Contributing Editors
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Are You Prepared For Impending Changes To U.S. Biologics & Biosimilars Law?
1/16/2020
Sponsors for insulins and other protein products originally submitted for premarket review under an NDA may be anticipating the arrival of March 23, 2020 with trepidation. On that date, the BPCIA requires that those NDA-approved products will be deemed to have a BLA approval instead of an NDA approval.
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Why You Need A World-Class Quality Culture — And How To Build One
1/13/2020
The quality culture of the organization has a clear and direct impact on the ultimate quality of the product, where either the quality is built into the product or is tested against the product for acceptance. This article discusses several ideas for implementing a quality culture that is based on innovation while ensuring compliance with regulations.
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An Introduction To Forced Degradation Studies For Drug Substance & Drug Product
1/9/2020
The forced degradation study is a vital analytical aspect of the drug development program for small molecules. Commonly known as stress testing, it is carried out to demonstrate as specificity to developed a stability-indicating analytical method, using high-performance liquid chromatography (HPLC). As per ICH Q1A, stability studies must be performed to propose the shelf life of new drug substances and/or drug products.
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UPDATED: New EMA Requirements On Nitrosamines — What ALL Pharma Companies Need To Know
1/7/2020
The EMA recently issued two new publications containing information on nitrosamines for marketing authorisation holders (MAHs). Every MAH and manufacturer of chemically synthesized APIs and resulting drug products should carefully read the new EMA expectations on potential nitrosamine contamination.
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Packaging Good Manufacturing Practices (GMPs) For Medicinal Products
1/6/2020
Has your supplier of primary packaging materials for medicinal products established and implemented — and continued to maintain — an adequate quality management system (QMS)? Generally, most suppliers of packaging materials maintain an ISO 9001 QMS. However, the requirements of ISO 9001 may not provide the necessary levels of good manufacturing practices (GMPs) and rigor to ensure the packaging materials are adequate for their intended use.
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Pulling Double Duty: Packaging Considerations For Combination Products
1/2/2020
Blending formula and function into one neatly packaged item may seem to simplify the drug delivery process for end users, be they healthcare professionals or patients, but a product that pulls double duty comes with its own set of challenges. Combination products require their own precautions and packaging measures that help to ensure quality, safety, and reliability.
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They’re Not Mind Readers: Have You Told Your Suppliers What You Want?
12/30/2019
There are many reasons for issues to crop up in a supply chain. For some, there aren’t realistic, economical work-arounds available to every company to mitigate all consequences.
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How “Two People With A Molecule” Can Build A Quality Culture
12/30/2019
Robert Lutz, Ph.D., is chief science officer of Iksuda Therapeutics, a 20-person start-up developing new antibody drug conjugates (ADCs) to target difficult-to-treat cancers. With an extensive background in ADC development, he believes that building mature quality capabilities is what your company must do every day from day one.
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An Analysis Of The FDA’s Drug Shortages Root Cause Report
12/27/2019
In Oct. 2019, the FDA's Drug Shortage Task Force published a report that identified root causes of drug shortages across the U.S. healthcare system and made recommendations for effectively resolving those underlying issues. This article summarizes the report's findings and discusses potential next steps the FDA may take.
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When Should Formal Quality By Design Documentation Begin?
12/23/2019
When is the best time to start quality by design (QbD)? This question is asked most frequently among many small firms. A better way to phrase it is: When should I formally document my QbD activities?