Featured Pharma Online Editorial
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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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A Checklist For Risk Assessment Of Nitrosamine Impurities In Oral Solid Dose Drugs
3/12/2021
Nitrosamine impurities such as N-nitrosodimethylamine (NDMA) are being identified in high-volume drug products such as valsartan, losartan, irbesartan, and ranitidine at levels well above the acceptable daily intake limits. The credit for identifying the higher NDMA levels goes to an independent pharmacy that tests every batch it dispenses, exposing limitations in drug substance and drug product post-approval change assessment and analysis requirements at pharmaceutical manufacturing organizations.
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Slow-Walking The Isolator: A Cautionary Tale
12/2/2020
Our industry has, with not insignificant regulatory assistance, obstructed the implementation of a technology that has proven safe and effective and was an enormous improvement over the conventional cleanrooms universally in place in the mid-1980s.
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Advancing The State Of Aseptic Processing: Let’s Get Serious
11/23/2020
It seems pitiful that, for whatever reason, industry has failed to universally adopt more effective technologies to control contamination resulting in safer sterile drugs. On the other hand, the regulators must share substantial blame because of their historically lukewarm acceptance of emerging and even established advanced technologies.
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Identifying Difficult-To-Clean Surfaces In Manufacturing And Packaging Equipment
4/15/2020
This article describes a practical risk-based approach for assessing and identifying the surfaces, areas, or sites of manufacturing and packaging equipment that are cleaned upon completion of oral solid dosage manufacturing production.
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Pigeons In The Plant: 10 Real-Life Pharma Facility Blunders (And How To Avoid Them)
11/13/2019
There are situations we have come across where we really scratch our heads and say, “What did they just do, and what were they thinking?” This article describes a series of events and activities that we have seen that are at once amusing, baffling, and revealing of the flaws in our industry.
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Mystery And Danger: Flammables And Oxidizers In Pharma Filling Operations
5/21/2019
BPO, benzyl peroxide, a compound that has both a fuel source and oxygen (two legs of the fire triangle) built into it, can make handling of a purified version of this compound very interesting.
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How Technology Will Reshape The Future Of Aseptic Processing
2/11/2019
Using new and existing technologies to improve aseptic processing manufacturing may provide the need and opportunity for new approaches to process control and monitoring.
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3D Printing In The Pharmaceutical Industry: Where Does It Currently Stand?
12/21/2018
In 2015, Aprecia Pharmaceuticals produced the first tablet manufactured through 3D printing to be approved by the FDA. Now, with applications in controlled release, short-run medicines, and even the potential for on-site printing at pharmacies, 3D printing technology has the ability to transform the pharmaceutical industry.
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Janssen’s Fruitful Continuous Manufacturing Collaboration
6/24/2015
Janssen Supply Chain’s ongoing partnership with the Rutgers University School of Engineering has produced valuable research and intelligence on continuous manufacturing processes that are enabling the pharma giant to effectively turn the concept into reality.