Biocon insulin facility in Malaysia completes FDA PAI Inspection
Despite some observations, Biocon Biologics is confident that it will not affect commercialisation plans
Breaking News
Edana holds second Circular Nonwovens Forum
The programme covered biodegradable testing and certification, innovations in materials and production processes, and ...
Clover Biopharmaceuticals receives green light for Zhejiang facility
Clover's in-house, commercial-ready biologics manufacturing Changxing facility has a centrally-automated and flexible ...
ADMA Biologics get FDA nod for aseptic fill-finish
US biopharma ADMA Biologics, dedicated to speciality plasma-derived biologics, has announced approval for the company's ...
The rules for validating a disinfectant
There are many acronyms that will be used when discussing disinfectants and their validation, FDA, EPA, BPR, AOAC, EN, ...
Moderna reveals findings of vaccine contamination event
A rare presence of Grade 316 stainless steel particles in the vaccine vials has been found but does not pose an undue ...
FDA "strongly recommends" Syntec engage a GMP consultant after warning letter
Syntec Pharma has received notice from the US agency for reasons that include using laundry detergent as a ventilation ...
Disinfectant efficacy testing: US vs Europe
There are many standard disinfectant efficacy test methods available in both Europe and the United States but the ...
Thomas Scientific achieves ISO certification for QMS
The scientific product distributor has now received the ISO 9001:2015 seal of approval for QMS and operational ...
Forge Biologics announces university partnership for GMP operators
The partnership has been formed to launch the Gene Therapy Workforce Development programme
Clearing up the bioplastic confusion
In clean and sterile environments there is a need for a lot of single-use consumables that contain plastic, but this ...
The characteristics of water purity levels and how to verify them
Water is one of the most important variables in a controlled environment for maintaining cleanliness and even the most ...
Clearing the air: The new rules of automated airborne disinfection
As of October 2020, regulators have changed from requiring efficacy data using the French standard NFT 72-281 to a new ...
EN 17141: Putting it into context
The new European standard outlines the importance of understanding the risks of microbial contamination. Being able to ...
Telstar to present aseptic process solutions at Achema Pulse 2021
In recent years, the company has reinforced its development of process equipment & integrated solutions for isolation ...
In Brief
Most Popular in Regulatory
Featured Companies
Reports
