The GMP Certification Audit Process


Posted June 6,2021 in Other.

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Gaining your GMP certification is a long process, but it is meant to check that your production process is safe and that you are providing the high-quality products that your consumers are looking for. When you are ready to begin the process, some of the steps that will happen include:

Getting Started

To become GMP certified, you will be guided by a GMP certification expert. You will meet up with this expert to have a discussion that helps see where your current level of compliance is and can help you pick out the GMP Auditor to get the work done. From there, you can fill out a self-evaluation for the facility, the quality system, and current computer system. When all the forms are done and an Auditor has time to contact you, it is time for the on-site visit.

Facility Evaluation

When ready, the facility evaluation will start. The Auditor will take a look at the production areas and compare them to what you put on your own evaluation form. If you think the facility is in good shape, you can submit the form to the Auditor who will get back to you with the steps you can take next.

While you are waiting to hear back, you will compile the facility and equipment SOPs and then send the table of contents for evaluation to the Auditor. They can review the information and give you some feedback to help you prepare.

Quality System

Your quality system will be made up of the Standard Operating Procedures that can govern how you control and manage the operations. This process is similar to the facility evaluation because there will be a comparison between the quality system and the form you filled out in the first step. You can submit this to the Auditor and submit the SOP Table of Contents for Evaluation too. If this and the facility evaluation look good, then the Auditor will schedule your on-site audit.

Computer Systems

If you use any kind of computer software and hardware to help with the manufacturing process, then this will also need to be evaluated and audited for certification. You will need to send this information in as well.

On-Site Visit

After the Auditor has time to view all of the forms, your on-site visit is scheduled. During this visit, the facility and the equipment documentation will go through an inspection, the quality system is evaluated and compliance with the written procedures is determined. You will receive a written report once the audit is done. If everything looks good, then you will receive your GMP certification.

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