The cleaning validation processes of companies manufacturing active ingredients continues to be at the forefront of concerns of federal regulators, especially to protect the health and well-being of consumers. Per cGMP and FDA guidelines, cleaning procedures must be repeatable, verifiable and recorded.
In recent times, numerous pharmaceutical companies have been publicly criticized for not properly cleaning their equipment that comes into contact with Active Pharmaceutical Ingredients (APIs) and thus contaminating other products that are manufactured by that machinery. These contaminated products can then be consumed by patients, potentially causing life-threatening complications. More than ever, it’s become essential for these pharmaceutical manufacturing companies to ensure the cleanliness of every piece of apparatus used in manufacturing these products.
Here’s how one multinational pharmaceutical company became GMP compliant whilst increasing production and reducing costs. Find out more by submitting the form below.
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Welcome Pharma Focus Readers! Below you will find the Pharma Focus Winter 2019 edition, provided from IWT. Click the link to download the full version. Happy Pharma Days! Pharma Focus Edition 2
Today, in line with the evolution of bio-processing techniques to satisfy the concepts on Pharma 4.0, there is heavy emphasis on cell line and expression system improvements. With this background, the demands on bioreactors have become more exacting over recent years, requiring paradigm shifts in manufacturing efficiencies. Continuous optimization, design improvements and characterization of bioreactors are crucial factors placing high demands for innovation in bio-pharmaceutical manufacturing. Therefore, it is inevitable that a focus is placed on new approaches in plant engineering to keep pace with the technological developments of the bio-pharmaceutical industry.