If you are a small finished product manufacturer, you will face new challenges from June. On June 25, small supplements and vitamin producers join large and medium-sized companies to meet the current GMP (FDA) Good Manufacturing Practice (GMP).
These GMPs really come in for a long time. When it was delivered in 1994, the Nutrition and Health Act (DSHEA) required the FDA to establish and enforce GMPs. But only 13 years later, in 2007, the FDA finally listed them. In 2008, FDA started out with large-scale manufacturers, followed by medium-sized manufacturers in 2009.
Now it's the turn. For Small Vitamin Manufacturers, GMPs also Benefit the Challenges While some of these rules may seem to be difficult, to a certain extent, they are actually a blessing for an industry that is spreading unequal standards and the consumer's mistrust that comes with it. For this reason, many companies have welcomed the enforcement of this long-delayed regulation. Industry experts predict that GMP implementation will improve the image of the industry and increase market stability for food supplements.
However, taking care to survive this tricky year, the manufacturing process may require significant changes. And in any case, you have to have a solid manufacturing partner who is ready to do it.
In order to make sure you have the right partner, there are three strategic questions that ask them about GMP compliance:
1. What is the story of GMPs being used in manufacturing processes and what do you do now to ensure compliance?
Previously, before the FDA GMP came into effect in 2007, manufacturers followed the good manufacturing practices borrowed from the pharmaceutical industry, from other countries or formed informally within the nutrition industry.
Certainly, it is possible that some companies will be able to comply with the FDA's guidelines without limitation. But there are obvious benefits when you work with a partner who has been doing most of the work:
A company that has implemented the GMP guidelines before the FDA is more likely to have a quality engagement. Do you prefer to work with a manufacturer who has invested in quality control rather than forced by regulation?
Secondly, getting the right gear is one thing … Staff are experienced in using equipment … And a corporate culture created by these experienced people – a culture that focuses on and locates problems – even better.
The effective use of GMPs for production requires more than just new equipment or even new staff. It takes on a company that has shaped production to work. Well-proven systems and experienced people are well suited to GMP requirements.
2. Do you use any internal audit method before detecting a problem before an external audit?
At a particular point or place, in cooperation with the manufacturer, the FDA monitors the plant. Hopefully this is going smoothly, maybe some recommendations, but there are no serious problems.
However, the only way to avoid disturbing surprises is to be proactive by checking compliance with the inspector. To this end, see that the supplementary manufacturer has established an internal control system.
With this system, the Internal Audit Team regularly receives surprises from visits to various departments and evaluates their performance. The team reports help you in initiating discussions, solving problems, and improving production procedures. Best of all before the FDA supervisor swallows his neck.
3. How does regulation affect the implementation of production costs and the timetable?
All vitamin producers must make sure they comply with the new regulations. This includes costs such as new equipment, new facilities or the recruitment of new staff. These requirements have also welcomed the new procedures and the implementation of steps such as raw material analysis. Both cost and scheduling can ultimately affect production costs and scheduling.
These new releases are inevitable. Some companies will not be able to meet the new costs and will end up as a result. Those who pass but are looking forward to growing consumer confidence can only increase the continued growth of the food supplement industry.
In the short term, a good partner not only shares with you the increased financial burden, but also works with you to seek cost savings. Sometimes this means that new raw ingredients have to be provided or the production needs to be larger. Perhaps this means that you need to identify the new packaging that will help save shipping.
A good complementary vendor will help you find alternatives that will help you continue production on time without losing a healthy profit margin.
Ask a Companion Producer for a productive partnership These issues
Meeting the new requirements is a challenge for the business in many areas. By working with a good contract manufacturer, however, you can simplify the adjustment of your changes and ensure that your products and business meet.
If you already work with a contract manufacturer, ask your partner about the three questions. This will not only gain the ability to meet your GMP requirements but also your commitment to working with you in delivering high quality products and strong business. This discussion will be successful in your partnership.
On the other hand, if the contract partner partner can not help you meet these requirements for your satisfaction, find out who is capable. You can avoid countless headaches if you are looking for a solid GMP-compliant manufacturer. Use these questions as part of the initial interview process.
Source by sbobet