Annex 3 GUIDELINES TO ASSURE THE QUALITY, SAFETY AND EFFICACY OF LIVE ATTENUATED ROTAVIRUS VACCINES
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چکیده
PART A.GUIDELINES ON MANUFACTURING A.1. Definitions ...................................................................... A.2. General manufacturing recommendations .................................. A.3. Control of source materials ................................................... A.4. Control of vaccine production ................................................ A.5. Filling and containers .......................................................... A.6. Control tests on final product ................................................. A.7. Records ........................................................................... A.8. Samples ........................................................................... A.9. Labelling ......................................................................... A.10. Distribution and shipping ...................................................... A.11. Storage and expiry date .........................................................
منابع مشابه
Vaccines against rotavirus and human papillomavirus (HPV).
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