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EU GMPs with Annex 11, 15, 16 and ICH Q7

EU GMPs with Annex 11, 15, 16 and ICH Q7

SKU:978-1-935131-97-7

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The EU GMPs include Chapters 1-9 EU Guidelines to Good Manufacturing Practice Medicinal Products for Human and Veterinary.
Includes:

  • Annex 11 - Computerized Systems
  • Annex 15 - Qualification and Validation
  • Annex 16 - Qualified Person and Batch Release
  • ICH Q7 - GMP Guide for Active Pharmaceutical Ingredients
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