GXP guidelines may seem extraordinarily difficult to follow, given the length, complex language framing, and constant updates. However, staying in compliance is critical for the welfare of everyone involved, from the assembly line employees to the end consumers. Here are the major highlights regarding GXP in the pharmaceutical manufacturing sector. Find out how compliance benefits your operations and more indirectly, your company’s bottom line. And explore our GXP training courses on our website, such as Good Distribution Practice (GDP) and Introduction to Good Laboratory Practice (GLP).
Avoid costly fines
GXP guidelines aren’t merely recommendations; they’re mandatory, and audits do occur. U.S. companies from small businesses to Fortune 500s are subject to their rules. According to a report from the Pharmaceutical Processing World, 26 pharmaceutical companies were subject to fines totaling $33 billion between 2003 and 2016. Offenders included nationally-recognized brands like Pfizer and Johnson & Johnson, which paid $3 billion and $2.7 billion in non-compliance penalty fees, respectively.
That’s not all; between 2015 and 2022, the FDA doubled the number of warning letters sent to companies for non-compliance, according to a report from Technology Networks Informatics. 15% of the violations stemmed from bad data quality in the drug manufacturing process. Fines can be as high as $1 million per incident.
Whether intentional or due to clerical errors, faithfully following GXP guidelines can drastically lower the chances of a failed audit.
Promote patient welfare
The pharmaceutical manufacturing industry produces a range of products, from over-the-counter medications to medical equipment. As the point of origin of these products, it’s your legal responsibility to ensure they are safe for the end user. Good Manufacturing Practices (GMP), Good Clinical Practices (GCP), and Good Laboratory Practices (GLP) outline the procedures for ensuring the safety and efficacy of a pharmaceutical item over its product development lifecycle.
Ensures record traceability
GXP sets guidelines on record-keeping and maintenance. This ensures documentation is available throughout every stage of the production process, from product pre-production to release. A good way to maintain traceable records is through a traceability matrix. This provides a visual way of showing how each process is interlinked with one another. This helps HR and auditors alike review the production process and determine what went wrong in the event of a recall, defect, etc.
Ensures employee accountability
GXP also establishes standards for employee ethics and accountability. The roles and contributions of each staff member are carefully documented. Auditors reviewing the records should be able to identify the role and responsibilities of individual employees. Records need to be specific and should include a log of when the person worked, what this contributor did, and duties during stages X, Y, and Z.
Elearning as a solution for GXP compliance
How does e-learning fit into this? GXP compliance is the responsibility of every member of the workforce. It’s not solely the responsibility of HR and higher-ups. Misconduct or failure of a single member to follow the rules can impact the entire company. However, this can be mitigated if you demonstrate a good-faith effort to train employees on industry-specific guidelines.
Consider these advantages of learning management system (LMS) adoption for GXP training.
1. Automated data traceability and security
Modern e-learning solutions include built-in features like automatic data-saving, data backup, and data mapping capabilities. The data sits in the cloud, and the LMS vendor employs the latest encryption and security protocols in line with GXP mandates. The LMS, in effect, handles the data traceability and accountability aspect, eliminating the guesswork on the user’s end.
2. Maintain FDA and EMS compliance
Strict environmental measures must be in effect when handling medicine, medical devices, etc. The Food and Drug Administration (FDA) and Environmental Monitoring System (EMS) contain regulatory oversight regarding environmental parameters, such as room temperature, pressure, and particle counts. LMSs utilize pre-made course templates with the latest FDA and EMS information available.
3. Create certified courses through diverse media
Pertinent GXP information, such as FDA CFR Part 11 regarding electronic records and signatures, can be found on the FDA official site. However, it’s inadequate to point employees to the link and expect them to read the lengthy manuscript and become experts. LMSs ensure information retention and the ability to employ the knowledge in a real-world setting. This is done through learning modules that incorporate diverse learning strategies that utilize:
- Courses broken down into short digestible nodes
- Visual and interactive media
- Gamification (scoreboards, digital trophies, and other competitive elements)
- Live webinars and remote classrooms
- Instant collaboration via live chats, comments, and conference calls
- Full archive and retrieval of past modules and webinars
Simplify pharmaceutical manufacturing with GXP Training
GXP violations can lead to heavy fines, not to mention they can lead to more audits and damage your hard-built reputation. This is why GXP training is so essential in an industry steeped in regulatory oversight.
At GXP Training, we’ve harnessed the expertise of top-quality assurance professionals to curate an online catalog of certified regulatory trainings, meticulously designed for the exacting standards of highly regulated industries. Our courses are a testament to their excellence and effectiveness. Our catalog encompasses a wide array of individual certifications, 100% online for your convenience. Additionally, our courses are accredited for CPD (Continuing Professional Development) and CEU (Continuing Education Unit) credits, providing professionals in the pharmaceutical sector with the essential knowledge and credentials required to thrive in this rigorously regulated industry. Explore our catalog today to elevate your career and meet the stringent standards of compliance. Contact us today !
