GMP auditing service is a must-have to run a successful pharmaceutical business, and it can be an overwhelming process when you’re not prepared. This blog will give you some essential steps to prepare for a GMP audit in the pharmaceutical industry.
Pharmaceutical companies will have to pass GMP audits from time to time. Preparing for a GMP audit is indeed a tiresome and time-consuming process. This article consists of essential tips you need to keep in mind to prepare for the GMP auditing service in the pharmaceutical industry.
Steps to prepare for GMP audit in the pharmaceutical industry
GMP stands for Good Manufacturing Practice. The purpose of a GMP audit is to review a company’s compliance with Good Manufacturing Practices or GMPs. GMP audit companies are conducted to ensure that the products and services available to the customers are safe and reliable.
The following are the steps to prepare GMP audit in the pharmaceutical industry –
Ready your documents
An inspector will visit your shop or industry for a GMP audit. Make sure your team has examined all necessary documentation before an inspection in case the inspector requests it. Ensure that all documentation is available and that all copies distributed are current and “controlled copies.” make a list of every document relevant to the auditing process. You will find these detail in detailed GMP audit reports, including batch manufacturing records, Standard operating procedures, master formula records, deviations, change controls, the analysis process, and more.
Prepare a GMP audit plan.
After ensuring your document is ready and updated. Now, prepare a complete proof plan to make your GMP audit successful. It will help you discover your industry’s strengths and present them to the auditors. It is essential to find the strength and weaknesses of the company before the audit.
Pick key people
After making a plan, you should pick one or two persons having detail of the necessary document and every aspect of the company. These people should be responsible for handling auditing and explaining everything to the auditors.
Responsible
You should divide overall work and areas among each member of the company. Everyone should be responsible for the correctness and completion of the work on time and before the audit.
Arrange internal audit
You might remember the final rehearsal before the annual school or college function. Internal audit is the same as the final rehearsal of the school’s annual function. That is why you should arrange an internal audit before the main GMP audit to enhance the confidence of your staff. Internal audits are a foundation of a successful GMP audit.
Conclusion
The GMP is the essential document for pharmaceutical products. If you want to start the GMP audit process, you must first make a list of your processes and understand them, and then you can make the improvement plan according to the GMP audit pharmaceutical requirement. However, a complete guide to preparing GMP audits in the pharmaceutical industry is provided in this article.