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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Our manufacturing partner, Matachana Group, has been producing premium, small to bulk steam sterilizers for more than 50 years. They provide services in over 110 countries. These sterilizers are engineered for flexibility, and to support your cGMP, QC testing and QC application needs. Have you read their latest publication?
We’ve had some exciting times at STEQ America, recently partnering with even more multinational, pioneering equipment manufacturers to bring you advanced solutions for R&D and manufacturing in pharmaceuticals, biotechnology, and life sciences. Click here to download our new product line flyers and stay current with the innovative technologies you need to be leaders in your industry.
Pharmaceutical production is moving in a new era, one in which personalized medicine and drug-device configurations will be significant areas of interest. This will require equipment to process dedicated and smaller batches, still comply with cGMP, be custom-designed, all while meeting the needs your current operational requirements.