Featured article by Tom Ricardo, Cloud Practice Director
Consumers extend a certain degree of trust to manufacturers of different food and medicine products. There’s an expectation that what people ingest or use on their bodies is high quality and won’t result in harm. Not only do consumers get a say in the products they use by choosing what they purchase, but governments also play a role in the manufacture of various nutritional and medical goods by setting procedures, standards, and regulations that companies must adhere to.
For consistency and optimal protection, these companies need to utilize trusted tools and techniques that support GxP compliance and help them overcome associated challenges. Businesses can navigate GxP compliance challenges, mitigate risks, and emerge stronger in an increasingly regulated landscape by implementing effective strategies, fostering a culture of compliance, and leveraging modern technologies that account for the complex and demanding process of maintaining compliance with GxP requirements.
What Is GxP?
GxP is an acronym for Good (x=variable, such as manufacturing, clinical, laboratory, etc.) Practice. It refers to regulations and guidelines that ensure the quality, safety, and efficacy of food, pharmaceuticals, and other medical products, such as medical devices and software applications. There are different ways that governing bodies, such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), monitor and enforce these requirements, including mandatory certifications, surprise inspections, and chance audits.
Although complying companies are sometimes given some latitude in creating their standard operating procedures (SOPs), the “bigger picture” guidelines and regulations still need to be checked off the list. Because these overarching standards are not optional for regulated industries (i.e., pharmaceuticals, medical devices, and biotechnology), it’s important to be mindful of data integrity in making product-related safety decisions.
Who’s Impacted by GxP?
GxP standards and regulations impact several industries involved in developing, manufacturing, and distributing products with significant implications for public health and safety. These industries operate in highly regulated environments to ensure their products and services’ quality, safety, and integrity.
From drug development and manufacturing to clinical trials and product distribution, GxP principles influence every product lifecycle stage. By adhering to GxP requirements, industries can demonstrate their commitment to product quality and safety while protecting public health.
GxP compliance is essential for businesses operating in these sectors as it provides a framework for maintaining governing standards and meeting the expectations of regulatory authorities. However, it’s important to note that specific GxP regulations and their applicability may vary depending on the industry and the region where businesses operate.
The industries primarily affected by GxP include:
- Pharmaceutical Industry
- Biotechnology Industry
- Medical Device Industry
- Food and Beverage Industry
- Clinical Research and Contract Research Organizations (CROs)
- Cosmetics Industry
- Animal Health Industry
GxP Compliance Challenges
While GxP standards are crucial for maintaining regulatory compliance, businesses often face several challenges in meeting these requirements. To effectively address GxP compliance challenges, companies must adopt a proactive approach that includes dedicated resources, robust quality management systems, and a strong organizational compliance culture.
Also, it’s essential for businesses to continuously assess their GxP compliance efforts and implement appropriate measures to mitigate risks and ensure ongoing adherence to regulatory requirements.
Common GxP compliance challenges include:
GxP regulations are subject to updates and revisions to stay current. Organizations must invest time and resources to monitor regulatory changes and adapt their processes accordingly.
Documentation and Recordkeeping
GxP compliance involves meticulous documentation and recordkeeping to demonstrate adherence to regulations. Maintaining accurate, complete, and up-to-date records can be even more challenging for large organizations with complex operations.
Training and Competency
GxP compliance requires well-trained, knowledgeable personnel who understand the regulations and follow appropriate procedures. Ensuring all employees receive adequate training and maintain competency levels can be a continuous challenge.
Data integrity is critical to GxP compliance, ensuring that data is accurate, complete, and reliable from generation to storage and retrieval. This is not always easy due to the complexities of modern systems and the potential for human errors.
Many organizations rely on external suppliers and vendors for various components, materials, or services. Managing suppliers’ compliance with GxP standards, including audits and assessments, can get complicated, particularly when dealing with many suppliers.
GxP compliance requires organizations to identify and mitigate risks that could impact product quality, patient safety, or data integrity. Implementing effective risk management processes and integrating them into the organization’s operations is difficult, as it involves assessing risks across multiple functions and making informed decisions.
Implementing processes, equipment, or systems changes is another challenge within a GxP-compliant environment. Organizations must follow rigorous change control procedures to ensure that modifications are properly evaluated, validated, and documented without compromising compliance.
Regulatory authorities conduct inspections to assess compliance with GxP regulations. Being inspection-ready at all times requires continuous monitoring, self-assessment, and preparation. This challenge is significantly greater for businesses operating in multiple locations or with complex procedures.
Defining GxP on AWS: Why AWS for GxP Compliance?
To effectively prioritize and best handle GxP compliance, companies generally follow established procedures and processes that help them maintain quality control and regulatory conformity. Often, they do this by implementing comprehensive systems to ensure the proper maintenance of regulatory compliance and continue producing safe products that work.
Likewise, life sciences organizations increasingly embrace GxP compliance on Amazon Web Services (AWS), a leading cloud computing platform. According to Forbes, many life sciences companies are still clinging to paper formats, with one 2022 survey finding that “over a third of life sciences quality professionals still rely entirely on paper and spreadsheets.”
However, the landscape is expected to change in 2023, with digital transformation remaining a priority. The COVID-19 pandemic was pivotal in alerting the world to the need for heightened digital transformation. According to the article, “Remote audits, decentralized clinical trials, and ‘collaboration from a distance’ since 2020 forced life sciences businesses to experience what the future could look like,” describing the new age workplace as “connected, accelerated, and digitized.”
AWS knows what a fully connected, accelerated, and digitized future can look like, even regarding GXP compliance. Therefore, the massive cloud computing platform offers a secure, scalable, and reliable infrastructure, enabling life sciences companies to leverage GxP principles. Businesses can address their industry’s unique compliance requirements while benefitting from cloud computing’s flexibility and innovation when taking advantage of AWS’s robust services for key GxP-related activities.
GxP compliance on AWS focuses on data integrity, security, privacy, and regulatory adherence. The platform’s wide range of services and features that support GxP requirements include:
- Secure Storage—ideal for storing and processing sensitive research, clinical, and patient data
- Data Encryption
- Access Controls (e.g., identity and access management or IAM and security monitoring)
- Audit Logging
- Validation & Qualification (e.g., AWS Artifact and AWS CloudFormation)
- Regular Compliance Certifications (e.g., HIPAA, GxP, and HITRUST)
Finally, the AWS Compliance Center is a dedicated resource that offers comprehensive information, tools, and guidance to build custom solutions and help with compliance requirements when using AWS. Also, the AWS Compliance Resource Finder can assist customers with compliance requirements and regulations specific to their industry and geographic region.
Overall, life sciences organizations find that AWS provides a solid foundation for GxP compliance. With AWS for GxP compliance, these organizations are empowered to receive the benefits of cloud computing while maintaining the highest standards of quality, safety, and integrity. The cloud-based infrastructure further allows them to focus on core activities like drug discovery, clinical research, and patient care while leaving the technical aspects of GxP compliance to AWS.
Getting Started With Oxford
As an AWS partner, Oxford has proven expertise in specific areas of AWS cloud services. These competencies showcase our deep knowledge, technical proficiency, and track record of success in delivering solutions in specialized categories like Data Science, AI/Machine Learning, Security, DevOps and more. We have demonstrated insights and abilities to provide clients seeking AWS services for GxP compliance with exceptional guidance, implementation, and support.
Additionally, Oxford has proven success within the life sciences industry. For example, we assisted a leading international pharmaceutical company launch a COVID-19 vaccine by implementing automation tools while ensuring GxP compliance at all sites.
We are committed to success because we know we are only as successful as our clients. Therefore, we begin early, positioning our clients to achieve satisfactory outcomes. Our partnership with AWS and our pre-vetting approach to transactions keep us one step ahead of the competition. In other words, we are prepared to meet our clients’ needs before they’ve even contacted us. We have The Right Talent. Right Now. so the businesses we serve aren’t left without the resources they require to meet their goals.
At Oxford, we promise to be with you every step of the way, accelerating your cloud journey and maximizing the benefits of AWS technologies.