This private blog replaces the earlier archives I had posted on the Internet and includes various memos sent to the clients of the VitaminLawyer.com (now the Vitamin Consultancy). It includes archived copies of memos from 2004 through 2007 and subsequent memos will be posted as they are issued.
SPECIAL BONUS eBOOK! 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.
QUALITY COUNTS! And Increases Your Bottom Line Nutrient Sales Surge During Declared Pandemic
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 firstname.lastname@example.org 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!