How To Get a GMP Certification

How To Get a GMP Certification

Pharmaceutical quality affects every individual who takes medications, dietary supplements, or utilizes other drug products. Consumers assuredly expect that the drug they receive meets quality standards for safety and efficiency. To do so, the U.S. Food and Drug Administration (FDA) has established certain best practices called current Good Manufacturing Practices (cGMP). The manufacturing, packaging, and labeling of pharmaceuticals must follow these standards.

GMP Manufacturers must officially register with the FDA and follow regulations that the FDA enforces for GMP compliance. However, the FDA does not issue an official GMP certification program to acknowledge full compliance. This is where third-party leaders become operative by offering certification opportunities. Here’s more information about how to get a GMP certification.

What GMP Is All About

GMP is an acronym that stands for Good Manufacturing Practices. Once again, these best practices cover all the encompassing aspects of the production process. Examples include raw materials, a production site, manufacturing equipment, personnel on-site training, and drug distribution.

No consumer desires lackluster products that fail to meet standards and achieve results. Therefore, it’s critical for proper conditions to be met to ensure built-in quality at each step of the production cycle.

Steps To Becoming GMP-Certified

Following Good Manufacturing Practices is ideal, but it's often not enough. Manufacturing facilities should become GMP-certified from a leading quality organization within the pharmaceutical industry for quality control.

If you’re wondering how to get a GMP certification, be aware there are several lengthy steps involved in the process. Organizations must meet a high level of compliance through self-evaluations of standard operating procedures, comprehensive facility inspections, or audits, as well as GMP-related documentation.

After an auditor issues certification, a company must continue to demonstrate its commitment to current GMP (cGMP) standards. Earning GMP certification is advantageous for marketing and company reputation. This certification also displays an ongoing responsibility of going above and beyond to ensure quality products. A GMP-certified logo on a product increases a consumer’s confidence in an enterprise long-term.

GMP-Certified Manufacturers

The organizations that go to great lengths to ensure quality control are the GMP-certified manufacturers of the industry. For those needing to outsource their production needs, the benefits of working with such manufacturers for projects can enhance credibility and image, enable improved operational habits, and optimize management capabilities in quality assurance.

For a GMP-certified manufacturer that you can trust, contact Moravek. With over 40 years of compound labeling and synthesizing experience, we are a dependable contract manufacturing organization of APIs. Our work continually supports worldwide medical and clinical trial research. Contact us to learn more about our services and quality system.