Process Validation

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 02, 2015
Pharmaceutical Technology
New guidelines and best practices may lead to improved quality and reduced recalls due to visual defects.
Feb 02, 2015
Pharmaceutical Technology
This article gives an overview of the concept and contents of the revised guidance and outlines how it has changed from the previous version.
Feb 02, 2015
Pharmaceutical Technology
By Pharmaceutical Technology Editors
Working with biological matrices and understanding the intended use are crucial.
Nov 26, 2014
By Pharmaceutical Technology Editors
The Baxter recall in the US of one lot of highly concentrated potassium chloride is due to a mislabeled overpouch.
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