Manufacturers that use custom polymer solutions, compounds, colorants, and plastic additive Masterbatches in the medical or pharmaceutical markets may benefit greatly by using a Drug Master File (DMF). DMFs are important because they contain information on the chemistry, manufacturing and specifications of several packaging components used for certain medical products.
Maintaining a DMF is critically imperative in both medical and pharmaceutical markets. Some drugs can react with certain polymers within plastic packaging or plastics applications in a way that produces a negative effect on the drug. Understanding the regulatory requirements and end-use is essential to successfully formulate a concentrate or additive package that meets all requirements.
The primary benefits of a DMF for plastic use include legal protection for all entities involved, the confidentiality of specific formulations, documented accuracy of chemistries, and communication of different parties involved.
Basics of A DMF:
A Drug Master File is a confidential, detailed document submitted by active pharmaceutical ingredient (API) manufacturers. It houses the information that will be needed when the end user/brand owner is applying for approval of their end product.
Although there is no specific requirement to file a DMF, the benefit of use is overwhelming. The document provides the regulatory authorities with confidential, detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of one or more components.
The main objective of a DMF is to support regulatory requirements and to prove the quality, safety and efficacy of a product for obtaining a needed rating.
Why Is A DMF So Important?
A Drug Master File aids medical device and pharmaceutical packaging companies when applying for approval with brand owners in both the medical device and pharmaceutical packaging markets.
A DMF filing allows a firm to protect its intellectual property from its partner and yet comply with regulatory requirements for disclosure of product details. It is not mandatory to have a product listed in a DMF for it to be used in the pharmaceutical industry. However, it does make it easier for plastic suppliers to work with end-users and allows them a neutral location to obtain the necessary information for testing to assure compliance with laws and regulations.