Elixir Department: SOP for Identification of Critical vs Non-Critical Materials – V 2.0

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Elixir Department: SOP for Identification of Critical vs Non-Critical Materials – V 2.0

Standard Operating Procedure for Identification of Critical and Non-Critical Materials in Elixir Manufacturing

Department Elixir Department
SOP No. SOP/ELX/046/2025
Supersedes SOP/ELX/046/2022
Page No. Page 1 of 8
Issue Date 11/04/2025
Effective Date 15/04/2025
Review Date 11/04/2026

1. Purpose

To establish a procedure for categorizing raw materials into critical and non-critical classes based on their role in product quality, safety, and regulatory compliance in elixir manufacturing.

2. Scope

This SOP is applicable to all raw materials, including active pharmaceutical ingredients (APIs), excipients, preservatives, solvents, flavors, and sweeteners used in the Elixir Department.

3. Responsibilities

  • R&D/Technical Team:
    • Perform initial material classification during product development.
  • QA Department:
    • Approve the classification and maintain the criticality list.
    • Ensure any reclassification is documented and justified.
  • Warehouse and Dispensing Staff:
    • Handle materials as per criticality category, following specific SOPs where applicable.
See also  Elixir Department: SOP for Environmental Monitoring of Dispensing Area - V 2.0

4. Accountability

The Quality Assurance Manager is accountable for the maintenance and periodic review of the critical and non-critical material classification database.

5. Procedure

5.1 Definition

  1. Critical Materials: Any
raw material that directly affects the identity, potency, safety, efficacy, or stability of the final product. Examples:
  • APIs (e.g., Diphenhydramine HCl)
  • Preservatives (e.g., Sodium Benzoate)
  • Solubilizers (e.g., Propylene Glycol)
  • Non-Critical Materials: Materials that do not directly influence the performance or safety of the product but are used for aesthetic or processing purposes. Examples:
    • Flavors
    • Colorants
    • Sweeteners

    • 5.2 Material Categorization Process

    1. During formulation development, the R&D department shall evaluate each component based on:
      • Function in formulation
      • Impact on CQAs (Critical Quality Attributes)
      • Risk assessment reports
      • Regulatory requirements
    2. Submit the proposed classification to QA for final review and approval.

    5.3 Labeling and Documentation

    1. Once classified, update the Master Material List (Annexure-1) with criticality status.
    2. Mark containers of critical materials with a red band and non-critical with a green band (if applicable).
    3. Ensure Material Dispensing Log (Annexure-2) reflects the classification for traceability.

    5.4 Review and Reclassification

    1. QA shall review material criticality every 12 months or when:
      • There is a change in formulation or manufacturing process
      • A regulatory update occurs
      • A deviation or quality issue is linked to material performance
    2. Any change must be documented in the Material Reclassification Log (Annexure-3).

    6. Abbreviations

    • API: Active Pharmaceutical Ingredient
    • CQA: Critical Quality Attribute
    • SOP: Standard Operating Procedure
    • QA: Quality Assurance

    7. Documents

    1. Master Material List (Annexure-1)
    2. Material Dispensing Log (Annexure-2)
    3. Material Reclassification Log (Annexure-3)

    8. References

    • ICH Q8 – Pharmaceutical Development
    • 21 CFR Part 211 – Subpart E (Control of Components and Drug Product Containers and Closures)

    9. SOP Version

    Version: 2.0

    10. Approval Section

    Prepared By Checked By Approved By
    Signature
    Date
    Name
    Designation
    Department

    11. Annexures

    Annexure-1: Master Material List

    Material Name Material Code Type Criticality Reviewed By Review Date
    Sodium Benzoate SB102 Preservative Critical Sunita Reddy 01/04/2025

    Annexure-2: Material Dispensing Log

    Date Material Batch No. Qty Criticality Dispensed By
    11/04/2025 Sodium Benzoate SB2288 0.500 kg Critical Rajesh Kumar

    Annexure-3: Material Reclassification Log

    Date Material Previous Category Revised Category Reason Approved By
    10/03/2025 Sorbitol Non-Critical Critical Function impacts viscosity & shelf life QA Head

    Revision History:

    Revision Date Revision No. Revision Details Reason for Revision Approved By
    01/01/2024 1.0 Initial SOP Issue New SOP QA Head
    11/04/2025 2.0 Annexures Added, Clarification of Roles Process Enhancement QA Head
    See also  Elixir Department: SOP for Environmental Conditions for Dispensing of Elixirs - V 2.0
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