I support Nutritional and Cosmetics products that are marketed globally across a wide variety of International markets.
Due to escalating and constantly-changing Regulatory/Registration requirements that vary widely from Market to Market, avoiding unpleasant regulatory surprises at time of registration renewal or importation of product can be challenging.
There is interest here in developing an internal program to periodically assess Regulatory risk in particular areas (e.g., risks for “Southeast Asian Markets/ Nutritionals” or for “Latin America/ Cosmetics”).
The idea is to have an internal Regulatory Affairs program to sample current product information (formulas, raw materials, manufacturing process, labeling, etc.), comparing to information in the Product Registration and also comparing to current requirements of the Market(s).
Program findings would be intended to identify gaps in Regulatory change-control systems, gaps in information systems, etc. This is envisioned to be a Regulatory program somewhat analogous to Quality Assurance Capability Programs in which internal audit findings feed back into self-improvement plans.
Have Regulatory programs such as this been developed and described by others? I would like to learn from what others have done in this area before I re-invent the wheel.
Thanks,
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David Kloosterman RAC
Regulatory and Product Safety Analyst
Amway Corp
Ada MI
United States
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