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CGMP Are Good Manufacturing Practices Regulations Enforced By The FDA

CGMP are Good manufacturing practices regulations enforced by the FDA

Understanding Good Manufacturing Practices (CGMPs)

In any industry, quality control is essential to customer satisfaction. However, many industries also face a web of complex regulations and compliance standards, which means poor quality control can result in more than dropping sales. Without embracing modern manufacturing standards, your company can face major legal challenges and lose customer trust.

More Than Regulations: What Good Manufacturing Practices Mean for Your Pharmaceutical Business

In the pharmaceutical industry, quality control is not only a good idea, it’s a government requirement. The FDA regulates all aspects of drug production to ensure quality and consumer safety.  The regulations that control pharmaceuticals and other substances are called Current Good Manufacturing Practices, or CGMPs.

What Are Current Good Manufacturing Practices (CGMPs)?

CGMPs are a series of rules and regulations established by the FDA to guarantee the quality and safety of a product. CGMPs might regulate:

  • Raw material quality and purity
  • Design, monitoring, and control of manufacturing processes
  • Design, monitoring, and control of labs and facilities
  • A company’s process for detecting and investigating product quality deviations

When pharmaceutical manufacturers fail to meet stringent standards, the drugs they produced are considered “adulterated” under the law. In rare cases, the company must stop all production and distribution. Clearly, failure to comply is undesirable.

However, meeting compliance standards don’t just help companies avoid legal consequences. CGMPs can also make a business’s operations run more smoothly. Following good manufacturing practices can help prevent the following inefficiencies and problems:

  • Product recalls
  • Drug contamination
  • Packaging mix-ups
  • Quality deviations
  • Operation or equipment failures
  • Equipment and human errors

How Human Error Solutions Can Help Your Company Comply With Current Good Manufacturing Practices

Compliance with CGMPs is essential to the success of any pharmaceutical business or company under GMP regulation. As experts in preventing costly errors and operational problems, Human Error Solutions has helped many companies maintain a record of compliance. Here are a few services we offer that can help:

Our consultancy can make recommendations before the FDA inspects your facilities and processes. When the time comes for evaluation, your team will be prepared to pass with flying colors.

For more information about how Human Error Solutions can help your business reduce human error and manage CGMPs, give us a call today.