Pharma Logistics Editorial
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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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PIC/S Annex Update: What Is Your ATMP Control Strategy?
6/30/2021
Recently, the Pharmaceutical Inspection Co-operation Scheme (PIC/S) revised Annex 2 of its GMP guide addressing the manufacturing of advanced therapy medicinal products (ATMPs). While this guide is not an FDA or EMA guidance, it represents the consensus thoughts of a group that those regulators participate in.
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Data Integrity In Supply Chain Risk Management During Zero Trust
6/21/2021
Due to the pandemic, we have had to reconsider our approaches to supply chain risk management and to develop new and creative risk management strategies and tactics in response. This article examines how data integrity principles mitigate ALCOA concerns during this period of zero trust.
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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.
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Is The U.S. Ready For A Re-shored Pharma Supply Chain?
7/2/2020
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.
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Are We Adequately Assessing U.S. Pharma Supply Chain Risks?
6/26/2020
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.
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Challenges With Fill Finish Services Not Finished
2/11/2019
Ours is a responsive Editorial Advisory Board, but no question posed to them elicited the range and rate of response as this one: “What are the biggest challenges you face with outsourcing fill finish services – what keeps you up at night?” Chances are Outsourced Pharma readers are also experiencing the challenges board members told us about.
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2 Reasons Your CDMOs Are Consolidating: Money & Muscle
11/7/2018
Private equity is providing the M&A fuel for CDMOs, fill-and-finish specialists, and clinical and commercial packaging partners. Big Pharma readily encourages this industry consolidation. But not everyone is on board. Two experienced financiers agree both investors and Big Pharma have their reasons for pushing consolidation, but the verdict is still out on to what degree, big is better for the industry as a whole.