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RECRUIT LIFE SCIENCE
TOP TALENT
Volume 02 Issue 32
August 27, 2021
Because life depends on us™
BSMA Clearing House
for latest news and information
...at a glance
ORGANIZATION NEWS!















EXECUTIVE NEWS!
The Editorial
FDA leads global work on continuous manufacturing approaches to up quality, supply chain resilience - Long-Awaited ICH Q13 draft guidelines on CM of drug products released

Hogan Lovells, [co-author: Stephanie Slater]

Under FDA's leadership, the International Council for Harmonisation (ICH) recently published Q13 draft guidelines on continuous manufacturing (CM) to advance the brand and generic drug industries ability to obtain approvals for products manufactured using CM processes in multiple regions. The ICH Q13 guideline is an important milestone in clarifying the regulatory paradigm for more flexibility and reliability in manufacturing processes. The ICH guideline describes scientific and regulatory considerations for the development, implementation, operation, and lifecycle management of CM in small and large molecule drug products. The guidelines also offer clarification on CM concepts, describe scientific approaches, and present regulatory considerations specific to CM of drug substances/products. While FDA has not yet adopted the ICH’s guideline to apply to biological products, it is expected that both CDER and CBER will continue to prioritize the agency’s efforts to promote CM to improve quality and increase supply chain resilience.
Potential advantages of continuous manufacturing
Quality is the critical

INNOVATIONS!
INFRASTRACTURE
CHALLENGES & SOLUTIONS!











UPCOMING EVENTS:

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Once again BSMA Forum will be a catalyst
for supply chain innovation.
[In-Person Event]
The BSMA Europe Annual Event is taking place on October 28th, 2021. As a global alliance, we continue our efforts to bring the best to your organization while building the future of the industry. By bringing life sciences supply chain professionals together, BSMA targets excellence and improvements across the supply chain by fostering innovation and exchanges between peers.


Details, Click Here
Register, Click Here
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Visit our online Calendar for other events
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RECRUIT LIFE SCIENCE TOP TALENT
Message from the BSMA Team: Please stay safe...wash your hands, don't touch any part of your face after being out and about, wear a mask to avoid touching your face or if you are coughing, keep the social distancing rule, and most of all be patient, positive, and proactive ... and we need to be kind to each other. Thank you.
Editor:
Devendra Mishra
Executive Director & Co-Founder
BSMA
+1-818-224-1552
Editor:
Dotti Yells
VP, Marketing Technology
BSMA