Technology transfer is essential to advancing pharmaceutical products from development, through clinical and into commercial operation. The complexity of transferring the production of a product from a sending unit to the receiving unit is challenging even in the best of conditions. Since the onset of the COVID-19 pandemic the industry…
Having led many large capital projects around the world that had very strong safety records, I was asked by an HSE leader about my approach for creating and inspiring a strong safety culture… this was my response:
ISPE held its second Facilities of the Future conference. The conference brought together over 160 professionals from pharmaceutical and biotech manufacturing, equipment suppliers, academics, and regulators. Jim Breen, Vice President Lead Biologics Expansion, Janssen Pharmaceuticals, was the Program Planning Chair.
If the pharmaceutical distribution network is at risk, so is patient safety. With counterfeit drugs on the rise, serialization programs are being implemented to safeguard the integrity of product reaching the market. Serialization also provides better controls to communicate recall information should it become necessary.