Recently, the FDA has been providing much heavier guidance - and more Form 483s for objectionable conditions - with respect to the regulatory requirements of cGMP controlled raw materials.
Maintaining standards and best practices surrounding cGMP guidelines are critical for those in the pharmaceutical industry. Learn more about these regulations and how MediZap can help keep you ahead of the curve.
MediZap is the only contract terminal sterilizer by E-Beam | X-Ray irradiation built for compounders. Our 4 Pillar Service includes Advanced Sterilization, Packaging Solutions, Compliance, and Exclusive Partnerships. We offer 48-hour processing, dedicated capacity, group pricing, and a compounding center of excellence. USP 797 and cGMP guidelines start with terminal sterilization, and our technology is the most advanced solution, ensuring low-risk 10-6 SAL and delivers the safest drug products to hospitals, practitioners, and patients.
