Good Manufacturing Practice (GMP) refers to the Good Manufacturing Practice Regulations asserted 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, food, and blood take measures to warrant that their products are safe and effective to consumers.
GMP regulations demand a quality approach to manufacturing, allowing companies to reduce and eliminate contamination risks and mistakes. These regulations protect the consumer from buying a defective product, such as a defective duodenoscope or insulin pump. Failure to observe GMP regulations can result in severe penalties, including recall, seizure, fines, and jail time.
What Are Some of the Requirements of This Quality Assurance Program?
When designing the device, the manufacturer should have procedures requiring the user and patient to be considered 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 consider this when designing the device. In addition, manufacturers should review the ease of use of their product by coming up with tests/surveys that collect data about the use of the device in the real world.
How Can Manufacturers Achieve the Requirements?
Manufacturers can complete the requirements needed by the Quality Assurance Program by having a group of individuals who would represent the potential operators in the real world, test out the device and then remark on its ease of use.
Manufacturers must also assess the risk of using the device to know 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 a qualified group of potential operators tests the use of the device.
Liability in Manufacturing Defects
To bring a lawsuit for a manufacturing defect, you must demonstrate:
- There was a defect in the manufacture.
- The defect caused an injury.
- There were no alterations to the product by the consumer to cause the defect.
If the consumer proves all these elements, the plaintiff may win their case and be awarded appropriate damages caused by the product defect.
Companies that intentionally fail to comply with GMP regulations might violate the False Claims Act if false claims for payment were submitted to programs like Medicare, Medicaid, and TRICARE, for the contaminated drugs.
What Is Manufacturing Law?
Manufacturing laws are those laws and statutes that relate to the manufacturing industry. While much has been made of the downfall of manufacturing in the U.S. over the past 50 years, the sector remains an integral part of the American economy and legal landscape. Manufacturing contributes nearly $2 trillion yearly to the country’s gross domestic product. There are substantial amounts at stake in cases of manufacturing practices.
Product Liability
Some manufacturers, especially automakers, are a significant issue dealing with alleged product defects. These cases can be very lucrative for plaintiffs’ lawyers, so they are of exceptional appeal to those specializing in personal injury and auto cases. An entire industry has grown up around the legal profession for these cases, including the experts and testing methods required to resolve whether the blame for an accident is the fault of a manufacturer or driver.
Consolidation
Because of the changing face of American manufacturing, consolidation has been a movement for manufacturers for several years. As such, manufacturing regulations can also be considered to bleed into corporate formation, governance, and mergers. When one business acquires or unites with another, it may not merely acquire its assets but also any liability for the products it manufactured before the merger.
Advertising and Marketing
Another area manufacturers often have to be mindful of is the regulation of marketing and promoting their products. The Federal Trade Commission (FTC) monitors these matters. It promulgates regulations, such as what advertisements must say and must not, discouraging inaccurate and deceptive claims, measures for representations about “green” products, etc.
Employment and Labor
Of course, no product can reach the market without the work of human beings. That means there is always an opportunity for problems connected to employment and work. Indeed, manufacturers are often excellent targets for organized labor problems like unions, collective bargaining, and strikes.
The manufacturing industry faces many difficult legal challenges, and regulations that affect these industries cross into other legal practice areas.
Considerations in GMP Auditing
The following is a quick list of things to do as an auditor:
Maintain and Use a Written SOP for GMP Auditing
Designating a written audit procedure will help assure that all audits are performed consistently and that they meet the minimum conditions. The audit process is your roadmap to a successful audit. Some details you could include in an audit process might be the commonness of audits, the systems to check, whether audits are announced or unannounced, and who should be retained on the audit team.
Assure Confidentiality of Outcomes
Ensuring the confidentiality of the audit and audit reports results is extremely important as an auditor fosters a good relationship with the people you will be auditing. Ensure that they know you are not trying to unsettle or catch them doing something bad. Remind them that the goal of your audit is to review systems to make sure that there are no lapses in quality and that the results will not be used in a way that targets people publicly. In most circumstances, even the FDA will not be able to glance at internal audit results.
Make Sure That All Auditors Have Proper Qualifications
GMP rules mandate that workers be appropriately qualified (through proper training, education, experience, or a combination thereof) to do their jobs. Therefore, it should be documented that auditors can adequately conduct their duties.
Eliminate Any Conflicts of Interest
Integrity is one of the essential characteristics of a reasonable auditor, and preserving integrity necessitates eliminating any conflicts of interest you may have. The most typical conflict of interest for an internal auditor is when they have accountability for an area being audited. External or supplier auditors can encounter other conflicts of interest, including having a family member or friend who works for the business, owning a substantial amount of stock in the business, or having previously worked there.
Address Scheduling Issues
When considering when to schedule audits, make sure you do a GMP audit at least once a year. Also, you will have to choose whether to do an announced or unannounced audit. Unannounced audits are more standard.
Assume a Cooperative and Non-Confrontational Fashion While Auditing
The position of an internal GMP auditor is to help the business by confirming that all proper quality and GMP specifications are being adequately met. Therefore, work to establish a good working relationship with those you audit.
Seeking Legal Help
If a defective product has injured you, you should consult with a defective products lawyer in your local area. If a company seeks to comply with GMP, an attorney can help you understand your obligations and protect you from potential legal actions. Use LegalMatch to find the right lawyer for your needs today.
