Does a quality assurance program need to be documented formally in writing?

A quality assurance program being documented formally in writing is essential to ensure consistent practices, compliance with regulatory standards, and accountability within sterile compounding processes. Written documentation serves as a foundational element that provides clear guidance on procedures, responsibilities, and quality controls. This organized approach allows for systematic tracking of quality measures, training protocols, and audits, which are critical for maintaining safety in compounded sterile preparations.

Furthermore, formal documentation aids in demonstrating compliance during inspections by regulatory bodies, ensuring that facilities adhere to the stringent requirements set by USP 797. It also contributes to continuous quality improvement by allowing for the identification and rectification of issues in the compounding process.

Other options suggest less rigorous approaches to documentation, which would not meet the stringent standards required in sterile compounding practices, potentially compromising patient safety and product quality.