7.1.1 Legal structure

In all 10 countries, there are laws giving drug regulatory authorities (in the person of their inspectors) the power to inspect manufacturing plants and distribution channels. In each country, inspection and surveillance are the responsibility of the government and are carried out by specialized agencies. These activities are never contracted out to the private sector. In some countries, Ministry of Health staff working in the regions and districts who are not members of the DRA are delegated to carry out inspections, but this delegation is not supported by legal provisions.

In Estonia, the Netherlands, Tunisia, Uganda, Venezuela and Zimbabwe, inspections both of GMP and of distribution channels are organized under one unit or agency. In Cyprus, GMP inspection is the responsibility of the DCQSS, but distribution channels are inspected by the Inspectorate Sector, both of which come under the Pharmaceutical Services Division. A similar arrangement is found in Malaysia. The GMP inspection function has been assigned to the GMP and Licensing Division of the NPCB, while distribution-channel inspection is the responsibility of the Licensing and Enforcement Unit of the Pharmaceutical Services Division. Both functions come under the Pharmaceutical Services Division, but are carried out by different inspectors. In addition, inspection of distribution channels in the states is delegated to state-level employees.

Australia has a GMP Licensing and Audit section within the TGA at the Commonwealth level. Inspection of distribution channels is carried out by each state or territory. The federal and state levels are linked through the National Coordinating Committee on Therapeutic Goods and the National Drugs and Poisons Schedule Committee. In Cuba, even though inspection of distribution channels is not required by law, the function is performed by three different supervisory agencies: the National Centre for Drug Quality Control, the Pharmaceutical Industry Union and the Pharmacy Division of the Public Health Ministry. Table 7.1 presents an overview of the laws, organizations and guidelines for GMP and distribution-channel inspection in the 10 countries.

Because distribution channels are usually dispersed throughout a country, inspection is sometimes delegated to the public administration at lower levels. This is the case in Australia, Malaysia, the Netherlands, Tunisia, Uganda and Venezuela. The remaining countries do not decentralize this function. In general, an inspectorate at central headquarters level is responsible for GMP inspection and inspection of distribution channels located in the capital city and ports. Distribution channels located in state and regional administrations are supervised by an inspectorate at the state level.

Table 7.1 Legal framework and tools for inspection of GMP and distribution channels

• = Yes = No - = information or data not available

* There is a system for inspection of pharmacies in each state.

In Australia and Malaysia, which have a federal system of government, the delegation of inspection responsibilities and reporting systems is organized in different ways. In Malaysia, inspection of distribution channels in the states comes under the authority of the State Deputy Director of Health (Pharmacy), and there is a direct route for reporting between the states and the federal agencies.

Several countries (Cyprus, Estonia, Venezuela and Zimbabwe) have adopted the WHO GMP guidelines (25) as their statutory GMP standards. Australia has its own GMP guidelines. Malaysia uses the GMP guidelines of the ASEAN (26). The Netherlands has adopted the European Union guidelines on GMP inspection (27). The majority of the countries have also developed SOPs for their inspectors, as indicated in Table 7.1. Australia, Cuba, Cyprus, Malaysia, Uganda and Venezuela have not developed guidelines for GDP.

7.1.2 GMP certificates

Only three countries, Tunisia, Uganda and Zimbabwe, do not issue a GMP certificate. The drug regulatory authorities in these three countries do conduct GMP inspections, but do not issue a specific document which indicates that a manufacturing plant has attained GMP standards. The MCAZ does, however, provide a GMP certificate at the manufacturer’s request to facilitate international registration and export of products. In Malaysia, various types of certificates are issued: GMP certificates; Certificate of Pharmaceutical Product for export; and Certificate of Free Sale for medical devices and cosmetic products. Cyprus has no clear criteria for issuing a GMP certificate: instead, the inspectors make a decision which they must then justify to the Drug Council. In Australia, compliance with the national GMP code is required in order to obtain a GMP certificate. In Venezuela, four types of certificates are issued: general certificates for all areas of manufacture; certificates for production; certificates for partial fabrication; and certificates for export of pharmaceuticals.

7.1.3 Appeals procedures

Procedures for appealing against decisions resulting from GMP and distribution-channel inspections exist in each of the countries. Some countries employ administrative procedures to handle appeals, some employ judicial control, while others combine both approaches.