OR WAIT null SECS
April 02, 2015
Industry awaits the final revision of USP General Chapter and the impact it will have on the evaluation of sterile product package integrity.
Process design experimental data and risk assessments are used to predict expected process performance and establish process performance qualification acceptance criteria.
The authors outline a validation approach for the manufacture of a “legacy product,” taking into consideration recent guidelines. The aim is to demonstrate the validity and capacity of the manufacturing process following a change in the manufacturer.
March 13, 2015
McNeil-PPC pleads guilty in connection with adulterated infants' and children's over-the-counter liquid medications.
February 18, 2015
The all-synthetic 3M Emphaze AEX Hybrid Purifier contains both an anion-exchange nonwoven media and a fine-particle, bioburden reduction membrane.
February 02, 2015
Working with biological matrices and understanding the intended use are crucial.
This article gives an overview of the concept and contents of the revised guidance and outlines how it has changed from the previous version.
New guidelines and best practices may lead to improved quality and reduced recalls due to visual defects.
November 26, 2014
Aurobindo Pharma USA issued a voluntary nationwide recall of Northstar Label Gabapentin Capsules, USP 300 mg, due to complaints of empty capsules.
The Baxter recall in the US of one lot of highly concentrated potassium chloride is due to a mislabeled overpouch.