As one of the top certifying bodies in the pharmaceutical industry, BSI offers accreditations to drug, biologic and device manufacturers. BSI offers these accreditations to help assure that organizations are in compliance with standards for their business operations. The accreditation process is a mutual cooperation of BSI and its customers to identify and enhance the customer’s business performance. All BSI accreditations, except those for the NSB, are worth 1, 5, or 10 years and are focused on a particular functional area, such as quality systems, technology, or operational effectiveness.
For its NSB accreditation, BSI helps companies achieve and maintain compliance with the requirements to standardize pharmaceutical products. The accreditation process ensures that healthcare institutions are equipped and prepared to provide safe medicines. In addition, BSI’s NSB enables companies to prepare for the future by standardizing their products and verifying their compliance with relevant standards.
How are DMFs identified?A DMF name is a unique identifier that links a particular DMF to a generic drug approval. DMF names are assigned after publication of an approval in the FDA’s Approved Drug Products With Therapeutic Equivalence Evaluations (the Orange Book).Every DMF name is unique and not reused across multiple approvals. If the FDA makes any modifications to an Orange Book approval, this change is reflected by a DMF name change. Multiple DMF names can coexist on a single approval, because the FDA recognizes the need to use different DMF names in different parts of the assessment process. A DMF name change can result from broadening the approval or by narrowing the scope of a particular product or indication. Similarly, approval of a generic product for a new biological product can result in the need to change the DMF name of the approval to reflect the type of product being approved.
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