Dr. Mike Long, ValSource03.09.16
The FDA has announced its intention to standardize quality metrics as one tool, but not the only tool, for prioritizing levels of effort and scrutiny for drug manufacturers. The FDA wishes to use standard metrics to compare relative quality results between similar establishments, companies, and products.
This has been driven in part by resource needs to address issues arising from: Drug shortages; complex supply chains; proliferation of foreign manufacturing; aging facilities; counterfeiting; and a whole host of other issues that may impact quality of the supply chain of a drug.
So what problem is the FDA really trying to solve? In October 2005 Janet Woodcock of the FDA stated that a “maximally efficient agile flexible pharmaceutical manufacturing sector that reliably produces high-quality drug products without extensive regulatory oversight” is the goal.
However, since she made that statement issues such as data integrity, supply-chain integrity drug shortages and an increase in the number of lagging key indicators such as complaints and recalls have occurred. Now, these may be a result of greater effectivity in report
This has been driven in part by resource needs to address issues arising from: Drug shortages; complex supply chains; proliferation of foreign manufacturing; aging facilities; counterfeiting; and a whole host of other issues that may impact quality of the supply chain of a drug.
So what problem is the FDA really trying to solve? In October 2005 Janet Woodcock of the FDA stated that a “maximally efficient agile flexible pharmaceutical manufacturing sector that reliably produces high-quality drug products without extensive regulatory oversight” is the goal.
However, since she made that statement issues such as data integrity, supply-chain integrity drug shortages and an increase in the number of lagging key indicators such as complaints and recalls have occurred. Now, these may be a result of greater effectivity in report
Continue reading this story and get 24/7 access to Contract Pharma for FREE
FREE SUBSCRIPTION
