The FDA calculated the costs of Good Manufacturing Practice (GMP) when the Food Supplement Health and Education Act (DSHEA) was first made. The food supplement GMP specifications in the federal register include the estimated cost of compliance according to which the business will take place depending on the size of the business. The FDA estimates that dietary supplements spend a total of 56,000 hours as a one-off load in writing procedures. In addition, 930,000 hours were estimated for all companies to keep track of their records. The FDA then used this data to calculate the economic impact of companies of different sizes
Cost of Building Size
Small Installations (with less than 20 employees, $ 1 million in annual revenue)
= $ 26,000
Annual Costs = $ 46,000
Medium Enterprises (20-500 Employee Annual Sales Revenues $ 5M – $ 10M)
Costs = $ 20,000
with less than 20 employees and an annual revenue of less than $ 1 million, it is expected to spend nearly $ 26,000 for initial setup of compliance systems and nearly $ 46,000 a year to keep systems up and running. Medium-sized facilities with 20-500 employees earning $ 5 million and $ 10 million in annual revenue should plan to pay $ 20,000 in cost structure and $ 184,000 to maintain their systems each year. These estimates assume that medium-sized companies already have the most required systems and small businesses are starting from scratch.
Differences in GMP Requirements
While the GMP rules for supplements are similar to drug specifications, there are some differences. The FDA issued the rules on supplements and medicines in a separate area of the Federal Register. The big difference is that the drugs must be approved by the FDA before marketing, while dietary supplements do not. Another important difference is that all active ingredients of a medicinal product must be drug tested, but there are exceptions to dietary supplements. In addition, equipment and analytical methods must be fully validated for drug preparations, but only need additional products. The general effect is that it is less costly for dietary supplement manufacturers than pharmaceutical companies.
Good manufacturing requirements are complex and wide-ranging regulatory requirements that are challenging to meet new standards. Initial setup and annual maintenance require a lot of human time, which entails a high cost to start up and maintain a quality assurance system. Once the system is in place, there are often many documentation for long-term quality reviews and evaluations of corrections and changes. In addition, the training of GMP and SOP employees is time consuming but necessary to ensure compliance. Manufacturing implementation systems have been created with electronic bundling software to make GMP manufacturing standards easy and to alleviate many of these challenges
Electronic Manufacturing Systems Reducing Costs
Manufacturing Execution Systems and Electronic Bundling Software can greatly reduce the cost of manufacturing GMP food supplements. Manufacturing software systems seamlessly integrate all manufacturing processes in one place. When it's web-based, all the data is constantly visible to everyone through the cloud. Provide flexibility, speed and real-time access to information. There is a system that incorporates built-in quality procedures and automated GMP compliance and includes full standard manufacturing procedures. It can speed up the launch of new GMP operations or allow rapid paper-based production to be transformed into an electronic cGMP manufacturing implementation system
There are several reasons why companies want to accept a manufacturing implementation system that is an electronic bundle paper system. GMP manufacturing software can reduce the risk of GMP compliance problems. They allow the use of electronic documents and diaries instead of paper. The system checks the quality and multiple checks and the built-in processes. It's more effective than manual systems because it can eliminate the redundant processes and shapes that occur in manual systems. It can help you reduce errors, omissions and differences, especially in batch production records. Probably the most important benefit is that switching to the manufacturing implementation system will give you the opportunity to reorganize and update processes so that the whole plant works better. All of these benefits together bring greater performance and quality and reduce compliance costs
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