What is a cGMP Violation?
cGMP stands for Current Good Manufacturing Practices. These are the rules and regulations that pharmaceutical companies must follow when manufacturing human drugs, medicines and other pharmaceutical products. These rules are intended to make sure that pharmaceutical products are safe, fit for consumption, and meet label claims.
The federal government has published the cGMP rules at 21 CFR parts 210 and 211. The rules set forth the minimum standards for the manufacturing of pharmaceuticals, including the following:
- Companies must ensure that the people engaged in the manufacturing of pharmaceuticals have the proper training and background to do their jobs.
- Companies must have ongoing training for employees regarding cGMP standards.
- Companies must have a procedure to ensuring that the raw ingredients used on the assembly line are actually what they purport to be.
- Companies must use, maintains and follow a master formula for each and every pharmaceutical product.
- Companies must use and maintains batch records to record the precise ingredients, amounts of ingredients and processes followed in the manufacture of each batch of pharmaceutical products.
- Companies must have a testing process in place that tests the product for purity and strength, in the middle of the manufacturing process and at the end of the manufacturing process.
- Companies must have procedures to test the active ingredient in each pharmaceutical product. If the product contains two little active ingredient, the product is sub-potent. If the product contains too much active ingredient, the product is super-potent.
- Companies must have procedures to ensure that manufacturing facilities are clean and not contaminated.
- Companies must have procedures to ensure that machines used in the manufacturing process are properly maintained and calibrated.
- Companies must have scientific testing procedures and data to determine pharmaceutical stability. This refers to the amount of time that a given pharmaceutical maintains its strength.
- Companies must have procedures to ensure proper labeling. In other words, the company must have procedures to make sure the right label gets on the right bottle.
- Companies must have quality control personnel responsible for supervising the manufacturing process for compliance with cGMP rules.
If a pharmaceutical company violates the CGMP rules, the end result product can be considered adulterated within the meaning of the law.
Moreover, a violation of cGMP rules could lead to a qui tam whistleblower lawsuit under the False Claims Act. This is particularly true if the violations are so extensive or severe that the product does not meet label claims. In that scenario, the representations on the label are false. Moreover, in the case of government programs such as Medicare and Medicaid, the pharmaceutical company has caused others, namely, pharmacies, doctors and other healthcare providers, to submit false claims to the government for reimbursement of adulterated pharmaceutical products.
Most importantly, this type of fraud puts patients at serious risk. Doctors and patients trust that pharmaceutical products are safe and that they actually contain the proper amounts of active ingredients listed on their labels.
Please Note: McCabe Rabin, P.A. provides these FAQ’s for informational purposes only, and you should not interpret this information as legal advice. If you know about government fraud and want advice as to how the law might apply to the specific facts and circumstances of your case, please click here to contact one of our attorneys.