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Compliance Quiz: Cold Chain Management

1. Fill in the blanks: US FDA: Adulterated Drug Products, FD & C Act Chapter V, Sec 501, subchapter A (2)(B) states: "A drug or device shall be deemed to be adulterated if it is a drug and the methods used in, or the facilities or controls used for, its manufacture, processing, packing, or __________ do not conform to or are not operated or administered in conformity with_________ ___________ ____________ _________ to assure that such drug meets the requirements of this chapter as to safety and has the identity and strength, and meets the quality and purity characteristics, which it purports or is represented to possess."
2. The FD&C Act and GMPs, CFR Part 211, Sec. 211.196 "Distribution records" states that "Distribution records shall contain . . . "
3. Under Title 21, Part 211, Subpart H – Holding and Distribution, Sec. 211.150 Distribution procedures, Warehousing procedures must be established and followed. These procedures must include:
4. In Canada and the European Union, other guidelines have been published for describing proper cold chain management of drugs. These include respectively:
5. According to the World Health Organization's "Good distribution practices for pharmaceutical products" Annex 5, WHO Technical Report Series 957, 2010: "All [temperature] monitoring records should be kept for at least . . . "
6. According to the Code of Federal Regulations Title 21, Part 205, section 205.50, inventories and records on prescription drugs must be kept for review and photocopying:
7. Under USP <1079> "Distribution and shipment of Pharmacopeial Articles," several methods may be used to obtain information that may aid in determining the ability of pharmaceuticals to maintain their Pharmacopeial requirements of identity, strength, quality, and purity through the distribution channel. Which in the list below is NOT a method?
8. The Parenteral Drug Association's Technical Report 39 outlines the Transport Process in five areas. Which of the following is NOT an area of the Transport process according to PDA TR 39?
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