GxP is the heart and soul of how we do business in regulated industries. GxP is a general abbreviation for the “good practice” quality guidelines and regulations. The “x” in the term stands for the various aspects of good practice that are essential to the operation of a compliant organization.
What exactly are Good “x” Practices? This all-encompassing term, GxP, actually includes GAO – Good Agricultural Practice, GMP – Good Manufacturing Practice, GLP – Good Laboratory Practice, GSP – Good Supply Practice and GDP – Good Distribution Practice. They each are a set of practices that comply with regulations and industry standards that ensure that your products are as effective as claimed and are pure and defect free throughout their entire lifecycle.
Every country to include the US through the FDA has their own set of governing GxP regulations. Some of these practices are harmonized with others while some are not. They are not guidelines…they have the weight of law. They essentially dictate how every aspect of product development, production, and distribution is executed.
The purpose of these regulations? It is very simple – to ensure that foods, medical devices, medicinal products are safe and effective. Achieving this safety and effectiveness requirement however is not so simple. It is achieved by implementing what is known as a Quality System consisting of many regulatory requirements as specified in the governing regulations that must be:
- Documented in the form of Standard Operating Procedures and Work Instructions
- Integrated into the fabric of how the business executes the activities required to place a medical/medicinal product into the marketplace
- Be managed on a daily basis to ensure the organization’s compliance to the tenants of the regulation
- Be provable when externally audited to verify its effectiveness and compliance with the regulation
How do GxP’s relate to the Quality System? The quality system documents all of the policies, processes, procedures, and assigned responsibilities that are required for the organization to be compliant and meet all of their regulatory responsibilities. The Quality System is the bridge between all of the relevant GxP regulations and the reality of the operation.
Why You Should Attend:
This virtual seminar will examine all of key aspects of this subject as it relates and can contribute to efficient, effective, and compliant operations. Topics such as Complaint Handling and CAPA, documentation and documentation control and the role they play, and change control will be addressed during the 6-hour presentation. The quality system itself will also be discussed in terms of its critical importance, its contents, and its structure.
If you work within the life sciences or even the food industry, almost everything that you do every day is somehow touched by GxP practices. Ignorance of their importance, their application to what you do, and how they govern each facet of your product’s lifecycle is no excuse for non-compliance. It takes a complete thorough understanding to ensure your compliance. This virtual seminar will provide that level of understanding and some basic guidance to assure compliance. FDB3388
