GMP Supplement Manufacturer and Other 3rd Party Certifications
We offer many options when needing a GMP certified facility to manufacture your product . Whether that is a 3rd party certification from the Natural Products Association (NPA), National Sanitation Foundation (NSF), SQF, Organic and more, we have you covered.
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What is a GMP Certified Manufacturer?
What exactly does the term mean? Why is it so important to choose a GMP Certified Manufacturer? What could go wrong when your manufacturer isn’t GMP certified?
Simply put, GMP – short for Good Manufacturing Practice – is a set of guidelines that manufacturing companies should follow to ensure safety, purity and effectiveness of their final products.
But understanding the GMP regulations and how they apply to your situation could be tricky. If you search the internet for “What is a GMP certified manufacturer?” – You can easily get overwhelmed with information overload. Most of that information is not even related to what you are looking for.
But you don’t have to drink from the fire-hose! We have already done the hard work for you.
Here are six things you need to know before you start looking for a GMP certified manufacturer.
1. What is a GMP certified manufacturer?
A GMP certification validates a manufacturing company’s commitment to set and maintain quality standards in every step of their manufacturing process. For a pharmaceutical manufacturer to be GMP certified, they must prove that their manufacturing procedure meets the minimum requirements for producing high quality products safe for human consumption. Doing business with a GMP certified manufacturer gives you the peace of mind that all products are well-tested, free from contamination, safe for human use and correctly labeled.
2. What is CGMP?
Most countries have their own regulatory bodies to monitor and enforce good manufacturing practices (GMP) in pharmaceutical productions. In the United States, the Food and Drug Administration (FDA) is responsible for the job; and their GMP guidelines are called Current Good Manufacturing Practices or CGMP.
As the term suggests, CGMP guidelines recommend that a manufacturer should use the latest or “current” tools and techniques to ensure the safety and effectiveness of their final products. Typically, the FDA inspects a manufacturing facility every two years and gives a GMP compliance rating to the manufacturer. That brings us to the next question.
3. What are the different types of CGMP compliance rating by FDA?
The FDA issues mainly three types of compliance rating – VAI, NAI and OAI. Imagine you want to hire a GMP certified supplement manufacturer for your pharmaceutical company. How would you know their current compliance status? And what do the ratings VAI, NAI and OAI actually mean?
First of all, you can visit the FDA’s “Inspection Classification Database Search” page to find out the manufacturer’s current compliance status. If the manufacturer was rated VAI, which stands for Voluntary Action Indicated, it simply means that the FDA is happy with their quality standards but still recommends some voluntary actions to improve their current system. Similarly, NAI means No Action Indicated. But if the status says OAI, short for Official Action Indicated, you can tell that the company’s operating procedures do not completely comply with CGMP guidelines.
4. What are some basic guidelines that a GMP certified manufacturer should follow?
A GMP certified manufacturer needs to have a solid system in place for implementing good manufacturing practices. However, the company is free to decide how they want to meet the GMP requirements in their respective countries. In other words, companies have the flexibility to create and implement their own GMP guidelines. But most guidelines have similar goals, such as,
- To keep the manufacturing areas clean and hygienic
- To use premium quality raw materials
- To prevent contamination and mix-ups
- To keep good records of all activities
- To perform regular audits
- To establish effective testing and quality management systems
- To keep the machinery tools calibrated and in good working condition
- To create well-written standard operating procedures (SOPs) for employees
- To establish a system for detecting any product quality deviations
5. Why do we need GMPs when we already have quality control testing?
Testing of finished products in a quality control laboratory is a great way to detect poor quality medicines. However, it is practically impossible to test every product for quality. For instance, from a batch of 3 million capsules, maybe only 200 will be tested for quality. Even if they clear the test, that doesn’t guarantee every product in that batch has the same quality.
That’s exactly why it is important to implement, monitor and enforce good manufacturing practices (GMPs) in every step of the manufacturing process. Suffice to say, GMPs help prevent errors from occurring in the first place rather than simply detecting errors afterwards.
6. What steps can FDA take against a manufacturer that doesn’t follow CGMPs?
If the FDA notices any CGMP violations during its inspection to any manufacturing facility, it can request the company to recall its products. However, the FDA cannot force a recall.
Typically, the manufacturer will remove the products in question from market upon FDA’s request. But if they decline the request, then the FDA can publish a warning letter to the public. In FY 2018, the FDA published 89 warming letters for CGMP violations.
The FDA can even take legal action against the company for CGMP violations. Depending on the severity of the violation, the FDA can file a seizure, an injunction or even a criminal case in court.
A seizure case often leads to a court order that requires immediate removal of the drug from the market, while an injunction case often results in a court order that requires the company to take immediate actions to rectify or upgrade its manufacturing process, tools and technology. Criminal cases may even result in fines and jail time.
Now you know why it is so important to choose a GMP certified manufacturer for your pharmaceutical company. If you are planning to sell or distribute generic drug products in the United States, also make sure that your manufacturer pays the Generic Drug User Fee Act (GDUFA) fees.