SeerPharma have been invited by the Stevanato Group and Lonza to present on Pharmaceutical Quality Management System Certification at The Innovative Solutions for Pharmaceutical Packaging Roadshow in Singapore.
The stages required for applying ISO 14971 principles to risk management for medical devices can be typically broken into 6 steps:
UTS International student Tong Zhao is a Pharmacy graduate from Liaoning Province, China, currently undertaking the Master of Good Manufacturing Practice here in the UTS Graduate School of Health. We sat down with Tong to hear her story.
Most of us follow a professional sporting team. Each year we start the season with hope and enthusiasm that ‘this year’ will be ‘our year’. Have our recruiters and management assembled the right mix of youth and experience and will they be coached to their strengths? Is the framework in place to raise our odds of success ?
Australian biotech company VivaZome Therapeutics has announced that it has been awarded an Australian Government CRC-P grant of $2.18m in support of the project “Enabling Exosome Therapy: Developing an Advanced Manufacturing Process”, with the funds provided under the Advanced Manufacturing Scheme.
INFOGRAPHIC: A snapshot of how SeerPharma has supported its clients in 2017 on matters of QA and GMP compliance.
There are many phases in a computerised system project and all are important, but none more so than gathering User Requirements.
The launch of new temperature sensitive biologics, increasing regulations, growing cost- pressures are putting more complex demands on the biopharma industry’s high-stakes logistics environment.
The biologics manufacturing industry has undergone several changes over the past few years starting from the development of better expression systems to modular and flexible manufacturing facilities including the emergence and use of disposables. However, there is a need for higher productivity with upstream process development and...
The TGA has published details of the 12 month graduated transition period to PIC/S Guide to GMP PE 009-13, commencing 01 January 2018. The key changes and a transition plan have been summarised in tables by chapter and appendix and are linked here for your convenience.