By Mark Gunn
MGD Services
We have had clients inform us that many on their staff believe that 21 CFR Part 11 is no longer in force. 21 CFR is still in force and in all likelihood will be for some time. Some of the confusion arose out of the adoption of the 21st Century cGMPs for the Pharmaceutical industry. This initiative allows the pharmaceutical industry to be smart about compliance while putting the burden of proof on the industry itself. It requires documentation of risk analysis (Risk Based Approach) and the impact on patient health, product quality and data integrity. While this does narrow the interpretation and scope of Part 11 it does not eliminate it.
The current interpretation of the Part 11 rule focuses on only those records required by predicate rules (GLPs, GMPs and GCPs) that are in electronic format. This means that fewer records are covered and that predicate rule requirements are still enforced. The FDA still expects systems to be validated based on the predicate rules. You should consider the impact on accuracy, reliability, integrity, availability, and authenticity of any documentation that has been identified based on the risk based approach. You should base the approach on a justified and documented risk assessment that evaluates the effect on product quality and safety and record integrity.
What is still being enforced for Part 11 compliance is comprised of the following areas:
- Security
- Accountability for e-signatures
- Electronic signatures
- Operational, device, and authority checks
- Record protection
- Training and experience
- Open systems
At a minimum the Validation Plan and Report, Requirements, System Acceptance Test, IQ/OQ/PQ, and Maintenance Procedures are required to be validated. But with only these minimum requirements there are liable to be gaps in compliance if the required documents are not comprehensive and issued in a timely manor. The risk based approach must not be looked at as a way around the regulations but as a more structured and fairer approach to 21 CFR Part 11 compliance.
Mark Gunn has 25 years experience in the Quality Assurance and FDA validation fields. If you have any questions about these topics, please email Mark at Mark@mgdservices.com
On April 30th, 2005 a determined and damp group known as the Band of Babes gathered with thousands of other fund raisers to walk or run in support of finding a cure for woman’s cancers. Our words of inspiration sounding similar to those imbedded in the stone of NYC’s General Post Office:
“Neither snow nor rain nor heat nor gloom of night stays these couriers from the swift completion of their appointed rounds.”
In the case of the Band of Babes, our mantra was:
“Neither rain nor wind nor water soaked sneakers stays these supporters from their trek from Times Square through Central Park in their search for a cure!”
As we waited for the race to begin, we listened as guest speakers, Julianna Moore and Mariska Hargitay exalted our fund raising efforts. The flashing neon of Times Square gave plenty for us to wonder over as well. Some huddled together for warmth, while others, no names mentioned (MARK) shook their water laden umbrellas over the shuddering masses, adding to their soggy plight. After a thirty minute stutter-step to the start line, we were on our way. Rain was still falling but we were moving and warming up. Our original plan was for some of the gang to act as ground crew and hold our luggage, and take action shots as we passed by. However, the weather being a deterrent, our sideline supporters opted to join the walk. Away we went, weaving our way through the throngs of people to the finish line where we gobbled potatoes chips washed down with Smart Water.
Our youngest member, nine year old Makenzie got a three mile piggy back ride from her very resilient mother, Bilynda. The Band of Babes raised $1,250.00 which will go to continued research for cures for woman’s cancers. Better weather has already been requested for next year’s event and we hope to see more new faces when we line up in Time’s Square next year!
For more information about race results or to make a contribution until
June 1, please visit: Revlon Run/Walk>Revlon Run/Walk
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