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SOP-22.1: Final Product Item Number and CMO Batch/Item Numbers Register

Log Form SOP-22.1: Final Product Item Number and CMO Batch/Item Numbers Register provides a structured, GMP-compliant tool for documenting the link between your company’s Final Product Item Numbers and the batch/item numbers assigned by CMOs. It ensures complete traceability across outsourced manufacturing, testing, warehousing, and distribution activities.

 

This register template is ready to use and requires only product- and batch-specific entries. It captures all identifiers needed to demonstrate regulatory control and supply chain transparency, including CMO batch numbers, material/component item numbers, manufacturing and testing dates, release dates, and QA verification.

 

Includes:
• Final Product Item Number and product description
• CMO name and batch number
• CMO item numbers for materials/components
• Manufacturing, testing, and release dates
• QA verification fields

 

Why it matters:
Accurate cross-referencing of internal and CMO identifiers is essential for GMP compliance, batch release, quality investigations, and inspection readiness. This log form supports robust traceability and consistent documentation across all outsourced partners.

SOP-22.1: Final Product Item Number and CMO Batch/Item Numbers Register

SKU: SINGLE-SOP-22.1
189,00€Precio
Impuesto excluido
  • Product Details & Purchase Terms

    You will receive:

    • Downloadable Word files (.docx)
    • ~98% pre-filled templates
    • Immediate access after purchase

    Important:

    • No refunds (digital product)
    • Requires customization

    Read full Terms and Conditions here.

  • Consulting Support

    If you prefer expert guidance, OZQA provide QA Services, such as:

    • GxP compliance (GMP and GDP)
    • ISO 9001 and ISO 13485 quality systems
    • QMS structure and implementation
    • SOP development and process documentation
    • Deviation, CAPA, Change Control, and OOS processes
    • Audit and inspection preparation
    • Oversight of outsourced partners
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