Procedure for Weighing of Raw Materials for Ointment Manufacturing

Department	Production/Quality Control
SOP No.	SOP/Ointment/004
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 establish guidelines for accurately weighing raw materials for ointment manufacturing. This ensures compliance with Good Manufacturing Practices (GMP), maintains batch consistency, and prevents cross-contamination.

2. Scope

This SOP applies to the weighing of all raw materials used in ointment production. It includes equipment calibration, environmental conditions, weighing procedures, and documentation requirements.

3. Responsibilities

• Production Operator: Responsible for executing the weighing process as per batch records.
• Quality Control (QC) Personnel: Ensures the accuracy of weighed materials.
• Production Supervisor: Verifies compliance with standard procedures.
• Quality Assurance (QA) Officer: Conducts audits and ensures GMP compliance.

4. Accountability

The Production Manager is accountable for ensuring that all weighing activities are conducted according to established procedures.

5. Procedure

5.1 Pre-Weighing Preparations

• Ensure that the dispensing area is clean and free from any contamination.
• Verify that all weighing balances are calibrated and within tolerance limits.
• Ensure that the required personal protective equipment (PPE) is worn.
• Check that the required raw materials are available and properly labeled.

5.2 Verification of Raw Materials

• Confirm that the raw material name, batch number, and expiry date match the batch manufacturing record (BMR).
• Ensure that the Certificate of Analysis (CoA) has been approved.
• Inspect packaging integrity before weighing.

5.3 Weighing Procedure

• Use dedicated, labeled weighing balances for different types of raw materials to prevent cross-contamination.
• Weigh each raw material as per the approved batch manufacturing formula.
• Record the actual weighed quantity in the Weighing Log.
• For each material, use separate scoops and containers to avoid contamination.
• Ensure that the balance display is stable before noting the weight.

5.4 Handling of Deviations

• If any material is over- or under-weighed, document the deviation and obtain approval from QA before adjusting.
• If contamination occurs, discard the material following standard disposal procedures.
• Report any weighing discrepancies to the Production Supervisor immediately.

5.5 Post-Weighing Procedure

• Return unused raw materials to their designated storage areas.
• Ensure all weighed materials are labeled with material name, batch number, and weight.
• Clean weighing equipment and the surrounding area.
• Ensure all records are signed and countersigned by authorized personnel.

6. Abbreviations

• GMP – Good Manufacturing Practices
• QA – Quality Assurance
• QC – Quality Control
• BMR – Batch Manufacturing Record
• CoA – Certificate of Analysis

7. Documents

• Weighing Log (Annexure-1)
• Calibration Record (Annexure-2)

8. References

• WHO GMP Guidelines for Pharmaceutical Manufacturing
• 21 CFR Part 211 – Current Good Manufacturing Practices
• ICH Q7: Good Manufacturing Practice Guide

9. SOP Version

Version 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Weighing Log

Date	Material Name	Batch Number	Theoretical Weight (kg)	Actual Weight (kg)	Weighed By
01/02/2025	Material A	Batch 12345	5.00	5.01	John Doe
02/02/2025	Material B	Batch 67890	3.50	3.49	Jane Smith

Annexure-2: Calibration Record

Date	Balance ID	Calibration Standard	Result	Checked By
01/02/2025	Balance-01	5.000 kg Standard	5.001 kg	QA Officer
02/02/2025	Balance-02	3.000 kg Standard	2.999 kg	QA Officer

12. Revision History:

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By	Page No.	Ref. Point No.	Details of Revision
01/01/2024	1.0	Initial Version	New SOP	QA Head	All	All	Created new SOP
01/02/2025	2.0	Updated SOP Format	Standardization of Document	QA Head	All	All	Revised to meet new documentation standards