GMP regulations require that all manufacturing processes must be documented and can be traced from beginning to end. Complying with GMP guidelines makes sure that companies produce high-quality medicinal products for patients and ensures that risks are minimised in production. For example, GMP minimises the risk of contamination of products, incorrect labelling, and insufficient or excess active ingredient, which could cause adverse reactions or a lack of efficacy.
In this article, I would like to outline the main components of Good Manufacturing Practice (GMP), and how the drug manufacturer must incorporate these into their operations.
Firstly, being able to ensure that the highest quality materials are used through a robust vendor management process is critically important. This results in high-quality end products and having good GMP standards as part of the supplier approval and procurement processes ensure that the products are consistently manufactured to deliver high-quality medicines.
A sound Quality Management System (QMS) ensures that all of the processes carried out in the manufacturing plant such as goods inspection, QC analysis, complaint handling etc., are clearly documented and managed consistently. By obtaining GMP certification, companies verify that the QMS procedures comply with their Competent Authority regulations and meet the highest product quality standards.
Manufacturing sites and laboratories must be maintained to a high standard with regular qualification and calibration of all equipment and machinery. They should ensure that they have a comprehensive internal audit program and conduct inspections to ensure that products are consistently made to a high standard and are tested to ensure their safety and effectiveness.
Not following some of these basic GMP requirements could result in products or pharmaceuticals being recalled which not only impacts patient lives but also the company’s reputation and costs. When implementing a self-inspection program it is a good idea to check that company sites are GMP compliant on a regular basis. Doing this ensures that the site is always up to the latest cGMP compliance standards, i.e. the most current guidelines issued.
Manufacturing procedures will be scrutinised in a regulatory inspection. All processes and procedures need to be checked and revised regularly to ensure that GMP guidelines are followed and that the technology is up to date. These should be written clearly and straightforward to be easily understood by everyone involved in the process. Not having this in place can lead to mistakes by staff which causes problems in the manufacturing process.
Procedures involved in GMP need to be maintained and followed to show that proper processes are being followed and that there is documentation to show this. This documentation is critical during a competent authority inspection. Each process should be shown in detail from beginning to end, and the manufacturing process must be followed throughout each step. Having the documents laid out like this can be used to help with decision making and training and shows that the process is GMP compliant. Not having this in place could lead to mistakes being made, which in turn costs the company in compliance, time and money.
Lastly, staff and training procedures are vital. Having entirely up to date trained staff is paramount in manufacturing pharmaceuticals and medicinal products. Having this in place ensures the site is GMP compliant, ensuring that they are helping to create safe and high-quality products.
Having your site GMP compliant is mandatory for manufacture and distribution in the EU. This shows that the products being made are kept to a high standard in a top-class facility with fully up to date training for staff and procedures and protocols that can be easily followed and are reliable. This ensures good business practice, and not having this in place can have an adverse effect on the company’s reputation. In addition, it is designed to minimise risks that cannot be eliminated in final product testing and shows that each time the product is manufactured it is to the exact same standard as before.
Here at Orion GXP Consulting we have consultants on hand with decades of experience in Quality Assurance and ensuring our clients manage their operations to the highest GMP standards. So whether you need revisions to the QMS, assistance with the audit program or help with facility qualification, we can assist.
To discuss your needs further contact us at info@oriongxp.com or call +353 7198 10101.