PCAB Accreditation Standards require an organization to ship pharmaceuticals in a manner that maintains appropriate sanitation, light, and temperature conditions.

These requirements are supported by standards in several USP general chapters, including USP <659>, <1079>, and <1079.2>.  Chapter <659> sets the standards and details any allowed excursions, and Chapter <1079.2> addresses the excursion evaluation.  USP Chapter <1079> provides guidance on evaluating your validated shipping process.

Chapter <1079>

USP Chapter <1079>, Risks and Mitigation Strategies for the Storage and Transportation of Finished Drug Products, establishes that operational and performance shipping studies should be part of a formal qualification protocol that may use controlled environments or actual field testing. These studies should reflect actual load configuration conditions and expected environmental extremes.

Chapter <1079> provides a list of factors that should be considered when developing a thermal package qualification protocol. A chart listing these factors is available to download.

Whether you have a third party validate your pack-out system or do it yourself, ensure your system is tested to withstand anticipated environmental extremes during transport of medications.

The validation must consider the initial product start temperature; payload size, weight, and types of insulation used; thickness of the insulation; weight of the phase-change material; the phase-change material start temperature; and various ambient temperatures expected in transit.

Bottom Line

The goal is to design a pack-out system that can be taught to staff and ensures pharmaceuticals in transit maintain the temperature required by the manufacturer, USP, and/or other applicable requirements.

Here to Help

ACHC is more than an accreditor. We are your partner. For more information, contact your Account Advisor, email [email protected], or call (855) 937-2242, ext. 458.