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Guides

  • ICH Guidelines

    • Stability Testing of New Drug Substances and Products Q1A(R2)
    • Stability Testing: Photostability Testing of New Drug Substances and Products Q1B
    • Quality of Biotechnological Products: Stability Testing of Biotechnological/Biological Products Q5C
    • ICH Harmonised Tripartite Guideline Evaluation for Stability Data Q1E
  • TITCK Guidelines

    • TITCK Etkin Maddelerin ve Bitmiş Ürünlerin Stabilite Testlerine İlişkin Kılavuz
    • Beşeri Tıbbi Ürünler İmalathaneleri İyi İmalat Uygulamaları (GMP) Kılavuzu
HPRAFDA
Stability StorageStorage ConditionsThermal CycleSample ManagementDisaster Recovery

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