsules, Isoniazid tablets and injection, Rifampicin/Isoniazid tablets
    • Kanamycin powder for injection, Ofloxacin tablets and solution for infusion
  • Eastern Europe and NIS
    • Countries with high multidrug-resistant TB and extensively drug-resistant TB
    • Armenia, Azerbaijan, Belarus, Kazakhstan, Ukraine, Uzbekistan
  • Close cooperation with NDRAs and WHO EURO regional office
  • 360 samples planned to be collected
  • Testing
    • OMCLs of Austria and Luxembourg, in EDQM, SGS (Belgium)
    • Comparative dissolution study of Rifampicin capsules and Rifampicin/Isoniazid tablets at Goethe University, Germany (both conditions from Ph.Int. and USP)
quality survey of antituberculosis medicines 2
Quality survey of antituberculosis medicines (2)
  • Tests performed
    • Appearance
    • Identity and content of active ingredient/s
    • Related substances (for rifampicin and ofloxacin only)
    • For tablets and capsules uniformity of mass, dissolution
    • For parenteral products volume in container, pH, sterility, bacterial endotoxins (for infusion only)
  • Specifications
specific quality monitoring projects
Specific quality monitoring projects
  • Comparative dissolution study of Coartem tablets (2007)
    • Artemether / lumefantrine innovator - problems with dissolution reported
    • 5 batches manufactured in different manufacturing sites and collected in Tanzania, tested in RIIP, South Africa
    • Dissolution profiles compared to the mean of all data  SIMILAR
  • Generic products containing nelfinavir (2007)
    • Triggered by Roche worldwide withdrawal of Viracept
    • Test on EMS/MMS impurity using Roche method
    • Samples of finished product from Cipla, Hetero, GPO Thailand and of API from Matrix, Hetero collected from manufacturers, as well as from markets, tested in Swissmedic
    • All samples ≤ 0.5 ppm
    • For the purposes of Ph.Int. monograph dissolution tested
testing on request from countries un agencies
Testing on request from countries/UN agencies
  • Artesunate+Amodiaquine tablets (co-blistered), Guilin Pharmaceuticals, China – request from NGO in Indonesia
  • Diethylcarbamazine citrate tablets, Asian Pharmaceutical Company, Nepal – request from Ministry of Health in Nepal
  • Praziquantel tablets, Merck, Mexico – cooperation with WHO procurement and Neglected Tropical Diseases - Schistosomiasis control project
  • Artesunate tablets, Guilin Pharmaceuticals, China – request from WPRO
  • Miltefosin capsules, Popular Pharmaceuticals, Bangladesh - request from Ministry of Health in Bangladesh
  • Rifampicin capsules and Clofazimine capsules, Sandoz, India - cooperation with WHO procurement and Neglected Tropical Diseases – Leprosis elimination project
thanks for your attention
Thanks for your attention

prequallaboratories@who.int www.who.int/prequal