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level: Level 3

Questions and Answers List

level questions: Level 3

Question	Answer
Containers, including the closures, for preparations for injections do not interact physically or chemically with the preparations in any manner to alter the strength, quality, or purity beyond the official requirements under the ordinary or customary conditions of handling, shipment, storage, sale, and use.	.
Validation of container integrity must demonstrate __	no penetration of microbial contamination or chemical or physical impurities
Validation of container integrity must demonstrate __ of microbial contamination or chemical or physical impurities.	no penetration
The solutes and the vehicle must maintain their __ when exposed to anticipated extreme conditions of manufacturing and processing, and storage, shipment, and distribution.	specified total and relative quantities or concentrations
__ permit the withdrawal of the contents without removal or destruction of the closure. permits penetration by a needle and, upon withdrawal of the needle, closes at once, protecting the container against contamination.	Closures for multipledose containers
also known as secondary infusion containers. are usually intravenous infusion containers used to administer a second infusion through a connector of some type or an injection port on the administration set of the first fluid, thereby avoiding the need for another injection site on the patient's body	Piggyback containers
The use of a black closure system on a vial (e.g., a black flipoff button and a black ferrule to hold the elastomeric closure) or the use of a black band or series of bands above the constriction on an ampul is prohibited, except for __	Potassium Chloride for Injection Concentrate.
must be packaged in vials with a cautionary statement printed on the ferrules or cap overseals. container cap ferrule and the cap overseal must bear in black or white print Warning: Paralyzing Agent” or “Paralyzing Agent	Injectable preparations of neuromuscular blocking agents and paralyzing agents
A container for a __ permits the addition of a suitable solvent and withdrawal of portions of the resulting solution or suspension in such manner that the sterility of the product is maintained.	sterile solid
Preparations intended for intraspinal, intracisternal, or peridural administration are packaged only in __	single dose containers.
The volume of injection in single dose containers provides the amount specified for parenteral administration at one time and in no case is more than sufficient to permit the withdrawal and administration of __	1 L
A multipledose container contains a volume of Injection sufficient to permit the withdrawal of __	not more than 30 mL.
are exempt from the 1L restriction of the foregoing requirements relating to packaging.	Injections packaged for use as irrigation solutions, for hemofiltration or dialysis, or for parenteral nutrition
Containers for Injections packaged for use as hemofiltration or irrigation solutions may be designed to	empty rapidly and may contain a volume of more than 1 L
Injections labeled for veterinary use are exempt from packaging and storage requirements concerning the limitation to singledose containers and the limitation on the volume of multipledose containers.	.
1 Good pharmaceutical practice requires also that each final container of Injection be subjected individually to a __ 2 and that every container whose contents shows evidence of __ should be rejected	1 physical inspection 2 contamination with visible foreign material be rejected
An article packaged as both a large-volume and a small volume Injection meets the requirements set forth for small volume Injections where the container is labeled as __ if the individual monograph includes a test for Particulate Matter	containing 100 ml or less
Injections packaged and labeled for use as __ are exempt from requirements for Particulate Matter.	irrigating solutions