Annex 1 provides technical guidance on the principles and guidelines of good manufacturing practice (GMP) for medical products. It applies principles of Quality Risk Management (QRM) and requires the implementation of Contamination Control Strategies (CCS) to ensure that microbial, particulate and endotoxin/ pyrogen contamination is prevented in the final product.
USP Chapter <797>, Pharmaceutical Compounding: Sterile Preparations, delineates the standards and outlines the required procedures for compounding sterile preparations (CSPs) in all pharmacy settings ensure patient benefit and reduce risk.
USP Chapter <800> provides standards for safety handling of hazardous drugs (HD) to minimize risk of exposure to healthcare personnel, patients and the environment.
One commonality across all these regulatory standards is risk reduction. Saturix is a comprehensive surface cleaning system that pairs our expertise in specialty textile with patented innovative hardware. It can help you enhance your regulatory compliance by significantly reducing risk during cleaning for all surfaces in critical environments…
Read more on how Saturix reduces risk for surface cleaning, here.
