Cold Chain Control

Cold Chain Control ensures that medicinal products are not only made to a high quality in accordance with current Good Manufacturing Practice (cGMP) but that the quality and integrity of these medicinal products are maintained through the entire supply chain to the end-user.

  • Supplier
  • Factories
  • Warehouses
  • Outlets
  • Consumers

Qualification of serialized packaging lines

A successful serialization project requires experts that can design, configure, and qualify serialized packaging lines In order to secure compliance and prevent business risks by devising and implementing a bullet-proof validation plan, executing validation quickly and cost-effectively.

  • Unit
  • Bundle
  • Case
  • Pallet

Shipping validation

Medicinal products are required to be transported in such a way that maintain and control the environmental conditions that may affect product quality and safety in the shipping and distribution a system. To meet the current GDP regulatory requirements, transportation providers or containers or packaging configurations are required to be qualified.

Transportation procedures should also be qualified to ensure that appropriate conditions/temperatures are maintained under probable extremes of ambient temperature. Robust Master Shipping Validation Plan (MSVP) should be developed and drive the execution activities.

  • Shipping Validation Plan and Responsibilities.
  • Description of Shipping Materials.
  • Shipping Process Flow.
  • Risk Assessment and Justification for Qualification.
  • Qualification Test Protocols.
  • Thermal Profile Study and Data analysis.
  • List of Equipment Used during Qualification.
  • Summary Report.

Transport types

  • AirAir
  • RailRail
  • RoadRoad
  • WaterWater
  • Validated
  • In transit
  • Wireless
  • Wireless
  • Temp

Facilities Mapping

Temperature controlled storage areas must be temperature and humidity mapped as part of a fully documented qualification process. Before the facility can be used for storage, it’s critical that the facility housing the production process complies with current regulatory requirements and performs its function perfectly from the very start of production, and even before. In order to demonstrate that facility compliance has been achieved. The temperature mapping procedures should:

  • Demonstrate temperature & humidity profile throughout the storage area, when empty and in a normally loaded condition.
  • Define zones which should not be used for storage of the sensitive pharmaceutical product.
  • Demonstrate the time taken for temperatures to exceed the designated limits in the event of power failure.
  • Demonstrate successful recovery study.
  • Demonstrate temperature profile compliance at winter and summer time.