USP〈1079〉 RISKS AND MITIGATION STRATEGIES FOR THE STORAGE AND TRANSPORTATION OF FINISHED DRUG PRODUCTS

1. INTRODUCTION

Proper storage and transportation of finished drug products are critical activities in an integrated supply chain. These finished drug products include but are not limited to temperature-sensitive small molecules, vaccines, biologics, biotechnological products, radiopharmaceuticals, and combination products. With the globalization of the pharmaceutical industry, various individuals and organizations from locations around the world can come into contact with the finished drug product. The storage and transportation processes for a drug product may involve complex movements with differences in documentation, handling requirements, and communication between the various entities throughout the supply chain.

Environmental controls play a key role in maintaining drug safety, quality, and efficacy. Temperature is one of the most important parameters to control. Drugs must be stored and transported according to predetermined conditions (e.g., temperature) as supported by stability data. Temperature excursions outside of their respective labeled storage conditions, for brief periods, may be acceptable provided that stability data and scientific/technical justification exist, demonstrating that product safety, quality, and efficacy is not affected.

To maintain the original quality, every party involved in the storage and transportation of a finished product should have an in-depth understanding of the storage and transportation risks and have the appropriate mitigation strategies in place to control these risks. The intent of this chapter is to identify common risks in the storage and transportation of drug products and to recommend mitigation strategies. The chapter is not meant to prescribe specific approaches or discuss regulatory frameworks currently in place, but rather to focus on risks and mitigation strategies for quality processes to maintain product and supply chain integrity. The principles of this chapter can be used to facilitate the storage and transportation of drug products throughout a supply chain that is controlled, measured, and analyzed for continuous improvements while also maintaining the integrity of the drug product in its packaging during distribution.

2. SCOPE

This chapter applies to organizations and individuals involved in the storage and transportation of drug products, including but not limited to the following:

Manufacturers of drug products, radiopharmaceuticals, biological products, and biotechnological products

Repackaging operations in which the product may be owned by a company other than the primary manufacturer

Healthcare providers and institutions such as hospitals; outpatient, ambulatory, and urgent care centers; home health providers; vaccine clinics; emergency departments; and medical, dental, and veterinary offices

Pharmacies, including but not limited to retail, compounding (sterile and nonsterile), specialty, mail order, hospital, nursing home, and hospice

Importers and exporters

Wholesale distributors

Third-party logistics providers, brokers, freight forwarders, consolidators, and other organizations involved in storage; road, rail, sea, and/or air transport services, or mail distributors that offer expedited or controlled-temperature shipping services

Manufacturers of active pharmaceutical ingredients, excipients, packaging materials, medical devices, and dietary supplements are not within the scope of this chapter. However, the concepts, risks, and mitigation strategies discussed in this chapter may be useful and can be applied in these cases, if desired.

Source from USP and Please refer to USP for details:

https://online.uspnf.com/uspnf/document/2_GUID-5EE764A5-0531-405E-9475-5D0D11E0921C_50101_en-US

plastic pharmaceutical packaging