Use of the WHO Certification Scheme on the Quality of Pharmaceutical Products Moving in International Commerce - EDM Research Series No. 016
(1995; 156 pages) Voir le document au format PDF
Table des matières
Afficher le documentACKNOWLEDGMENTS
Afficher le documentPREFACE
Afficher le documentEXECUTIVE SUMMARY
Ouvrir ce répertoire et afficher son contenu1. INTRODUCTION
Afficher le document2. RATIONALE AND OBJECTIVE OF THE ASSESSMENT
Afficher le document3. ACTIVITIES UNDERTAKEN: Preparations and Method of Work
Ouvrir ce répertoire et afficher son contenu4. ANALYSIS OF RESULTS FROM IMPORTING COUNTRIES
Ouvrir ce répertoire et afficher son contenu5. ANALYSIS OF RESULTS FROM EXPORTING COUNTRIES
Afficher le document6. ANALYSIS OF RESULTS FROM INTERNATIONAL SUPPLY AGENCIES
Ouvrir ce répertoire et afficher son contenu7. SUMMARY ANALYSIS
Afficher le document8. CONCLUSIONS
Afficher le documentANNEX 1: Resolution adopted by the Twenty-second World Health Assembly
Afficher le documentANNEX 2 (a): Resolution Adopted by the Twenty-Eighth World Health Assembly
Afficher le documentANNEX 2 (b): Certificate of Pharmaceutical Product(S)1
Afficher le documentANNEX 3 (a): Resolution adopted by the Forty-first World Health Assembly
Afficher le documentANNEX 3 (b): Certificate of Pharmaceutical Product(s)1 (Proposed Layout)
Afficher le documentANNEX 4 (a): Proposed Guidelines on the WHO Certification Scheme on the Quality of Pharmaceutical Products Moving in International Commerce
Afficher le documentANNEX 4 (b): Certificate of a Pharmaceutical Product
Afficher le documentANNEX 4 (c): Statement of Licensing Status of Pharmaceutical Product(s) Model Statement of Licensing Status of Pharmaceutical Product(s)
Afficher le documentANNEX 4 (d): Manufacturer’s/Official Batch Certificate of a Pharmaceutical Product
Afficher le documentANNEX 5: Protocol for the Assessment of the Use of the WHO Certification Scheme by Importing Country
Afficher le documentANNEX 6: List of Participants in the Study
Afficher le documentANNEX 7: Protocol for the Assessment of the Use of the WHO Certification Scheme by Exporting Country
Afficher le documentANNEX 8: Protocol for the Assessment of the Use of the WHO Certification Scheme in an International Supply Organization
Afficher le documentANNEX 9: Study Instrument for Assessment of the WHO Certification Scheme by Importing Country
Fermer ce répertoireANNEX 10: Summaries of Mission Reports on the Assessment of the Use of the WHO Certification Scheme
Ouvrir ce répertoire et afficher son contenuA. IMPORTING COUNTRIES
Ouvrir ce répertoire et afficher son contenuB. EXPORTING COUNTRIES
Fermer ce répertoireC. INTERNATIONAL SUPPLY AGENCIES
Afficher le documentInternational Dispensary Association (IDA)
Afficher le documentUnited Nations Children’s Fund (UNICEF)
Afficher le documentBACK COVER
 

United Nations Children’s Fund (UNICEF)

1. General Information

UNICEF has a supply branch, located in Denmark, which furnishes developing countries with various commodities necessary for health and educational programmes. The value of essential drugs and vaccines that were supplied in 1992 was US$ 123 million (essential drugs: US$ 61 million; and vaccines: US$ 62 million). In addition, essential drugs valued at US$ 20 million were supplied to Romania under a World Bank financed project.

The main countries of destination of essential drugs were Bangladesh, China, Ethiopia, India, Iran, Sudan and the countries of former Yugoslavia. The supply activities are on a non-profit basis, hence prices are as low as possible. In 1992, pharmaceutical products were purchased from 81 manufacturers located in 31 countries. Main suppliers were manufacturers located in Austria, Belgium, Canada, France, Germany, Italy, Japan, Switzerland, UK and USA.

2. Functioning of procurement and quality assurance mechanism

Procurement is effected through open and restricted tender as well as by using a group of permanent suppliers.

The quality of purchased products is assured by operating a control system which includes the following control stages:

i) Qualification of manufacturers (suppliers):

• manufacturers are required to submit documents describing the manufacturing premises and facilities, and information on products that are manufactured and on the size of production;

• a copy of the manufacturing license issued by the national authorities;

• a copy of the last inspection report.

 

The documents are examined at the Health and Nutrition Branch with the assistance of experts from the National Board of Health of Denmark. A decision is then made to accept or reject the supplier. A decision to accept the supplier is sometimes conditional. In that case, the manufacturer is subjected to an audit by a team composed of inspectors from the National Board of Health of Denmark. The costs of the audit are paid by the manufacturer. If the results of the audit are positive, a final decision to accept the manufacturer is made. Such decision is valid usually for two years and can be reviewed. In some cases, the acceptance of a manufacturer may be limited to some specific pharmaceutical forms (e.g. tablets) only.

i) Qualification of specific products:

• for each product, a product certificate or a Free Sale certificate is required, attesting that the product is authorized to be placed on the market in the country where it is manufactured;

• a quality specification for the product is then established, usually that of the British Pharmacopoeia or the United States Pharmacopoeia;

• a decision is also made concerning the requirements on the container and on labelling of the product; special attention is paid to the properties of the container of the product so that it will be compatible with conditions of storage in subtropical countries (high temperature and humidity).

 

The quality of purchased products is controlled by:

a) sampling all batches on arrival for visual review (type of container, appropriate labelling, appearance of the product);

b) analysis of selected batches.

In 1992, samples taken from 500 batches were sent for analysis. The following criteria are considered to decide whether a batch is to be subjected to analysis:

• price of the product (more expensive products are analyzed more frequently);

• the size of the batch;

• previous experience with the manufacturer;

• properties of the product (less stable products are analyzed more frequently).

Analyses are carried out by collaborating laboratories: the Pharmaceutical Control Laboratory of the National Board of Health of Denmark; the National Control Laboratory in Uppsala; the Analytical Laboratory of the German Pharmaceutical Society in Eshborn, Germany; and the Stein Laboratory in Denmark. The cost of analysis is in the range of US$ 500 to US$ 1500 per batch (sample).

The above-mentioned procedure covers approximately 80% of drugs that are supplied. Other drugs and all vaccines, due to their perishable nature, are shipped directly by the manufacturers to the final destination.

3. Use of quality certificates, including WHO Certification Scheme mechanisms

Product certificates are requested in the course of qualification of manufacturers and their products. In some cases, they are not considered as fully reliable. This occurs especially when it is not clear whether the national GMP requirements conform to the WHO GMP requirements, and if there are doubts whether the regulatory authority in the country of manufacture is able to perform adequate inspection of the manufacturer and evaluate the results. Two examples of unreliable product certificates, issued in Egypt, were quoted to support this opinion: one issued in English but lacking any date, another issued in Arabic on a company letterhead and validated only with a stamp of the Ministry of Health.

In 1992, about 200 product certificates were received from 70 countries. Batch analytical certificates are required from all suppliers for all batches of purchased products. They are reviewed when the goods are accepted. Analytical certificates are usually not linked to product certificates and therefore do not conform to the Certification Scheme.

When drugs are forwarded to importing countries, invoices are not accompanied by quality control certificates. Copies of batch certificates are sometimes sent to the recipients, but on a specific request by the importing countries.

Observations:

• The use of experienced pharmaceutical inspectors to audit GMP compliance of prospective suppliers is an expensive element of the control system and cannot be used repeatedly.

• Wider use of the WHO Certification Scheme should be made.

• Analytical testing of products received at the Copenhagen warehouse should be done on a larger percentage of batches, possibly by using cheaper testing facilities.

• The possibility exists to create a small analytical laboratory, located at the warehouse, to perform basic tests on all products received.

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