Instant GMP Compliance Series for Dietary Supplements – Introduction
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Since 2010, the FDA has stepped up their inspections of dietary supplement manufacturers. At least 1 in 4 of those companies inspected received a Warning Letter to improve cGMP compliance or suffer regulatory action. This prompted us to prepare a series of presentations that will focus on good manufacturing practices and cGMP compliance for dietary supplements manufacturing. It’s brought to you by the quality and manufacturing experts at InstantGMP in the hope that it will help you avoid any cGMP compliance issues in your shop.
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Instant GMP Compliance Series for Dietary Supplements – Introduction
- 1. InstantGMP Compliance Series for Dietary Supplements Introduction
- 2. Background • Dietary Supplements are orally ingested products that contain an ingredient that is intended to supplement the diet • Not controlled by the FDA until 2007 • By 2010 all dietary supplements had to be in compliance with cGMP requirements • Now 1 in 4 manufacturers inspected by FDA receive Warning Letters • GMP Compliance Series will provide guidance and education Electronic cGMP Manufacturing Execution System 2
- 3. Dietary Ingredients • A ingredient intended to supplement the diet which could be one or more of: – an amino acid – a concentrate or extract of a plant material – an herb or other botanical – An enzyme – A hormonal product – a mineral or a vitamin • Generally available without a prescription Electronic cGMP Manufacturing Execution System
- 4. New Dietary Ingredients • Most dietary ingredients have been around for thousands of years • Some new dietary ingredients have recently been discovered • “New Dietary Ingredients” are ones not sold in US before 1994 • FDA requires pre-market review Electronic cGMP Manufacturing Execution System
- 5. GMP for Dietary Supplements • Required for manufacturing, packaging, labeling, or holding operations • Has to be done per master manufacturing record • Must meet specifications for identity, purity, strength, and composition and limits on contaminants • Does not apply to establishments that only manufacture dietary ingredients Electronic cGMP Manufacturing Execution System
- 6. FDA Regulatory Actions • Details for compliance detailed in the Federal Register • FDA inspects dietary supplement manufacturers • Infractions are cited on an FDA Form 483 • Next step is an FDA Warning Letter • Last step is to force company to halt manufacturing or to close down Electronic cGMP Manufacturing Execution System
- 7. GMP Compliance Series • GMP Regulations are in Volume 72, Number 121 of the Federal Register • A lot to read and understand • GMP Compliance series will focus on hottest issues • Based on FDA Form 483s and Warning Letters • Each of the series will cover one topic in detail Electronic cGMP Manufacturing Execution System
- 8. Highlights of DSHEA Final Rule • Establishes requirements for personnel, facility, equipment and utensils • Requires written procedures (SOPs) • Requires specifications • Requires a quality control unit • Requires master manufacturing records for each unique formulation and batch size • Requires a batch production record for each batch Electronic cGMP Manufacturing Execution System
- 9. FDA Review and Approval • Dietary supplements do not need FDA approval • Except FDA must conduct a pre-market review on new dietary ingredients before marketing • Manufacturers need to register themselves per the Bioterrorism Act with FDA before producing or selling supplements Electronic cGMP Manufacturing Execution System
- 10. Who is Responsible for cGMP? • Firms that manufactures or distributes dietary supplements must: – Make sure their products are safe – Assure that any claims made about them have adequate evidence to show that they are not false or misleading – Register with the FDA – Manufacture their products in accordance with cGMPs Electronic cGMP Manufacturing Execution System
- 11. Basics of cGMPs • Instructions and procedures are clear and unambiguous • Manufacturing processes are clearly defined and controlled • Facilities designed to minimize cross-contamination and mix-ups • Operators are trained • Records demonstrate that all required steps were taken • Distribution minimizes any risk Electronic cGMP Manufacturing Execution System 11
- 12. Manufacturing Facility Compliance • Facility and flow designed to minimize potential contamination and mix-ups • Separate defined areas needed for: – Receipt – Quarantine – Storage – Production – Packaging – Washing Electronic cGMP Manufacturing Execution System 12
- 13. cGMP Inspections • FDA only conducts facility inspections for drug products to be sold in the US • FDA does not inspect dietary ingredient facilities • Sponsor has to qualify their dietary ingredient and component suppliers • Sponsor has ensure cGMP compliance • FDA will only react if they discover a product is adulterated, then they can recall the product or shut down the manufacturer Electronic cGMP Manufacturing Execution System 13
- 14. Differences in cGMP Requirements • FDA regulations for dietary supplements and for pharmaceuticals are issued separately • Drugs have to be pre-approved before marketing, dietary supplements do not • Complete testing needed for drug products; exceptions available for dietary supplements • Equipment and analytical methods have to be fully validated for drugs, but only qualified for dietary supplements Electronic cGMP Manufacturing Execution System 14
- 15. GMP Compliance Made Easy • Document what you do • Do what you document • InstantGMP Compliance series will explore commonly cited failures • We will offer suggestions to avoid common errors Electronic cGMP Manufacturing Execution System
- 16. InstantGMP™ - makes cGMP compliance easy! • Web-based application makes all data visible to everyone at all times • Seamlessly incorporates everything necessary for cGMP manufacturing in one place • Uses built-in quality procedures to check and control cGMP compliance • Provides opportunities for more flexibility, visibility and productivity Electronic cGMP Manufacturing Execution System
- 17. InstantGMP™ Find more videos on cGMP Compliance for Dietary Supplements in the Resource Center at www.instantgmp.com
Notes de l'éditeur
- Since 2010, the FDA has stepped up their inspections of dietary supplement manufacturers. At least 1 in 4 of those companies inspected received a Warning Letter to improve cGMP compliance or suffer regulatory action. This prompted us to prepare a series of presentations that will focus on good manufacturing practices and cGMP compliance for dietary supplements manufacturing. It’s brought to you by the quality and manufacturing experts at InstantGMP in the hope that it will help you avoid any cGMP compliance issues in your shop.
- Dietary Supplements are orally ingested products that contain an ingredient that is intended to supplement the diet. Manufacturing of dietary supplements was not controlled by the FDA until 2007. At that time the Dietary Supplements Health and Education Act became law. It required all manufacturers or distributors of dietary supplements to be in compliance with current cGMP requirements by 2010. This series was started to provide education and guidance for dietary supplement manufactures who want to improve their good manufacturing practices compliance.
- According to the Office of Dietary Supplements at the FDA, ingredients are usually defined as including plant extracts, enzymes, vitamins, minerals, amino acids, and hormonal products that are available without prescription and are consumed in addition to the regular diet.
- The great majority of dietary ingredients have been around for hundreds to thousands of years. There are a few, however, that have recently been discovered and introduced as new dietary ingredients. If these were not sold in the US before 1994, the FDA requires that they are submitted for a pre-market review before being sold.
- The FDA issued their Dietary Supplements Health and Education Act (DSHEA) which went into effect in 2007. It requires compliance with Good Manufacturing Practice (GMP) in manufacturing, packaging, labeling, or holding operations of dietary supplements. Manufacturing Packaging and labeling has to be done as described in a master manufacturing record and then held under conditions that prevent adulteration. Each dietary supplement product must meet specifications for identity, purity, strength, and composition and limits on contaminants. A full description of all cGMP requirements are in FDA’s “Final Rule” on dietary supplements which is available at http://www.gpo.gov/fdsys/pkg/FR-2007-06-25/html/07-3039.htm. It should be noted that these regulations do not apply to establishments that only manufacture dietary ingredients.
- The FDA requirements for cGMP for Dietary Supplements are the laws that come from the Dietary Supplements Health and Education Act. There are 206 pages which contain very detailed descriptions of each of the regulations. The FDA uses this document when they conduct a cGMP inspection of a dietary supplement manufacturer and when they implement a regulatory action. If the FDA inspector notices an infraction during their inspection, they will write a citation on an FDA Form 483. If the citations are not addressed and the infractions are not corrected, the FDA can issue a Warning Letter. The letter warns that if the company fails to come into compliance, the FDA can force them to halt production or can close down the company.
- The cGMP requirements are in Pages 34752 to 34958 of the Federal Register Volume 72, Number 121. This is quite a bit to read and understand so we have used a short cut to focus in on the topics most important to dietary supplement manufacturers. We analyzed the citations written in FDA Form 483s and in Warning Letters sent to dietary supplement companies. We then organized this series of presentations to help educate and inform cGMP Dietary Supplement manufacturers about the most common citations that we found. Each of the cGMP Compliance Series presentations will address the hottest issues in detail one at a time.
- The Dietary Supplement Health and Education Act applies to anyone who manufactures, packages, labels, or holds dietary supplements. The Act establishes the cGMP requirements for personnel, the physical plant and grounds, and for equipment and utensils. One of its most important and most frequently violated sections is the one that requires written procedures (SOPs) for equipment, sanitation, manufacturing operations, quality control, packaging and labeling, and product complaints. It requires specifications be set up initially and then applied in the production and process control system in order to manufacture a product that is considered to be under control. The testing section of the Act allows a certificate of analysis from a component supplier to be used instead of having the manufacturers conduct tests or examinations on the components they receive. It does requires testing of a subset of finished batches of dietary supplements based on a sound statistical sampling or all finished batches and requires a quality control unit to ensure the quality of a dietary supplement. Another requirement that is commonly abused is need to have written master manufacturing records for each unique formulation and unique batch size of manufactured dietary supplements. A batch production record that follows the master manufacturing record must be used every time a dietary supplement batch is made . Most of the warning letters and 483 citations derive from failing to meet these major requirements.
- Dietary supplements do not need approval from FDA before they are marketed unless they contain a new dietary ingredient. The “approved” dietary ingredients are the ones that were on the market prior to 1994. The FDA has a list of these ingredient. If an dietary ingredient is not on the list, the FDA must conduct a pre-market review for safety data and other information before marketing. Regardless of whether their ingredients are on the list or “new”, manufacturers need to register themselves with FDA before producing or selling supplements according to the Bioterrorism Act. http://www.fda.gov/Food/FoodDefense/Bioterrorism/FoodFacilityRegistration/default.htm
- Firms that manufacture or distributes dietary supplements are responsible for ensuring their products were made under compliance with cGMPs. They have to m ake sure their products are safe. They have to assure that any claims made about them have adequate evidence to show that they are not false or misleading.
- The basics of current Good Manufacturing Practices according to International Conference on Harmonization include the following: - Instructions and procedures are clear and unambiguous. - Manufacturing processes are clearly defined and controlled. - Facilities designed to minimize cross-contamination and mix-ups. - Operators are trained. - Records demonstrate that all required steps were taken. - Distribution minimizes any risk
- According to cGMPs, the manufacturing facility’s compliance with cGMPs is the sponsor’s responsibility regardless if they own the facility or contract out the work. They have to make sure the f acility and flow of components around the facility are designed to minimize potential contamination and mix-ups. There have to be defined areas for receipt, quarantine, storage, production, packaging and washing.
- cGMP Inspections of their own facility or a contractor’s facility are the sponsor’s responsibility. The FDA only conducts facility inspections for drug products to be sold in the US. They do not inspect dietary ingredient manufacturing facilities. The sponsor or product owner has to qualify their dietary ingredients and component suppliers and have to ensure cGMP compliance of their own facilities and those of their suppliers. The FDA will only react if they discover a product is adulterated, then they can recall the product or shut down the manufacturer.
- While the cGMP regulations for dietary supplements seem similar to regulations for pharmaceuticals, there are some differences. The FDA issued the regulations for dietary supplements and for pharmaceuticals in separate areas of the Federal Register. A big difference is that drugs have to be pre-approved before marketing, dietary supplements do not. Another important difference is that drug testing must be done for all active components in a product whereas there are exceptions available for dietary supplements. Also, equipment and analytical methods have to be fully validated for drugs, but only qualified for dietary supplements.
- The basics of cGMPs can be distilled down to one concept that can help make compliance easy. If you remember to “Document what you do” and “Do what you Document” you will capture the essence. In this InstantGMP compliance series, we will address the most commonly cited failures and we’ll offer suggestions on how to avoid these errors.
- InstantGMP™ makes cGMP compliance easy! This web -based application makes all data visible to everyone at all times. It seamlessly incorporates everything necessary for cGMP manufacturing in one place that is easily accessed through any internet connection. It uses built-in quality procedures to check and control cGMP 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 cGMP compliance for Dietary Supplements. You can find the rest at the Resource Center at www.InstantGMP.com.