Services: Dietary Supplements
Ensuring Quality
Manufacturers of Dietary Supplements are now 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 is responsible through research and adverse event monitoring for taking 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.
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Services Offered:
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Training Offered:
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Continuous Improvement Analysis of Entire cGMP Operations
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cGMPs Current Perspective
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Laboratories Operations Assessments
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cGMP Basics Training
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Production and Process Controls Assessments
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Good Documentation Practices Training
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Packaging & Labeling Assessments
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Records & Recordkeeping Training
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Manufacturing Equipment Qualifications
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Executive Management & Supervisors Responsibility Training
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Process & Cleaning Qualifications
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Customized cGMP seminars
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Continuous Improvement Analysis
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FDA Inspection Etiquette Training
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Metal Detection Equipment Qualification
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Adverse Reporting Requirements Training
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Quality Assurance System Assessments, Implementation of New Procedures or Optimization of Current Procedures
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Product Complaint Handling and Returned Product Training
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