An Indian pharmaceutical company was planning to shred quality control records ahead of an FDA inspection, found officials.
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Substandard and counterfeit drugs can negatively impact the pharmaceutical industry and patients. Here, we investigate counterfeits in south-east Asia and possible solutions.
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.
Microbial risk in pharmaceutical process is not limited to living microorganisms and intact microbial cells.
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.
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.
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.
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.
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.
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.
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...
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.
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...