Featured Pharma Online Editorial
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EPCIS Implementation: 4 Takeaways, Next Steps For DSCSA Compliance
12/28/2021
With the Nov. 27, 2023, DSCSA deadline quickly approaching, the HDA Research Foundation recently released a survey to assess how the industry is preparing. This article summarizes the 4 key takeaways as well as your next steps for DSCSA compliance.
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Solving The 4 Serialization Challenges Of Track & Trace
11/17/2021
More than 10 years after introducing track and trace, the pharmaceutical industry still faces a number of technical challenges and limitations related to regulatory expectations, with many companies still transforming their packaging operations to meet them.
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How To Find & Manage Biotech Consultants Effectively
9/6/2021
The roles being filled by biotech consultants have grown considerably, as companies are becoming more familiar with working with consultants and more people are interested in pursuing a consultant career. But how do we find good consultants, and how do we ensure that our consultants are as committed and engaged as our full-time employees? Here's how to accomplish that.
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What’s The Role Of Interim Consultants In The Life Sciences & How Do We Use Them Effectively?
9/3/2021
When life sciences companies need new talent, they typically have two options: bring in a consultant or hire a full-time employee. Usually, this decision is dictated by the permanence of the role, but sometimes, timelines complicate things. In this situation, an interim consultant can be the solution. But what is the interim consultant's role, really, and how do we use them effectively?
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Best Practices For Raw Material Supplier Change Notifications: New BioPhorum Guidance
8/27/2021
Managing the large volume of supplier change notifications while safeguarding the continuity and compliance of a complex and tightly regulated supply chain is a resource-intensive task. To address the challenges, the BioPhorum Raw Material Variability Workstream has developed a guidance document designed to streamline the process without straying from essential and strict risk mitigation procedures.
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Best Practices To Ensure Quality Of Raw Materials Used To Manufacture Therapeutic Proteins
8/25/2021
Across biologics, raw material quality is a key driver of product quality and consistency. This article recaps a recent U.S. Pharmacopeia (USP) workshop on the subject, including recaps of best practices and experiences shared by the FDA, Merck, Biogen, and more.
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How Does A Mature QMS = Fewer Drug Supply Chain Disruptions?
8/16/2021
The FDA’s Office of Quality Surveillance launched a voluntary program to evaluate manufacturers’ quality management systems to inform decisions on the future development of an FDA rating system characterized as quality management maturity. This article explains the importance of QMM and what that looks like to the FDA.
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Navigating DSCSA Implementation: Key Requirements & 4 New FDA Guidances
7/5/2021
In the U.S., you're grappling with how to set up a fully interoperable electronic system for securing and tracing products across industry sectors per the Drug Supply Chain Security Act (DSCSA) by Nov. 2023. Here's how to navigate the key requirements, as well as the FDA's four new guidances on the subject released in June.
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How To Use DMF Content To Support Your Application To The FDA
4/30/2021
A drug master file (DMF) is a voluntary regulatory application submitted to the U.S. FDA. It is used to provide confidential detailed information about the manufacturing, processing, packaging, and storing of APIs and/or human drugs. What are the types of DMF submissions, what is involved, and how does the FDA evaluate your submission?
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Biopharma Cold Chain Logistics 101
4/9/2021
Cold chain logistics can be complex and intricate. Maintaining the integrity of controlled-temperature products requires holistic consistency between design and development, manufacturing and packaging, qualification and validation, cold storage, transportation, and monitoring as the product moves from its point of origin to the end user.