8 November 2022 - 8 November 2022
ISPE Singapore Soccer Tournament 2022 8 Nov 2022 | 7-9pm | Golazo Futsal Singapore Option A: Register a Team of 5-8 members (S$50 per team) Option B: Register individually and have a team assigned to you (S$10 per person) Location: Golazo Futsal...
iSpeak Blog

Winners in this category exemplify application of novel approaches, standards, and practices which result in efficient processing, resourceful utilities, and business advantage by increasing patient access and preventing drug shortages through in-country-for country manufacturing; outbreak, epidemic, or emerging health crisis response via rapid deployment and fast-track drug production; and...

17 November 2022 - 17 November 2022
Webinar - Fast, Efficient and Space Saving: Maximising Yield from Easy-to-operate Single Use Separator 17 Nov 2022 *4.30-5.30pm | Online Hosted by: Synopsis: In upstream and downstream processing, single-use components have been highly successful in...
Media & Press Releases
20 September 2022
Pharmaceutical Engineering® is delighted to announce the finalists for the 2021 Roger F. Sherwood Article of the Year Award. The articles were selected by the judges from 35 feature and technical articles published in PE during calendar year 2021...
13 October 2023 - 13 October 2023
Digital Transformation Journey The idea of Digital Transformation is built on the goal of using plant data to improve quality, productivity, cost of goods manufactured, and time to market for manufacturing products and process development initiatives...
22 September 2022 - 22 September 2022
Join us for a great networking event at Upslope Brewing in Boulder, CO! Come catch up with your Rocky Mountain ISPE friends and enjoy a beverage! We can't wait to see you at Upslope Brewing! 1898 S Flatiron Ct, Boulder, CO 80301 Huge Thank You to Our...
9 November 2022 - 9 November 2022
STERIS Workshop: Important Elements of Cleaning Validation and Health-Based Exposure Limits 9 Nov 2022 9.30-11.00am SGT | Online Hosted by: Abstract: Cleaning validation is the documented evidence that the cleaning procedure can effectively remove...
18 October 2022 - 18 October 2022
18 Oct 2022 5.30-6.30pm SGT | Online Led by: Pierre Winnepenninckx, Chief Executive Officer - No deviation & CQV Lead, ISPE Singapore Affiliate Register Now!
iSpeak Blog

Annex 1 of the EC GMP Guide "Manufacture of Sterile Medicinal Products" has a long history. First published in 1989, there have been a total of 5 adaptations in 1996, 2003, 2005, 2007 and 2009, but no complete revision. In 2012, there was a proposal for a complete revision which resulted in a concept paper in 2015. The first draft for comments from industry stakeholders was...

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