Process Validation

May 02, 2015
Pharmaceutical Technology
The author reports results of evaluations and concludes that a disinfectant composed of a low-concentration suspension of silver ions is completely sporicidal with only a one-minute contact time.
Apr 16, 2015
Pharmaceutical Technology
By Pharmaceutical Technology Editors
At the request of FDA, US Marshals seize unapproved prescription drugs from Florida distributor.
Apr 15, 2015
Pharmaceutical Technology
By Pharmaceutical Technology Editors
The document serves as guidance for the pharmaceutical industry in data integrity issues and complements existing EU GMP relating to APIs and dosage forms.
Apr 14, 2015
Pharmaceutical Technology
By Pharmaceutical Technology Editors
The European Medicines Agency releases guidelines for addressing and reporting risks associated with medication errors.
Apr 02, 2015
Pharmaceutical Technology Europe
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.
Apr 02, 2015
Pharmaceutical Technology
Process design experimental data and risk assessments are used to predict expected process performance and establish process performance qualification acceptance criteria.
Apr 02, 2015
Pharmaceutical Technology
Industry awaits the final revision of USP General Chapter <1207> and the impact it will have on the evaluation of sterile product package integrity.
Mar 13, 2015
By Pharmaceutical Technology Editors
McNeil-PPC pleads guilty in connection with adulterated infants' and children's over-the-counter liquid medications.
Feb 18, 2015
By Pharmaceutical Technology Editors
The all-synthetic 3M Emphaze AEX Hybrid Purifier contains both an anion-exchange nonwoven media and a fine-particle, bioburden reduction membrane.
Feb 02, 2015
Pharmaceutical Technology
New guidelines and best practices may lead to improved quality and reduced recalls due to visual defects.
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