GMP Training and CGMP Audits

 

Good Manufacturing Practices (GMP) is something that every production facility strives to attain and maintain. But what happens if your manufacturing processes shift, you onboard new employees, or you face a CGMP audit? These can be good reasons to get additional GMP training for your team.

What Is GMP
GMP refers to a system of practices that guarantees that the manufacturing process is controlled and consistent, and that quality standards are met. GMP is also often referred to as “cGMP,” with the “c” standing for current – an accent that emphasizes that importance of staying current on best practices as they evolve.

The origins of GMP began in the early 1900s as the Food and Drug Administration began to enact legislation that was designed to protect consumers. Over time, the FDA’s role has become more prominent.

Today, GMP practices are applied to many types of manufacturing, including pharmaceuticals, aerospace, semi-conductors, medical devices, and more. Some companies choose to incorporate GMP voluntarily, while others are required to implement GMP practices because of compliance or regulatory requirements.

Most GMP systems include protocols that include:
•materials
•equipment
•facility
•personnel

Importance Of GMP Training
Ideally, GMP training is “baked into” your GMP implementation. But processes change, regulations are added or modified, new members are introduced to the team, people become forgetful or complacent – these situations and more drive home the importance of ongoing GMP training.

When guidelines are put into place to ensure that strict practices are followed, consistently, by everyone, from start to finish, quality and efficiency are the results.

CGMP Compliance Audits
To ensure compliance with cGMP standards, cGMP audits are conducted. These cGMP audits can be internal audits, supply chain audits, or regulatory audits (performed by a cGMP regulator). The purpose of a cGMP audit, simply put, is to ensure that the manufacturing facility is in compliance with regulatory standards and industry standards.

GMP Training – One-Day Course
In order to provide a value-added service to our cleanroom, lab, and manufacturing clients, we’re pleased to offer a 1-day, comprehensive course on GMP training and how to prepare for a cGMP audit. Held at our facility in the Denver metro area, this GMP training includes components on:
•how to prepare for a cGMP audit
•site presentation (including systems and utility validations)
•quality management systems (including SOPs, work instructions, and risk management)
•manufacturing processes (including equipment, cleaning, and production controls)

If you have any questions about our GMP training course or cGMP audits, please contact us at (303) 752-0056 or info@cleanroomworld.com. 

Click here for a schedule of our upcoming GMP training courses and cleanroom training courses.

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