Ship It! Shipping Qualification 101


Shipping Qualification is one part of the qualification of a drug’s supply chain qualification that protects the quality of a regulated drug product. Other parts include qualifying/auditing suppliers, testing raw materials, manufacturing processes, warehousing, etc.

Shipping Qualification focuses on the parameters that may affect critical quality attributes such as temperature, humidity, light exposure, vibration exposure, etc. You must know your product and the risks associated to it through each of these avenues.

Shipping Qualification is particularly important because some degree of control is lost in shipping product, and the new risks must be understood and mitigated if not acceptable.


  • PDA Technical Report 39 – Temperature controlled medicinal products
  • WHO/BS/10.2129 – Model guidance for the storage and transport of time and temperature-sensitive pharmaceutical products
  • WHO, Annex 5, Good distribution practices for pharmaceutical products
  • EU GDP, Guidelines for Good Distribution Practice of Medicinal Products for Human Use
  • Guidance for the Qualification of Temperature Controlled Transport – Active Unit Load Devices (Group PCCIG – PDA)
  • PDA Technical Report 52 – Guidance for good distribution practices for
    pharmaceutical supply chain
  • USP 1079 – Good storage and shipping practices
  • USP 1118 – Monitoring Devices – Time Temperature and Humidity
  • USP 1150 – Pharmaceutical Stability

Overview of Shipping Qualification

  1. Design Qualification (DQ)
    1. Transportation Methods
    2. Container Requirements
    3. Load Configurations
    4. Temperature/Humidity Profiles
  2. Installation Qualification (IQ)
    1. Containers (what the product gets shipped in)
    2. Components (what can be shipped in what configurations)
    3. Control Instruments (how is the environment controlled)
  3. Operational Qualification (OQ)
    1. Alarms (on control instruments)
    2. Power/battery
    3. Recovery Time (e.g on open door)
    4. Extreme Temperature Tests (find out what you configuration can handle)
  4. Performance Qualification (PQ)
    1. Choose worst-case route and worst-case configuration
    2. Perform in Summer and in Winter
  5. Requalification
    1. Perform when necessary

2 thoughts on “Ship It! Shipping Qualification 101”

  1. Dear. Mike Williamson.
    I’m working for a biosimmilar pharmaceutical company.
    Now we are preparing to perform shipping qualification and looking for a consulting company.
    Does your company provide the consulting service?
    Could I get more information about your company?

    Best Regards,

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