Joanne S. Eglovitch
Latest From Joanne S. Eglovitch
Greater clarity on which drugs outsourcing facilities can compound from bulk ingredients and what good manufacturing practice requirements they will have to meet would go a long way toward enabling them to help prevent and resolve drug shortages, Pew report says. Another factor to consider: whether any loosening of restrictions during the pandemic will continue afterward.
EU report on “lessons learnt” from the valsartan crisis calls for tighter GMP controls on API suppliers.
The ICH is expected to release for public comment early next year its draft Q14 guideline establishing a lifecycle approach for analytical testing, as well as a Q2(R2) guideline to add some newer analytical methods.
The biopharmaceutical industry is expanding its presence on college campuses to address a shortage of workers proficient in advanced manufacturing, cell and gene therapies and combination products. Executives say that not having enough of these skilled workers keeps them up at night.
CBER director says lack of a clear regulatory structure is holding back the development and acceleration of gene therapy products, while industry says regulations should be flexible to keep up with changing technology for these products.
The COVID-19 pandemic has prompted the ICH to delay by six months its efforts to develop Q13 guideline on continuous manufacturing, now not expected until May 2022.