API Monogram Audit Frequency Update
In response to industry requests and a recent Monogram Program Board decision to enhance Program integrity, we are pleased to announce that Monogram-only Program participants will be audited annually. This means that during a 3-year licensing cycle, each facility will undergo one renewal audit and two surveillance audits. The surveillance audits will be performed to ensure consistent manufacturing of product that meets the applicable API product specification. Typically, surveillance audits will be shorter in duration and will focus on the verification of conformance to product specification requirements under the established quality management system (QMS).
To assist Program participants during the transition to these new Program aspects, API will implement this change using a phased approach beginning in July 2019 and continuing to phase in participants through July 2022. This change will become effective at your facilities upon the next renewal date of your license.
