Embed Size (px)
DESCRIPTION
The FDA requires specifications for identity, strength, purity and composition for dietary supplement products. This presentation explains how to meet these GMP requirements.
Citation preview
InstantGMP Compliance Series for Dietary Supplements
Improving Specifications
Electronic cGMP Manufacturing Execution System
GMP Problems - Specifications
• Common citation in FDA Warning Letters
• Failure to set specifications for each component and for final product– Identity
– Purity
– Strength
– Composition
Electronic cGMP Manufacturing Execution System
GMP Problems - Specifications
• Specifications have to be set and met
• Failure to make or met specifications can lead to regulatory action such as an injunction
3
Electronic cGMP Manufacturing Execution System
Why Specifications are Important
• Ensures you can verify identity, purity, strength and composition of final product
• Identify specs ensures you have the right ingredients in the product
• Strength allows calculation of precisely how much to add to a batch
• Purity specs keep contaminants from adulterating a batch
Electronic cGMP Manufacturing Execution System
Specifications Needed For:
• Components• In-process production• Labels and packaging• Finished batch of dietary supplement• Product you receive from a supplier for packaging
and labeling• Packaging and labeling for the finished dietary
supplement
Electronic cGMP Manufacturing Execution System
Specifications Parts:
• Test - Measurement of a quality attribute such as potency or water content
• Method - The procedure by which the quality attribute is measured
• Limit - The acceptable range for the attribute• Other Requirements
– Safety and Handling– Sampling Instructions
Electronic cGMP Manufacturing Execution System
Component Specifications
• Identity for each component of a dietary supplement
• A salt in a vitamin and mineral supplement may include the physical characteristics of the solid such as color and the state of hydration
• Identity of a botanical may include the part of the plant (e.g., roots or leaves), the color, and whether the part of the plant is in a native state or has been ground.
Electronic cGMP Manufacturing Execution System
Component Specifications
• Component specifications must ensure purity, strength, and composition of final product
• Limits for types of contamination that may adulterate or may lead to adulteration of the finished batch
Electronic cGMP Manufacturing Execution System
Vitamin and Minerals ID
• Specifications might include:– 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 ID
• Identity of a botanical may include:– The part of the plant (e.g., roots or leaves) to be used
– 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 System
In-Process Specifications
• Needed for any point where control in the manufacturing process ensures quality, for example:– Heating steps– Cooling steps– Specific sanitation procedures to protect product– Points where cross-contamination might occur– Where environmental hygiene is necessary
Electronic cGMP Manufacturing Execution System
Final Product Specifications
• Required for Dietary Supplements– Identity– Purity– Strength– Composition
• Limits on contaminates that may adulterate the final product
• May exempt spec if no scientifically valid method is available
Electronic cGMP Manufacturing Execution System
Preventing Adulteration
• Prevent adulteration by taking precautions during manufacturing
• Eliminate possible microbial contamination from raw materials
• Clean and/or sanitize critical equipment• Test components and equipment• Use established specifications and tests• Limit the contaminates that could be introduced
into the batch
Electronic cGMP Manufacturing Execution System
Specifications: Packaging/Labeling Firms
• Firms who perform labeling operations must establish specifications
• Ensure product received is adequately identified
• Set specs for packaging that may be in contact with dietary supplements
• Ensure product is consistent with purchase order
Electronic cGMP Manufacturing Execution System
Some Specs Not Needed
• Dissolution• Disintegration• Bioavailability• Premature to impose requirements in areas where
science is still evolving• Aesthetic appearance of dietary supplement• Various constituents that are normally present in a
natural product
Electronic cGMP Manufacturing Execution System
Exempted Specifications
• Specifications are exempted if you show that:– The spec selected is not able to verify that the control
system is producing a dietary supplement that is within that spec
– There is no scientifically valid method for testing or examining the exempted product spec at the finished batch stage
– You document why other information, such as component and in-process testing, will show the spec is met without finished batch testing for that spec
Specification List Example
Electronic cGMP Manufacturing Execution System
InstantGMP™ - makes specifications easy!
• Web-based manufacturing execution system
• Includes specification system with version control for GMP manufacturing
• Uses built-in quality procedures to check and control GMP compliance
• Provides opportunities for more flexibility, visibility and productivity
InstantGMP™
Find more presentation and videos on GMP Compliance for Dietary
Supplements in the Resource Center at
www.InstantGMP.com
