Accountability

The Production Manager is accountable for ensuring that this SOP is followed and that any deviations are addressed promptly. The overall compliance to this SOP is under the supervision of the Quality Assurance (QA) Manager.

5. Procedure

5.1. Segregation of Materials

1. Ensure that materials from different batches or different types (e.g., active ingredients, excipients) are stored and dispensed in a manner that prevents cross-contamination. Materials must be clearly labeled and segregated in designated storage areas.
2. Whenever possible, use dedicated equipment (e.g., weighing containers, dispensing tools) for each type of material to prevent mixing.
3. In cases where dedicated equipment is not possible, ensure thorough cleaning between uses of different materials.

5.2. Cleaning and Sanitization

1. Cleaning of dispensing equipment and tools must be carried out before using them for a different material. A documented cleaning procedure should be followed, including the cleaning agents and methods to be used.
2. Cleaning logs should be maintained, detailing the equipment cleaned, the cleaning procedure used, and the person performing the cleaning.
3. Ensure that the dispensing area is thoroughly cleaned and sanitized at regular intervals, particularly after dispensing highly potent or allergenic materials.

5.3. Personnel Protocols

1. Personnel working in dispensing areas should wear appropriate personal protective equipment (PPE), such as gloves, masks, hairnets, and gowns, to minimize the risk of contamination from skin or clothing.
2. Staff should avoid touching raw materials with bare hands or using the same PPE for different materials. When handling different materials, change gloves and other PPE between tasks.
3. Ensure that all personnel are trained in cross-contamination prevention techniques and that they understand the importance of maintaining cleanliness and material segregation.

5.4. Equipment Maintenance and Inspection

1. All dispensing equipment must be regularly inspected to ensure it is in good working condition and free from residues of previous materials.
2. Equipment that is used for dispensing must be cleaned and inspected for any signs of contamination before being used for a different material.
3. Ensure that material containers, dispensing equipment, and other tools are labeled with clear identifiers to avoid the accidental mixing of materials.

5.5. Environmental Controls

1. Ensure that the dispensing area is properly ventilated to minimize the buildup of dust or fumes from raw materials.
2. Environmental monitoring, including particle counts, air quality, and temperature, should be conducted regularly to ensure that conditions do not promote cross-contamination.
3. Use of air locks or controlled airflow systems should be considered in areas where sensitive or highly active materials are being dispensed.

5.6. Corrective and Preventive Actions (CAPA)

1. If cross-contamination is suspected or detected, the affected batch or material should be quarantined immediately, and the cause of the contamination should be investigated thoroughly.
2. Corrective actions may include retraining personnel, revising procedures, increasing cleaning frequency, or implementing new segregation methods.
3. Preventive actions should be put in place to avoid recurrence, including additional controls, equipment upgrades, or enhanced monitoring practices.

6. Abbreviations

• GMP: Good Manufacturing Practice
• QC: Quality Control
• CAPA: Corrective and Preventive Actions

7. Documents

1. Cross-Contamination Prevention Log (Annexure-1)
2. Cleaning and Sanitization Log (Annexure-2)
3. Environmental Monitoring Log (Annexure-3)
4. CAPA Log (Annexure-4)

8. References

This SOP is based on the following regulatory guidelines and industry standards:

• Good Manufacturing Practice (GMP) Guidelines
• FDA Code of Federal Regulations (CFR) Title 21, Part 211
• ISO 9001:2015 – Quality Management Systems

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

Material Name	Batch No.	Dispensing Date	Preventive Action Taken	Responsible Party
Example Material	12345	06/02/2025	Segregation confirmed, equipment cleaned	Ravi Kumar

Annexure-2: Cleaning and Sanitization Log

Equipment	Cleaning Date	Cleaning Method	Cleaning Personnel	Remarks
Weighing Balance	06/02/2025	Soap solution and distilled water	Rajesh Patel	Pass

Annexure-3: Environmental Monitoring Log

Monitoring Date	Temperature	Humidity	Particle Count	Operator
06/02/2025	22°C	50%	80 particles/m³	Rajesh Patel

Annexure-4: CAPA Log

Issue	Root Cause Analysis	Corrective Action	Preventive Action	Follow-up Date
Cross-contamination risk	PPE issue	Retrained personnel on PPE usage	Improved segregation methods	06/03/2025

12. Revision History:

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By	Page No.	Ref. Point No.	Details of Revision
01/01/2024	V 1.0	Initial Release	First Issue	Anjali Sharma	Page 1	[Ref Point]	First Release
01/01/2025	V 2.0	Updated preventive measures and added corrective actions	To comply with updated GMP regulations	Anjali Sharma	Page 1	[Ref Point]	Updated procedures