Standard Operating Procedure for Labeling of Raw Materials with Status Tags in API Manufacturing
| Department | API Manufacturing |
|---|---|
| SOP No. | SOP/API/005/2025 |
| Supersedes | SOP/API/005/2022 |
| Page No. | Page 1 of 10 |
| Issue Date | 13/04/2025 |
| Effective Date | 15/04/2025 |
| Review Date | 13/04/2026 |
1. Purpose
To define the standard method for labeling raw material containers using color-coded status tags (Quarantine, Sampled, Approved, Rejected) to ensure proper identification, traceability, and compliance with GMP during the receipt, testing, and disposition stages in API manufacturing.
2. Scope
This procedure applies to all raw materials including APIs, excipients, solvents, and processing aids received in the API manufacturing warehouse.
3. Responsibilities
- Warehouse Staff: Affix the appropriate status tag at each stage of material disposition.
- QC Analyst: Ensure “Sampled” labels are affixed after drawing the sample.
- QA Officer: Authorize replacement of tags based on test results and maintain status logs.
4. Accountability
The QA Manager is accountable for ensuring that all materials bear the correct and current status label, and that obsolete tags are removed without delay.
5. Procedure
5.1 Types of Status Tags
- Quarantine Tag (Red): Applied upon material receipt until testing and approval. Indicates material must not be used.
- Sampled Tag (White): Applied after QC draws samples. Positioned beside the quarantine label.
- Approved Tag (Green): Applied when material passes QC tests. Authorizes release to production.
- Rejected Tag (Yellow): Applied when material fails to meet specifications. Indicates it must not be used.
5.2 Label Format and Content
- Each tag must be color-coded and pre-printed as per GMP requirements.
- Information on each tag must include:
- Material Name
- Batch Number
- Received Date
- Status (Quarantine / Sampled / Approved / Rejected)
- Sign and Date of Person Affixing the Tag
- Labels must be securely affixed to the outer surface of each container using permanent adhesive or tie-tags.
5.3 Labeling Process
- Upon receipt, warehouse personnel affix the red “Quarantine” label immediately after inward entry.
- QC Analyst affixes “Sampled” label after sampling, referencing the sampling log number.
- Post-analysis, QA removes the quarantine tag and affixes:
- Green “Approved” label if material meets specifications
- Yellow “Rejected” label if material fails to comply
- Only one status tag should be visible on a container at any time, except during “Sampled” condition which can coexist with “Quarantine.”
5.4 Disposal of Obsolete Tags
- Removed tags shall be defaced and archived in the “Tag Removal Register” (Annexure-2) along with reason and initials of QA personnel.
- Ensure the tag removal is documented before affixing the new tag.
5.5 Handling Illegible or Missing Tags
- Any container found with:
- Illegible
- Torn
- Incorrect or missing tags
should be quarantined and a deviation form raised.
- QA shall investigate and re-tag the material only after verifying records.
6. Abbreviations
- QA: Quality Assurance
- QC: Quality Control
- SOP: Standard Operating Procedure
- GMP: Good Manufacturing Practices
7. Documents
- Status Tag Log (Annexure-1)
- Tag Removal Register (Annexure-2)
- Label Template Master (Annexure-3)
8. References
- ICH Q7 – GMP for Active Pharmaceutical Ingredients
- WHO TRS 986 Annex 2
- 21 CFR Part 211.80 – Labeling of Components
9. SOP Version
Version: 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | Rajesh Kumar | Sunita Reddy | Manoj Verma |
| Designation | Warehouse Assistant | QA Executive | QA Manager |
| Department | API Manufacturing | Quality Assurance | Quality Assurance |
11. Annexures
Annexure-1: Status Tag Log
| Date | Material | Batch | Tag Type | Affixed By | Verified By |
|---|---|---|---|---|---|
| 13/04/2025 | Citric Acid | CA20250413 | Quarantine | Rajesh Kumar | Sunita Reddy |
Annexure-2: Tag Removal Register
| Date | Material | Old Tag | New Tag | Removed By | Remarks |
|---|---|---|---|---|---|
| 15/04/2025 | Citric Acid | Quarantine | Approved | Sunita Reddy | Passed QC Testing |
Annexure-3: Label Template Master
| Tag Color | Status | Mandatory Fields | Print Code |
|---|---|---|---|
| Red | Quarantine | Material, Batch, Date, Sign | QA/QUAR/01 |
| Green | Approved | Material, Batch, Date, Sign | QA/APPR/01 |
| Yellow | Rejected | Material, Batch, Date, Sign | QA/REJ/01 |
Revision History:
| Revision Date | Revision No. | Revision Details | Reason for Revision | Approved By |
|---|---|---|---|---|
| 01/01/2022 | 1.0 | Initial Version | GMP Implementation | QA Head |
| 13/04/2025 | 2.0 | Color Code and Register Inclusion | Audit Observation | QA Head |