all partially used raw material containers are correctly labeled and stored. The QA Manager is responsible for auditing and ensuring compliance with regulatory requirements.

5. Procedure

5.1 Labeling Requirements for Partially Used Containers

1. Primary Label Requirements:
   • Original manufacturer’s label must remain intact and legible.
   • Ensure that batch number, material name, and expiry date are clearly visible.
   • If the primary label is damaged, replace it immediately with a new label replicating the original information.
   • Document primary label replacements in the Label Replacement Log (Annexure-1).
2. Secondary Label Requirements:
   • Attach a secondary label indicating the following:
     • Date of first use
     • Remaining quantity
     • Name and signature of the person who used the material
     • Storage conditions if different from the original label
   • Use color-coded labels for quick identification of partially used materials.
   • Document secondary labeling in the Secondary Label Log (Annexure-2).
3. Tertiary Label Requirements (for Hazardous Materials):
   • Include hazard symbols and safety precautions on the label.
   • Indicate special storage or handling instructions if applicable.
   • Ensure labels are waterproof and resistant to the stored material’s properties.
   • Document hazardous material labeling in the Hazardous Material Label Log (Annexure-3).

5.2 Handling and Storage of Partially Used Containers

1. Return to Warehouse:
   • After partial use in production, return containers to the warehouse with proper labeling.
   • Inspect the container for any signs of contamination or damage before returning it to storage.
   • Document the return process in the Material Return Log (Annexure-4).
2. Storage Conditions:
   • Ensure partially used containers are stored according to the specified conditions on the label.
   • Segregate partially used materials from full, unopened containers to prevent mix-ups.
   • Document storage conditions in the Storage Log for Partially Used Materials (Annexure-5).

5.3 Periodic Review and Audit of Labels

1. Monthly Label Review:
   • Conduct monthly reviews of all partially used containers to ensure labeling compliance.
   • Identify and correct any labeling discrepancies immediately.
   • Document monthly reviews in the Label Review Log (Annexure-6).
2. Audit Procedure:
   • QA will conduct quarterly audits to verify proper labeling and storage of partially used materials.
   • Non-compliance issues will be addressed with corrective and preventive actions (CAPA).
   • Document audit findings in the Label Audit Log (Annexure-7).

6. Abbreviations

• SOP: Standard Operating Procedure
• GMP: Good Manufacturing Practice
• QA: Quality Assurance
• CAPA: Corrective and Preventive Action

7. Documents

1. Label Replacement Log (Annexure-1)
2. Secondary Label Log (Annexure-2)
3. Hazardous Material Label Log (Annexure-3)
4. Material Return Log (Annexure-4)
5. Storage Log for Partially Used Materials (Annexure-5)
6. Label Review Log (Annexure-6)
7. Label Audit Log (Annexure-7)

8. References

• 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals
• WHO Guidelines on Good Manufacturing Practices for Pharmaceutical Products
• OSHA Hazard Communication Standards

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

Annexure-1: Label Replacement Log

Date	Material Name	Batch Number	Reason for Replacement	Replaced By	Verified By
19/03/2025	Citric Acid	CA-5678	Original label damaged during handling	Ravi Kumar	Neha Verma
19/03/2025	Sodium Hydroxide	NAOH-2345	Label faded due to exposure to light	Amit Joshi	Priya Singh

Annexure-2: Secondary Label Log

Date	Material Name	Batch Number	Date of First Use	Remaining Quantity	Labeled By
19/03/2025	Glucose Monohydrate	GM-9876	17/03/2025	25 kg	Ravi Kumar
19/03/2025	Potassium Chloride	KCL-4567	15/03/2025	15 kg	Amit Joshi

Annexure-3: Hazardous Material Label Log

Date	Material Name	Batch Number	Hazard Symbols Applied	Special Handling Instructions	Labeled By
19/03/2025	Hydrochloric Acid	HCL-1234	Corrosive, Toxic	Use PPE; store in acid-resistant container	Neha Verma
19/03/2025	Sodium Hypochlorite	SH-7890	Irritant, Oxidizer	Store in a cool, ventilated area	Priya Singh

Annexure-4: Material Return Log

Date	Material Name	Batch Number	Quantity Returned	Returned By	Inspected By
19/03/2025	Magnesium Stearate	MS-4321	10 kg	Amit Joshi	Neha Verma
19/03/2025	Lactose Monohydrate	LM-6543	5 kg	Ravi Kumar	Priya Singh

Annexure-5: Storage Log for Partially Used Materials

Date	Material Name	Batch Number	Storage Location	Storage Conditions	Stored By
19/03/2025	Calcium Carbonate	CC-9876	Rack A2	Room temperature, dry area	Ravi Kumar
19/03/2025	Aspartame	ASP-5432	Rack B1	Cool, dark storage	Neha Verma

Annexure-6: Label Review Log

Date	Reviewer Name	Materials Reviewed	Issues Identified	Corrective Actions Taken	Status
19/03/2025	Priya Singh	Citric Acid, Magnesium Stearate	Label wear due to moisture exposure	Replaced with waterproof labels	Resolved
19/03/2025	Neha Verma	Hydrochloric Acid, Sodium Hypochlorite	Missing hazard symbols on one container	Updated with appropriate symbols	Resolved

Annexure-7: Label Audit Log

Date	Auditor Name	Area Audited	Findings	Corrective Actions	Audit Status
19/03/2025	Amit Joshi	Warehouse Rack A1	Secondary labels missing on two containers	Secondary labels applied immediately	Closed
19/03/2025	Priya Singh	Hazardous Material Storage	Inconsistent font size on warning labels	Standardized labeling format applied	Closed

Revision History:

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By
01/01/2024	1.0	Initial Version	New SOP Implementation	QA Head
19/03/2025	2.0	Updated labeling requirements for hazardous materials	To align with revised GMP guidelines	QA Head