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.
Access our previous white papers also available for download.
Supporting capital equipment projects, downstream from receiving purchase orders. You will be an integral part of the Operational Team, supporting both equipment manufacturers and clients to make sure timelines are established and met, and installations progress seamlessly with outstanding communication, both verbal and written, with all stakeholders and suppliers.
ISPE Aseptic Conference is in it’s 28th year and this event is great for pharmaceutical professionals focusing on aseptic processing. We are pleased to be going with Comecer. Stop by our table and share your Pharma and ATMP manufacturing challenges and see if we can provide some technology options.