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Services: Dietary Supplements

Medical Device | Combination Product | Pharmaceutical | 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.

Services Offered:

Training Offered:

Continuous Improvement Analysis of Entire cGMP Operations

cGMPs Current Perspective

Laboratories Operations Assessments

cGMP Basics Training

Production and Process Controls Assessments

Good Documentation Practices Training

Packaging & Labeling Assessments

Records & Recordkeeping Training

Manufacturing Equipment Qualifications

Executive Management & Supervisors Responsibility Training

Process & Cleaning Qualifications

Customized cGMP seminars

Continuous Improvement Analysis

FDA Inspection Etiquette Training

Metal Detection Equipment Qualification

Adverse Reporting Requirements Training

Quality Assurance System Assessments, Implementation of New Procedures or Optimization of Current Procedures

Product Complaint Handling and Returned Product Training

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