What is the GMP Certification Process?

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What is the GMP Certification Process?

Many customers come to InstantGMP because we provide an efficient way for them to become GMP compliant.  After this is accomplished, they want to know how they can become GMP certified.  Our partners at the GMP Compliance Resource Center can provide a thorough answer.  In the main, the process is described in this article.

Becoming GMP Certified is an accomplishment that shows to the public that you meet the highest standards for manufacturing products regulated by the Food and Drug Administration.  When you receive certification, you can display a GMP Certificate on your company’s website and on your company’s product labels.  This will tell your customers that they are getting high-quality products.

Getting Started

The process for becoming GMP Certified is typically guided by a GMP Certification Expert.  You will first have a discussion that will will help establish your level of compliance and will drive the decision for picking a GMP Auditor to help you.  You will then fill out self-evaluations for your facility, your quality system, and your computer system.  Once the forms are completed, and the Auditor has contacted you, an on-site visit will be scheduled.

Facility Evaluation

The facility evaluation starts with comparing your production areas with the information requested in the Self Evaluation Form for a GMP Facility. If you think your facility is in good shape, you will submit this form to your Auditor who will get back to you with some next steps.  In the meantime, you will compile your facility and equipment SOPs.  You will send your SOP Table of Contents for evaluation to your Auditor who will review your information and give you feedback about your facility’s acceptability for certification.

Quality System

A quality system is typically made up of Standard Operating Procedures and Policies that govern how your operations are managed and controlled.  The Quality System Evaluation process is similar to the facility evaluation.  You will start by comparing your quality system with the Self Evaluation Form.  You then will submit the Self-Evaluation Form to your Auditor.  Next you will compile your SOPs and policies, and submit your SOP Table of Contents for evaluation.

Your Auditor will review your information, and give you feedback about your quality system’s acceptability.  If all submitted forms are deemed acceptable, the Auditor will schedule an on-site audit to complete this part of the process.

Computer Systems

If your company uses computer hardware or software that are a critical part of the manufacturing process, then these will need to be evaluated and audited as part of the certification process.  You will compare your hardware and software to the Self Evaluation Form.  You will then submit the Computer Systems Self-Evaluation Form to your Auditor.  You will also compile your computer system SOPs and submit the SOP Table of Contents for evaluation.  Your Auditor will review your information and give you feedback about your computer system’s acceptability.

On-Site Visit

After all your forms are reviewed, you can talk to your auditor to schedule an on-site visit.  During this visit your facility and equipment documentation will be inspected, your quality system will be evaluated and compliance with your written procedures will be determined.  The Auditor will provide you with a written report after the visit.  If everything is acceptable, your GMP Certification will be awarded.

Industry Standards

Each facility that will be certified must meet the compliance standards of their industry. The Code of Federal Regulations 21 Part 111 requirements governs the manufacturing of dietary supplements.  Biotech and pharmaceutical companies are governed by CFR 21 Part 211.  CFR 21 Part 11 describes the requirements for electronic signatures and electronic documentation.  The Good Automated Manufacturing Practices, Version 5 describe the requirements for computer system validation.

You can compare your compliance with a checklist of compliance requirements in the self-evaluation forms. Not all requirements are needed for all industries. An auditor can review your forms and give you feedback about specific requirements your company must meet.

The GMP Certification Organization is dedicated to promoting awareness of Good Manufacturing Practices (GMP) and encouraging emerging life science industries to enjoy the benefits of producing products that meet the highest quality standards.  Please go to www.gmpcertification.org for more information.