InstantGMP Compliance Series - Testing
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Transcript of InstantGMP Compliance Series - Testing
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InstantGMP Compliance Seriesfor cGMP Dietary Supplements
Testing
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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
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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
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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
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Electronic cGMP Manufacturing Execution System
Product Specifications
• Specifications for finished batch of dietary supplements
• Identity• Purity• Strength• Composition• Limits for possible contaminants
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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
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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
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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
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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
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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
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Quality Testing Request
InstantGMP generates testing request form that can be sent with sample to QC
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InstantGMP™
Find more presentations on cGMP Compliance for Dietary
Supplements in the Resource Center at
www.instantgmp.com