Are you looking to get GMP certification for your business? Getting certified is a process that involves understanding and meeting regulatory requirements, effectively documenting procedures, and demonstrating compliance. This guide provides an overview of the steps you need to take to successfully get GMP-certified.
The GMP (Good Manufacturing Practice) system is a set of guidelines for manufacturing drugs and health products. It ensures that your products are made under controlled conditions and that the quality is consistent.
What is GMP Certification?
GMP certification is an internationally recognized quality assurance system designed to ensure that products are consistently produced and controlled according to certain standards. It stands for “Good Manufacturing Practice” and is a set of requirements defined by the World Health Organization (WHO) that must be met for products to meet safety, quality, and efficacy standards. GMP-certified companies have a documented system that shows they are following all relevant laws, regulations, and guidelines.
Check if your business must meet the GMP Certification criteria:
To get GMP certification, you need to determine whether your business meets the established criteria. If you’re in the drug or health product industry, you must meet the criteria. For example, if you want to manufacture pharmaceuticals for human consumption (or animal consumption), then you must be GMP-certified. If you are in any other industry that does not manufacture health products for human or animal consumption—such as medical devices and cosmetics—then you aren’t required to be GMP-certified.
Research the Different Types of GMP Certifications:
There are several different types of GMP certifications, so it’s important to research them and understand the potential benefits. Certification options vary depending on the type of product you manufacture, its intended use, and the country or region in which you do business. Make sure to familiarize yourself with the requirements specific to each type of certification, as they may differ. It is also important to make sure that all of your staff members fully understand what each certification requires.
Understand Contract Manufacturing’s Role in the Process:
It’s essential for those seeking GMP certification to understand the role contract manufacturing plays in the process. When a company contracts with another party for GMP-certified procedures, it’s important to ensure that the manufacturer/supplier adheres to all applicable regulations and quality standards. This includes reviewing documents, negotiating agreements, and overseeing compliance throughout the chain of production. Ensuring proper contract management is a key factor in attaining GMP certification.
Create a Detailed Plan for Meeting GMP Requirements:
After identifying the GMP requirements, you’ll need to create a detailed plan for meeting them. This should include the timeline, tasks, and personnel required. You should also assign resources and responsibilities to ensure that all necessary steps are taken to achieve certification. A good plan will make it easier to remain on track and address any potential issues that arise during the process. Have your plans reviewed by a qualified individual before submitting them for certification.
Develop a Quality Management System (QMS) Plan and Begin the GMP Auditing Processes:
An effective quality management system is central to any GMP certification process. Create a QMS plan to document how each requirement will be met along with the sequence, methods, and tools that your company will use to achieve it. This document should include all processes, procedures, and other resources used to manage quality in your organization. In addition to this plan, begin auditing various processes within your operation by GMP requirements. This can include production, packaging, and labeling activities as well as personnel training and maintenance of records.
How to prepare your business to Undergo a GMP Inspection:
Before your facility is inspected, you need to prepare the business itself for GMP certification. While there are several steps you can take, the most important thing is to clean and sanitize your entire facility. You should also make sure that all equipment and tools are ready for inspection, that all paperwork is organized and up to date (including training records), and that employees have received adequate training on how to adhere to GMP requirements. Finally, records must be available from previous inspections so that inspectors can see how well you maintain them over time.
GMP Audit after Documentation is Reviewed:
After the documentation has been reviewed and approved by your GMP auditor, he or she will schedule an on-site inspection of your business. You should expect to be inspected at least once every two years, but it could also happen more frequently if there are any questions about your product’s safety or quality control procedures.
During the inspection, the inspector will walk through each area of your facility with you, assessing how well you’ve implemented each step of their respective processes—in other words, whether they think that what you’re doing meets all requirements outlined in their Guidelines for Good Manufacturing Practices (GMPs). The inspector may ask questions about things like how often employees wash their hands during production shifts; what kinds of cleaning equipment and chemicals are used; if employees understand proper handling procedures; etc.
What if an issue is discovered during the GMP inspection?
If an issue is found during this visit, then it’s common practice for inspectors to let businesses know beforehand so they can make changes before further action is taken (which includes fines). If everything checks out fine on paper but something goes wrong later down the line—like an outbreak caused by improper sanitation measures —then these incidents can result in immediate shutdowns without warning due to serious public health risks.
How Quality Smart Solutions can help:
We can help you with your pharmaceutic regulatory needs in the United States or Canada. If you’d like to learn more about GMP Inspections, GMP Audits and the GMP Certification criteria contact us.
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