Montesino’s experienced team offers in-depth regulatory compliance and technical consulting in the realms of packaging and polymers, globally. After decades of hands-on experience, Montesino’s worldwide network of experts guides customers through highly regulated industries to achieve compliance, efficiency and sustainable business success.
As a result of FDA updates over the past several years, there is now a greater focus within the agency upon packaging suppliers’ DMFs. Post-approval “interchangeability” guidelines specify that NDA (New Drug Application) reviewers are now essentially approving packaging materials for all future applications, as opposed to solely for use with the specific drug under review. Under this heightened scrutiny, reviewers have proven to issue multiple deficiencies to DMF holders for missing information, poor organization and a host of other issues. Subsequently, even suppliers who have maintained DMFs with little or no change for years are now receiving deficiency letters.An NDA approval which is delayed due to supplier DMF issues has a significant negative impact on both the pharmaceutical company and supplier. Such a delayed product launch translates into an untimely roadblock and requires immediate action and resources to address the FDA’s concerns.
To decrease the risk of these delays, pharmaceutical companies can be proactive by involving a confidential third party to review suppliers’ DMFs and identify potential deficiencies before they become a problem. At Montesino, we perform DMF audits and maintain the confidentiality of their contents while working with the DMF holder to correct any deficiencies. These follow-up audits ensure issues are addressed in a timely manner, while status reports to pharmaceutical companies summarize findings without revealing details or violating any confidentiality agreements.
Montesino offers world-class technical service for pharmaceutical blister packaging. Our focus is aligned with our customers’ – deliver a package that assures the safety and efficacy of the product it protects. Our knowledgeable team of experts combines years of experience with materials and machinery to identify a range of solutions for blister packaging problems.
Here are some of the many technical challenges surrounding pharmaceutical blister packaging today:
And some of the many factors that can further complicate these areas are: child resistant packaging, consolidating machines across various plants and operations, and changes in materials and/or suppliers, to name a few.