OR WAIT null SECS
February 07, 2017
FDA's Warning Letter to an Indian API manufacturer alleges cGMP violations and improper cleaning and validation
February 02, 2017
Laboratory tests can determine critical cleaning parameters for passivation treatments used to prevent rouge on GMP stainless-steel equipment.
Drug manufacturers need to work closely with excipient suppliers to ensure supply chain safety.
Reducing regulatory roadblocks requires more than the stroke of a pen.
The authors survey deficiency letters issued for 190 drug master files supporting abbreviated new drug application submissions.
Susan Schniepp, distinguished fellow at Regulatory Compliance Associates, discusses how to ensure sterility when manufacturing small-scale parenteral batches.
User fee reauthorization is crucial to implementing the Cures Act and refining the approval process.
The authors look at challenges and considerations to continuously improve inspection efficiency.
February 01, 2017
FDA’s focus on the quality culture and its request for quality metrics may ensure a successful company-CMO relationship.
As the date for implementation of the Drug Supply Chain Security Act approaches, bio/pharma companies and contractors should focus on key areas.