Containers closure and packaging

A description of the drug product containers, closures, and packaging materials, including a specimen or copy of each label and all other labeling signed and dated by the person or persons responsible for approval of such labeling ... 

Containers, Closures, and Packaging Components Production and Process Controfa.-Mother Liquors, In-Process Blending/ Mixing, Validation of Process and Control Procedures, Reprocessing, Process Change, Impurities... 

A description of the drug product containers, closures, and packaging materials. 

Container closure and packaging system information provided... 

Containers, closures and other component parts of drug packages, to be suitable for their intended use, must not be reactive, additive or absorptive to the extent that the identity, strength, quality or purity of the drug will be affected. All drug product containers and closures must be approved by stability testing of the product in the final container in which it is marketed. The stability test includes testing filled containers at room temperature (e.g., 70°F) as well as under accelerated conditions (e.g., 105 and 120°F). 

PACKAGING MATERIAL The containers, closures, and labels employed in the packaging of a product... 

Written specifications and test procedures shall be established for all packaging materials, especially immediate containers, closures, and other components in contact with the contents. 

Specifications for containers, closures, and other component parts of drug packages must be established to ensure that they are suitable... 

The packaging material should normally be selected so as to allow the optimal sterilization process to be applied to the product as a whole. Lfowever, factors other than the method of sterilization have to be taken into account in selecting a container material, such as the route of administration and patient convenience and compliance. Where the choice of container-closure precludes the use of terminal processing in the final container, the application should include appropriate documentation to explain and scientifically justify such a choice. The guidelines indicate that in such cases it is still the manufacturer s duty to continue the search for alternative containers that would allow terminal processes while providing the necessary product characteristics. 

Some products and packages are more susceptible to insect infestation than others. These products can serve as insect reservoirs, leading to the infestation of other products (Highland, 1984). For example, dry pet foods packed in multiwall paper bags are generally not very insect resistant because they lack adequate seals and closures, whereas bird seed packages often contain ventilation holes that can allow insect entry. 

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