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Ointments: SOP for Cross-Verification of Dispensed Quantities – V 2.0

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SOP for Cross-Verification of Dispensed Quantities – V 2.0

Procedure for Cross-Verification of Dispensed Quantities

Department Production/Quality Assurance (QA)/Quality Control (QC)/Warehouse
SOP No. SOP/Ointment/176
Supersedes V 1.0
Page No. Page X of Y
Issue Date [Insert Issue Date]
Effective Date [Insert Effective Date]
Review Date [Insert Review Date]

1. Purpose

The purpose of this Standard Operating Procedure (SOP) is to define a systematic approach for cross-verifying dispensed quantities of raw materials in pharmaceutical manufacturing. Proper verification ensures accuracy, minimizes material discrepancies, and maintains compliance with Good Manufacturing Practices (GMP) and regulatory guidelines.

2. Scope

This SOP applies to all personnel involved in the weighing, verification, and approval of dispensed raw materials in the Production, Quality Assurance (QA), Quality Control (QC), and Warehouse departments.

3. Responsibilities

  • Dispensing Operator: Ensures correct dispensing and prepares materials for verification.
  • QA Officer: Verifies and approves dispensed quantities.
  • QC Analyst: Conducts random sampling checks to validate dispensed materials.
  • Warehouse Supervisor: Ensures accurate material tracking and documentation.
  • Production Supervisor: Oversees the verification process and ensures adherence to procedures.
See also  Ointments: SOP for Evaluating Physical Properties of Ointment Samples - V 2.0

4. Accountability

The QA Manager is accountable for ensuring that all cross-verification activities comply with GMP, FDA, ICH, WHO, and company policies.

5. Procedure

5.1 Preparation for Cross-Verification

  • Ensure the **weighing and dispensing area is clean** and free from contaminants.
  • Verify that the weighing balance is **calibrated and within its validity period**.
  • Ensure that dispensed materials are labeled correctly, including:
    • Material Name
    • Batch Number
    • Weighed Quantity
    • Weighing Date
    • Operator Name
  • Check that the dispensed material is stored in **appropriate containers** to prevent contamination.

5.2 Cross-Verification Process

  • QA personnel must verify each dispensed material against the **Batch Manufacturing Record (BMR).**
  • Use an **independent weighing balance** to verify the quantity of each dispensed material.
  • If a discrepancy is detected:
    • Reweigh the material to confirm the deviation.
    • Record the deviation in the **Cross-Verification Log (Annexure-1).**
    • Notify the Production Supervisor and QA department for corrective action.
  • If the verification confirms the correct quantity:
    • QA must sign off on the **Cross-Verification Log (Annexure-1).**
    • Material is **approved for further processing.**
See also  Ointments: SOP for Monitoring Utility Validation Parameters - V 2.0

5.3 Handling Cross-Verification Deviations

  • If the dispensed quantity **exceeds or falls below** the required limit:
    • Material must be **reweighed in the presence of QA personnel.**
    • Document the issue in the **Deviation Report (Annexure-2).**
    • Corrective action must be implemented before the material is approved.
  • Rejected materials must be:
    • Quarantined and labeled as **”Rejected”.**
    • Disposed of according to waste management SOPs.

5.4 Post-Verification Activities

  • Ensure that approved materials are transferred to the appropriate **production or storage areas.**
  • Update the **Material Usage Log** to track dispensed and verified quantities.
  • Submit completed **cross-verification records** to the QA department for review.

5.5 Periodic Review and Audit

  • QA must conduct **weekly random checks** to ensure compliance with cross-verification protocols.
  • All records must be **retained for at least five years** for audit purposes.
  • Deviations must be reviewed in **monthly QA meetings** to identify trends and corrective actions.
See also  Ointments: SOP for Conducting Periodic Revalidation of Utilities - V 2.0

6. Abbreviations

  • GMP – Good Manufacturing Practices
  • QA – Quality Assurance
  • QC – Quality Control
  • BMR – Batch Manufacturing Record
  • FDA – Food and Drug Administration
  • ICH – International Council for Harmonisation

7. Documents

  • Cross-Verification Log (Annexure-1)
  • Deviation Report (Annexure-2)

8. References

  • ICH Q7 – GMP for Active Pharmaceutical Ingredients
  • WHO Guidelines on Raw Material Handling
  • FDA Guidance on Pharmaceutical Manufacturing

9. SOP Version

Version 2.0

10. Approval Section

Prepared By Checked By Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Cross-Verification Log

Date Material Name Batch No. Weighed Quantity Verified Quantity Operator QA Review
02/02/2025 API X SOP/Ointment/1001 5.0 kg 5.01 kg John Doe Approved

Annexure-2: Deviation Report

Date Material Name Batch No. Deviation Type Root Cause Corrective Action QA Approval
02/02/2025 API X SOP/Ointment/1001 Overweight Operator Error Reweighed Approved

12. Revision History

Revision Date Revision No. Details Reason Approved By
02/02/2025 2.0 Expanded Verification Procedures Improved Compliance QA Head
Ointments V 2.0 Tags:Ointment application SOP, Ointment batch record SOP, Ointment compounding SOP, Ointment dispensing SOP, Ointment filling SOP, Ointment formulation SOP, Ointment manufacturing SOP, Ointment microbiological testing SOP, Ointment pH testing SOP, Ointment production SOP, Ointment quality control SOP, Ointment stability study SOP, Pharmaceutical ointment SOP, SOP for ointment homogenization, SOP for ointment labeling, SOP for ointment mixing, SOP for ointment packaging, SOP for ointment preparation, SOP for ointment raw material testing, SOP for ointment shelf-life determination, SOP for ointment stability testing, SOP for ointment sterilization, SOP for ointment storage, SOP for ointment testing, SOP for ointment viscosity testing

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Standard Operating Procedures V 1.0

  • Aerosols
  • Analytical Method Development
  • Bioequivalence Bioavailability Study
  • Capsule Formulation
  • Clinical Studies
  • Creams
  • Data Integrity
  • Dental Dosage Forms
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  • Environment, Health and Safety
  • Formulation Development
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  • Good Distribution Practice
  • Good Warehousing Practices
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  • Maintenance Dept.
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  • Powder & Granules
  • Purchase Departments
  • Quality Assurance
  • Quality Control
  • Raw Material Stores
  • Regulatory Affairs
  • Tablet Manufacturing
  • Rectal Dosage Forms
  • Transdermal Patches
  • Vaginal Dosage Forms
  • Validations and Qualifications

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NEW! Revised SOPs – V 2.0

  • Aerosols V 2.0
  • Analytical Method Development V 2.0
  • API Manufacturing V 2.0
  • BA-BE Studies V 2.0
  • Biosimilars V 2.0
  • Capsules V 2.0
  • Creams V 2.0
  • Elixers V 2.0
  • Ointments V 2.0
  • Raw Material Warehouse V 2.0
  • Tablet Manufacturing V2.0

New Publication: A must for All.

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