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GxP Compliance

Assess and continuously monitor quality and safety in your supply chain

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. Common types of GxP include:

  • GMP (Good Manufacturing Practice) focuses on manufacturing processes. Examples include US FDA 21 CFR Parts 210, 211 and 820; EU GMP EudraLex Volume 4; and WHO GMP.
  • GLP (Good Laboratory Practice) pertains to non-clinical laboratory studies. Examples include US FDA 21 CFR Part 58 and OECD GLP.
  • GCP (Good Clinical Practice) is related to clinical trials and human subjects. Example regulations include US FDA 21 CFR Parts 50, 56, 312, 812; and ICH GCP E6(R2) Guidelines.
  • GDP (Good Distribution Practice) concerns the proper distribution of goods. Example regulations include EU GDP and WHO GDP.
  • GPP (Good Pharmacovigilance Practice) relates to the safety of pharmaceutical products. Example regulations include EU GVP and US FDA 21 CFR Part 314.
  • ISO standards, including ISO 9001, ISO 13485 and ISO 15189.

The Prevalent Third-Party Risk Management Platform combines regulatory-specific assessments with continuous monitoring of supplier risks to address multiple GxP regulatory requirements throughout the supplier lifecycle

Relevant Requirements

  • Ensure the integrity, safety and quality of products

  • Mitigate the risks of costs and corrective actions

  • Ensures transparency and accountability throughout the supply chain

  • Promote ethical practices in the development, manufacturing, testing, and distribution of products

Key Features for GxP Compliance

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    Sourcing and Selection

    With the Prevalent TPRM Platform, you can conduct thorough third-party due diligence to ensure potential vendors and suppliers have the necessary qualifications and history of GxP compliance. Build a central supplier profile that includes demographic information, ESG scores, business and reputational insights, sanctions and compliance history, data breach history, and financial performance to inform risk-based supplier selection decisions.

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    Inherent Risk Scoring

    Use the Prevalent Platform to profile and tier all onboarded suppliers to understand their criticality to operations. Use the results of the inherent risk assessment to guide decisions on conducing further due diligence.

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    Intake and Onboarding

    Leverage Prevalent to establish clear third-party supplier contracts that specify GxP compliance requirements, right-to-audit, and expectations, including clauses that outline consequences for non-compliance.

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    Risk Assessment and Remediation

    Assess third-party supplier quality and safety practices against specific government regulations or industry frameworks using the library of more than 750 assessment templates available in the Prevalent Platform. Use built-in remediation guidance to recommend risk mitigations to suppliers.

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    Continuous Monitoring and Validation

    The Prevalent Platform enables you to continuously monitor supplier cyber breaches, operational updates, reputational concerns, and financial news, while performing routine audits to assess third-party adherence to GxP standards.

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    SLA and Performance Monitoring

    With Prevalent, you can establish and measure key performance indicators and key risk indicators, while establishing a cadence of feedback with suppliers that are out of compliance with GxP standards.

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    Offboarding and Termination

    Implement systems for continuous monitoring and timely reporting of any GxP-related issues post-contract with Prevalent while warranties or other agreements may still be in place.

2024 Pharma Quote Feature Image

We are looking to build out a single pane of glass view for risk. We’re planning to utilize Prevalent to consolidate as many of our vendor tasks into one tool, because I don’t think there is anything else out there that can do that.

— Cybersecurity Manager, Enterprise Pharmaceutical Organization

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