Quality Assurance of Pharmaceuticals - A Compendium of Guidelines and Related Materials - Volume 1
(1997; 248 pages) [French] View the PDF document
Table of Contents
Open this folder and view contentsIntroduction
Open this folder and view contents1. National drug regulation
Open this folder and view contents2. Product assessment and registration
Close this folder3. Distribution
Close this folderQuality assurance in pharmaceutical supply systems1
View the document1. Introduction and general considerations
Close this folder2. Elements of quality assessment and assurance
View the document2.1 Legal base
View the document2.2 Regulatory elements
View the document2.3 Technical elements
Open this folder and view contents3. Pre-marketing quality assessment
Open this folder and view contents4. Drug quality surveillance during marketing
View the documentReferences
Open this folder and view contents4. The international pharmacopoeia and related activities
Open this folder and view contents5. Basic tests
Open this folder and view contents6. Laboratory services
Open this folder and view contents7. International trade in pharmaceuticals
Open this folder and view contents8. Counterfeit products
Open this folder and view contents9. Training
View the documentSelected WHO publications of related interest
View the documentBack cover
2.2 Regulatory elements

2.2.1 General

The regulatory elements of a quality assessment system include a central administrative entity, inspection services and drug quality control laboratories.

Regulatory implementation of quality assessment requires a legal base, as mentioned in section 2.1, giving authority to a designated agency to establish and enforce quality requirements throughout the manufacturing and distribution processes.

At the manufacturing stage, the aim is to ensure that all manufacturers, whether local or foreign, comply with good manufacturing practices. At the distribution level, the aim is to ensure that the quality of all pharmaceutical products, particularly imported items, has been properly assessed and that adequate control exists over the transport, storage and rotation of supplies, including the conditions in customs, premises, warehouses, and other places in which the products are stored before reaching the final user. This also includes procedures for the recall, if necessary, of unsatisfactory products.

2.2.2 Governmental drug control agencies

To facilitate adequate national control of pharmaceutical supply systems, authority should be vested in a ministry which is responsible for health matters. This would permit the establishment of a drug control agency and the development of administrative and regulatory procedures for the control of pharmaceuticals such as drug notification, authorization or registration and for the carrying out of adequate drug quality surveillance.

Administrative and regulatory procedures based on notification, authorization or registration must provide an adequate definition or specification for each drug.

To perform drug quality surveillance, the agency needs expert staff whose training is consistent with their responsibilities. For the quality surveillance of manufacturing operations the expertise required is comparable to that described in “Good practices in the manufacture and quality control of drugs” (4).

Inspection, sampling and analysis of pharmaceutical products on the market, supplemented by information from other sources (manufacturer, distributor, other regulatory agencies and advisers, and investigations of reported defects) provides the basis for action to minimize health hazards due to poor-quality products. Study of the consolidated information provides guidance for priorities in future activities.

To perform adequately its tasks on drug quality surveillance a fully developed agency should be supported by inspection and laboratory services. Where resources are adequate, there are advantages in uniting these services in the same organization; otherwise they must be closely coordinated to maximize the efficiency of the surveillance procedures.

In countries with decentralized systems of administration the agency may be located at a central point, or it may be structured to comprise centrally coordinated regional components.

The term “agency” is capable of wide interpretation, but in the present context it is intended primarily to designate the centre of authority for drug control activities without regard to the size of the administrative organization. Alternative regulatory procedures may exist and the type and extent of control exercised will determine the resources required. Inspection services. The inspection services act as the field arm of an agency by verifying that all elements within the pharmaceutical supply system comply with the regulations and that data submitted to the agency are factual. Verification by inspection includes assessment of manufacturing and distributing firms, as well as retail and dispensing outlets such as pharmacies and hospitals. There is scope for international cooperation in the field of inspection services, the activities of which are dealt with in more detail in section 4. Drug quality control laboratory. A governmental drug control laboratory carries out tests and assays required to establish whether drugs conform to the specifications claimed for them. Such a laboratory may also carry out investigations on new or improved analytical methods. Its type and size will be determined by a number of factors. These include the nature of the pharmaceutical supply system, the extent of local drug production and the quantum of pharmaceutical imports, and, in addition, the availability of support from other laboratories involved in drug quality testing.

Under certain circumstances it might be useful for a group of countries to pool their efforts towards the creation of a regional control laboratory. In other circumstances, a fully established national drug control laboratory can serve neighbouring countries.

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