Good Acceptance Records Are Key When FDA Comes Calling
Devicemakers may need to brush up on their acceptance activities, as these are among the most frequently cited issues in warning letters for 2012 and 2013, says Dan O’Leary, partner with Ombu Enterprises.
“There’s a lot of opportunity to miss things and make mistakes,” he told attendees of a May 29 FDAnews webinar. O’Leary stressed the importance of procedures, recordkeeping and identifying the status of products. Every time the quality system regulation says to “establish” a procedure, “it means ‘define, document and implement,’” he said.
Verification is typically accomplished by one of two techniques — verifying everything produced by a process or verifying via a sampling plan. If used, a sampling plan should be documented and based on a valid statistical rationale. Devicemakers also will need procedures explaining how to use the sampling plan, O’Leary said. “They are quite flexible and, as a result, require you to make choices. Your procedures define the choices you make.”
Acceptance of product based on a supplier’s certificate is one type of verification activity, and the FDA will expect devicemakers to have audited their supplier’s process for preparing certificates of analysis, O’Leary said.
Keeping thorough records may just help you avoid a warning letter from the FDA. Learn how: Device History Records Sec. 820.184: FDA Inspectors Are Reviewing Them Carefully — Are You? Let experts show you what you need to track and how. Sign up for this webinar today.