Standard Operating Procedure for Cross-Contamination Control in Multi-Product Facilities

Department	Tablet
SOP No.	SOP/TAB/190/2025
Supersedes	SOP/TAB/190/2022
Page No.	Page 1 of 7
Issue Date	01/03/2026
Effective Date	06/03/2026
Review Date	01/03/2027

1. Purpose

To define procedures that control cross-contamination risks in multi-product tablet manufacturing facilities, ensuring that products are manufactured in compliance with regulatory standards, with no risk of contamination between different tablet batches.

2. Scope

This SOP applies to all tablet production areas within the facility where multiple products are manufactured, including blending, granulation, compression, and coating areas. It outlines the procedures to prevent cross-contamination during manufacturing and storage.

3. Responsibilities

• Quality Assurance (QA): Responsible for overseeing the implementation of this SOP, performing audits, and ensuring that cross-contamination risks are minimized through proper procedures and controls.
• Production Team: Responsible for following the cross-contamination control procedures during the manufacturing process and ensuring that equipment is properly cleaned and maintained between product runs.
• Maintenance Team: Responsible for ensuring that all equipment is cleaned and maintained according to the defined cleaning schedules to prevent cross-contamination.
• Warehouse Team: Responsible for properly storing raw materials and finished products to prevent mix-ups or contamination between different tablet products.

4. Accountability

The QA Manager is accountable for ensuring the implementation of this SOP, including conducting audits and ensuring the prevention of cross-contamination in multi-product manufacturing areas. The Production Manager is accountable for enforcing the SOP in their areas of responsibility.

5. Procedure

5.1 Cross-Contamination Risk Assessment

1. Conduct a risk assessment to identify potential sources of cross-contamination in multi-product areas, including shared equipment, tools, and storage areas.
2. Document the risk assessment findings and implement controls to mitigate identified risks.
3. Review the risk assessment periodically to ensure that all potential risks are addressed as new products are introduced.

5.2 Cleaning and Decontamination Procedures

1. Implement cleaning procedures to ensure that all equipment, tools, and manufacturing areas are thoroughly cleaned between different product batches. The cleaning procedure should follow the approved Cleaning Validation SOP (Annexure-1).
2. Verify that cleaning materials and methods are suitable for the type of equipment and the products being manufactured.
3. Ensure that cleaning and decontamination records are maintained and include details such as equipment cleaned, cleaning agents used, and the personnel responsible for cleaning.
4. All cleaning procedures should be validated and documented to confirm that they are effective in removing residues from previous products.

5.3 Equipment Design and Segregation

1. Ensure that equipment used for different products is designed to minimize contamination risks. If possible, use dedicated equipment for specific products.
2. If equipment is shared between different products, establish clear segregation procedures, including labeling and physical barriers to prevent cross-contact between products.
3. Ensure that products with similar characteristics are manufactured sequentially to reduce the risk of contamination.

5.4 Personnel Practices

1. Ensure that all personnel involved in the manufacturing process are trained in cross-contamination prevention procedures, including proper use of personal protective equipment (PPE), hygienic practices, and adherence to cleaning protocols.
2. Ensure that employees change into clean, product-specific PPE before entering the manufacturing areas. Provide clean uniforms, gloves, and footwear as necessary to avoid product mix-up or contamination.
3. Implement procedures for personnel to thoroughly wash and disinfect their hands before handling materials, equipment, or products.

5.5 Material Handling and Storage

1. Ensure that raw materials and finished products are properly stored and labeled to prevent cross-contamination during storage and transportation (Annexure-2).
2. Segregate materials based on product type to minimize the risk of cross-contamination. Use dedicated storage areas for each product.
3. Implement procedures to ensure that raw materials are correctly labeled with batch numbers, product codes, and any other relevant information to prevent mix-ups.

5.6 Product-Specific Cross-Contamination Controls

1. For products with higher risk profiles, such as potent drugs or allergenic substances, implement additional controls such as dedicated equipment, more frequent cleaning, and enhanced monitoring.
2. Establish clear guidelines for cleaning equipment between batches of different products, especially those that pose a higher risk of contamination.

5.7 Monitoring and Auditing

1. Regularly monitor manufacturing areas to ensure that procedures to control cross-contamination are being followed correctly.
2. Conduct periodic audits to verify compliance with cross-contamination control procedures and identify any areas for improvement (Annexure-3).
3. Monitor the effectiveness of controls through sampling, product inspection, and analysis to detect any potential cross-contamination.

5.8 Corrective Actions and Documentation

1. If cross-contamination is detected, initiate corrective actions immediately, including isolation of affected products, investigation of the cause, and implementation of corrective measures to prevent recurrence.
2. Document all deviations and corrective actions taken, including a root cause analysis, and maintain these records in the Cross-Contamination Log (Annexure-4).
3. Review and update cross-contamination control procedures regularly based on audit findings and any incidents of contamination.

6. Abbreviations

• SOP: Standard Operating Procedure
• QA: Quality Assurance
• QC: Quality Control
• GMP: Good Manufacturing Practice
• PPE: Personal Protective Equipment

7. Documents

1. Cross-Contamination Log (Annexure-1)
2. Raw Material Storage and Handling Log (Annexure-2)
3. Cross-Contamination Audit Log (Annexure-3)
4. Corrective Actions Report (Annexure-4)

8. References

• 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals (US FDA)
• ISO 14644-1 – Cleanrooms and Associated Controlled Environments
• ICH Q7 – Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Cross-Contamination Log

Date	Product	Contamination Source	Corrective Action Taken	Remarks
01/03/2026	Tablet A	Equipment contamination	Re-cleaned equipment	Issue resolved, no further action needed

Annexure-2: Raw Material Storage and Handling Log

Material ID	Product Name	Batch Number	Storage Location	Handling Instructions
RM-001	Tablet A	Batch-12345	Storage Room 1	Keep separated from other product materials

Annexure-3: Cross-Contamination Audit Log

Audit Date	Audit Findings	Corrective Action	Responsible Person
01/03/2026	No cross-contamination detected	N/A	QA Manager

Annexure-4: Corrective Actions Report

Action ID	Issue	Corrective Action	Completion Date
CAPA-001	Cross-contamination risk identified	Implemented enhanced cleaning procedures	01/03/2026

Revision History:

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By
01/01/2024	1.0	Initial Version	New SOP Creation	QA Head
01/02/2025	2.0	Enhanced cross-contamination control measures	Improved monitoring and corrective action procedures	QA Head