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July 02, 2017
FDA’s process validation guidance has evolved and the current lifecycle approach has profoundly influenced validation practice.
Greater transparency and reliability of information are needed in the quality assessments of biosimilars.
June 26, 2017
Fagron Sterile Services has voluntarily recalled three lots of Succinylcholine Chloride 20mg/mL 5mL syringe to the hospital/clinic level.
June 14, 2017
FDA sent a warning letter to drug compounder DCA, Inc. dba Beacon Prescriptions for failing to ensure sanitary conditions.
June 02, 2017
Informing your clients of possible changes in equipment is imperative when upgrading a laboratory, says Susan Schniepp, distinguished fellow at Regulatory Compliance Associates.
May 16, 2017
Archana M. Akalkotkar, PhD, research scientist I at Charles River, discusses the use of process validation to ensure quality.
May 15, 2017
A multi-pronged approach to raw materials testing can help mitigate the risk of future contamination events.
May 02, 2017
In this study, the authors investigated the relationship between the 0.001 MinDD and the PDE values for 140 drug substances as an attempt to identify high-risk groups of products for patient safety. This comparison can serve as a method for prioritization of APIs for development of PDEs.
April 27, 2017
Truxton, Inc. is voluntarily recalling one lot of Phenobarbital Tablets, USP, 15 mg because of a labeling error on declared strength.
April 02, 2017
The complex nature of biologics adds additional CQAs that must be determined to ensure the safe development of biologics