Articles in this Issue
Vision impairment and blindness are critical problems worldwide. Major causes of vision loss include age-related macular degeneration (AMD), diabetes, retinitis pigmentosa (RP), and glaucoma. In order to improve treatment outcomes...
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The purpose of the production and process control subsystem (including sterilization process controls) is to manufacture products that meet specifications. Developing processes that are adequate to produce drug products that meet ...
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We often take for granted the human aspect of meeting objectives for compliance. While the patient is our ultimate customer, developing a program of contamination control is complex and is significantly dependent on proper human ...
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Both PDA TR 90 and the European Union’s recently revised GMP Annex 1 require manufacturers of sterile pharmaceuticals to implement and document a holistic contamination control strategy (CCS) that covers the entire manufacturing ...
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Laboratory analysts who have been performing compendial Bacterial Endotoxins testing (BET) for a number of years have come to accept the idea that the range of error of any BET compendial assay is 50- 200%. The reality is, the ...
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The goal of this study was to compare the lubricant functionality of LUBRITAB
® RBW with that of the lubricants magnesium stearate, sodium stearyl fumarate (PRUV
®), and hydrogenated vegetable oil (LUBRITAB
®).
The tablet model ...
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As a leading global Testing, Inspection, and Certification (TIC) company, SGS supports pharmaceutical and biotech companies in the development of Cell and Gene Therapies (C>) by providing comprehensive testing of raw materials, ...
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More than twenty years ago, companies started introducing rapid microbiological methods (RMMs) to the industry. Some call these methods alternative microbiological methods. Rapid or alternative microbiological methods refer to ...
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In the pharmaceutical industry, maintaining a clean and sterile environment is of utmost importance to ensure product quality, safety, and efficacy. Mold contamination poses a significant risk to pharmaceutical manufacturing ...
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The issue at hand is not whether to include the recombinant Factor C (rFC) reagent in the U.S. Pharmacopoeia, but rather how to implement this change with minimal risk. The authors suggest that a gradual implementation approach, ...
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Pharmaceutical and biopharmaceutical manufacturers need faster data related to microbial contamination in all aspects of production. Relying on growth-based methods that take days is not fast enough to make actionable changes when...
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There remains debate on both how to conduct a triple clean evaluation as well as what data generation is optimal during the process in order to demonstrate in situ effectiveness of a disinfection program. A triple clean can be ...
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With the release of the new EU GMP Annex 1 revision, a review of current practices is required to ensure that the installed monitoring system, chosen to meet the needs of Annex 1, complies with the requirements. This chapter will ...
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Timothy Francis, Senior Technical Specialist for the LAL Division of FUJIFILM Wako Chemicals U.S.A. Corporation: From the viewpoint of the pharmaceutical industry clients that I work with, one of the most impressive developments I...
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Sterility assurance is a critical aspect of pharmaceutical manufacturing, which commonly includes single-use systems. Single-use systems off er numerous advantages, including reduced contamination risk, increased operational ...
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Code is a system of words, letters, or signs used to represent a message in a secret, shorter or in a convenient form. DNA (deoxyribonucleic acid) is such a code to all living cells in the universe. DNA holds the instruction ...
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People undergoing treatment for attention deficit/hyperactivity disorder (ADHD), certain cancers, various infectious diseases, and pain management may find themselves on a medication waiting list due to a worldwide drug shortage. ...
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The purpose of this column is to highlight
and summarize recent key patents in the
pharmaceutical arena issued by the US
Patent Office in May 2023.
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Have you heard the term: liminal space?
I first learned of the term while watching the excellent AppleTV series Severance.
Without giving too much away, the series is about a team of office workers whose memories have been ...
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