When FDA checks a drug, it must assures that the package for a specific drug will preserve the drug’s efficacy, purity, identity, strength and quality for its shelf life. The FDA regulations in respect to drug states, containers, closures and other parts of the drug packages must be non- reactive, non-absorptive and non-additive to a limit that the identity, purity, efficacy of drug dies not affected. Inspite of these, there is not specific provisions or standards for containers and closures in Drug and cosmetic act. The FDA only approves the material used for manufacturing of the container and closure system but does not approves the manufactured container. The FDA has published the regulations (part 133) that implement the cGMP requirements of the Act. Part 133.9 of these regulations sets criteria with respect to product containers. Any product container must be approved after manufacturing of it along with the drug before going into the market. The drug manufacturer must include data on container and package components which are in contact with drugs.
The main requirements include:
NDA (New drug application): It should be submitted and approved before sale of the product in the market.
Supplemental NDA type I: It should be submitted when major process changes are required. It requires FDA approval before implementation.
Supplemental NDA type II: It can be submitted before approval of FDA. It includes new methodology to ensure better quality control, safe use of drug or small change in packaging system etc.
Annual NDA reports: It includes minor changes that take place within a year after approval of FDA. These do not require supplemental application.
DMF (Drug master file): It is a submission to FDA which includes detailed information about processes, facilities used in manufacturing, packaging and storage of products.