How Medical Device Manufacturers Can Improve Quality by Applying the Principles of Process Analytical Technologies (PAT)

This white paper reviews how the Process Analytical Technologies (PAT) originally developed by the FDA for the pharmaceutical industry can also improve quality and efficiency in medical device manufacturing. The underlying principle of the PAT approach is that quality should be designed into the product based on a fundamental understanding of the critical manufacturing processes.

Spotlight

Hansyn Pharmaceutical Co., Ltd.

Hansyn Pharmaceutical Co., Ltd is a pharmaceutical company committed to increasing access to high-quality healthcare by development and manufacture of generic drugs of active pharmaceutical ingredients. Hansyn has cGMP veterinary drug production falicities and associated infra-structures producing veterinary ingredients such as Florfenicol and Thiamphenicol. Since 2012, Hansyn is entering human pharmaceutical area by investment of new cGMP multi-purpose plants (large scale plant, small scale plant, steroid plant), utility facilities, QC laboratories and R&D Centers, planned to be finished by 2013.

OTHER WHITEPAPERS
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Transforming Patient Journey in Clinical Trials

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Year after year, the Life Sciences industry expands at a breakneck pace, with pharmaceutical development leading the way.

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Every viable pharmaceutical packaging system must comprise materials proven to protect its contents against moisture and other atmospheric variables, and be safe for use with the specified dosage form and the route of administration1

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Research and Development in the Pharmaceutical Industry

whitePaper | April 1, 2021

Every year, the U.S. pharmaceutical industry develops a variety of new drugs that provide valuable medical benefits. Many of those drugs are expensive and contribute to rising health care costs for the private sector and the federal government. Policymakers have considered policies that would lower drug prices and reduce federal drug expenditures. Such policies would probably reduce the industry’s incentive to develop new drugs.

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BUILDING A TOMORROW-READY LAB

whitePaper | September 8, 2022

Charles Darwin famously said on survival, "It is not the strongest of the species that survives, nor the most intelligent; it is the one most adaptable to change." Resilience has become an essential message in today's post-covid, next-normal world.

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Pharma R&D Annual Review 2022 Navigating the Landscape

whitePaper | May 7, 2022

Citeline, Welcome to Pharmaprojects' 2022 reviews of trends in pharmaceutical R&D. Take a look at the evolution of pharma R&D and in this article, examine the state of play at the start of 2022.

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QbD and PAT in Biopharmaceutical Development

whitePaper | July 12, 2022

As the pharmaceutical industry tries to embrace the methodologies of quality by design (QbD) provided by the FDA ’s process validation (PV) guidance (1) and International Conference on Harmonization.

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Spotlight

Hansyn Pharmaceutical Co., Ltd.

Hansyn Pharmaceutical Co., Ltd is a pharmaceutical company committed to increasing access to high-quality healthcare by development and manufacture of generic drugs of active pharmaceutical ingredients. Hansyn has cGMP veterinary drug production falicities and associated infra-structures producing veterinary ingredients such as Florfenicol and Thiamphenicol. Since 2012, Hansyn is entering human pharmaceutical area by investment of new cGMP multi-purpose plants (large scale plant, small scale plant, steroid plant), utility facilities, QC laboratories and R&D Centers, planned to be finished by 2013.

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