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 cost-effective...
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.
SeerPharma reached a milestone this quarter with the 10,000th trainee going through our cloud-based online GMP training, "E-learning".
A multinational pharmaceutical company required assistance to Validate equipment used in the manufacturing of an Active Pharmaceutical Ingredient (API). The facility was recently refitted to handle the manufacturing of a new API for global supply.
A global provider of medical device implants approached SeerPharma to conduct an internal ISO 13485 audit of their operations.
Yusen Logistics Singapore Pte Ltd provides freight forwarding and solutions which range from stand-alone operations to control-tower managed global supply chains, combining expertise with unique technology capabilities and a global service network. Globally, Yusen Logistics have offices in 43 countries, with over 22,000 employees. Yusen Logistics’...
The University of Technology Sydney’s Graduate School of Health has partnered with SeerPharma to deliver innovative, university-accredited graduate programs in Good Manufacturing Practice. Practice-based and contemporary, the programs are unique in Australia and the Asia-Pacific region.
The TGA announced on 13 September 2017 that it will adopt the current version of the PIC/S Guide to Good Manufacturing Practice for Medicinal Products (PE 009-13) as the Manufacturing Principles for medicines, active pharmaceutical ingredients and sunscreens from 31 December 2017.
The Parenteral Drug Association (PDA) is the leading global provider of science, technology and regulatory information and education for the pharmaceutical and biopharmaceutical community. Founded in 1946 as a nonprofit organization, PDA is committed to developing scientifically sound, practical technical information and resources to advance...
The Biotherapeutics Association of Australasia (BAA) is the peak body representing cellular therapy and tissue bankers in Australia and New Zealand.
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