Pharma Solutions Bangladesh Limited (PSBL) has extensive experience in managing temperature-sensitive pharmaceutical and healthcare products across Bangladesh through a fully compliant, GDP-aligned cold chain infrastructure. The company’s cold chain capability was developed while handling multinational pharmaceutical portfolios including GlaxoSmithKline (GSK), RAK Pharmaceuticals, Reckitt Benckiser, Novartis Bangladesh Limited, Sandoz, Elanco, Roche Diabetes Care, Menarini, Omron Healthcare, Marie Stopes and Sebamed and continues to support both multinational and local healthcare manufacturers requiring strict temperature control and product integrity.

End-to-End Cold Chain Coverage

PSBL maintains uninterrupted cold chain integrity from product receipt to final delivery. The cold chain process includes:

  • Import and manufacturer intake handling
  • Temperature-controlled warehousing
  • Validated cold room storage (2°C–8°C)
  • Frozen storage (<-18°C) where required
  • Cryogenic handling (<-197°C) for specialized products
  • Temperature-controlled picking and packing
  • Validated passive cold chain packaging
  • Temperature-monitored transportation
  • Customer-level temperature verification at delivery
  • Reverse logistics for temperature-sensitive returns

This integrated approach ensures that temperature-sensitive pharmaceuticals such as vaccines, biologics, insulin, oncology products, and specialty medicines maintain stability throughout the distribution lifecycle.

Cold Chain Infrastructure

GDP-Compliant Storage Facilities

PSBL operates a Central Distribution Center (CDC) in Ashulia along with 18 nationwide stocking branches, all equipped with calibrated temperature monitoring systems. The facilities support multiple controlled temperature zones:

  • Ambient Storage: <30°C
  • Controlled Room Temperature (CRT): <25°C
  • Cold Chain Storage: 2°C–8°C
  • Frozen Storage: <-18°C
  • Cryogenic Storage: <-197°C

All cold rooms and refrigeration units are qualified and validated according to WHO Good Distribution Practice (GDP) requirements. Storage areas are temperature mapped to ensure uniform cooling and eliminate risk zones.

Temperature Monitoring & Control

PSBL implements continuous temperature monitoring across all cold chain storage and distribution points.

Controls include:

  • Calibrated digital temperature and humidity monitoring devices
  • Continuous temperature recording at critical points
  • Three-times-daily manual verification logs
  • Alarm-based deviation alerts
  • Escalation and corrective action procedures
  • Annual revalidation of cold chain infrastructure
  • Preventive maintenance schedule for refrigeration units

Temperature mapping studies are conducted periodically to validate thermal consistency within storage areas.

Validated Cold Chain Packaging

For transportation of temperature-sensitive products, PSBL uses validated passive cold chain systems including:

  • Insulated cold boxes
  • Ice packs / gel packs
  • Qualified thermal packaging
  • Pre-conditioned packaging materials
  • Route-specific pack-out configurations

Each packaging configuration is validated to maintain required temperature range during transit. Delivery personnel are trained to handle cold chain shipments and ensure minimal exposure time.

Customers are permitted to verify product temperature at delivery, ensuring transparency and compliance.

Temperature-Controlled Distribution

Cold chain distribution is managed under validated transport conditions:

  • Temperature-controlled dispatch process
  • Validated passive packaging for last-mile delivery
  • Thermometer-based monitoring during transit
  • End-time temperature recording before handover
  • Trained delivery personnel
  • Documented cold chain SOPs
  • Deviation reporting and investigation

PSBL’s nationwide distribution network includes fixed delivery routes with defined transit time validation to maintain cold chain integrity.

Quality Management & Certification Framework

PSBL’s cold chain operations are governed under a structured Quality Management System aligned with international standards:

Certifications & Compliance

  • ISO 9001:2015 – Quality Management System
  • ISO 27001:2015 – Information Security Management System
  • WHO Good Storage and Distribution Practices (GSDP) compliant operations

Cold chain management is embedded within the QMS and controlled through:

  • Quality & GDP Manual
  • Cold Chain SOPs
  • Temperature deviation management procedures
  • CAPA (Corrective and Preventive Action) system
  • Training and competency assessments
  • Internal and external audits
  • Mock recall exercises

Validation & Qualification

PSBL performs structured validation activities for cold chain assurance:

  • Temperature mapping of cold rooms
  • Qualification of refrigerators and cold rooms
  • Validation of passive packaging systems
  • Transit validation studies
  • Seasonal validation for summer conditions
  • Annual requalification of cold chain infrastructure

These validations confirm the ability to maintain temperature stability under Bangladesh’s climatic conditions.

Cold Chain Risk Management

Cold chain risks are proactively managed through:

  • Backup power generators
  • Emergency response procedures
  • Temperature excursion management
  • Alternate storage arrangements
  • Business continuity planning (BCP)
  • Disaster recovery procedures
  • Continuous monitoring and audit checks

This ensures uninterrupted cold chain operation even during power failures or transport disruptions.

Operational Experience

PSBL has successfully handled temperature-sensitive pharmaceutical products including:

  • Vaccines
  • Insulin
  • Oncology products
  • Biologics
  • Specialty injectables
  • Hormonal products
  • Hospital critical care medicines

The company’s experience supporting multinational pharmaceutical companies has strengthened its ability to meet stringent global cold chain requirements.

Compliance with WHO GDP Cold Chain Requirements

PSBL cold chain operations align with WHO GDP expectations:

  • Defined cold chain SOPs
  • Validated storage conditions
  • Continuous temperature monitoring
  • Qualified packaging systems
  • Trained personnel
  • Documented transport controls
  • Traceability and recall readiness
  • Deviation management and CAPA
  • Audit readiness and documentation

PSBL delivers a fully compliant, validated, and nationwide pharmaceutical cold chain distribution platform. Through GDP-aligned infrastructure, validated packaging, trained personnel, and ISO-certified quality systems, PSBL ensures safe storage, handling, and distribution of temperature-sensitive healthcare products across Bangladesh, maintaining product integrity from manufacturer to patient.