Drug product containers

The previous chapters examined the process for the development and authorisation of a drug product containing a ne v active ingredient for human use. This represents the most arduous path to market for any medicinal product. This chapter proceeds to examine the process of bringing a veterinary medicinal product to market. While the process shares most of the principles that apply to human drugs, there are some additional features that are unique to veterinary products. These include methods of use and the requirement to evaluate vithdra val periods and maximum residue limits in food-producing species. 

Subpart E--Control of Components and Drug Product Containers and Closures... 

Sec. 211.82 Receipt and storage of untested components, drug product containers and closures. Sec. 211.84 Testing and approval or rejection of components, drug product containers and closures. 

Sec. 211.86 Use of approved components, drug product containers and closures. 

Sec. 211.184 Component, drug product container, closure, and labeling records. Sec. 211.186 Master production and control records. 

Component, drug product container, closure, and labeling records. 

Holding rejected components, drug product containers, ciosures, and iabeiing before disposition ... 

Each lot of a component, drug product container, or closure that is liable to contamination with filth, insect infestation, or other extraneous adulterant shall be examined against established specifications for such contamination. 

Components, drug product containers, and closures shall be retested or reexamined, as appropriate, for identity, strength, quality, and purity and approved or rejected by the quality control unit in accordance with 211.84 as necessary, e.g., after storage for long periods or after exposure to air, heat or other conditions that might adversely affect the omponent, drug product container, or closure. 

Rejected components, drug product containers, and closures shall be identified and controlled under a quarantine system designed to prevent their use in manufacturing or processing operations for which they are unsuitable. 

For an active ingredient in an OTC drug product that is exempt from bearing an expiration date under 211.137, the reserve sample shall be retained for 3 years after distribution of the last lot of the drug product containing the active ingredient. 

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