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How decentralised storage networks can change the game for the pharmaceutical industry

pharmaphorum

A potential solution could be provided by decentralised storage, which could not only improve data security, but also open opportunities for business process automation, improved data governance, and potentially new revenue streams. Is there anything that can be done about this? What is decentralised storage?

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Sustainability: Corporate Ambition, Governance, & Accelerated Delivery

ISPE

Transforming Our World: The 2030 Agenda for Sustainable Development.” The Paris Agreement.” link] As emphasized at the recent UN Climate Change Conference COP27 (held at the end of 2022 in Sharm el-Sheik, Egypt), international focus is now on implementation. 1 United Nations. Climate Change.

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Streamlining Postapproval Submissions Using ICH Q12 & SCDM

ISPE

Prior to implementation of a change, manufacturers conduct risk assessments and generate data to confirm there would be no adverse impact to product quality through shelf-life as a result of the change. Postapproval change management of pharmaceuticals is an essential part of life-cycle management but is associated with regulatory challenges.

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Challenges for Net Zero Carbon Pharmaceutical Manufacturing

ISPE

Beattie, CEng Michael Hell, PhD Sarah Mandlebaum Ester Lovsin Barle, DVM, MSc, PhD, MScTox 1 March 2023 The scientific community accepts that greenhouse gas (GHG) emissions cause global warming and climate change. 1 Intergovernmental Panel on Climate Change (IPCC). Finalized 9 August 2021. C global warming scenario. But most companies do not.

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A New Regulatory Approach to Drive Sustainable Medicines

ISPE

For decades, the pharmaceutical industry has worked to transform the lives of patients by researching, developing, and manufacturing medicines for a wide variety of common and rare diseases, something that will continue for many years to come. This article reviews two case studies that cover sustainable pack types and extension of shelf life.

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Using Technology for Continuous Process Verification 4.0

ISPE

This article is based on the defined framework and the implementation approach described herein. Value Proposition The end goal of a CPV implementation is to ensure process robustness through the adequate and timely monitoring of processes. This article is the second part of the “Reimagining CPV for a Pharma 4.0™ Applying Pharma 4.0™