Quality Control/Quality Assurance

EMA Sets Up Infrastructure to Support Real-World Monitoring of COVID-19 Vaccines

July 23, 2020

The European Medicines Agency has set up an infrastructure to support real-world monitoring of the efficacy and safety of COVID-19 vaccines and treatments.

Stevanato Group, Colanar Partner Up on Fill/Finish Capabilities

July 23, 2020

Stevanato Group and Colanar have signed an agreement for lab scale fill/finish capabilities to study container closure systems at Stevanato Group’s US TEC in Boston, MA.

EDQM Publishes New General Chapter in European Pharmacopoeia Supplement 10.3

July 07, 2020

The European Directorate for the Quality of Medicines and Healthcare (EDQM) has published a new general chapter (2.6.32) in the European Pharmacopoeia (Ph. Eur.) supplement 10.3.

Analytical Assays Determine Biosimilar Product Quality

July 01, 2020

Appropriate analytical assays are needed to determine and ensure that biosimilar critical quality parameters are on track.

Detecting Microbial Contamination in Bioprocessing

July 01, 2020

Safeguarding against microbial contamination requires rapid detection and innovative technology.

Improving mAb Manufacturing Productivity by Optimizing Buffer and Media Prep Process Flow

July 01, 2020

Innovative approaches, including ready-to-use materials and in-line dilution, can significantly streamline overall bioprocessing operations.

Pandemic Spurs Efforts to Boost Pharma Manufacturing in US

July 01, 2020

FDA can better monitor quality production of domestic versus foreign firms.

Performing Remote Audits During the Pandemic

July 01, 2020

It is important to consider the feasibility, benefits, and limitations of each type of audit in advance.

Sartorius Stedim Biotech Launches Consultancy Services for Viral Clearance Validation

June 30, 2020

The company now offers its CONFIDENCE virus clearance services to support validation of viral clearance processes.

FDA Publishes Guidance on CGMP Requirements During COVID-19

June 22, 2020

The guidance document provides recommendations for CGMP expectations to prevent contamination of drugs and exclude sick workers from participating in drug manufacturing.