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Drug manufacturer planned to shred cGMP documents ahead of inspection
An Indian pharmaceutical company was planning to shred quality control records ahead of an FDA inspection, found officials.
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The impact of counterfeit drugs in south and south-east Asia
Substandard and counterfeit drugs can negatively impact the pharmaceutical industry and patients. Here, we investigate counterfeits in south-east Asia and possible solutions.
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On-demand webinar: Get Merck’s winning combination for Air Monitoring in Isolators to stay compliant to ISO 14698
In this webinar, we will introduce you to the microbial environmental monitoring in production isolators. You will learn how to be compliant and ease your workflow.
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On-demand webinar: Pyrogenic Risk in Pharma Process Webinar – from bioburden to pyrogens
Microbial risk in pharmaceutical process is not limited to living microorganisms and intact microbial cells.
Whitepapers/App Notes/Posters
Whitepaper: Stability testing blister packs inspected with Sepha’s VisionScan test method
It is a requirement of both US and EU regulations that pharmaceutical packaging operations demonstrate integrity. As technology-based solutions remain somewhat of an unknown quantity, this whitepaper tests the hypothesis that Sepha’s VisionScan test method is considered non destructive.
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Pharmaceutical intermediates market to see growth
The global pharmaceutical intermediates market is likely to see year-on-year growth in 2019, by an estimated 3.6 percent rate.
Whitepapers/App Notes/Posters
Whitepaper: Influence of different lubricants on tabletting characteristics and dissolution behaviour
Lubricants have a far more wide-reaching impact on the characteristics of the finished tablet than merely easing their means of production. A study was carried out to investigate precisely what those effects were.
webinar
The role of an integrated LIMS solution on supporting data integrity in current cGMP environments
14 May 2019 | By Abbott Informatics
Understand the role of data integrity in current good manufacturing practice for drugs as required in 21 CFR parts 210, 211, and 212.
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FDA approves novel treatments for heart disease
The US Food and Drug Administration (FDA) has approved new treatments for heart disease caused by ATTR-CM in adults.
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Single-use trays for bulk lyophilisation helps increase profitability by reducing cleaning time and associated costs
Single-use GORE LYOGUARD freeze-drying trays help reduce operating costs by minimising time spent cleaning freezers and by eliminating tray cleaning.
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Taking the difficulty out of API process filtration
Amazon Filters has selected the Making Pharmaceuticals Exhibition & Conference 2019 to showcase its latest filter housings and microfiltration filter cartridges, which are used in the manufacture of Active Pharmaceutical Ingredients (API) and are the essential components when creating pharmaceutical products.
Whitepapers/App Notes/Posters
Application note: Cleaning validation from HPLC to TOC: three factors to consider
This application note from SUEZ outlines the factors that companies should consider when choosing their cleaning validation procedure, highlighting the benefits of TOC analysis over HPLC.
webinar
Don’t let difficult substances control your cleaning validation
18 April 2019 | By SUEZ
TOC analysis is a widely adopted method for detecting residual product or cleaning agents on manufacturing equipment. Compared to specific methods such as HPLC, TOC can provide better process understanding and efficiency for cleaning validation (CV), verification and continuous monitoring...
news
Further advances in cell-based influenza vaccine technology announced
An influenza vaccine manufacturer has announced it is filing an Annual Strain Update with the US Food and Drug Administration (FDA) in the coming weeks due to advances in influenza vaccine technology.
news
FDA identifies hundreds of devices affected by sterilisation facility closures
FDA has launched a notification system where device manufacturers and users may notify the agency of any shortages or related supply issues stemming from sterilisation facility shutdowns...