Teva Pharmaceuticals USA is a leading generic and branded pharmaceutical manufacturer and distributor. It markets a wide product range in multiple therapeutic areas. In order to improve compliance and document control for shipments of refrigerated (at 2⁰C to 8⁰C) and controlled room temperature (CRT) (at 20⁰C to 25⁰C), the management team needed to assess and implement changes. Temperature-controlled trucks are used to convey palletized shipments of pharmaceutical products from the manufacturer to the distribution centers and, in many cases, between distribution centers. Fleets of trucks are owned by 3PL logistics companies and utilized on a contract basis. The regulatory expectations, expressed in numerous GDP guidance documents, are for the pharmaceutical manufacturer to establish the suitability of these contracted trucks for their intended purpose and implement an effective monitoring and controls process through quality agreements.
Value to TEVA
- Assess shipments of refrigerated (2⁰C to 8⁰C) and CRT (20⁰C to 25⁰C) drug products being shipped in 53-foot controlled temperature trailers against standards
- Properly document information in reports and protocols
- Prepare a Quality Agreement template
- Update procedures as necessary
The assessment, qualification and monitoring and controls strategy allowed TEVA to:
- Ensure compliance with cGMP expectations for temperature control for temperature controlled trailers used during shipment of drug products
- Gain alignment to corporate procedures
- Complete selection of a cost-effective approach to temperature monitoring of shipments
Our approach included the following steps:
- Developing a technical report that established a standards-based strategy for trailer qualification.
- Establishing an operating standard for carriers in the quality management system.
- Writing protocols and reports for both refrigerated and CRT that established the rationale for the number and placement of temperature monitors.
- Preparing a Quality Agreement template for use with contract carriers with temperature control truck/trailers to enforce the operating standard.
- Updating standard operating procedures for trailer loading that aligned with the qualification report.
The project incorporated the "family” approach to trailer validation by leveraging the existing trucking industry standards and certifications that serve as the IQ/OQ for trailers. The critical aspects of trailer loading were addressed. Without understanding the impact of trailer loading has on temperature control, the qualification process could not be considered completed. It is only through a solid understanding of how the loading affects temperature flows that an optimal location for temperature monitors could be ascertained.