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
Open this folder and view contentsNational laboratories for drug quality surveillance and control1
Close this folderGood laboratory practices in governmental drug control laboratories1
View the document1. General
Close this folder2. Management and operational issues
View the document2.1 Organizational structure
View the document2.2 Staffing
View the document2.3 Incoming samples
View the document2.4 Analytical worksheet
View the document2.5 Testing
View the document2.6 Evaluation of test results
View the document2.7 Retention samples
View the document2.8 Specifications repertory
View the document2.9 Reagents
View the document2.10 Reference materials
View the document2.11 Instruments and their calibration
View the document2.12 Safety in drug control laboratories
View the documentReferences
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
2.12 Safety in drug control laboratories

Safety depends on the maintenance of exemplary technical standards and laboratory discipline. Safety instructions, both general and specific, should be given to each new member of staff and should be regularly supplemented with written material, poster displays, audio-visual material, and occasional seminars.

General rules for safe working include:

(1) prohibition of smoking, eating, and drinking in the laboratory;

(2) familiarity with the use of fire-fighting equipment, including fire extinguishers, fire blankets, and gas masks;

(3) use of laboratory coats or other protective clothing;

(4) adequate insulation and spark-proofing of electrical wiring and equipment, including refrigerators;

(5) full labelling of all containers of chemicals, including prominent warnings (e.g., “Poison”, “Flammable”) whenever appropriate;

(6) observation of safety rules in handling cylinders of compressed gases and familiarity with their colour identification codes;

(7) avoidance of solitary work in the laboratory;

(8) provision of first-aid materials and instruction in first-aid techniques, emergency care, and use of antidotes.

Protective clothing should be available, including goggles, masks, and gloves. Rubber suction bulbs should be used on all pipettes and siphons. Staff should be instructed in the safe handling of glassware, corrosive reagents, and solvents, and particularly in the use of safety containers or baskets to avoid spillage from containers. They should also be warned of the danger of violent, uncontrollable or dangerous reactions when mixing specific reagents. They must be instructed in the precautions required when, for example, mixing water and acids, acetone-chloroform and ammonia, or flammable products and oxidizing agents, and they should avoid the use of peroxidized solvents. They must also be instructed in the safe disposal of unwanted corrosive or dangerous products by neutralization or deactivation and of the need for safe and complete disposal of mercury and its salts.

While particularly poisonous or hazardous products must be singled out and appropriately labelled, it should not be taken for granted that all other chemicals are safe. All unnecessary contact with reagents, especially with solvents and their vapours, should be avoided. The use of known carcinogens and mutagens should be limited or totally excluded if required by local regulations. Replacement of toxic solvents and reagents by less toxic materials should always be the aim, particularly when new techniques are developed.

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