Ensuring GxP compliance in pharma is no easy feat — especially when you account for regulatory disparities and supply chain complexities. In this article, we help pharmaceutical companies standardize their operations, centralize their resources, upskill their employees, and create a thorough trail of GxP evidence. All of which can help to improve inspection outcomes, reduce recalls, and enhance market success.
After years of research and development, testing, and wrangling supply chains for the correct materials, you’ve finally perfected your latest drug… Or so you thought. At the final hurdle, your product is taken off the shelves of every chemist in the country.
Why? Because you failed to comply with the relevant GxP regulations.
This is a common occurrence in the pharma industry. According to a recent analysis of FDA drug recalls, the most frequent reason for removing products from the market were “sterility issues and inadequate compliance with current good manufacturing practices (cGMP).”
Beyond wasting time and money, GxP non-compliance can seriously harm your company’s reputation. Not to mention impact hundreds if not thousands of customers and patients.
In this article, we’ll help you tighten GxP compliance, standardize your operations, and improve your inspection outcomes.
Depending on your services, you may be required to comply with a swathe of different “good practice” standards, including GMP, GLP, GCP, and GVP. Throughout these touchpoints, every team must ensure quality management, operational consistency, data integrity, governance, training, and auditability.
On top of this, you must also contend with the following challenges:
Needless to say, there are a lot of plates to spin. And it isn’t easy to spin them all at once.
To overcome GxP compliance challenges and increase your chances of market success, you must strengthen and standardize your operations wherever possible.
Here’s how.
Disparate documents and fragmented tools undermine your data integrity and cause company-wide confusion. Without one source of truth to hold everything together, compliance breaks down.
To prevent this from happening, digitize and store your knowledge in one mobile-friendly location. That way, everyone from lab technicians to qualified persons and data specialists can access the materials they need to uphold GxP compliance. What’s more, you’ll have one source of truth to share with auditors whenever an inspection rolls around.
Secure digital workplace solutions are an ideal home for this knowledge. With dedicated applications for internal communications, policies, SOPs, and project documentation — as well as secure extranet capabilities and granular user permissions — you can share the right resources, with the right people, in the right way.
Every procedure, document, and policy needs an owner. These owners must rigorously review and update their respective documents when necessary — whether it’s to reflect SOP changes, regulatory updates, or new findings from R&D trials.
To ensure every document is up to date, use content and policy management applications that streamline review cycles, notify owners of upcoming deadlines, and automate version controlling. This mitigates the risk of employees following outdated and non-compliant guidance.
Your SOPs and policies are meant to be read more than once. But if your staff find them too inaccessible, they won’t be able to.
UX improvements to your digital workplace, such as menu and layout changes, can help with this. But to enhance knowledge discovery and accessibility even further, consider adopting AI capabilities.
AI search can help staff find the resources they’re looking for in seconds. There’s no need to type precise keyword-based queries either, as the system understands user sentiment and intent. On top of this, policy and document chatbots can simplify complex jargon and summarize content for quick dissemination. All of which improves competency and, as a result, regulatory compliance.
Auditors need hard proof that every team member has read and accepted your policies and SOPs. Verbal acknowledgment isn’t enough.
To gain concrete evidence, use a policy management application with acceptance mechanisms built in. When distributing a new policy or SOP, the application will notify the relevant employees and request they open, read, and “check” each document. Every acknowledgement is captured within the system, ready for inspection.
Training is crucial for socializing policies, cementing SOPs, and upskilling team members. It’s also an area that auditors scrutinize closely during their inspections.
To cover all of your operational and regulatory needs, we recommend distributing a blend of in-person and e-learning training. The former is useful for walking employees through responsible equipment handling, drug testing protocols, and laboratory cleaning practices. Whereas the latter can be helpful for explaining regulatory obligations, company policies, data handling best practices, and inspection procedures.
A learning management system (LMS) enables you to coordinate both types of training. With the right platform, you can:
When operational or regulatory changes do occur, it’s easy enough to update course materials and arrange new events. This encourages you to stay proactive.
Inconsistent operations are often a precursor to non-compliance. To prevent deviations and ensure employees follow the correct protocol each and every time, create standardized tools and templates.
With a no-code business process automation platform, you can:
By turning written SOPs into robust, repeatable templates, you can enhance efficiency, capture GxP compliance evidence, and streamline inspections.
The best way to improve your inspection outcomes is to conduct your own trial runs.
These internal audits and assessments should rigorously test every aspect of your operational workflows — especially those related to GxP regulations. This includes (but certainly isn’t limited to); laboratory and equipment maintenance procedures; SOP and policy distribution; testing protocols; data integrity; system security; materials production and sourcing; and so on.
In addition to this, conduct risk assessments to ensure that you’re prepared for any unexpected incidents. For example, supply chain disruptions, spikes in consumer demand, or cybersecurity breaches.
During these assessments, make a note of any instances of non-compliance, including noncomforties, incomplete or falsified records, product defects, unsafe operating conditions, inconsistent procedures, and similar. It is then your responsibility to enact Corrective and Preventative Actions (CAPA) in order to prevent these issues from reoccurring.
The earlier you can spot an issue, the earlier you can fix it.
By unifying your data in one dashboard, you can keep tabs on compliance at all times.
These dashboards should include a blend of data points, including training completions, policy acceptance rates, and process-specific status updates. For example, recent internal inspection logs, test results, and supplier checklists. When the data doesn’t look right — or an employee flags non-compliance — you can then work towards fixing the issue.
GxP regulations are complex by nature. Where patient safety is concerned, they have to be.
Although maintaining compliance is challenging, there are ways to simplify the process.
With a secure digital workplace like Claromentis, you can centralize your knowledge in one source of truth, standardize your operations, and bring clarity to your compliance efforts.
Here’s how that looks in practice:
Want to learn more about our digital workplace for regulated industries? Schedule a quick requirements call and platform demo with one of our experts.