GxP Compliance and Third-Party Risk Management
What Is GxP Compliance?
In a time of increasingly global supply chains and the growing risk of disruptions, it has never been more important to ensure that products are safe, meet their intended use, and adhere to quality processes. That’s where GxP compliance comes in. GxP (Good [Industry] Practice) refers to a collection of quality guidelines and regulations created to ensure that products in industries such as pharmaceuticals, medical devices, and food production meet established good practices. Some common types of GxP include:
- GMP (Good Manufacturing Practice): Focuses on manufacturing processes
- GLP (Good Laboratory Practice): Pertains to non-clinical laboratory studies
- GCP (Good Clinical Practice): Related to clinical trials and human subjects
- GDP (Good Distribution Practice): Concerns the proper distribution of goods
- GPP (Good Pharmacovigilance Practice): Relates to the safety of pharmaceutical products
Third-party vendor and supplier risk management professionals in these and other industries should assess and monitor their suppliers’ adherence to these best practices in line with their own organization’s practices to reduce the impact of safety and quality problems that could lead to supply chain disruptions.
This post examines common GxP regulatory requirements; discusses why achieving GxP compliance is important; and reviews best practices for third-party risk management teams to address GxP requirements in their supply chains.
Meeting GxP Regulatory Requirements
Compliance with GxP regulations is a legal requirement in many countries. Non-compliance can result in severe consequences, including fines, product recalls, and legal action. Regulatory bodies hold the primary company responsible for any GxP non-compliance, even if it occurs at a third-party site. There are various GxP regulations and frameworks established by regulatory bodies to ensure that products are produced and controlled according to quality standards. These regulations and frameworks vary depending on the industry and the specific type of GxP involved. The table below summarizes key regulations.
| Category / Regulator | Description |
|---|---|
|
GMP (Good Manufacturing Practice) |
|
|
Regulations for manufacturing, processing, packing, or holding of drugs. |
|
|
Quality system regulation for medical devices. |
|
|
EU GMP (European Union Good Manufacturing Practice) EudraLex Volume 4 |
Guidelines for the manufacture and distribution of medicinal products in the EU. |
|
International standards for ensuring quality and safety of pharmaceutical products. |
|
|
GLP (Good Laboratory Practice) |
|
|
Regulations for non-clinical laboratory studies. |
|
|
OECD GLP (Organisation for Economic Co-operation and Development) |
Principles of GLP to ensure quality and integrity of non-clinical safety studies. |
|
GCP (Good Clinical Practice) |
|
|
International ethical and scientific quality standards for designing, conducting, recording, and reporting clinical trials. |
|
|
Regulations related to the protection of human subjects, IRBs, and investigational new drugs and devices. |
|
|
GDP (Good Distribution Practice) |
|
|
Guidelines for the proper distribution of medicinal products for human use in the EU. |
|
|
Guidelines to ensure the quality of pharmaceutical products during distribution. |
|
|
GVP (Good Pharmacovigilance Practice) |
|
|
Guidelines for monitoring the safety of medicinal products and ensuring compliance with pharmacovigilance obligations in the EU. |
|
|
Regulations concerning post-marketing safety reporting. |
|
GxP and ISO Standards
In addition to government regulations, global ISO standards provide frameworks for quality management systems applicable to GxP, including:
- ISO 9001: Quality management systems requirements
- ISO 13485: Quality management systems for medical devices
- ISO 15189: Quality management for medical laboratories
These regulations and frameworks are designed to ensure that products consistently meet quality, safety, and efficacy standards. Organizations must comply with these regulations to maintain market authorization and ensure consumer safety. Compliance involves stringent documentation, regular internal and third-party audits, employee training, and robust quality management systems.
Uncover SCRM Best Practices for Your Industry
This best practices guide examines SCRM priorities and requirements specific to manufacturing, retail, healthcare, technology, food and beverage, government, pharmaceuticals, life sciences, and biotech.
Why GxP Compliance Is Important
GxP compliance is crucial in industries such as pharmaceuticals, biotechnology, medical devices, and food production. It is a cornerstone of responsible and sustainable business operations in regulated industries and has implications throughout supply chains.
- Ensuring Product Quality: GxP guidelines ensure that products are consistently produced and controlled according to established quality standards. Third parties must comply with GxP standards to ensure the integrity and quality of the final product. This consistency is essential for maintaining the integrity, potency, and purity of the product.
- Protecting Patient Safety: Patient safety is paramount in industries like pharmaceuticals and medical devices. GxP compliance helps to ensure that products and components are safe for their intended use, minimizing the risk of harm to patients and consumers.
- Building Consumer Trust: Adhering to GxP standards helps build trust with consumers and patients. Knowing that a product is manufactured, tested, and distributed following stringent guidelines provides assurance of its quality and safety.
- Avoiding Financial Penalties and Recalls: Non-compliance can lead to costly product recalls, financial penalties, and damage to the company's reputation. Ensuring GxP compliance helps mitigate these risks and avoid the significant costs associated with corrective actions.
- Facilitating Market Access: Compliance with international GxP standards is often required for market access in different countries. It enables companies to distribute their products globally, expanding their market reach.
- Enhancing Operational Efficiency: Implementing GxP guidelines can lead to improved operational efficiency. Standardized procedures and thorough internal and third-party documentation can streamline processes, reduce errors, and enhance overall productivity.
- Supporting Continuous Improvement: GxP compliance involves regular audits, inspections, and reviews, which foster a culture of continuous improvement. This proactive approach helps organizations identify areas for enhancement and implement best practices.
- Ensuring Data Integrity: GxP regulations emphasize the importance of data integrity, ensuring that all records are accurate, complete, and reliable. This is critical for making informed decisions based on trustworthy data.
- Promoting Ethical Practices: GxP compliance promotes ethical practices in the development, manufacturing, testing, and distribution of products. It ensures that companies operate with transparency and accountability not only for their consumers but also within their supply chains.
Third-Party Risk Management and GxP
Third-party risk management solutions play an essential role in addressing GxP compliance when outsourcing critical business functions to third-party vendors, suppliers, and service providers. Consider taking the steps outlined in the following table to meet GxP compliance requirements across the third-party lifecycle.
| Third-Party Lifecycle Stage | Action |
|---|---|
|
Conduct thorough third-party due diligence to ensure potential vendors and suppliers have the necessary qualifications and history of GxP compliance. As part of this process request appropriate certifications and screen for any sanctions, lawsuits or negative news related to the company that could signal a reputational concern. |
|
|
Establish clear third-party supplier contracts that specify GxP compliance requirements, right-to-audit, and expectations. Include clauses that outline consequences for non-compliance. |
|
|
Profile and tier all onboarded suppliers to understand their criticality to operations. Use the results of an inherent risk assessment to guide decisions on conducing further due diligence – especially with top-tier suppliers. |
|
|
Assess third-party supplier quality and safety practices against specific government regulations or industry frameworks. Look for third-party risk management platforms that include libraries of pre-built assessment templates for common GxP compliance regulations along with built-in remediation guidance to reduce residual risk. |
|
|
Continuously monitor third parties to validate their practices, controls and processes. Monitor cyber breaches, operational updates, reputational concerns, and financial news. Perform routine audits to assess third-party adherence to GxP standards. |
|
|
Use measures established during the contracting phase to gauge adherence to established service level agreements, key performance indicators (KPIs) and key risk indicators (KRIs). Establish a cadence of feedback with suppliers that are out of compliance with GxP standards. |
|
|
Implement systems for continuous monitoring and timely reporting of any GxP-related issues post-contract while warranties or other agreements may still be in place. |
Next Steps for Third-Party Risk Management and GxP Compliance
GxP compliance is essential for ensuring product quality and safety, and it significantly impacts third-party risk management. Effective management involves stringent qualification processes, regular audits, clear contractual obligations, and continuous monitoring to mitigate risks associated with third-party non-compliance.
For more information on how your organization’s third-party GxP compliance processes stack up to industry best practices, request a demonstration with Prevalent today. Or, download our strategy guide, Navigating the Vendor Risk Lifecycle: Keys to Success at Every Stage.
It All Starts Here
Ready to see how Prevalent can take the pain out of your TPRM program? Request a free, no-obligation demo today.
Request Demo-
SEC Cybersecurity Disclosure Rules: 9 Key Questions to Ask Third Parties
Ask your vendors and suppliers about their cybersecurity risk management, governance, and incident disclosure processes to...
10/24/2024
-
NIST CSF 2.0: Implications for Your Third-Party Risk Management Program
Enhanced cybersecurity supply chain risk management guidance has arrived with the final NIST CSF 2.0. Check...
09/25/2024
-
NIST Privacy Framework for Third-Party Risk Management
Learn how integrating the NIST Privacy Framework with third-party risk management (TPRM) helps organizations enhance data...
09/12/2024
-
Ready for a demo?
- Schedule a free personalized solution demonstration to see if Prevalent is a fit for you.
- Request a Demo