21 CFR Part 11 Revision Delayed, But Moves Forward

Interphex, New York, NY (Apr. 24)-Although the second revision of 21 CFR Part 11, the Electronic Records and Signatures Rule, has not been finalized, there is some progress being made. This was the topic of a presentation given by John English, manager of computer system validation for BE&K BioPharm (Newark, DE, www.bek.com) at today’s Interphex Pharmaceutical Manufacturing Conference and Exhibition.

English provided examples of current events by emphasizing the importance of establishing and maintaining electronic record security, maintenance, and backup systems. In these cases, companies lost billions of dollars, had to recall product, received warning letters, or had to shut down operations.

“Electronic data has a big impact on our industry and if you want to know the place where the FDA will go, it’s not only adverse events, it’s your quality assurance records,” says English. “Even if you swear up and down that you only use the paper records and the notebooks, FDA will look at electronic records, and if they find that the test you pasted into the notebook doesn’t exist in the audit trail or the test that should have released the batch is something different than what is in the notebook, then they are going to say that no matter what your policy is, you’re lying.”

As the industry awaits the second revision of the second draft of 21 CFR 11, there is a need to address certain underlying principles. Most notably, the industry must comprehend what is considered “risk-based,” said English. “What does risk-based really mean? What risk-based really should be is, and we forget this sometimes, What is the impact on the patient from the product that you are making in your facility? Our direct impact on the patient is the effect on the product.”

English also emphasized the requirements to comply with the predicate rules. Clarifying what is meant by predicate rules, English said, “What is currently in the good manufacturing practices requires records. Of those, what has FDA placed in the docket that they say they will accept electronic records for.” English gave an example of how Part 11 may be applicable in pharmacies and clinics. “[Part 11] is not supposed to be there, but it’s coming. And it’s the predicate rules that drive it.”

Some of the key areas in the current draft of Part 11 include the definition of the electronic record, definition of an audit trail, electronic copies for inspection, record retention, hybrid and procedural solutions, and the application of electronic signatures. Another area is whether the task force working on the revision should take a quality-based approach or an approach that is enforcement-based, said English.