Good Manufacturing Practice Regulations

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What Is the GMP Regulation?

Good Manufacturing Practice (GMP) refers to the Good Manufacturing Practice Regulations declared by the US Food and Drug Administration under the authority of the Federal Food, Drug, and Cosmetic Act. The legal regulations require that manufacturers, processors, and packagers of drugs, medical devices such as hip implants, some food, and blood take required measures to warrant that their products are safe and effective to consumers.

GMP regulations require a quality approach to manufacturing, enabling companies to decrease and eliminate risks of contamination and errors. These regulations protect the consumer from purchasing a defective product, such as a defective duodenoscope or a defective insulin pump. Failure to follow with GMP regulations can result in very serious penalties including recall, seizure, fines, and even jail time.

What Are Some of the Requirements of This Quality Assurance Program?

When designing the device, the manufacturer should have procedures that require that the user and patient be taken into consideration when the product is designed. The product must be reasonably easy for the operator to use.

Sometimes the operator is the patient herself, so the manufacturer should take this into account when designing the device. In addition, manufacturers should check the ease of use of their product by coming up with tests/surveys that gather information about the use of the device in the real world.

How Can Manufacturers Achieve the Requirements?

Manufacturers can achieve the requirements needed by the Quality Assurance Program by having a group of people who would represent the potential operators in the real world, test out the device and then comment on its ease of use.

Manufacturers must also assess the risk of using the device so that they are aware of the kinds of dangers it could pose to a potential operator or patient. After a basic design analysis, this can be assessed by the same method mentioned above in which the use of the device is tested by a qualified group of potential operators.

Liability in Manufacturing Defects

To bring a lawsuit for a manufacturing defect, you must prove:

  1. There was a defect in manufacture.
  2. The defect caused injury.
  3. There were no alterations to the product by the consumer to cause the defect.

If all these elements are proven by the consumer, the plaintiff may win their case and be awarded appropriate damages that was caused by the product defect.

Companies that knowingly fail to comply with GMP regulations may be in violation of the False Claims Act if false claims for payment were submitted to programs like Medicare, Medicaid, and TRICARE, for the contaminated drugs.

Seeking Legal Help

If you have been injured by a defective product, you should consult with a personal injury attorney. If you are a company seeking to comply with GMP, an attorney can help you understand your obligations and can protect you from any potential legal actions.

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Last Modified: 11-25-2015 07:39 PM PST

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