Maximizing cGMP compliance is not easy; however, one can at least reference relevant requirements and guidelines e.g. 21 CFR Part 210-211, Eudralex Volume 4, etc. Quite often, the interpretation of these rules and guidelines will result in variation in their application.

Minimizing risk can be much more difficult due to the inherent variation not only in the interpretation of the requirements but in the natural variation that exists in any system designed and governed by people. Risk is manifested in a variety of forms which we must anticipate, recognize, and mitigate to the extent possible.

• Investigation systems struggle with differences in the evaluation of risk. Therefore, there can be great variation between investigators on quite similar issues. Solutions to reduce this variation and standardize approaches are important.
• Supply chain assurance will always have to deal with the variation inherent in determining what to audit, when to audit, and how often. Then there is the interpretation of the audit data which can vary between auditors. Solutions to reduce this inherent variation are key.
• Combination product design and development is complex partially due to the merging of drug, device, and biologic regulatory requirements. Development teams and CMC experts work hard to arrive at a consensus regarding risk, primary function, and key performance requirements.

IQS Consulting will offer solutions that reduce risk by working with your internal experts to ensure risk reduction strategies are in place, risk reduction guidance is being used appropriately, and deploy approaches which will minimize interpretative variation and bias. Solutions range from simple strategies which minimize variation to more programmatic approaches covering supply chain assurance and product development.