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
 

International Dispensary Association (IDA)

1. Economic data

IDA is a large-scale supplier of essential drugs and related medical supplies to the public sector in developing countries. The total value of pharmaceuticals supplied in 1992 amounted to US$ 80 million. Over 4000 orders are filled every year. The main recipient countries number 20, but the total number of customers is about 100. The value of products exported in 1992 was: African countries 70%; Central American countries 10%; and Middle Eastern countries 8%.

The flow of pharmaceuticals is that products purchased are delivered by the manufacturers to the IDA warehouse in Amsterdam, where they are put in stock. Here the goods are assembled according to orders and shipped to their destinations. The average value of the stock in the warehouse is about US$ 10 million.

2. Functioning of procurement and quality assurance mechanisms

2.1 Procurement

Essential drugs are purchased by IDA, preferably from generic drug manufacturers who produce the raw materials and the finished dosage forms, and from contract manufacturers. It has approximately 120 approved suppliers. In practice, the majority of purchases is obtained from 60 suppliers. The number of products supplied by IDA is about 300. The main source countries are Austria, Belgium, China, Denmark, France, Germany, India, Italy, Mexico, Portugal, South Korea and UK. IDA also has a manufacturing plant in Malta, PHARMAMED, which manufactures tablets and dry syrups. The plant supplies some 20% of IDA's turnover. Products of PHARMAMED are not registered in the Netherlands.

The actual suppliers are selected through a supplier pre-qualification process. There is a group of suppliers who have provided IDA with pharmaceuticals of an appropriate quality for a long time and who are considered reliable. New suppliers are asked to produce documentary evidence that they are licensed by the local drug regulatory authority and furnish a GMP certificate delivered by this authority. On review of these documents, a decision is made whether an on-site audit is necessary. In 1993, some 30 such audits were made according to a "Manufacturer Audit Check-List" established internally by IDA. During the audit, the stability data on products offered by the manufacturer are also reviewed. The costs of the audit are borne by IDA. On the basis of the results of the audit, a decision is made whether to approve the new supplier.

Qualification of manufacturers is followed by qualification of individual products offered by them. This process includes the following: the supplier is asked to provide samples of his products. These samples are analyzed at the IDA laboratory in Amsterdam, or if more complex testing is necessary, sent to an external laboratory, usually the laboratory of Dutch pharmacists. Specifications are next established for the product, usually the British Pharmacopoeia (BP) or USP are used.

For the BP specifications, the dissolution test is frequently added. If a product is not included in these pharmacopoeias, the manufacturer's specification is used, but after review and approval by the IDA laboratory. For some products, the IDA laboratory has evolved its own quality specifications, which include bioequivalence testing. In 1992, some 300 new and revised product specifications were approved. All products bear the name of the manufacturer on the label.

2.2 Quality assurance

IDA's operation involved the procurement of approximately 3000 batches per year, in all cases visual inspection of the product, including labelling, is done and a retention sample is taken and stored; some 655 batches are analyzed in the IDA laboratory (25%), mostly critical parameters only. About five batches per year are rejected after laboratory analysis. In addition, the laboratory performs another 400 analyses: approval samples from new manufacturers and testing of products provided by new sources. All together approximately 700 samples are analyzed per year at the IDA laboratory.

All batch certificates are reviewed after the goods are received at the warehouse. They are checked to see if they bear the signature of a responsible analyst. After the review, all certificates are kept in files.

Product certificates are requested from manufacturers at the stage of product approval. They are received in some 80% of the cases. The certificates are considered as valid for three to five years from the date of issue, then a renewal of the certificate is requested. In 1992, some 150 product certificates were received. At present, all the data are being placed in a computerized system to facilitate the control over renewals.

A system for dealing with quality complaints received from customers exists. It is laid down as a written procedure with a recall system (all products and batch numbers shipped to each customer are kept as computerized records). There were 25 complaints received in 1992, and in three cases, a recall was made.

When requested, copies of product certificates are attached to consignments of distributed products. But such requests are very rare. When requested, copies of GMP certificates and batch certificates are also attached to consignments.

 

Observations:

• An audit of the manufacturers to check GMP compliance is an expensive element of the control system to be used repeatedly.

• The use of a batch certificate as recommended by WHO should be increased.

• Attempts should be made to obtain a Certificate of a Pharmaceutical Product for all products purchased by IDA.

• Analytical testing of products received at the Amsterdam warehouse should be done on a much larger percentage of batches using the full range of tests included in product specifications.

• IDA also plays the role of an export organization. All products supplied by IDA, therefore, should be accompanied by batch certificates.

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