Drug packaging materials containers

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 ... 

The cGMP regulations assign specific duties to the quality control unit. The unit is required to have the responsibility and authority to approve or reject all components, drug product containers, closures, in-process materials, packaging material,... 

HDPE by itself is a safe plastic material on account of its chemical inertness and lack of toxicity . Film and containers made from HDPE are used on a large scale in food and drug packaging and HDPE has been used in prosthetic devices including hip and knee joint replacements. All these applications underscore polymer safety. If articles made of HDPE contain fillers, processing aids, and colorants, their toxic effects must be estimated separately. 

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

Drug product containers and closures specifications In-process materials Packaging material Labeling specifications Drug products specifications Procedures and specifications Batch production and control records, including Products from contractors Production records Packaging records... 

Due to the need to check for particles, fibers, and possible discoloration in drug solutions transparent and colorless packaging materials are desirable. Hence, uncolored glass and plastic, bottles and bags, are commonly used as primary packaging for parenteral. To attain photo protection without losing VIS controllability, transparent containers or covers are necessary. 

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