Simply put, GxP is an abbreviation for “good practices.” What does this have to do with compliancy? Certain manufacturers, like food and drug producers, should follow these “good practices” to be GxP compliant, meaning they have improved safety, product quality, and data integrity. GxP compliance guidelines cover topics like laboratory, manufacturing, research, distribution, and clinical practices and can vary widely from organization to organization.
Closely following GxP guidelines can help you improve business operations across your organization.
Your GxP Compliance Checklist
While GxP applies to different activities and industries, there are some commonalities all types of GxP share:
Data integrity: Just as you can’t trust everything you read on the internet, you can’t trust every piece of data within an organization. This is where establishing robust data integrity can help. Data integrity occurs through GxP-compliant processes and ensures the accuracy, security, and recency of the information being used to inform business operations.
Quality management systems (QMS): A QMS serves as a home base for the many different factors of GxP. It provides a convenient platform for assessing quality and saving records.
Documentation: Keeping careful records is necessary for many businesses and types of GxP. Does your business have solid recordkeeping policies and procedures in place?
In addition to these important factors, here are a few questions you’ll want to ask yourself about your organization:
Good Manufacturing Practice (GMP): GMP guidelines help manufacturers create consistently high-quality products that fit their intended use and meet authorization requirements for marketing and clinical testing. You should ask:
Do your employees have clearly defined roles and appropriate training?
Are your processes well-documented and defined?
Is equipment calibrated for performance, cleaned regularly, and logged accurately?
Good Clinical Practice (GCP): All stages of clinical work must be ethical and scientific as outlined by appropriate regulatory organizations. These requirements address questions like:
Is your trial based on evidence and run by qualified personnel?
Does it offer more benefits than risks?
Are records easily accessible?
Good Pharmacovigilance Practice (GPvP): GPvP is about monitoring products after they enter the market. Typically, GPvP works closely with your QMS.
Do you have a dedicated pharmacovigilance department or individual to collect data, monitor performance, and prevent adverse effects?
Good Distribution Practice (GDP): To keep quality and data integrity throughout your supply chain, you’ll want to ask questions like:
How are your products stored?
How are theft and contamination prevented?
What does the recall process look like?
These are just a few instances of GxP, but many others exist, from storage and auditing to agricultural and recruitment practices.
How Kinetix Can Help You Establish GxP
Abiding by GxP requirements is essential if you want to avoid fines, legal action, safety problems, and damage to your reputation in the industry. Here at Kinetix, our experts can help you establish robust GxP by improving data integrity and implementing documentation systems like QMS and GxP-compliant cloud software. As a one-stop-shop for IT services, we’ll create solutions tailored to the unique GxP landscape that applies to your organization.
To start talking with an IT expert and improving your GxP management, reach out today!
