Tips to Pass GMP Certification Audit Easily!

Would you like to know how to easily get your GMP certification? Whether you are present in any country, and how to pass the audits of this certification easily? And the things you have to remember when getting your best tips to clear the GMP certification. Getting any certification or registration for a manufacturer is very important in terms of running your business smoothly. The GMP audit preparation for manufacturers is one of them.

If you are a businessman who is doing business in the pharma, food, or health-related sector, then the certification of GMP becomes an important thing for you. And during the process of getting your certification. If you are facing issues in your audit processes, and you don’t know how to deal with them.

So, in this blog, you will learn how to pass a GMP audit easily. Some tips and their processes.  The auditation of GMP certification is not that hard; you only have to follow some easy steps, or implement some things in points in your production unit, and then you can make GMP certification yours easily. But if any issue or non-compliance is found in your manufacturing unit, then we can say that it becomes a longer process for your production unit. 

1. Some Points for Passing Your GMP Certification Audit Smoothly

If you are struggling or facing problems in passing your audit easily. Then, in that case, learn some tips and tricks that help you in your auditing step. Firstly, make sure your manufacturing unit is always prepared for audit and for ensuring it conducts regular internal audits in your facility, always make sure that the staff who are working in your unit, whether it is workers and employees, are fully trained. Regularly organize and prepare all of your documentation and facilities.

For easy auditing, focus on some key areas like cleanliness, proper labeling, and the quality management system etc. And always make sure that your unit is adhering to GMP compliance and address any issues proactively.

Some detailed tips for smooth auditing are as follows:

Maintains your staff and quality systems

1. Always ensure that your staff is fully trained on GMP principles and that you have the necessary documents for your facility to perform their jobs correctly.
2. Familiarize the GMP standards in your production unit that apply to your facility, including any relevant laws, regulations, and your own policies.
3. Before the audit of your unit, perform simple internal audits in terms of identifying and correcting any compliance gaps. And also use a systematic approach with the help of a checklist.
4. When you implement all these tips in your production unit, then conduct a real GMP audit preparation for manufacturers with the help of a supervisor who acts as an inspector to identify areas where your manufacturing is facing issues and processes are unclear.

Maintain your documents and your facility

1. Before going for your real audit, ensure all areas in which you can include walls, floors, and equipment are fully clean and are in good condition. And also keeps your housekeeping in the facility up to date.
2. Verify that every Standard Operating Procedure (SOP) is up to date, regulated, readable, and easily available.  Create a method for approving and controlling document changes.
3. Ensure that all your systems and machines are in place, which depicts the accuracy and integrity of all data, which involves audit trails for electronic systems.

Prepare yourself for the audit

1. Checks the previous reports of audit and inspection, and checks that the mistakes that you made previously are not happening now in your facility.
2. Inform your authorized body about your audit’s scope, schedule, and what you expect from them.
3. Explains to the auditor the clear view of your quality processes. That provides the auditor a transparent and organized overview of your processes to make them smoother.
4. Make sure you have all your necessary records of your operations, such as training records, batch records, and equipment records, in the form of organized and ready form for review.

2. Also, Get Some Tips on the GMP Certification Online Process

Now, you have some tips on auditing, and also get some tips for your GMP process also because before auditing, the process is also important. Mainly, the process of getting it is kinda not that easy because it includes many steps, through which you can get your GMP certification easily. There is no shortcut for getting GMP certification in India, but there are some tips that speed up your GMP process, which include adopting a quality-first culture and becoming “audit-ready” long before the official inspection.

Common issues that impact the process of GMP audit preparation for manufacturers are that they do not have proper documentation, inadequate training, and poorly maintained facilities. Because of these, they face serious problems in their production unit.

Some more tips for your GMP certification process before and after the audit are mentioned below:

GMP processes before your audit

1. Creates a “war room” – War room means choose and create a room from your facility in which you can easily store your documents, like your organizational chart, site master file, SOPs, and training, so that you can easily access them.
2. Make yourself transparent – Invite the auditors in your unit, and answer their questions directly, so that which doubts are cleared about your facility. But avoid offering unnecessary information.
3. Conducts a walk-through – Support your auditors and provide them with a separate person who answers their questions. And use that opportunity to demonstrate your systems and records in action.
4. Observation – Then those auditors will find any deficiency and non-compliance in your facility. Creates a plan for you to correct and prevent actions. Then provide them with a documented commitment to fixing these issues.

GMP processes after your audit

1. Fix non-compliances – When your audit is done and if any non-compliance is found in your facility, execute a CAPA plan for responding to any observations from the audit.
2. Maintain your facility – GMP is a regular commitment to quality rather than a single event.  Conduct routine internal audits to maintain compliance and continuously enhance your processes.
3. Improvement – Take the help of audit findings and other performance data to regularly improve your performance in your manufacturing processes. 

3. Get Audited, Apply for GMP Certification with LegalRaasta!

We are an authenticated company that provides a ton of services to entrepreneur founders and manufacturers. We also offer GMP certification services, enabling you to obtain GMP certifications easily. Startups and scaling companies have the opportunity to avail of GMP audit preparation for manufacturers at LegalRaasta without any hassle for every business owner or seller. Finding a trusted GMP certification and product safety provider isn’t easy; there really aren’t that many out there. And surely, we’re one of them.

4. Frequently Asked Questions

Do these tips really help me in my GMP audit and process?

Ans. We can say that these tips fully provide you with your GMP certification. But we can also say that these tips help you a lot in your audit and process.

Is the audit of GMP certification hard?

Ans. If your facility is fully prepared before your GMP audit, it is prepared for the manufacturing process. Then it will surely not be hard for you.

What must I do for my smooth audit?

Ans. Nothing, just make sure that your facility is following all rules and regulations, that’s it.

Does my certification get rejected if any issue is found in my unit?

Ans. No, you can easily take your time to fix those issues and non-compliance in your facility.

After the audit, how much time does it take to issue my certification?

Ans. It depends on your other process, and normally it takes up to 3 – 12 months.