WHO good manufacturing practices for sterile pharmaceutical products

Introduction:

Following implementation of these WHO good manufacturing practices (GMP) guidelines (1) within the context of the WHO Prequalification of Medicines Programme, clarifying, editorial modifications have been proposed. These changes were adopted for maintenance purposes. In order to ease reading the full guideline has been reproduced again as an Annex to the current report of the WHO Expert Committee on Specifications for Pharmaceutical Preparations.

1. General considerations:

1.1 The production of sterile preparations should be carried out in clean areas, entry to which should be through airlocks for personnel and/or for equipment and materials. Clean areas should be maintained to an appropriate standard of cleanliness and supplied with air that has passed through filters of the required efficiency.

1.2 The various operations of component preparation (such as those involving containers and closures), product preparation, filling and sterilization should be carried out in separate areas within the clean area.

1.3 Manufacturing operations are divided here into two categories:

— first, those where the product is terminally sterilized; and

— second, those which are conducted aseptically at some or all stages.

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Table of Contents

1. General considerations

2. Quality control

3. Sanitation

4. Manufacture of sterile preparations

5. Sterilization

6. Terminal sterilization

7. Aseptic processing and sterilization by filtration