Regulatory

Breaking News

Trescal acquires Cleanroom Management International

CMI has been acquired to strengthen the group's life sciences offering in Belgium, France, and the Netherlands

Aizon launches GxP compliant data aggregation solution

The system, Aizon Unify, has been designed to provided a compliant digital platform for monitoring, analysis and optimisation of all stages in the...

Packaging specialist Amcor opens cleanroom facility in Singapore

The dedicated healthcare packaging facility has been fully certified to ISO 13485 for 'medical devices'

The impact of Annex 1 on environmental monitoring

The much-discussed revision to the EU GMP Annex 1 is hopefully nearing conclusion with the release of the document anticipated in early January 202...

Biocon insulin facility in Malaysia completes FDA PAI Inspection

Despite some observations, Biocon Biologics is confident that it will not affect commercialisation plans

Edana holds second Circular Nonwovens Forum

The programme covered biodegradable testing and certification, innovations in materials and production processes, and the challenges of recycling

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, EU GMP, USP, ASTM the list g...

Disinfectant efficacy testing: US vs Europe

There are many standard disinfectant efficacy test methods available in both Europe and the United States but the testing approach is very differen...

Clover Biopharmaceuticals receives green light for Zhejiang facility

Clover's in-house, commercial-ready biologics manufacturing Changxing facility has a centrally-automated and flexible start-to-finish platform base...

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 in-house aseptic fill-finis...

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 poses an obvious environmental...

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 robustly conceived project c...

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 risk to patient safety

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 European standard BS EN 1727...

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 hood cleaning agent

Six things to consider for a cGMP cell and gene therapy cleanroom

Biotech processes are complex and constantly evolving so there are some simple factors that need to be taken into account during the design stage o...