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Is The U.S. Ready For A Re-shored Pharma Supply Chain?

In the first part of this two-part article, we looked at how dependent the U.S. pharmaceutical supply chain is on critical ingredients produced in China and India and the risk that could pose to the nation’s drug supply. In this article, we will examine potential solutions to mitigate those risks and ensure the nation’s drug supply is secure.

Posted in: Manufacturing,
Tags: API, global economy, KSM, supply chain,
Remote Monitoring In The Wake Of COVID-19 — Practical & Regulatory Considerations

In the long term, as we move into the reopening phases of COVID-19, faced with increased expenses and the challenges with on-site monitoring, clinical research professionals need to ensure their quality management systems have the flexibility for the new normal for site management.

Posted in: Clinical,
Tags: COVID-19, remote monitoring, risk-based monitoring, telehealth, telemedicine,
A Brief History Of Parenteral Process Validation — How We Got Here

Process validation has been at the center of attention of regulators and parenteral industry practitioners for years — more than 40 years to be exact. This article will look at how process validation evolved to become the primary means of ensuring consistent, high-quality production of parenterals.

Posted in: Manufacturing,
Tags: guidances, process development, process validation,
Are We Adequately Assessing U.S. Pharma Supply Chain Risks?

There are gaps in our country’s collective knowledge required to determine the severity of the current pandemic’s risk to our supply chain for drugs. Undoubtedly, these gaps will remain, leaving questions that need to be answered and will, hopefully, serve as a road map for legislators and advocates of the industry.

Posted in: Manufacturing,
Tags: API, api manufacturing, COVID-19, KSM, supply chain,
Healing From A Pandemic And Building Resilience Into Future Clinical Trials

We must now rethink our design strategies and planning processes before starting studies to find the right fit-for-purpose virtual solutions and push the boundaries on our designs to ensure we are collecting what is truly important for research and our patients.

Posted in: Clinical,
Tags: COVID-19, pandemic, plan development, site selection, SOPs, study design,
Top 5 Mistakes To Avoid When Measuring Overall Equipment Effectiveness (OEE) In Pharma Packaging

Despite its (apparently) trivial formulation, overall equipment effectiveness (OEE) is one of the most misleading key performance indicators ever used in the manufacturing world. This article examines five common mistakes you’ll want to avoid when dealing with OEE.

Posted in: Manufacturing,
Tags: automation, OEE, overall equipment effectiveness, packaging machine, pharma packaging, serialization,