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

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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