Responsibilities

• Production Operator: Follow prescribed practices to prevent cross contamination.
• Production Supervisor: Verify adherence to preventive measures and perform risk assessments.
• QA Department: Ensure area cleanliness, review cleaning records, and validate preventive practices.
• Engineering Department: Maintain integrity of drying equipment and air handling units (AHUs).

4. Accountability

The Production Head is accountable for implementation of cross contamination prevention measures. QA Head is responsible for compliance monitoring and audit readiness.

5. Procedure

5.1 Equipment and Area Cleaning

1. Ensure all drying equipment (FBD, tray dryer, vacuum dryer) is cleaned as per validated cleaning SOP before and after use.
2. Verify cleaning status label is displayed as “Cleaned” with date and sign.
3. Use dedicated cleaning tools for each drying area to prevent cross-use.

5.2 Batch and Product Segregation

1. Do not dry different products or batches simultaneously in the same chamber or area.
2. If multiple dryers are used in parallel, maintain physical separation and labeled identification of each dryer and batch.
3. Implement scheduling to allow drying of only one product per session.

5.3 Environmental and Personnel Controls

1. Ensure personnel wear product-specific PPE and change it when moving between product zones.
2. Minimize human movement and material exposure during transfer to and from drying units.
3. Monitor temperature, humidity, and particulate matter as per environmental control plan.

5.4 Equipment Integrity and Design

1. Ensure all dryers are leak-free and have proper sealing mechanisms (e.g., door gaskets, clamps).
2. Use HEPA filters where applicable, and monitor differential pressure in ducting to detect leaks.
3. Perform regular maintenance and integrity testing of equipment and associated air handling units.

5.5 Line Clearance and Documentation

1. QA must perform and document line clearance before and after each drying operation.
2. Ensure that no remnants of previous batch/product remain in trays, ducts, or containers.
3. Record preventive actions and inspections in “Cross Contamination Prevention Log” (Annexure-1).

5.6 Risk Mitigation and Validation

1. Perform risk assessment for products with high cross-contamination potential (e.g., cytotoxics, beta-lactams).
2. Validate cleaning processes and recovery limits for each product changeover.
3. Review trends from environmental monitoring and product cross-checks in retained samples.

6. Abbreviations

• API: Active Pharmaceutical Ingredient
• SOP: Standard Operating Procedure
• FBD: Fluid Bed Dryer
• QA: Quality Assurance
• AHU: Air Handling Unit
• PPE: Personal Protective Equipment

7. Documents

1. Cross Contamination Prevention Log (Annexure-1)
2. Cleaning Checklist
3. Environmental Monitoring Record
4. Batch Manufacturing Record

8. References

• WHO TRS 986 Annex 2 – GMP for APIs
• EU Guidelines on Cross Contamination (Chapter 3 and 5)
• ICH Q9 – Quality Risk Management

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 Prevention Log

Date	Dryer ID	Batch No.	Cleaning Verified	Line Clearance Done	Remarks	Checked By
13/04/2025	VCD-02	API-20250413	Yes	Yes	Clean & Clear

Revision History:

Revision Date	Revision No.	Details	Reason	Approved By
01/01/2022	1.0	Initial SOP Release	New Compliance Requirement	QA Head
13/04/2025	2.0	Added Risk Assessment and Validation Elements	Regulatory Inspection Readiness	QA Head