When you want to work in healthcare industry and want to start your own manufacturing business, you should spend some time learning more about the importance of having a GMP manufacturing facility. A GMP is a system for ensuring that you are manufacturing products while maintaining high quality standards. The main purpose of introducing this system is to lower the risks involved in the production of drugs and medicines.
It is important to educate yourself about GMP. It actually covers all aspects of production, including the starting materials, quality of equipment and training, and personal hygiene of your staff. It is important to have detailed, written procedures for each process to ensure the quality of the finished product is up to the desired level. It is also important for businesses to provide documented proof showing that they consistently follow correct procedures while manufacturing.
Having a GMP Manufacturing Facility
It is worth mentioning that the FDA requires you to follow the GMP regulations, but it does not require you get certified as well. However, it will always improve your reputation if you decide to maintain GMP-certified status. In case you are interested in gaining certification, you will have to disclose your manufacturing facility along with all your records to a comprehensive audit. A third-party organization should conduct the audit.
During an audit, a team of auditors will inspect your manufacturing facility and audit all of the documents, procedures, and employee qualifications. Many third-party organizations are now capable of granting GMP certification, but they will consider many different factors before making a decision. Here are some factors that they may consider before granting a certification.
- They will inspect the design and construction of any physical plants you have.
- They will pay special attention to all the procedures you use to clean and maintain the plant and equipment.
- They will inspect your manufacturing procedures and ensure that they are as per the highest quality standards.
- They will inspect all your testing materials and products.
- They will also consider how you handle consumer complaints.
Once you have passed the audit, your facility will be GMP-certified. However, you need to bear in mind that you will have to undergo regular audits several times a year to ensure that nothing has changed in your manufacturing facility. As you can see, you have to go through a lot of hassle to get GMP-certified, but there are many benefits of taking all the pain. Statistics show that companies that implement a GMP program substantially increase the quality of their products and customer service. They also experience a quick increase in revenues. There may also be a drop in operating costs usually incurred by rework and penalties due to non-compliance issues. Above all, these companies manage to earn the respect and trust of employees, customers, regulators, stockholders, and competitors because they show their commitment to safety.