Standard Operating Procedure for Product Segregation

Purpose

The purpose of this SOP is to establish guidelines for segregating different types of products within the warehouse to prevent contamination, ensure product integrity, and maintain regulatory compliance in the pharmaceutical facility.

Scope

This SOP applies to all personnel involved in receiving, storing, picking, packing, and shipping pharmaceutical products in the warehouse.

Responsibilities

• Warehouse Manager: Overall responsibility for ensuring compliance with product segregation procedures and maintaining segregation plans.
• Inventory Control Team: Responsible for developing and implementing segregation plans, labeling products accordingly, and monitoring segregation compliance.
• Quality Assurance Department: Responsible for reviewing and approving segregation plans, conducting audits to verify compliance, and addressing non-conformities.
• Warehouse Personnel: Responsible for following segregation procedures, adhering to segregation signage and labeling, and reporting any deviations or concerns.

Procedure

1. Segregation Plan Development:
   • Identify different types of products requiring segregation based on factors such as storage requirements, temperature sensitivity, hazard classification, and regulatory requirements.
   • Develop a segregation plan specifying segregation zones, storage locations, aisle designations, and signage requirements for each product category to prevent cross-contamination.
   • Document segregation plans in written procedures, warehouse layouts, or digital systems accessible to all relevant personnel.
2. Segregation Implementation:
   • Physically separate incompatible products using designated storage areas, shelving units, pallet racks, or partitioned zones within the warehouse.
   • Label segregation zones and storage locations clearly with appropriate signage, color-coding, or labeling systems to indicate product categories, hazards, or special handling requirements.
   • Train warehouse personnel on segregation procedures, including proper handling, storage, and identification of segregated products to prevent mix-ups or contamination.
3. Segregation Monitoring and Compliance:
   • Conduct regular inspections and audits of segregation zones and storage areas to verify compliance with segregation plans and procedures.
   • Check product labels, signage, and storage conditions to ensure that segregated products are stored correctly and separated from incompatible items.
   • Address any deviations, discrepancies, or non-conformities observed during segregation inspections promptly, including corrective actions and retraining as needed.
4. Documentation and Record keeping:
   • Maintain records of segregation plans, including layout diagrams, storage maps, and labeling schemes, to facilitate compliance verification and audits.
   • Document segregation inspections, findings, corrective actions, and follow-up activities in segregation audit reports or logs for traceability and accountability purposes.
   • Archive segregation records and documentation according to document retention policies and regulatory requirements for future reference and audit purposes.

Abbreviations

• SOP: Standard Operating Procedure

Documents

• Segregation Plan
• Segregation Inspection Checklist
• Segregation Audit Reports
• Segregation Training Materials

SOP Version

Version 1.0