The previous article in our "Identifying And Resolving Errors, Defects, And Problems Within Your Organization" series focused on identifying manufacturing trends so you can know when to act and when to let your processes run without interference. This one discusses what needs to happen when a defect or nonconformance is detected and needs to be investigated, explaining one of the most broadly applicable and durable root cause analysis tools: the fishbone diagram.
Pharma companies ignore the issue of counterfeiting and drug diversion at their own peril. If anything, the problems will tend to multiply as transnational clandestine operations continue to be involved in the highly lucrative counterfeit drug market. This article discusses noteworthy examples of how drug manufacturers of various sizes are tackling this problem.
Seeking early guidance from regulators can be invaluable when navigating preliminary product development strategies. The need for feedback increases significantly when working with cell and gene therapy products (CT/GT). These therapies, once considered a kind of “wild-west,” are becoming more widely accepted. Still, the task of seeking approval from the FDA can be extremely challenging. It’s become vital to get your relationship with the FDA off to a solid start from day one.
In the global biosimilars industry, regulations are administered locally, on a country-by-country basis, inevitably leading to inefficiencies and contradictions in regulatory requirements for biosimilar approval from one country to the next. If those inefficiencies are too great, some companies may delay or forego entirely seeking approval in a jurisdiction where the costs or uncertainties of the regulatory path are too high.
The presence of visible particles in parenteral biopharmaceuticals remains a hot topic in the industry. Despite regulatory bodies targeting a goal of no visible particles, and despite industry’s focus on further improving the efficacy of inspection processes, particles will continue to be found during production and in the marketplace.
The U.K. has until March 29, 2019 to negotiate a deal with the EU to remain a member of the EMA. If no agreement is reached, MHRA has set forth the principles that will be in place on March 30 in case of a “no deal” scenario,including recently introduced new guidelines for the batch testing of medicines entering or leaving the U.K.
The question is no longer, “Will continuous manufacturing work?”, but “When will everyone be doing it?” But surprisingly, there are still many objections to continuous manufacturing within the biopharma industry.
Auditing programs perhaps implicitly provide feedback at the reporting stage of an audit. Most companies and third-party auditing programs conduct a technical review of completed audit reports.
The regenerative medicine sector is at a remarkable moment. Transformative products are now on the market and accessible to greater numbers of patients every day. Dozens of additional therapies are in late stage studies. The regulatory and policy environment has evolved rapidly alongside the science, enabling a surge of incoming innovation.
In July 2018, the FDA unveiled a Biosimilar Action Plan (BAP) intended to “facilitate the efficient development and approval” of biosimilar products. When FDA Commissioner Scott Gottlieb introduced the BAP, he emphasized the importance of building a market for biosimilar products and expressed concern that the market is not yet established.
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