Thursday, April 30, 2020

April 2020 Newsletter: Quality Counts

April 29, 2020

Labeling and Packaging Specs

Here is the LINK where you can download my latest eBook which explains how to keep a Labeling and Packaging Log in conformity with GMPs -- as provided in SOP #25 of the Vitamin Consultancy standard SOP format.


And Increases Your Bottom Line
Nutrient Sales Surge During Declared Pandemic

Quality Counts!
New ETQ Survey shows:  "An important shift is happening. Organizations now treat quality as a strategic initiative. Survey data shows 66% of organizations categorize quality as a strategic growth investment. Treating quality as a strategic business initiative is paying off as organizations see an average return of 23% on their investments."

Since Quality Counts, Quality Control must be a central concern.  Under FDA's GMP there is no question that quality counts and that the product label owner is the responsible party for quality control.  Your company needs to have Quality Control built into its Standard Operating Procedures (SOPs) and you need to have a designated Quality Control Manager.

The Vitamin Consultancy's standard SOPs include strong quality control provisions.  In the vitamin industry, according to numerous FDA Form 483 Inspection Observations that means controlling "identity, purety, strength and composition" of the DSHEA product.

Here is what the SOP says about the QC Manager: "The QC Manager shall review and evaluate with the company managers at least annually complaints, recalls, returned or salvaged products and internal investigations conducted for each."

QC Goals include:
  • Qualifying the Contract Manufacturer as capable meeting quality, strength, purity and identity standards
  • Approving (or rejecting) products manufactured, processed, packed or held under contract by another company
  • Approving (or rejecting) procedures and specifications impacting identity, strength, quality and purity
  • Approving (or rejecting) packaging, labeling and product containers
  • Reviewing and investigating consumer complaints.
Contact me at and let's talk about brining your SOPs up-to-date.  During this enforced period of self-shielding is a perfect time for you to get ready to get back to work! 
Learn more about my Systems Processing Integration!
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