News from the GMP Market | Valicare GmbH

32 Results found

11/21/2025

Computerized Systems: CSA instead of CSV?

Will computer software assurance (CSA) replace traditional computerized system validation (CSV)? The CSA industry guideline has already been ...

09/10/2025

10 years of cleaning validation based on PDE derived limits

Cleaning validation and regular monitoring of cleaning efficiency ensure the quality of medicinal products. The risk of a spot contamination must be ...

05/05/2025

Efficiently documenting a Contamination Control Strategy for Cell and Gene Therapy Products

Preparation of a contamination control strategy can be challenging. Join our webinar series and get help from our GMP experts.

03/14/2025

Efficient QMS according to EN ISO 13485: Innovation despite MDR and shortage of skilled workers

MDR and a shortage of skilled workers are challenging companies - but an efficient quality management system (QMS) creates opportunities for ...

06/05/2024

Automation and robotics for ATMPs

Robotics and automation offer groundbreaking manufacturing methods for ATMPs. ATMPs are achieving groundbreaking success in the treatment of ...

05/06/2024

Do your methods comply with the new ICH requirements?

ICH Q2(R2) and ICH Q14 describe mandatory requirements for the development, life cycle and validation of analytical methods.

12/05/2023

The first CRISPR/Cas9-based therapy has reached the market

The admission of Casgevy (Exagamglogene autotemcel) opens a new chapter in CRISPR/Cas9-based gene therapy and ATMP manufacture

11/10/2023

Transferring novel therapies successfully to patients and market

"ATMPs" – a long way from development to clinical trial – here's how to get there safely! ATMPs (advanced therapy medicinal products) are considered ...

08/22/2023

Prohibition of PFAS – Evaluate, assess risks, time to act

Valicare experts present solutions to you Per- und Polyfluoroalkyl substances (PFAS) are widely used in the pharmaceutical and biotech industry as ...