During January and February, IPQ explored impactful initiatives that are underway in different areas of the pharmaceutical manufacturing and control arena to create standards and databases that will make both industry and regulators more effective and allow them to communicate better.
One is a ground up, high-stakes effort – spearheaded by a consortium of major pharmaceutical firms and equipment suppliers called the “Allotrope Foundation” – to create a framework for standardizing and sharing lab data that will make analytical and manufacturing control processes a lot more efficient and effective.
The first of two companion stories in the January/February Monthly Update focuses on the problems in the current disconnected analytical environment that the consortium is working to address and the efforts underway to create the interoperable framework needed to overcome the communication gaps between systems. The follow-up story focuses on how Allotrope’s vision of the lab of the future aligns closely with FDA’s and speaks to the CMC and GMP concerns that are on FDA’s front burner.
Also in focus is the effort that is flowing down from Congress through FDA and out across the supply chain to fill the communication gaps that forestall the tracking and tracing of prescription pharmaceutical products. IPQ takes a look at where the agency is in addressing the various challenging issues involved in implementing the 2013 Drug Supply Chain Security Act – the guidances that have been forthcoming recently and what the agency is targeting for the next year. FDA will be mining industry for its expertise in coming up with viable solutions, as the story explains.
Other significant initiatives are underway – engaging FDA, industry, academia, pharmacopeias and other agencies internationally – to fill the gaps in existing pharmaceutical excipient information management systems and open up regulatory communication channels. The IPQ coverage delves into who is involved with these initiatives, what they are working to achieve, how they relate to each other, the challenges they face, their progress to date, and their potential impact on the excipient regulatory process. Included are insights from IPEC and FDA representatives directly involved.
The fifth story in the issue examines how Asian medicines agencies are joining those in the US and Europe in seeking to address the emerging regulatory challenges posed by: ● new classes of products such as cell-based regenerative medicines and engineered antibodies ● accelerated approval pathways ● biosimilars ● international convergence, and ● validation lifecycle management. The CMC Strategy Forum in Tokyo in December provided the opportunity for regulator and industry experts from Asia to compare notes with those from the US and Europe on where viable solutions and harmonization pathways lie and the hurdles that have to be crossed to achieve them.
Also in the issue are nearly four dozen briefs on other key developments during January and February in the global quality regulatory arena, along with a compilation of the drug recalls and GMP warning letters posted by FDA during the first two months of 2015.
Pharmacy compounding and data integrity in India continued as two prominent concerns in the FDA warning letters. Hospira was well-represented in the recall data, reflecting problems with particulate matter and lack of sterility assurance.
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