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
Open this folder and view contents3. Distribution
Open this folder and view contents4. The international pharmacopoeia and related activities
Open this folder and view contents5. Basic tests
Close this folder6. Laboratory services
Close this folderNational laboratories for drug quality surveillance and control1
View the document1. Introduction
View the document2. First-stage laboratory for drug surveillance
Close this folder3. Medium-size drug control laboratory
View the document3.1 Capability
View the document3.2 Premises
View the document3.3 Staff
View the document3.4 Equipment
View the document4. Scope of activity
View the document5. Factors influencing the size and location of a laboratory
Open this folder and view contents6. Implementation of control laboratory projects
Open this folder and view contentsGood laboratory practices in governmental drug control laboratories1
Open this folder and view contentsSampling procedure for industrially manufactured pharmaceuticals1
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
 
3.2 Premises

A floor space of 300-400 m2 is required. All laboratory rooms should be supplied with running water and drainage, electrical power, and gas (either centrally supplied or from a gas tank). Climatic conditions will determine the need for air-conditioning and heating systems. The supply of water should be of adequate pressure for the use of vacuum aspirators (at least 19 kPa or 20 N/cm2 are needed), otherwise suitable vacuum pumps should be installed. An arrangement to recirculate water used by vacuum aspirators through a collection tank may considerably reduce total water needs and should be considered if the water supply is scarce or irregular. A sewage treatment installation should also be provided (e.g. a lime pit to neutralize acidic effluents). The building should be constructed of fire-resistant material and the layout of the modules and connecting corridors should be determined not only by working efficiency but also by safety considerations, particularly in areas where inflammable liquids or compressed gases are used or stored. If large quantities of inflammable reagents are to be stored, the space should be planned and constructed in accordance with local fire regulations.

Each unit should be provided with rooms equipped for its specific requirements, including hooded benches in chemical rooms; ample electrical outlets in physicochemical rooms and voltage-stabilizing equipment if the local power supply is variable; movement-damping tables in balance rooms; laminar airflow equipment in microbiological rooms. All rooms should be provided with storage cabinets for reagents, glassware, and samples, wall shelving, and writing desks.

Control of temperature and humidity of at least a part of the laboratory area is imperative in tropical regions. In particular, the room for chromatographic work (primarily thin-layer chromatography) should be thermostatically controlled and in all cases protected from draughts and direct sunlight. Rooms equipped with hoods and extractor fans should receive an inflow of dry, cool air and additional dehumidifiers are required in storage areas for reference materials and samples.

Rabbits used for pyrogen testing should be kept in a room apart from other areas of the laboratory. A separate unit should be provided if other experiments on animals are contemplated. Both the animal house and the animal experimentation rooms should be thermostatically controlled within +2 °C. In warmer climates the temperature is usually maintained within the range 23-25 °C.

Advice on technical facilities required for microbiological testing is provided in the twenty-second report of the WHO Expert Committee on Biological Standardization.1

1 WHO Technical Report Series, No. 444, 1970.

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