Standard Operating Procedure for Disposal of Rejected Batches of Creams

Department	Creams
SOP No.	SOP/CRM/079/2025
Supersedes	SOP/CRM/079/2022
Page No.	Page 1 of 5
Issue Date	21/01/2026
Effective Date	26/01/2026
Review Date	21/01/2027

1. Purpose

This SOP outlines the procedure for the safe and compliant disposal of rejected cream batches. The goal is to ensure that non-conforming products are handled and discarded in a way that minimizes any risks to safety, quality, or the environment.

2. Scope

This SOP applies to all cream batches that do not meet quality standards or regulatory requirements and need to be discarded. It covers the steps for identifying, segregating, and disposing of rejected batches in compliance with environmental and regulatory guidelines.

3. Responsibilities

• Production Team: Responsible for identifying rejected batches, segregating them, and ensuring they are handled according to the SOP.
• Quality Control (QC): Responsible for verifying the rejection of batches and ensuring they meet the criteria for disposal.
• Quality Assurance (QA): Oversees the entire disposal process to ensure that it complies with GMP, regulatory standards, and internal policies.
• Environmental Health and Safety (EHS) Team: Ensures that rejected batches are disposed of following environmental safety standards and regulations.

4. Accountability

The Head of Production is accountable for ensuring that rejected batches are handled and disposed of as per this SOP. The QA Manager is responsible for ensuring that the process adheres to regulatory standards and internal policies.

5. Procedure

5.1 Identification of Rejected Batches

1. Rejected batches can be identified based on the following criteria:
   • Failure to meet quality specifications (e.g., texture, consistency, pH, microbial count).
   • Non-compliance with regulatory requirements.
   • Any other defect or issue detected during in-process checks or post-production testing.
2. Document the reason for rejection in the Batch Rejection Log (Annexure-1).
3. Inform the production and quality control teams about the rejection and initiate segregation procedures immediately.

5.2 Segregation and Labeling of Rejected Batches

1. Once a batch is identified as rejected, it must be physically segregated from other batches to prevent cross-contamination.
2. Label the rejected batch with clear markings such as “Rejected – Not for Use” and the batch number to ensure traceability.
3. Place the rejected batch in a designated storage area that is separate from other batches to prevent accidental use.

5.3 Disposal of Rejected Batches

1. Ensure that the disposal process follows all local environmental, safety, and regulatory guidelines.
2. The disposal method for rejected batches may include:
   • Safe incineration.
   • Disposal through authorized waste management services.
   • Disposal in accordance with hazardous waste management guidelines if the product poses environmental or safety risks.
3. For non-hazardous rejected batches, ensure they are disposed of in a manner that complies with waste disposal regulations.
4. Ensure all disposal actions are documented and that the Batch Disposal Record (Annexure-2) is updated accordingly.

5.4 Environmental Impact Assessment

1. The EHS team must assess the environmental impact of disposal, especially for hazardous or large quantities of rejected batches.
2. Implement measures to reduce environmental impact, such as using approved disposal services that comply with environmental safety standards.
3. Ensure that disposal records are maintained to verify compliance with local and international environmental regulations.

5.5 Final Documentation

1. Update all relevant records, including:
   • Batch Rejection Log (Annexure-1).
   • Batch Disposal Record (Annexure-2).
   • Environmental Impact and Disposal Report (Annexure-3).
2. Ensure that all disposal actions are signed off by the appropriate personnel in the EHS team and QA team.

5.6 Final Approval

1. The QA team must review all records related to the disposal of rejected batches and ensure compliance with GMP and regulatory guidelines.
2. The disposal of any rejected batch should only be considered complete once it has been reviewed and approved by both the QA and EHS teams.

6. Abbreviations

• GMP: Good Manufacturing Practices
• QC: Quality Control
• QA: Quality Assurance
• EHS: Environmental Health and Safety
• PPE: Personal Protective Equipment

7. Documents

1. Annexure-1: Batch Rejection Log
2. Annexure-2: Batch Disposal Record
3. Annexure-3: Environmental Impact and Disposal Report

8. References

• Good Manufacturing Practices (GMP) Guidelines – 21 CFR Part 211
• International Conference on Harmonisation (ICH) Q7 – Good Manufacturing Practice for Active Pharmaceutical Ingredients
• Environmental Protection Agency (EPA) Guidelines for Waste Disposal

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Batch Rejection Log

Batch Number	Reason for Rejection	Rejection Date	Operator	Comments
12345	Failed pH Test	21/01/2026	John Doe	Rechecked and confirmed non-compliance

Annexure-2: Batch Disposal Record

Batch Number	Disposal Method	Disposal Date	Disposal Personnel	Comments
12345	Incineration	21/01/2026	Jane Smith	Disposed according to EHS guidelines

Annexure-3: Environmental Impact and Disposal Report

Batch Number	Environmental Impact Assessment	Disposal Method	Environmental Compliance
12345	No significant environmental impact	Incineration	Compliant with local regulations

Revision History:

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By
01/03/2024	1.0	Initial Version	New SOP Creation	QA Head
01/03/2025	2.0	Format Revision and Updates	Standardization of Document	QA Head