Shipping Validation | FDA Guidance

As per FDA good manufacturing practice,

Material should be handled and stored in a manner to prevent degradation, contamination and cross-contamination.

From this aspect, shipping validation is very important for maintaining the quality of a material during transportation.

Shipping validation is a documented evidence that provide a high degree of assurance that during transportation of a material it's always ensuring the quality.

As per FDA guidance,

The manufacturer should ensure that the transportation of the API or Intermediate knows and follow the appropriate transport and storage condition.

Shipping Validation Strategy

  • During development of a shipping validation strategy following points can include -
  • Select program partners
  • Conduct risk assessment
  • Establish regulatory compliance requirements
  • Engage validation project partners
  • Define responsibility and develop validation protocol
  • Execute the protocol, compile results and write the final report

During risk assessment of shipping validation points need to be considered -

  • Temperature requirement
  • Routing & Time
  • Product packaging
  • Cost
  • Security

From regulatory aspects following points can be considered -

  • Export screening
  • Licence and Permits
  • Prior notification and/or registration

Read also: Resources for Storage and Transportation of Pharmaceutical Finished Products

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