InstantGMP Compliance Series - Improving Specifications
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The FDA requires specifications for identity, strength, purity and composition for dietary supplement products. This presentation explains how to meet these GMP requirements.
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InstantGMP Compliance Series - Improving Specifications
- 1. InstantGMP Compliance Series for Dietary Supplements Improving Specifications
- 2. 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
- 3. 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 Electronic cGMP Manufacturing Execution System 3
- 4. 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
- 5. 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
- 6. 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
- 7. 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
- 8. 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
- 9. 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
- 10. 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
- 11. 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
- 12. 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
- 13. 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
- 14. 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
- 15. 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
- 16. 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 Electronic cGMP Manufacturing Execution System
- 18. 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 Electronic cGMP Manufacturing Execution System
- 19. InstantGMP™ Find more presentation and videos on GMP Compliance for Dietary Supplements in the Resource Center at www.InstantGMP.com
Editor's Notes
- Welcome to the InstantGMP compliance Series for Dietary Supplements on how to improve specifications. The quality and manufacturing experts at InstantGMP prepared this GMP Compliance Series of presentations to review good manufacturing practices and cGMP compliance for dietary supplements manufacturing. Our experts hope these presentations will help you avoid any cGMP compliance issues in your facility. A common reasons for the FDA to issue Warning Letters to Dietary Supplement companies was due to lack of specifications or failure to meet specifications. This presentation describes how to implement and improve specifications.
- FDA inspectors have issued many Warning Letters citing dietary supplement manufacturers for failure to set specifications for identity, purity, strength and composition for each component used in manufacturing. Such specifications were also not established for the finished product.
- Specifications must be set and met. Failure to set or meet specifications can lead to regulatory actions such as an injunction.
- Setting up specifications is necessary to make sure it can be verified that the finished product meet the plants’ requirements for identity, purity, strength, composition. This identity specification is necessary to make sure the final product contains the right ingredients or components. The strength specification allows you for calculation of the weight or measure of precisely how much of an ingredient or component should be added. Setting up specs for purity or for cleaning and sanitizing equipment before using it is used in a batch can prevent contamination that may lead to adulteration of the finished batch.
- Specifications have to be established for components, in-process production, labels and packaging, the finished batch of dietary supplement, product received from a supplier for packaging and labeling and the packaging and labeling for the finished packaged and labeled dietary supplement.
- There are various elements or parts to specifications. For each critical attribute, there needs to be a test such as potency or water content. For each test there must be a tested method of procedure by which the quality attribute is measured. Each test and method combination needs an acceptance limit which defines the acceptable range for the attribute. Some other Requirements include descriptions for the Safety and Handling of the component and Sampling Instructions that the quality group will follow when sampling for testing.
- A specification has to be established for each component used in the manufacture of a dietary supplement. An identity specification is required for each component used in the manufacture of a dietary supplement. A specification for identity may include more than one attribute. For example, a specification for the identity of a salt used in the manufacture of a vitamin product may include the physical characteristics such as a crystal or as a powder, the color and the state of hydration. A specification for the identity of a botanical might 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 or extracted from.
- Component specifications are necessary to ensure that final product meets specifications for the purity, strength, and composition. Limits on acceptable contamination of these properties must be established to prevent adulteration of the finished batch.
- Vitamins or minerals might include: Identification Assay Appearance Odor Solubility Melting Point Loss on Drying or Residue on Ignition Heavy Metals Organic Volatile Impurities
- No specifications have to be set for the identity, purity, strength, or composition of the various constituents that are inherently present in a natural product such as a botanical. However, the identity of the botanical has to be confirmed. This could include establishing the identity of the part of the plant used and the color and the odor. A comparison to an authentic representative plant will be useful here.
- The regulations are very specific about establishing specifications for in-process production steps where control is necessary to ensure quality. If process steps like heating or cooling are critical to making a product that meets final specifications, then these steps have to be controlled. Likewise, if there is a certain piece of equipment that has to be cleaned or sanitized after handling certain raw materials to eliminate microbial contamination, then a specification has to be set. This is needed to make sure that products made with that equipment do not exceed their limits for contaminants. The same is true for a production step where cross contamination might occur or where specialized environmental precautions or aseptic techniques are necessary.
- It is imperative to verify that a finished batch of dietary supplement meets product specifications for identity, purity, strength, composition, and for limits on contamination. Product specifications may be exempt from verification if it is determined that there is no scientifically valid method for testing or examining that specification at the finished batch stage, having provided adequate documentation of scientific basis for why meeting the in-process specifications, in combination with meeting component specifications, will help ensure that specifications are met in the final product.
- Precautions must be taken during manufacturing to prevent adulteration of the final product. Important steps include eliminating risk of microbial contamination from raw materials and to clean and/or sanitize critical equipment. Components and equipment that may come in contact with microorganisms via the environment and certain raw materials must be tested for contamination. You will need to use established specifications and appropriate tests to limit the contaminants that could be introduced into the batch.
- Specifications must ensure the dietary supplement is packaged and labeled as specified in the master manufacturing record and ensure that the label you specify in the master manufacturing record is applied to the product. Manufacturers have to establish specifications for dietary supplement labels (label specifications) and for packaging that may come in contact with dietary supplements. Before packaging can be used, at least a visual identification test of the containers and closures must be conducted. It must be determined whether packaging specifications were met and that the product received is consistent with the purchase order.
- Some specifications are not needed for dietary supplements. For example, tests for dissolution, disintegration, and bioavailability of dietary supplements are examples of areas where scientific study is still evolving; thus it is premature to impose requirements for such tests. For botanicals, the are a variety of constituents that are normally present in a natural product; specifications are not needed for these.
- A product specification may be exempted if it can be proven that the specifications in question cannot verify that the product meets all product specifications; and there is no scientifically valid method for testing or examining the exempted product specification at the finished batch stage. Proof of other information, such as component and in-process testing, will determine whether the exempted product specification can be met without finished batch testing.
- InstantGMP™ makes specifications and GMP compliance easy! This web-based application has a complete electronic specification system with version control. It seamlessly blends specification control with everything else necessary for GMP manufacturing. It uses built-in quality procedures to check and control GMP compliance at multiple steps throughout the application. Most of all, it provides opportunities for increased flexibility, visibility and productivity in your manufacturing operation.
- This presentation is just one of many articles and videos available on GMP compliance for Dietary Supplements. You can access the rest at the Resource Center at www.InstantGMP.com.