Quality Assurance/Quality Control

Jul 05, 2018
By Pharmaceutical Technology Editors
The agency is reviewing products containing valsartan supplied by Zhejiang Huahai Pharmaceuticals, a company in Linhai, China.
Jul 03, 2018
By Pharmaceutical Technology Editors
The agency published guidance on how the Generic Drug User Fee Amendments Reauthorization of 2017 applies to amendments to ANDAs and PASs.
Jul 02, 2018
Pharmaceutical Technology
Maintaining good quality control practices throughout the entire manufacturing process requires robust development, a drive toward product and process understanding, and pre-established, comprehensive written procedures that are consistently reviewed and updated.
Jul 02, 2018
Pharmaceutical Technology
Pharmaceutical Technology spoke with Sharon Ayd, executive vice-president of Pre-approval Pharmaceuticals and chief scientific officer at Regulatory Compliance Associates, about developing a corrective action and preventive action (CAPA) plan.
Jul 02, 2018
Pharmaceutical Technology
Knowing and addressing regulatory expectations early on can avoid unexpected delays later, says Siegfried Schmitt, principal consultant at PAREXEL.
Jul 02, 2018
Pharmaceutical Technology
FDA seeks more efficient testing to spur development of less costly biotech therapies.
Jul 02, 2018
By Pharmaceutical Technology Editors
Fagron Sterile Services is voluntarily recalling two lots of Neostigmine Methylsulfate 5mL syringes due to mislabeling.
Jul 02, 2018
By Pharmaceutical Technology Editors
The European Directorate for the Quality of Medicines & Healthcare highlighted the organization’s achievements in 2017, including the first mAb monograph.
Jul 02, 2018
Pharmaceutical Technology's In the Lab eNewsletter
By Pharmaceutical Technology Editors
The company unveiled its latest innovations to its mass spectrometry portfolio at ASMS in San Diego.
Jul 02, 2018
Pharmaceutical Technology's In the Lab eNewsletter
By Pharmaceutical Technology Editors
The company’s new LCMS-9030 system is designed for high resolution and accurate mass detection.
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