Mapping Strategy Fundamentals For Regulatory Compliance In Pharmaceutical Manufacturing

By Bruce McDuffee

Why do I need a mapping strategy in pharmaceutical manufacturing?

In order to comply with regulatory mandates in the manufacture of pharmaceuticals, you need a mapping strategy several reasons. One, it’s important for any regulators or approvers to understand the philosophy employed for the mapping. A documented strategy will decrease questions from others reviewing your mapping study and help them understand the data that is produced. When others are reviewing your strategy they may also suggest ideas that will make your study produce better data or make your effort more efficient.

Another reason is that, as the study moves along, it will be your own reference guide, ensuring that you keep to the ‘game plan’ and do not make changes that will negatively affect the study.