WHO Expert Committee on Specifications for Pharmaceutical Preparations - WHO Technical Report Series, No. 908 - Thirty-seventh Report
(2003; 148 pages) View the PDF document
Table of Contents
View the documentWHO Expert Committee on Specifications for Pharmaceutical Preparations
View the document1. Introduction
Open this folder and view contents2. General policy
Open this folder and view contents3. Quality control - specifications and tests
View the document4. Quality control - international reference materials
Open this folder and view contents5. Quality control - national laboratories
Open this folder and view contents6. Quality assurance - good manufacturing practices
Open this folder and view contents7. Quality assurance - inspection
Open this folder and view contents8. Quality assurance - distribution and trade-related
Open this folder and view contents9. Quality assurance - risk analysis
Open this folder and view contents10. Quality assurance - drug supply
Open this folder and view contents11. Quality assurance - storage
View the document12. International Nonproprietary Names (INNs) programme
Open this folder and view contents13. Miscellaneous
View the documentAcknowledgements
View the documentReferences
View the documentAnnex 1 Recommendations on risk of transmitting animal spongiform encephalopathy agents via medicinal products
View the documentAnnex 2 The International Pharmacopoeia: revised concepts and future perspectives
Close this folderAnnex 3 Guidelines on Good Manufacturing Practices for radiopharmaceutical products
View the document1. Scope of these guidelines
View the document2. Principles
View the document3. Personnel
View the document4. Premises and equipment
View the document5. Production
View the document6. Labelling
View the document7. Production and distribution records
View the document8. Quality assurance and quality control
View the documentAcknowledgements
View the documentReferences
Open this folder and view contentsAnnex 4 Good Manufacturing Practices for pharmaceutical products: main principles
View the documentAnnex 5 Model certificate of Good Manufacturing Practices
View the documentAnnex 6 Guidance on Good Manufacturing Practices (GMP): inspection report
View the documentAnnex 7 Application of Hazard Analysis and Critical Control Point (HACCP) methodology to pharmaceuticals
Open this folder and view contentsAnnex 8 Procedure for assessing the acceptability, in principle, of pharmaceutical products for purchase by United Nations agencies
Open this folder and view contentsAnnex 9 Guide to good storage practices for pharmaceuticals1
View the documentBack cover

4. Premises and equipment

4.1 As a general principle, buildings must be located, designed, constructed, adapted and maintained to suit the operations to be carried out within them. Laboratories for the handling of radioactive materials must be specially designed to take into consideration aspects of radiation protection in addition to cleanliness and sterility. Interior surfaces (walls, floors and ceilings) should be smooth, impervious and free from cracks; they should not shed matter and should permit easy cleaning and decontamination. Drains should be avoided wherever possible and, unless essential, should be excluded from aseptic areas.

4.2 Specific disposal systems should be mandatory for radioactive effluents. These systems should be effectively and carefully maintained to prevent contamination and exposure of personnel to the radioactive waste both within and outside the facility.

4.3 Sinks should be excluded from aseptic areas. Any sink installed in other clean areas should be of suitable material and be regularly sanitized. Adequate precautions should be taken to avoid contamination of the drainage system with radioactive effluents.

4.4 Lighting, heating, ventilation and, if necessary, air-conditioning should be designed to maintain a satisfactory temperature and relative humidity to ensure the comfort of personnel working in protective clothing. Buildings should be in a good state of repair. The condition of the buildings should be reviewed regularly and repairs carried out when and where necessary. Special care should be exercised to ensure that building repair or maintenance operations do not compromise products. Premises should provide sufficient space for the operations to be carried out, allowing an efficient flow of work and effective communication and supervision. All buildings and rooms should be clean, sanitary and free from radioactive contamination.

4.5 Ventilation of radiopharmaceutical production facilities should meet the requirement to prevent the contamination of products and the exposure of working personnel to radioactivity. Suitable pressure and airflow patterns should be maintained by appropriate isolation/enveloping methods. Air handling systems for both radioactive and non-radioactive areas should be fitted with alarms so that the working personnel in the laboratory are warned of any failure of these systems.

4.6 Dedicated facilities and equipment should be used for the manufacture of any radiopharmaceutical product derived from human blood or plasma. Autoclaves used in production areas for radiopharmaceuticals may be placed behind a lead shield to minimize the radiation exposure of the operators. Such autoclaves should be checked for contamination immediately after use to minimize the possibility of cross-contamination by radioactivity of the products in the next autoclave cycles.

4.7 All containers of radiopharmaceutical substances, regardless of the stage of manufacture, should be identified by securely attached labels. Cross-contamination should be prevented by the adoption of some or all of the following measures:

- processing and filling in segregated areas;

- avoiding the manufacture of different products at the same time, unless they are effectively segregated;

- containing material transfer by means of airlocks, air extraction, changing clothes and careful washing and decontamination of equipment;

- protecting against the risks of contamination caused by recirculation of untreated air, or by accidental re-entry of extracted air;

- using “closed systems” of manufacture;

- taking care to prevent aerosol formation;

- using sterilized containers.

4.8 Positive pressure areas should be used to process sterile products. In general, any radioactivity should be handled within specifically designed areas maintained under negative pressures. The production of sterile radioactive products should therefore be carried out under negative pressure surrounded by a positive pressure zone ensuring that appropriate air quality requirements are met.

4.9 Separate air-handling units should be used for radioactive and non-radioactive areas. Air from operations involving radioactivity should be exhausted through appropriate filters that are regularly checked for performance.

4.10 Pipework, valves and vent filters should be properly designed to facilitate validated cleaning and decontamination.

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