FDA regulations mandate that manufacturing firms test dietary ingredients and establish identity specifications prior to using the ingredients in manufacturing. Regulations also state that manufacturers must conduct a minimum of one test or examination to confirm the identity of components classified as a dietary ingredient.

In most cases, certificate of analysis documents of dietary ingredients that are supplied by third party suppliers are not sufficient enough to prove identity for manufacturing firms. Supplier’s identity testing procedures may not be 100% compliant with the FDA regulations; therefore it is always safer to conduct individual tests at manufacturing plants. The results of these tests have to be sent in for review by the FDA. If incoming materials or components are not dietary ingredients, manufacturing firms are allowed to use the analysis certificates delivered by the supplier. However, if the supplier is not qualified to submit analysis certificates on non-dietary ingredient products, then the manufacturing plant must conduct their own tests.

The following FDA regulations must be met by either manufacturing firms or suppliers:

– Detailed instructions of the proper ways to establish the identity of a component should be sent with the certificate of analysis from the supplier to the manufacturer.

– The acceptable limits for the tests/examinations as well as the outcomes should be included in the certificate of analysis.

– Manufacturers must maintain all documentation regarding the conditions to be met by the supplier

– Manufacturers must periodically re-qualify suppliers and the certificates of analysis of dietary ingredients or components. Quality control personnel are responsible for review and approval for all documentation submitted by the supplier.

FDA regulations require that at least one of the following tests be conducted to confirm the identity of dietary ingredients/components:

– Microscopic analysis

– Gross organoleptic analysis

– Chemical analysis

– Macroscopic analysis

– Other scientifically valid methods of testing

Specific testing or examination methods are required for each dietary ingredient or component. Organoleptic analysis might be the right test for botanical parts which are coarsely or wholly cut, the suitability of that test may not be appropriate for botanical extracts and powders. Organoleptic analysis has been known to provide false identification for testing botanical products. Macroscopic analysis is the valid and correct test method to determine whether botanical extracts or powders have meet specification.

Qualities such as the identity, purity, strength, and composition of components in dietary supplements must be tested to ensure consistency whether the dietary supplements are composed of a single ingredient or are made up of a compound of ingredients. Consequently, manufacturers that produce multivitamins or mineral dietary supplements would have large and extensive record systems because their products contain many individual ingredients.

ANSI Standard 173 explains the required testing methods for microbiological contaminants and metals. Prior to the Standard, manufacturing firms were given freedom to conduct individual tests; however, testing goals of the CGMP were more standardized and consistent with the regulation. Therefore, it is strongly recommended to use the Standard when testing, so that the test results can easily be checked for compliance.

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Rick Soltero, President of InstantGMP designed an electronic manufacturing execution system that is cloud based and Part 11 compliant. He also developed InstantGMP-Lite, an electronic batch record system for cGMP manufacturing. These make staying in GMP compliance easy.

Rick Soltero, President of http://www.InstantGMP.com, designed this electronic manufacturing execution system that is cloud based and Part 11 compliant. He also developed http://www.InstantGMP-Lite.com, an electronic batch record system for cGMP manufacturing. These make staying in compliance easy

Author Bio: Rick Soltero, President of InstantGMP designed an electronic manufacturing execution system that is cloud based and Part 11 compliant. He also developed InstantGMP-Lite, an electronic batch record system for cGMP manufacturing. These make staying in GMP compliance easy.

Category: Wellness, Fitness and Diet
Keywords: GMP Compliance, Dietary Supplements, Manufacturing Execution Software, Electronic Batch Record