Operations

The purpose of an environmental monitoring program is to demonstrate that a facility performs within control and is protecting the compound, it is important to properly design, implement, and perform environmental monitoring at a practice site. Let us design or update your EM program so you can demonstrate that the facility performs within control, protects individuals, the environment, the process, and the product. 

 Our consultants have extensive  FDA 21 CFR parts 1271, 820, 210, 211, 11 regulations, ICH Guidelines, USP <795> / <797>, ISO 13485, ISO 14644, ISO 14791, and ISO 9001 experience. We provide on-site or remote personnel training so compounding staff may be trained to their specific procedures on their own equipment. 

 503B outsourcing facilities, hospitals, and 503A pharmacies engaged in non-sterile or sterile compounding need to follow a detailed master formula to satisfy various regulatory and accrediting bodies. Let us customize a master formula template, media fill, process validation, and any other documentation so that you can attain or maintain compliance. 

 Pharmacies, hospitals, and 503B outsourcing facilities need to follow the appropriate written SOP’s to satisfy various regulatory and accrediting bodies. Let us customize your standard operating procedures so that you can attain or maintain compliance.