Quality Assurance/Quality Control

Jan 02, 2018
Pharmaceutical Technology
A new algorithm uses a statistical approach to critical process parameter assessment, allowing for faster, more consistent, and less subjective critical process parameter quantification, visualization, and documentation.
Jan 02, 2018
Pharmaceutical Technology
Process validation is an extension of biologics development processes.
Jan 02, 2018
Pharmaceutical Technology
Enterprise-wide processes, procedures, and systems are the keys to data integrity and peace of mind, according to Siegfried Schmitt, PhD, principal consultant at PAREXEL.
Jan 02, 2018
By Pharmaceutical Technology Editors
PharMEDium Services, LLC voluntarily recalled some lots of product because of a lack of sterility assurance.
Dec 28, 2017
By Pharmaceutical Technology Editors
The recall was initiated due to a product complaint in which white particulate matter, identified as mold, was discovered in a flexible bag from one batch.
Dec 20, 2017
By Pharmaceutical Technology Editors
FDA sent a warning letter to Deserving Health International Corp. after inspectors found CGMP violations including failure to prevent microbiological contamination.
Dec 20, 2017
By Pharmaceutical Technology Editors
The company is voluntarily recalling one lot of Pantoprazole Sodium for Injection 40 mg per vial because of glass particles found in a vial.
Dec 07, 2017
An increasing number of warning letters shows that FDA is observing more problems with pharmaceutical contract manufacturing.
Dec 02, 2017
Pharmaceutical Technology
Rinse sample analysis or visual inspection are risk-based approaches that can be correlated to surface cleanliness to replace surface sampling in a biopharmaceutical equipment cleaning process.
Dec 02, 2017
Pharmaceutical Technology
SOPs need to reflect a company’s specific manufacturing or other operations, says Susan Schniepp, distinguished fellow at Regulatory Compliance Associates.
native1_300x100
lorem ipsum