USP offers information on storage and shipping, but no requirements.
The United States Pharmacopeia (USP; Rockville, MD) has proposed a new general informational chapter, <1079>, titled “Good Storage and Shipping Practices.” The proposed chapter is intended to provide information to manufacturers, re-packagers, distributors, shippers, and pharmacists on maintaining pharmaceutical integrity during storage and shipping. It was proposed in the September/October 2003 issue of the Pharmacopeial Forum (PF 29, Number 5).
This chapter is not the first one in which USP has covered storage and shipping. In 1999, it proposed chapter <1186>, titled “Shipping and Storage of Labile Preparations.” This chapter identified products not stable under adverse conditions. It required manufacturers to test those products to determine the appropriate means to ship and store them.
“But industry did not like the chapter’s requirements,” says Claudia Okeke. Okeke is a USP scientist who serves as liaison to the USP Expert Committee on Packaging, Storage, and Distribution. The chapter has since been revised, renamed, and renumbered and is now known as proposed chapter <386>, “Environmentally Sensitive Products.” It is still not an official requirement, says Okeke.
Chapter <1079>, however, is not meant to require any actions. “It covers the whole nine yards, but it is just meant to inform,” Okeke says. “It identifies what happens when a product leaves the manufacturer and goes to the wholesaler and then to the pharmacist. We just want to ensure that the product gets to the patient intact with its integrity maintained.” She says that members of the International Safe Transit Association (ISTA) assisted in reviewing the draft chapter when it was completed.
The chapter begins by covering the temperatures and validations necessary for warehousing. It advises manufacturers or other parties to obtain mean kinetic temperatures in any storage area and to validate the equipment used in cold stores.
Also described are the distribution channel, its likely hazards, and the ASTM and ISTA standards available to help manufacturers ensure that products are protected from those hazards. Information that may help determine a product’s ability to maintain integrity is also listed. It includes International Conference on Harmonization (ICH) stability studies, temperature cycling studies, stability shipping studies, ongoing regulatory stability commitment studies, market experience, and product labeling.
Product handling upon arrival is also covered. “Articles are to be transferred to their manufacturer-designated storage environment within two hours of receipt,” the chapter reads. It also recommends validating distribution and shipping vehicles.
The chapter also describes shipments from manufacturer to wholesaler, from manufacturer or wholesaler to pharmacy, and from pharmacy to patient or customer. Product returns from patients and customers are covered. So is storage of physician samples by sales representatives in automobiles and storage of drugs in emergency medical service vehicles.
ICH stability studies are also discussed. “The data gathered from ICH accelerated testing or from testing at an ICH intermediate condition may be used to evaluate the effect of short-term excursions outside the label storage conditions,” the chapter reads. Following are the ICH-recommended testing conditions and definitions of “significant changes” that may occur during accelerated testing.
Stability testing of drug products after reconstitution or dilution is covered at length.
Finally, recommendations are given on the language used in labeling that covers product storage.
USP has already received some comments on the proposed chapter, but Okeke still invites more industry reaction. The chapter will be revised and published again in the PF. If approved, the chapter may then be published in a supplement to the United States Pharmacopeia. Please send all comments to firstname.lastname@example.org.