April 14, 2013
By Karla L. Palmer & Jeffrey N. Gibbs –
On Thursday, April 11, 2013, FDA published a statement titled, “2013 FDA Pharmacy Inspection Assignment,” addressing the unprecedented recent nationwide wave of aseptic pharmacy inspections. The Agency states that it had taken critical look at its surveillance and enforcement approach to pharmacies that “produce” sterile drug products. The objective of FDA’s pharmacy inspection assignment was to determine whether certain pharmacies that produced high-risk sterile drug products in the past “posed a significant threat to public health from poor sterile production practices.” FDA developed a risk-based model when choosing the 29 pharmacies for the priority inspections. According to FDA, the risk criteria included consideration of serious adverse event reports, historical inspection data, and reports of product quality problems. FDA did not disclose from what sources it obtained information on the particular pharmacies at issue and how it applied that information to select the 29 pharmacies that made the inspection list. However, FDA said it targeted for inspection pharmacies that met at least two of three of the risk criteria or had a reported death from their products.
Continue reading here
On Thursday, April 11, 2013, FDA published a statement titled, “2013 FDA Pharmacy Inspection Assignment,” addressing the unprecedented recent nationwide wave of aseptic pharmacy inspections. The Agency states that it had taken critical look at its surveillance and enforcement approach to pharmacies that “produce” sterile drug products. The objective of FDA’s pharmacy inspection assignment was to determine whether certain pharmacies that produced high-risk sterile drug products in the past “posed a significant threat to public health from poor sterile production practices.” FDA developed a risk-based model when choosing the 29 pharmacies for the priority inspections. According to FDA, the risk criteria included consideration of serious adverse event reports, historical inspection data, and reports of product quality problems. FDA did not disclose from what sources it obtained information on the particular pharmacies at issue and how it applied that information to select the 29 pharmacies that made the inspection list. However, FDA said it targeted for inspection pharmacies that met at least two of three of the risk criteria or had a reported death from their products.
Continue reading here
No comments:
Post a Comment