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

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

Standard Operating Procedure for Receiving of Raw Materials for Elixirs

Department Elixir Department
SOP No. SOP/ELX/001/2025
Supersedes SOP/ELX/001/2022
Page No. Page 1 of 9
Issue Date 12/04/2025
Effective Date 15/04/2025
Review Date 12/04/2026

1. Purpose

To define the procedure for the receipt and initial verification of raw materials intended for elixir manufacturing, ensuring that all materials received meet the specified quality standards and regulatory requirements before they are accepted into the warehouse or production.

2. Scope

This SOP applies to all raw materials, including active pharmaceutical ingredients (APIs), excipients, solvents, and packaging materials received for use in the Elixir Department.

3. Responsibilities

  • Stores Officer:
    • Inspect delivery, check documentation, and coordinate with QA.
  • Quality Assurance (QA):
    • Review documents, approve material movement to quarantine, and initiate sampling.
  • Security Personnel:
    • Ensure only authorized vehicles and materials are allowed entry.

4. Accountability

The Head of QA is accountable for ensuring that all raw materials are received and processed as per this SOP and applicable GMP guidelines.

See also  Elixir Department: SOP for Storage of Raw Materials for Elixir Manufacturing - V 2.0

5. Procedure

5.1 Vehicle and Gate Entry

  1. Security shall verify the gate pass, delivery challan, and vehicle credentials before entry.
  2. Authorized vehicle shall proceed to the receiving bay at the designated area.

5.2 Preliminary Inspection by Stores

  1. Check packaging condition, seal integrity, and labeling of all containers.
  2. Ensure materials are not received during adverse weather without proper protection.
  3. If damage or leakage is found, inform QA and quarantine the material separately.

5.3 Verification of Documents

  1. Check the following documents accompanying the delivery:
    • Invoice
    • Certificate of Analysis (CoA)
    • Material Safety Data Sheet (MSDS)
    • Purchase Order (PO)
  2. Ensure batch numbers and quantities match with the PO.

5.4 Unloading and Labeling

  1. Unload the material manually or using a pallet truck/forklift as required.
  2. Affix “UNDER TEST” status labels with receiving date, supplier name, batch number, and quantity.
  3. Assign a unique material code and update the receiving register (Annexure-1).
See also  Elixir Department: SOP for Dispensing Solvents and Vehicles - V 2.0

5.5 Transfer to Quarantine Area

  1. Move all received materials to the quarantine storage area under QA supervision.
  2. Segregate APIs, excipients, and packaging materials in designated zones.

5.6 Intimation to QA for Sampling

  1. Stores Officer shall intimate QA via Raw Material Sampling Request Form (Annexure-2).
  2. QA shall perform sampling as per the sampling SOP and record details.

5.7 Entry in Receiving Logbook

  1. Update the Receiving Logbook (Annexure-1) with the following:
    • Date and time of receipt
    • Material name and code
    • Quantity received
    • Supplier and transporter details
    • Remarks on condition

5.8 Handling of Rejected Materials

  1. If QA identifies discrepancies or damage:
    • Affix “REJECTED” status label
    • Move material to rejected material storage
    • Update the rejection record (Annexure-3)

6. Abbreviations

  • SOP: Standard Operating Procedure
  • QA: Quality Assurance
  • QC: Quality Control
  • MSDS: Material Safety Data Sheet
  • CoA: Certificate of Analysis
  • PO: Purchase Order
See also  Elixir Department: SOP for Environmental Monitoring of Dispensing Area - V 2.0

7. Documents

  1. Material Receiving Logbook (Annexure-1)
  2. Sampling Request Form (Annexure-2)
  3. Rejection Report Log (Annexure-3)

8. References

  • WHO GMP Guidelines for Pharmaceutical Products
  • 21 CFR Part 211 – cGMP for Finished Pharmaceuticals

9. SOP Version

Version: 2.0

10. Approval Section

Prepared By Checked By Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Material Receiving Logbook

Date Material Name Code Batch No. Quantity Supplier Condition Remarks
12/04/2025 Sorbitol Solution RM-0025 SS/0425/001 100 L Shakti Chemicals Good None

Annexure-2: Sampling Request Form

Material Name Batch No. Quantity Date Received Requested By Signature
Sorbitol Solution SS/0425/001 100 L 12/04/2025 Rajesh Kumar

Annexure-3: Rejection Report Log

Date Material Name Batch No. Reason for Rejection Rejected By Remarks
12/04/2025 Glycerin GL/0425/005 Seal broken Sunita Reddy Container dented

Revision History:

Revision Date Revision No. Revision Details Reason for Revision Approved By
10/01/2022 1.0 Initial Version First Release QA Head
11/04/2025 2.0 Updated template and document control process Compliance Alignment QA Head
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