Demonstrate your commitment to product safety with a Good Manufacturing Practices (GMP) certification. Become an industry leader with trusted products and satisfied consumers. Discover how long your GMP certification lasts to know when it’s time to renew it.
What Is a GMP Certification?
A GMP certification is critical to support your facility's success. The certification identifies facilities that fully comply with all FDA regulations and have the proper systems to produce pharmaceuticals and dietary supplements with quality standards and control.
This certification appeals to industries that require manufactured products. More importantly, it guarantees consumers receive trustworthy products—they don't have to worry about drug impurities harming their bodies. The certification indicates products of higher quality than ones without a GMP-certified label.
How Long Do They Last?
The certification process includes analyses, reviews, and audits. Once your manufacturing facility meets requirements, your GMP certification lasts up to three years. It’s worth obtaining a certification because it increases the protection of your brand, fosters a culture of product safety, and demonstrates your commitment to quality.
People consume pharmaceuticals and dietary supplements to improve their well-being. Consumers have peace of mind knowing their products are safe under FDA regulations.
The Certification Process
Manufacturing facilities must apply for certifications on the GMP Certification Organization website. The organization sends an auditor to facilities, and they evaluate different processes. They define how the lab must improve through a series of audits. Here’s a closer look at the evaluations:
Quality Systems Analysis
The auditor confirms the manufacturing facility has the required Standard Operating Procedures (SOPs). They also verify that documents are clearly written to prevent misunderstandings or vagueness.
Computer Systems Analysis
Next, the auditor analyzes the manufacturing facility’s computer system. Facilities need valid systems that fit their needs and effectively complete tasks.
Facilities Analysis
Expect a thorough evaluation of the facility, equipment, and on-site materials. The auditor inspects the facility to verify that the floor plan and personnel flow prevent adulteration and cross-contamination.
Equipment Log Review
The auditor inspects the equipment logs to ensure personnel properly use tools. They also confirm people maintain and calibrate equipment. Lastly, the auditor evaluates the facility’s warehouse to verify inventory control.
Personnel Review
The auditor conducts a detailed evaluation of facility personnel. They review each operator’s training records and examine any relevant documentation.
Receiving the Certification
Every facility receives an audit report that illustrates the findings and lists violations or problems. The facility must resolve deficiencies to receive the certification. Afterward, the GMP Organization performs another audit to ensure the facility meets requirements. Once compliant, the facility receives the certification!
Contact Moravek for GMP 14C API manufacturing and other pharmaceutical manufacturing needs. Our team of highly skilled radiochemists is here to help you!