Process Validation

Nov 26, 2014
By Pharmaceutical Technology Editors
Aurobindo Pharma USA issued a voluntary nationwide recall of Northstar Label Gabapentin Capsules, USP 300 mg, due to complaints of empty capsules.
Nov 04, 2014
By Pharmaceutical Technology Editors
An FDA warning letter to Hikma Pharmaceuticals cites violations of CGMP at its plant in Portugal that manufactures finished drugs.
Oct 30, 2014
Gerresheimer, a company with expertise in pharmaceutical and medical technology, announced that it is applying an integrated mold qualification and validation concept for a fast and cost-efficient time-to-market. The company notes that this approach provides process windows for reliable large-scale production and offers options for different deployment scenarios and qualification levels.
Sep 17, 2014
Equipment and Processing Report
Understanding how to identify, remediate, and prevent facility infection is crucial for product quality.
Sep 04, 2014
By Pharmaceutical Technology Editors
Meggle Group Wasserburg has been granted an EXCiPACT certificate.
Aug 20, 2014
By Pharmaceutical Technology Editors
FDA found violations of cGMP at finished-drug manufacturer in India.
Jul 17, 2014
By Pharmaceutical Technology Editors
Baxter investigates root cause of cellulosic fibers and/or plastics in four lots of IV solutions.
Jul 11, 2014
By Pharmaceutical Technology Editors
Baxter Healthcare has initiated a nationwide recall of more than 20,000 containers of a pre-mixed beta blocker due to the presence of particulate matter.
Jul 11, 2014
By Pharmaceutical Technology Editors
Sun Pharma, Forest Pharmaceuticals and West-Ward Pharmaceuticals issue recalls over dissolution issues.
Jul 02, 2014
Pharmaceutical Technology
The authors look at the cleanability of pharmaceutical soils from a variety of materials of construction to determine the relative ease of cleaning and explore potential grouping strategies as part of a comprehensive cleaning validation program.
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