Procedure for Material Labeling Post-Weighing
| Department | Production/Quality Assurance (QA)/Quality Control (QC)/Warehouse |
|---|---|
| SOP No. | SOP/Ointment/175 |
| 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 a standardized method for labeling raw materials post-weighing to ensure accurate identification, traceability, and compliance with Good Manufacturing Practices (GMP) and regulatory guidelines.
2. Scope
This SOP applies to all personnel involved in the weighing, labeling, and handling of raw materials in the Production, Quality Assurance (QA), Quality Control (QC), and Warehouse departments in pharmaceutical manufacturing.
3. Responsibilities
- Weighing Operator: Accurately labels weighed materials according to batch specifications.
- QA Officer: Verifies labeling accuracy and ensures compliance with documentation standards.
- QC Analyst: Cross-checks labeled materials to ensure identity and quality compliance.
- Warehouse Supervisor: Ensures proper storage and segregation of labeled materials.
- Production Supervisor: Oversees the labeling process and ensures adherence to protocols.
4. Accountability
The QA Manager is accountable for ensuring that all material labeling activities comply with GMP, FDA, ICH, WHO, and company policies.
5. Procedure
5.1 Preparation for Labeling
- Ensure the **labeling area is clean** and meets environmental control conditions:
- Temperature: **15-25°C**
- Humidity: **30-50% RH**
- Verify that all raw materials have been **accurately weighed and documented**.
- Check the label template to ensure it includes
the required details:
Ensure **barcode or unique identification number** is assigned to each label.
- Material Name
- Batch Number
- Weighed Quantity
- Weighing Date
- Operator Name
- QA Verification Status
5.2 Labeling Process
- Prepare **pre-printed labels** or use **automated label printing systems**.
- Each label must be checked against the **Batch Manufacturing Record (BMR)** for accuracy.
- Affix the label securely on the container, ensuring it is:
- Legible and clear.
- Firmly attached.
- Placed in a **non-obstructive** location.
- Record the labeled material details in the **Material Labeling Log (Annexure-1).**
5.3 Handling Labeling Deviations
- If a label is found incorrect:
- Immediately stop further labeling.
- Notify the QA department for corrective action.
- Remove and replace the incorrect label.
- Document any incorrect labels in the **Labeling Deviation Log (Annexure-2).**
5.4 Post-Labeling Activities
- Store labeled materials in **designated areas based on their batch number and category**.
- Ensure that **segregation is maintained** between different batches.
- Submit completed **labeling records** to the QA department for verification.
5.5 Label Verification and Quality Checks
- QA must verify **all labels at the end of the labeling process**.
- Any discrepancies must be resolved before materials are transferred for manufacturing.
- QC must perform **random sampling checks** to ensure proper labeling adherence.
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
- Material Labeling Log (Annexure-1)
- Labeling Deviation Log (Annexure-2)
8. References
- ICH Q7 – GMP for Active Pharmaceutical Ingredients
- WHO Guidelines on Labeling and Packaging
- FDA Guidance on Pharmaceutical Labeling Compliance
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 Labeling Log
| Date | Material Name | Batch No. | Weighed Quantity | Label Status | Operator | QA Review |
|---|---|---|---|---|---|---|
| 02/02/2025 | API X | SOP/Ointment/1001 | 5.0 kg | Correct | John Doe | Approved |
Annexure-2: Labeling Deviation Log
| Date | Material Name | Batch No. | Deviation Type | Root Cause | Corrective Action | QA Approval |
|---|---|---|---|---|---|---|
| 02/02/2025 | API X | SOP/Ointment/1001 | Wrong Batch Number | Operator Error | Reprinted Label | Approved |
12. Revision History
| Revision Date | Revision No. | Details | Reason | Approved By |
|---|---|---|---|---|
| 02/02/2025 | 2.0 | Expanded Labeling Process | Improved Traceability | QA Head |