Creating the appropriate quality culture is arguably the most important element of being a manufacturing leader in the life sciences industry. Yet, reflecting back on my long career, I have not seen a single recipe for doing this, and I don’t profess to have a well-documented approach myself. But, boy, do I have some stories.
Change is very, very difficult to do in government,” says Steven Kozlowski, M.D. In 2012, the director of the FDA’s Office of Biotechnology Products (OBP) learned that the Center for Drug Evaluation and Research (CDER) would soon undertake a major restructuring. CDER had decided to reorganize around drug quality manufacturing, potentially including biologics.
It took a series of damning government reports and investigations documenting the growing abuse of the 340B discount program by nonprofit hospitals and generally lax oversight by the Health Resources Services Administration (HRSA) that administers the program to finally prompt the agency to issue new guidance on how those covered hospitals should operate under the program.
New regulations accelerating the approval of regenerative therapeutics in Japan took effect Nov. 25, 2014, propelling that nation onto the radar screens of life sciences companies around the world. The chief benefit of these new rules is that they enable companies to receive conditional marketing approval and generate revenue from regenerative products while trials are being conducted.
It’s true,” confirms Anders Vinther, chief quality officer at Sanofi Pasteur and a long-time chairman at Parenteral Drug Association (PDA), “global regulatory agencies have only now started to address the subject of harmonizing global post-approval change applications for drugs.”
Today, GMP-compliant manufacturing of biopharmaceutical drugs and vaccines is still only partially automated and not at the level of other manufacturing industries. Critical process steps such as sampling, sterile connection, or column packing are carried out manually by operators, which can negatively impact process reproducibility, product quality, and — in the worst case — even patient safety.
Parallel trade, the free movement of goods across Europe from lower-value to higher-value markets, has had a major impact on the European pharmaceutical industry since the 1970s.
At the PDA Quality Metrics Conference in December 2013, FDA CDER (Center for Drug Evaluation and Research) Director Janet Woodcock set out her goals for the conference: “to shift [the FDA’s] focus to performance and away from compliance.” Under the FDA’s lead, the life sciences community will have no choice but to follow suit in its own operations and approaches to quality.
EVMPD (EudraVigilance Medicinal Product Dictionary) requirements have moved back up the agenda for pharma companies marketing products in Europe, now that new requirements on data maintenance have finally been published.
Recently, we have been observing a change in the approach to outsourcing — more midsize and large biopharmaceutical companies are shifting to a strategic outsourcing model. Strategic outsourcing generally means assigning work to one or a maximum of two preferred (strategic) partners.