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How long may a firm store in-process/intermediate powder blends and triturations, sustained-release pellets/beads, and tablet cores, absent separate stability studies, before using them in finished drug products?

19/09/2021 | 4386

Similar question:

Reply:

For in-process/intermediate materials that are chemically and physically stable, a risk- and science-based assessment process can help identify which material attributes and process parameters might affect the critical quality attributes of the finished drug product in which they are to be used. This assessment should be designed to ensure that materials held (under appropriate storage conditions) for a specified period are appropriate for use in manufacturing the finished drug product without having to conduct formal stability studies to verify the holding periods. In some instances, the risk assessment may include sampling and testing the material being held (at the stage determined by the risk assessment) to verify the manufacturing holding period.   However, for unstable materials or for materials held longer than the period established in the risk assessment, firms should conduct stability studies according to an approved stability protocol to verify holding periods. The stability studies should include evaluations of the in-process/intermediate materials up to the time of their use in manufacturing a finished drug product and should include long-term monitoring of finished product batches manufactured with the in-process/intermediate materials.   In the latter case, until appropriate stability data are generated, firms should calculate the expiration date assigned to finished product batches based on the date of manufacture/release of the in-process/intermediate material rather than on that of the finished product.  

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  • GMPc Vietnam JSC
  • Head Office: No. 18, Mang Cam 1 Street, An Lac Green Symphony, Van Canh Ward, Hoai Duc District, Hanoi City
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  • Home
  • About Us
    • Summary information
    • Key Personnel
  • Services
    • WHO GMP Pharmaceutical facilities
      • Project feasibility study
      • Technology and Equipment consultation
      • Detail Construction and MEP drawing
      • Project Management and Supervision
      • WHO GMP Training and Guidance
      • Preparation of WHO GMP registration dossier
      • WHO GMP Re-evaluation consultation
    • EU GMP Pharmaceutical Factory
      • Feasibility study report
      • Design detailed construction drawings
      • QM documentation – Validation
      • GMP application and product dossier application
      • Project management - Construction supervision
    • CGMP, ISO 22716-certified cosmetics facilities
      • Project feasibility study
      • Technology and Equipment consultation
      • Detail Construction and MEP drawing
      • Project Management and Supervision
      • CGMP ASEAN Training and Guidance
      • Preparation of CGMP ASEAN/ ISO 22716 registration dossier
      • CGMP ASEAN Re-evaluation consultation
    • Health-supplement facilities
      • Project feasibility study
      • Technology and Equipment consultation
      • Detail Construction and MEP drawing
      • Project Management and Supervision
      • HS GMP Training and Guidance
      • Preparation HS GMP registration dossier
      • HS GMP - Re-evaluation consultation
    • Eligibility For Cosmetic Manufacturing
      • Overall consultation
      • Detail Construction and MEP drawing
      • Designing, Constructing, Ensured Certification
      • Preparation of Registration Dossier
    • Pharmaceutical distribution center
      • Feasibility Study
      • Design and Information Technology Solutions
      • Project Management and Supervision
      • GSP registration and operation consultancy
    • GSP warehouses
      • Project feasibility study
      • Detail Construction and MEP drawing
      • GSP Training and Guidance
      • Overall Consultation on Designing And Constructing
      • GSP Re-evaluation consultation
    • Veterinary Pharmaceutical Facilities
      • Project Feasibility Study
      • Technology and Equipment consultation
      • Detail Construction and MEP Drawing
      • Project management and Supervision
      • WHO GMP Training and Guidance
      • Preparation of WHO GMP registration dossier
      • WHO GMP Re-evaluation consultation
    • GMP, GLP, GSP training
      • Basis knowledge
      • Intensive Training
    • Other GPs’s consultation
      • GLP inspection laboratories
      • GDP distribution systems
      • GPP pharmacy
      • WHO GACP medicinal materials
    • Register and Announce
      • Announcement of Imported Cosmetic
    • Dairy Factory
      • Overall Planning
      • Detailed Construction & MEP Design - Project Budgeting
      • Contractor/Supplier Consultation and Project Management
      • Training, Drafting registration dossier
  • Project
  • Video
  • GMP-Handbook
  • Faqs
  • News
  • Jobs
  • Contact
 
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