Tuesday, July 21, 2020

July 2020 - Contemporaneous Log and Texas Trip

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COVID willing, my trip to Texas to speak at The Woodlands Lunch Forum to inaugurate the Texas office of the Institute for Health Research is now scheduled for the end of August.  This is the third postponement since February, but I do hope to see my Texas friends then. Tickets available through www.InHeRe.org

KEEPING A CONTEMPORANEOUS LOG
MEETING FDA RECORD KEEPING REQUIREMENTS

The most important step that a small or start-up natural product / dietary supplement company can take to meet regulatory requirements is to keep a Contemporaneous Log of all activities relating to the receiving, handling and shipping of its products.  Follow-up records, such as computer inventory systems or even my OPS for SOPs (Operating Procedures System for Standard Operating Procedures) with its private, password protected regulatory compliance web site -- www.SystemsProcessingIntegration.com -- are after-the-fact records.

What FDA tells us is that the product Label Owner "must be in a state of control" of all processes, whether contracted or handled in-house.  Further the Agency tells us that, "if it is recorded that is how it happened; if it is not recorded it did not happen..."

This means that a contemporaneous, handwritten, initialed Receiving, Handling and Shipping Log is exactly what you need to start off right. Below is the format for the Log, but there are more sophisticated Log formats that I have available and am providing to my regular retainer clients.  Those documents are part of the SOP system developed by The Vitamin Consultancy. Let me know if you need more specifics.

The Log:

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