SOP Guide for Pharma

Elixir Department: SOP for Sampling of Raw Materials for Elixirs – V 2.0

Auditor

Elixir Department: SOP for Sampling of Raw Materials for Elixirs – V 2.0

Standard Operating Procedure for Sampling of Raw Materials for Elixirs

Department Elixir Department
SOP No. SOP/ELX/002/2025
Supersedes SOP/ELX/002/2022
Page No. Page 1 of 8
Issue Date 12/04/2025
Effective Date 15/04/2025
Review Date 12/04/2026

1. Purpose

To lay down a procedure for the sampling of raw materials received for the manufacturing of elixirs, ensuring that the samples represent the entire consignment and are suitable for quality evaluation before approval for use.

2. Scope

This SOP applies to all APIs, excipients, and solvents received for elixir manufacturing in the Elixir Department and stored in the quarantine area before sampling and testing.

3. Responsibilities

4. Accountability

The Head of Quality Assurance is accountable for the implementation and compliance of this SOP.

See also  Elixir Department: SOP for Transfer of Materials to Quarantine Area Post Dispensing - V 2.0

5. Procedure

5.1 Preparation for Sampling

  1. Check availability of the following before sampling:
    • Sampling kit: sampling rods, triers, thief samplers
    • Sample containers (clean, inert, airtight)
    • Sterile gloves, masks, PPE, and gowning items
    • Sampling labels and forms
  2. Verify environmental conditions of the sampling area:
    • Temperature and humidity should be within defined limits.
    • Area should be clean and sanitized before each sampling session.

5.2 Review of Documents

  1. Collect and verify the following prior to sampling:
    • Purchase Order (PO)
    • Certificate of Analysis (CoA)
    • Material Receiving Checklist
  2. Ensure each container is labeled with a unique identification number and “UNDER TEST” label.

5.3 Sampling Procedure

  1. Randomly select containers as per the sampling plan:
    • √n + 1 sampling plan for ≤100 containers
    • For critical materials, 100% sampling may be performed
  2. Open containers aseptically and collect required quantity from:
    • Top, middle, and bottom layers (for powders and granules)
    • Center (for liquids using dip rod or pipette)
  3. Transfer samples to clean containers and label with:
    • Material name
    • Batch number
    • Date of sampling
    • Sampler’s initials
See also  Elixir Department: SOP for Issuance of Raw Materials for Elixir Production - V 2.0

5.4 Sample Types and Quantity

  1. Collect the following sample types:
    • Analytical Sample
    • Retain Sample (as per regulatory requirement)
    • Microbiological Sample (if applicable)
  2. Sample quantity depends on the testing protocol and nature of material:
    • Solvents: 500 mL to 1 L
    • Excipients: 250 g to 500 g
    • APIs: 100 g to 250 g

5.5 Post Sampling Activities

  1. Seal the sampled containers with “Sampled” sticker and sign/date it.
  2. Close and secure remaining containers with tamper-evident seals.
  3. Complete the Raw Material Sampling Record (Annexure-1).
  4. Deliver samples to QC with proper documentation and sample receipt log (Annexure-2).

5.6 Handling of Atypical Observations

  1. Report observations like:
    • Discoloration
    • Foul odor
    • Container damage
  2. Segregate suspected containers and inform QA for further investigation.

6. Abbreviations

See also  Elixir Department: SOP for Dispensing Excipients for Oral Liquid Formulations - V 2.0

7. Documents

  1. Raw Material Sampling Record (Annexure-1)
  2. Sample Receipt Log (Annexure-2)
  3. Environmental Monitoring Log (if applicable)

8. References

9. SOP Version

Version: 2.0

10. Approval Section

Prepared By Checked By Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Raw Material Sampling Record

Material Name Batch No. Sampled From Containers Sample Quantity Date Sampler
Citric Acid CA/0425/003 5 of 20 250 g 12/04/2025 Sunita Reddy

Annexure-2: Sample Receipt Log

Sample ID Material Name Batch No. Received By (QC) Date Remarks
QC-SMP-0425-013 Citric Acid CA/0425/003 Rajeev Sharma 12/04/2025 Accepted

Revision History:

Revision Date Revision No. Revision Details Reason for Revision Approved By
10/01/2022 1.0 Initial SOP Release New SOP Creation QA Head
12/04/2025 2.0 Updated sampling plan, annexures, and clarified responsibilities Regulatory Alignment QA Head
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