InstantGMP Makes cGMP Compliance Easy for Dietary Supplements
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InstantGMP is a manufacturing execution system that helps dietary supplement companies comply with cGMP requirements in an easy and cost-effective way. It incorporates all manufacturing processes electronically to provide flexibility, speed, and real-time information access. Using built-in quality procedures and automated compliance checks, it reduces errors, deviations, and the costs of compliance compared to traditional paper-based systems. The web-based application makes all manufacturing data visible at all times to streamline operations and increase quality and productivity for dietary supplement companies.
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InstantGMP Makes cGMP Compliance Easy for Dietary Supplements
- 1. InstantGMP Compliance Series for Dietary Supplements Cost of Compliance
- 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. 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
- 4. 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 4
- 5. 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
- 6. Cost of cGMP Compliance • FDA calculated economic impact of cGMPs on dietary supplement industry • One time burden to establish written procedures = 56,000 hours • Annual burden for record keeping = 930,000 hours • Cost per establishment was worked out for different sized companies Electronic cGMP Manufacturing Execution System
- 7. Cost per Establishment by Size Number of Annual Setup Annual Employees Revenue Costs* Costs* Small <20 Under $1 $26,000 $46,000 Establishment million s Medium 20 – 500 $5 to $10 $20,000 $184,000 Establishment million s * Excluding capital equipment and improvements Electronic cGMP Manufacturing Execution System
- 8. Challenges of cGMP Manufacturing – High cost of compliance – Good Manufacturing Practices are complex – Wide array of regulatory requirements – High time and cost to set up quality system – Long cycle times for QA review and corrections – Training and compliance to SOPs is lengthy – Documentation coordination and data tracking is laborious InstantGMP™ is the manufacturing execution system that has been built from the ground up to meet these challenges and to make cGMP easy! Electronic cGMP Manufacturing Execution System
- 9. InstantGMP™ Electronic cGMP Manufacturing Execution System • Seamlessly incorporates all manufacturing processes in one place • Provides flexibility, speed, real-time access to information • Uses built-in quality procedures and automated cGMP compliance • Accelerates startup of new cGMP operations or rapid conversion from paper based manufacturing to an electronic system Electronic cGMP Manufacturing Execution System
- 10. Benefits of InstantGMP™ • Reduces the risk of cGMP compliance issues • Uses electronic documents and logs instead of paper • Controls quality and compliance via software • Reduces errors, omissions and deviations • Provides opportunities to reorganize and to streamline processes • Increases throughput, quality and margins Electronic cGMP Manufacturing Execution System
- 11. 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
- 12. Quick Facts • Developed by the manufacturing and quality experts at PharmaDirections • Web-based application • Also available for in-house installation • Full set of Standard Operating Procedures and Policies available with system • 21 CFR Part 11 Compliant • Software has been in use since 2004 Electronic cGMP Manufacturing Execution System
- 13. InstantGMP™ Find more videos on cGMP Compliance for Dietary Supplements in the Resource Center at www.instantgmp.com
Editor's Notes
- This presentation is one in a series of presentations that 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.
- 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
- 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.
- The cost of cGMP compliance was calculated by the FDA when they drafted the DSHEA. The regulations for dietary supplement cGMPs in the Federal Register compliance contain estimated costs of compliance on small businesses depending on their size. They figured there would be a one time burden of 56,000 hours for all dietary supplement manufacturers to establish written procedures. They also figured that all companies would need to allow 930,000 hours for record keeping. They then used the total number of companies of different sizes to work out the economic impact on each type of company.
- Very small firms with less than 20 employees and annual revenue of under $1M should plan to spend about $26,000 to set up their compliance systems and about $46,000 to maintain them each year. Medium size establishments with 20 – 500 employees and $5M to $10M in annual revenue should plan to spend about $20,000 to set up their systems and about $184,000 each year to maintain them. The estimates took into account that medium size companies would already have most of the required systems in place whereas the small firms would be starting from scratch.
- The high cost of compliance is due to the challenges of cGMP manufacturing. Good Manufacturing Practices are complex with a wide array of regulatory requirements. There is a lot of time needed and typically a high cost to set up a quality system. After the system is established, there is a lot of documentation toe keep up with and there are often long cycle times for QA review and corrections. Initial training on cGMPs and ongoing compliance to SOPs is time consuming. Fortunately, InstantGMP™ is a manufacturing execution system for cGMP manufacturing that has been built from the ground up to meet these challenges and to make cGMP compliance easy!
- InstantGMP™ is an electronic cGMP Manufacturing Execution System that can be used for production of dietary supplements and pharmaceuticals. It seamlessly incorporates all manufacturing processes in one place where it is visible all the time to everyone via a cloud-based application. It provides flexibility, speed and real-time access to information. It uses built-in quality procedures and automated cGMP compliance. It can accelerate the startup of new cGMP operations or allows rapid conversion from paper based manufacturing to an electronic batch record system.
- There are many reasons that companies will want to adopt a manufacturing execution system or replace their paper system. InstantGMP can reduce the risk of cGMP compliance issues. It allows you to use electronic documents and logs instead of paper. The system controls quality and compliance with multiple checks and processes built into the software. It is more efficient than manual systems because it can eliminate the redundant process and forms that occur in manual systems. It can help you reduce errors, omissions and deviations especially in the batch production records. Probably the most important advantage is that a transition to an electronic system can provide opportunities to reorganize and to update processes to make the whole plant work better. All of these benefits taken together will result in increased throughput, quality and margins.
- 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.
- InstantGMP was developed by the manufacturing and quality experts at PharmaDirections. It is a cloud based web application that is also available for in-house installation. A full set of Standard Operating Procedures and Policies are available with system to allow a start up to get into compliance instantly. The entire application is completely validated and is 21 CFR Part 11 Compliant. This software has been in use since 2004 and has recently undergone a complete refresh and update.
- 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.