Search results with tag "Sterile pharmaceutical"
Quality assurance of pharmaceuticals
www.who.intpharmaceutical products 7 Quality management in the drug industry: philosophy and essential elements (update on sampling) (new) 7 Heating Ventilation and air-conditioning systems for non-sterile pharmaceutical dosage forms (new) 58 Validation (new) 101 Water for pharmaceutical use (new) 170 2. WHO good manufacturing practices: starting materials188
USP <1207> STERILE PRODUCT - PACKAGE INTEGRITY …
www.pda-it.orgSterile pharmaceutical dosage form packages Primary container closure systems Packages of nonporous, rigid or flexible, materials OTHER applications include, but are not limited to • Porous flexible packages • Critical secondary packages • Sterile API, Intermediates, final bulk volume packages • Drug/device combination packages
Annex 6 WHO good manufacturing practices for sterile ...
www.who.int4.3 For the manufacture of sterile pharmaceutical preparations, four grades of clean areas are distinguished as follows: • Grade A: The local zone for high-risk operations, e.g. fi lling and making aseptic connections. Normally such conditions are achieved by using a unidirectional airfl ow workstation. Unidirectional airfl ow systems should
GUIDELINES ON HEATING, VENTILATION AND AIR …
www.who.intWorking document QAS/15.639/Rev.2 page 4 50 BACKGROUND The World Health Organization (WHO)51 published the first edition of the WHO Guidelines on 52 good manufacturing practices for heating, ventilation and air-conditioning systems for non- 53 sterile pharmaceutical dosage forms in WHO Technical Report Series, No. 937, 2006. After …
Annex 5 Supplementary guidelines on good manufacturing ...
www.who.intAnnex 5 Supplementary guidelines on good manufacturing practices for heating, ventilation and air-conditioning systems for non-sterile pharmaceutical dosage forms 1. Introduction 2. Scope of document 3. Glossary 4. Protection 4.1 Products and personnel 4.2 Air fi ltration 4.3 Unidirectional airfl ow 4.4 Infi ltration 4.5 Cross-contamination
GUIDELINES ON HEATING, VENTILATION AND AIR …
www.who.intWorking document QAS/15.639/Rev.2 page 2 43 SCHEDULE FOR THE PROPOSED ADOPTION PROCESS OF DOCUMENT QAS/15.639 44 GUIDELINES ON HEATING, VENTILATION AND AIR-CONDITIONING 45 SYSTEMS FOR NON-STERILE PHARMACEUTICAL PRODUCTS Discussion of proposed need for revision in view of the current trends in engineering and experience gained during the
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