Quality

Jun 02, 2017
Pharmaceutical Technology
Informing your clients of possible changes in equipment is imperative when upgrading a laboratory, says Susan Schniepp, distinguished fellow at Regulatory Compliance Associates.
Jun 02, 2017
Pharmaceutical Technology
The authors summarize the current regulatory expectations regarding the number of PPQ batches required and provide potential approaches that can be used to determine and justify the number of PPQ batches.
Jun 02, 2017
By Pharmaceutical Technology Editors
The company voluntarily recalled one lot of Brilinta 90 mg professional samples because it contained another medicine.
Jun 02, 2017
By Pharmaceutical Technology Editors
The company recalled the tablets due to a packaging error.
May 23, 2017
By Pharmaceutical Technology Editors
FDA cited the facility for violations of quality management and data integrity CGMPs.
May 22, 2017
By Pharmaceutical Technology Editors
The agency is warning drug manufacturers about Burkholderia cepacia complex after product recalls due to contamination.
May 16, 2017
Archana M. Akalkotkar, PhD, research scientist I at Charles River, discusses the use of process validation to ensure quality.
May 15, 2017
Pharmaceutical Technology
The existing, obsolete highpurity water generation system and water-forinjection generation system were replaced with new, reliable technologies.
May 15, 2017
Pharmaceutical Technology
A multi-pronged approach to raw materials testing can help mitigate the risk of future contamination events.
May 15, 2017
Pharmaceutical Technology
Effective cleanroom disinfection programs require extensive testing and evaluation processes. A three-step process can help ensure that the cleanroom environment will satisfy regulatory requirements and be safe for biopharmaceutical manufacturing.
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