Dietary Supplements

Manufacturers of Dietary Supplements are responsible to evaluate the identity, purity, quality, strength, and composition of their products to meet 21 CFR Part 111 regulations for Good Manufacturing Practice (CGMPs) requirements.  FDA takes action against any unsafe dietary supplement product after it reaches the market.  All serious dietary supplement adverse events will soon be required to be reported the FDA. 

QIS, Inc. provides the tools to assess manufacturing processes and analytical testing capabilities to ensure Quality is a natural component built into every manufacturer’s daily practices.  QIS, Inc. can thoroughly assess your manufacturing, testing and quality systems using a Compliance Improvement Analysis (CIA).   This Analysis produces a clear and concise outline of all compliance activities necessary to meet the current FDA expectations for manufacturing, packaging, labeling, and holding dietary supplements.  You’ll be confident that Quality is not added work, but is naturally built into your business.

Services Offered

  • Continuous Improvement Analysis of Entire cGMP Operations
  • Laboratories Operations Assessments
  • Production and Process Controls Assessments
  • Packaging & Labeling Assessments
  • Manufacturing Equipment Qualifications
  • Process & Cleaning Qualifications
  • Continuous Improvement Analysis
  • Metal Detection Equipment Qualification
  • Quality Assurance System Assessments, Implementation of New Procedures or Optimization of Current Procedures

Training Offered

  • cGMP Basics Training
  • Good Documentation Practices Training
  • Executive Management & Supervisors Responsibility Training
  • Customized cGMP seminars
  • FDA Inspection Etiquette Training
  • Adverse Reporting Requirements Training