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.
Discover the essential pharmaceutical packaging solutions for freeze-dried products, from vials to dual-chamber syringes, ensuring product stability, sterility, and ease of use. Learn about quality control methods like Headspace Gas Analysis, Automated Visual Inspection, and Pressure Decay to protect patient safety and meet USP standards.
We are thrilled to present our new partnership with PIERCAN, the leader in containment gloves, setting the standard for quality and responsiveness. Ideal for use in Isolators, RABS, Biosafety Cabinets, and Glove Boxes.
We are excited to announce that STEQ America will be participating in the 32nd ISPE DVC Annual Symposium & Exhibition, alongside our esteemed partners, IWT Pharma and TEMA Sinergie.
