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Quality Systems Validation – Does it Apply to Consumer Products?

Today, I’ve asked Jacqueline McCulloch to discuss quality systems validation for the Consumer Products industry.  Jackie has more than 25 years of experience in FDA-regulated industries with a broad range of quality assurance experience including strategic quality systems compliance and regulatory strategy.

Did you know that teeth whitening toothpaste is actually considered a drug by FDA? FDA-regulated consumer products include food, cosmetics/personal care products, dietary products/supplements, and over the counter (OTC) drugs. Consumer Product companies have seen an increase in regulatory scrutiny from FDA, specifically companies manufacturing health and beauty products with anti-aging effects and other medicinal attributes. FDA views these products as OTC drugs based upon the product’s intended use.

The quality systems for FDA-regulated products are known as current good manufacturing practices (cGMPs). Consumer products companies that manufacture FDA-regulated products are required to follow cGMPs and thus have validated quality systems. If your consumer product is classified as a:

  • Medical device, follow the Quality System Regulation 21 CFR 820;
  • OTC drug, follow 21 CFR 210 & 211;
  • Cosmetic or personal care product, follow Good Manufacturing Practice Guidelines for Cosmetics.

Quality Systems validation is the action of proving in accordance with the principles of Good Regulatory Practices (GxP), that any procedure, process, equipment material, activity or system actually produces expected results. A robust quality system promotes process consistency by integrating effective knowledge-building mechanisms into daily operational decisions. Computerized systems that produce quality systems documentation and records are considered part of the Quality System and must be validated to 21CFR Part 11.

Why should a consumer products company have a validated quality system? The first reason is obvious, for FDA compliance. Compliance is less of a challenge with a robust quality system. Other benefits include:

  • Promotion of corporate image
  • Improvement in customer satisfaction by meeting requirements
  • Increased market share by increasing product loyalty
  • Lower costs through more efficient and effective internal operations
  • Improvement in manufacturing process control
  • Consistent products
  • Improvement in the product supply chain through quality inspections during the manufacturing process and quality checks before goods arrive at the customer

So with all of these benefits are you utilizing cGMPs in your company? If so, do you have established quality systems to promote process consistency and to support the implementation of cGMPs? If you have implemented quality systems, are they validated?  If you aren’t yet utilizing validated quality systems, do you think you should?

Read the next blog in this series, Quality Systems Validation Defined for the Consumer Products Industry.

Tags: Validation Strategy & Services