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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STEQ America and Tema Sinergie presents the new automatic glove test system developed in response to the requirements of the new Annex 1 The name is AGLTS 2, and it’s the brand new automatic glove leak testing system designed for …
STEQ America is delighted to announce its return to the prominent 2023 Interphex Trade Show this April! One of the most premier events in the pharmaceutical industry, INTERPHEX brings together leading brands and professionals from around the globe. This three-day …
We cordially invite you to join us at the 2023 ISPE Aseptic Conference in North Bethesda, Maryland, where you can engage with leading industry experts and gain insights into the latest advancements and best practices in the field.