Protocol Design
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. It is not enough to purchase and adopt cookie-cutter media fill kits or vague master formula templates. Your protocols must be detailed and applicable to your unique facility operations and regulatory requirements. Let us customize a master formula template, media fill, process validation, and any other documentation so that you can attain or maintain compliance with state Boards of Pharmacy, FDA, DEA, and if applicable USP <797>, USP <795>, USP <800> as well as PCAB or NABP accreditation standards.
What We’ll Do
Review Relevant Operations, Facility and Protocols, then Customize and Finalize the New Protocols