WHO good manufacturing practices for sterile pharmaceutical products (WHO TRS 961, Annex 6) – Free PDF download

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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. These areas are classified into four grades (see section 4).

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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