Transcription of Annex 1 : Manufacture of Sterile Products 2 Document map
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Annex 1 : Manufacture of Sterile Products 2 Document map
1 Annex 1 : Manufacture of Sterile Products 2. 3 Document map Section Number General overview 1. Scope Includes additional areas (other than Sterile Products ) where the general principles of the Annex can be applied. 2. Principle General principles as applied to the Manufacture of Sterile Products . 3. Pharmaceutical Quality Highlights the specific requirements of the PQS when applied System (PQS) to Sterile Products . 4. Premises General guidance regarding the specific needs for premises design and also guidance on the qualification of premises including the use of Barrier Technology. 5. Equipment General guidance on the design and operation of equipment.
5 168 4 Premises 169 170 4.1 The manufacture of sterile products should be carried out in appropriate cleanrooms, entry to 171 which should be through changing rooms that act as airlocks for personnel and airlocks for 172 equipment and materials. Cleanrooms should be maintained to an appropriate cleanliness standard 173 and supplied with air which has passed through filters …
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