Packaging/containers, drug product

Many pharmaceutical manufacturers have now taken to packaging their drug product in plastic containers. The plastics used most in these applications are those manufactured from polyethylene and polypropylene, though other materials have also been used. Since both polyethylene and polypropylene contain extremely small amounts of additives (mostly as antioxidants and antistatic agents), the possibility of their release in sufficient concentrations to endanger to patient is negligible. 

Data to demonstrate the stability characteristics of both the drug substance and the drug product must be collected. Studies using three different batches of both substance and product in their respective containers/packaging must be conducted. Real-time data should be collected under conditions of temperature and relative humidity in line with the recommended storage. Conditions in different world climatic zones must be taken into consideration for cases where normal environmental... 

The quality module must contain information on the identity, characteristics, manufacturing methods, control, packaging and stability of both the drug substance and final drug product. The standard headings used to present this information are shown in Figure 6.2. 

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 ... 

An elastomeric closure is a packaging component that is, or may be, in direct contact with a drug product. Elastomer selection for parenteral packaging principally involves consideration of chemical, physical, and biological properties, with emphasis on the stability profile of the drug/container system. Typical elastomeric closure compositions are listed in Tables 1 1. Although certain packaging applications frequently call to mind certain elastomer types, it is not feasible to prescribe specific... 

Chapter 1146 Packaging Practice—Repackaging a Single, Solid, Oral Drug Product into a Unit Dose Container... 

Subpart E Control of Components and Drug Product Containers and Closures Subpart F Production and Process Controls Subpart G Packaging and Labeling Control Subpart H Holding and Distribution Subpart I Laboratory Controls Subpart J Records and Reports Subpart K Returned and Salvaged Drug Products... 

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,... 

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