A Complete Guide to Good Manufacturing Practices

You may have health, safety, and manufacturing efficiency in mind when you run your business, but do you follow good manufacturing practices?

Maintaining high standards is not only good news for your productivity and efficiency, but it also keeps your employees and your customers safe.

Exactly what are good manufacturing practice guidelines and how do they affect your business?

In this article, we’ll explore good manufacturing practices. We’ll also talk about how these essential regulations can benefit your business.

What Are Good Manufacturing Practices?

Current Good Manufacturing Practices (cGMP) in the United States are set out by the Food and Drug Administration. These regulations focus on design, monitoring, and maintenance.

They also look at control in all manufacturing processes and for good standards to be kept at all times.

The onus on these regulations is that you maintain good current standards. That means that you need to maintain best-practice based on the most up-to-date technology. This should be done instead of using guidelines from several years ago.

Who Follows Good Manufacturing Practices?

FDA Good Manufacturing Practice regulations cover a wide range of industries. These includes:

These standards are implemented by manufacturers from around the globe.

What Do the Practices Cover?

The regulations cover a broad range of areas. These ensure that products that can cause a health risk to consumers or the environment are manufactured to the highest standards.

This means the following:

  • Ensuring good standards of hygiene
  • keeping products at the correct temperature
  • Ensuring there is no risk of cross-contamination
  • Ensuring there is no adulteration during the process of manufacturing

Pharmaceutical and biotech companies need to make sure that their products meet requirements. These requirements are for quality, strength, purity, and identity.

These are some of the key areas which are covered by good manufacturing practices:

  • Quality management
  • Quality assurance
  • Good Manufacturing Practice for Products
  • Personnel
  • Validation and qualification
  • Handling complaints.
  • Documentation and recordkeeping
  • Quality risk management
  • Sanitation and hygiene
  • Building and facilities/premises
  • Equipment
  • Raw materials

All businesses must carry out their own internal audits to ensure that they comply with all these key areas.

What are the Penalties For Not Following GMP Guidelines?

Several regulations could lead to criminal charges being sought if they are not met. Two examples of these come from the pharmaceutical industry. They relate to the manufacture of biological products as well as the monitoring of electronic records.

To ensure that good manufacturing practices are met at all times, many companies will create policies and procedures that are designed to maintain a higher standard than those mentioned in the regulations.

Ensuring Your Business is Compliant

All businesses must understand the Good Manufacturing Practices that apply to their specific industry. They should put in place strategies, policies, and procedures that will ensure they’re exceeding these standards.

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