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The procedures for testing dietary ingredients and dietary supplement products are described in this presentation.
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InstantGMP Compliance Seriesfor cGMP Dietary Supplements
Testing
Electronic cGMP Manufacturing Execution System
GMP Testing Problems
• FDA issued warning letter to neutaceutical lab• Firm failed to test identity of each dietary
ingredient• Requited by 21 CFR 111 – GMP regulations for
dietary supplements• Failure to correct could result in enforcement
actions• E.g. seizures of products or injunction against
further manufacturing
Electronic cGMP Manufacturing Execution System
Why Testing Is Important
• GMP requirement• Attributes tested to show:
– Potency– Strength– Identity = proper composition– Free from impurities or adulteration
• Guarantees quality of product• Provides proof consumer needs to know product
is useful and not harmful
Electronic cGMP Manufacturing Execution System
Tests and Specifications Needed For:
• Components• In-process production• Labels and packaging• Finished batch of dietary supplement• Product received from a supplier for packaging
and labeling• Packaging and labeling for the finished dietary
supplement
Electronic cGMP Manufacturing Execution System
Product Specifications
• Specifications for finished batch of dietary supplements
• Identity• Purity• Strength• Composition• Limits for possible contaminants
Electronic cGMP Manufacturing Execution System
Testing Dietary Ingredients
• Each dietary ingredient has to be tested for identity – Chose:
– Gross organoleptic analysis– Macroscopic analysis– Microscopic analysis– Chemical analysis– Other scientifically valid methods.
• May not use CoA from suppliers
Electronic cGMP Manufacturing Execution System
Vitamin and Minerals Tests
• Identification• Assay• Appearance• Odor• Solubility• Melting Point• Loss on Drying or Residue on Ignition• Heavy Metals• Organic Volatile Impurities
Electronic cGMP Manufacturing Execution System
Botanicals Tests
• Identity of a botanical may include:– Part of the plant (e.g., roots or leaves)
– Color
– Odor
• Whether the part of the plant is in a native state or has been ground up
• Characteristics that differentiate botanical from related species
Electronic cGMP Manufacturing Execution System9
Sponsor’s Responsibility
• Testing and Release of Final Product• Samples pulled from production batch• QC will test according to methods in
specifications• IQA will disposition batch after final product
testing• Products received for packaging and
labeling must be tested to ensure it matches purchase order
Electronic cGMP Manufacturing Execution System
Some Tests & Specs Not Needed
• Aesthetic appearance of dietary supplement• Various constituents that are normally present in a
natural product• Dissolution• Disintegration• Bioavailability• Premature to impose requirements in areas where
science is still evolving
11
Quality Testing Request
InstantGMP generates testing request form that can be sent with sample to QC
InstantGMP™
Find more presentations on cGMP Compliance for Dietary
Supplements in the Resource Center at
www.instantgmp.com