Are Drug Products Safe to use if Manufacture is not CGMP Certified?


Since a consumer is not often able to detect whether a product is safe or if it will work. This is where the CGMP certification comes into play. It ensures that there is a certain level of quality built into the design and the manufacturing process every step of the way to keep the consumer safe. When the facilities are in good condition, the equipment is maintained well, and employees are trained and fully qualified, then the drugs are more likely to be safe. All of these need to be in place before CGMP certification can be given.

However, if there is a company out there who does not comply with the regulations of CGMP, any drug that is made by that company will be seen as adulterated under the law. This kind of adulteration means simply that the drug was not manufactured under compliance with CGMP in some manner. It is not necessarily a sign that something is wrong for the drug.

For the consumers who are currently taking a medicine from a company who has not followed these regulations, the FDA will often advice that they continue to take their drug therapy to avoid serious health complications along the way. This should be followed unless there are serious issues with the product that make it ineffective and unsafe, and then the patient can seek advice from their doctors on switching or stopping the drug.

In some rare cases, FDA will need to take action to stop the manufacture of a violative product. This only happens when the drug is seen to be completely unsafe. But just because the drug manufactured is in violation of a CGMP does not mean that it is unsafe or ineffective. It could be as simple as the equipment not being up to date or a few employees not being fully trained at time of testing.

The CGMP is a good way for consumers to make sure the medications and drugs they take are safe. These standards are really high though, and there are many products that are completely safe and effective that may fail the CGMP during one of the certification processes. Finding out the exact reason that the company failed the CGMP and balancing out the risks and benefits for each medication and how it can help you will be the trick to getting the care that you need.