What is GVP in GMP?

GVP (Good Vigilance Practices) refers to a set of regulatory guidelines aimed at ensuring the ongoing safety monitoring of medicinal products once they reach the market. Within the broader GMP (Good Manufacturing Practices) framework, GVP plays a critical role in pharmacovigilance—the science and activities related to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problems.

GVP is essential for maintaining patient safety and product efficacy after a drug is authorized, and complements GMP, which ensures consistent product quality during manufacturing.

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The Relationship Between GVP and GMP

While GMP governs the manufacturing, testing, and quality assurance of pharmaceuticals, GVP focuses on post-marketing safety monitoring. Together, they form a comprehensive quality system that safeguards public health from production to patient use.

Integrating GVP into GMP frameworks helps organizations ensure both regulatory compliance and continuous product improvement.

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Key Components of GVP in GMP Context

1. Adverse Drug Reaction (ADR) Monitoring

Pharmaceutical companies must have systems to collect, assess, and report adverse events related to their products. This includes:

• Spontaneous reporting

• Patient-reported outcomes

• Healthcare professional feedback

2. Risk Management Plans (RMP)

Under GVP, companies must develop RMPs to identify, characterize, and minimize the risks of medicinal products. These are often required during the approval process and updated post-marketing.

3. Signal Detection and Evaluation

GVP mandates the continuous monitoring of data to detect potential new risks (“signals”) and assess their impact on the product’s benefit-risk balance.

4. Periodic Safety Update Reports (PSURs)

PSURs (also known as PBRERs) are submitted to regulatory authorities to provide a comprehensive review of a drug’s safety profile at defined intervals.

5. Qualified Person for Pharmacovigilance (QPPV)

Organizations must appoint a QPPV responsible for ensuring compliance with all pharmacovigilance obligations, including GVP adherence.

6. Corrective and Preventive Actions (CAPA)

In case of safety issues, CAPAs must be documented and implemented as part of the continuous improvement process—bridging the gap between GMP and GVP.

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Why GVP Matters in a GMP-Compliant System

1. Enhances Patient Safety
   GVP ensures ongoing monitoring of drug safety, helping to prevent harm and improve patient outcomes.

2. Regulatory Requirement
   Regulatory bodies like the EMA, FDA, and Health Canada mandate adherence to both GMP and GVP standards.

3. Supports Product Lifecycle Management
   GVP is critical to managing a product’s lifecycle, especially for post-marketing surveillance and ongoing benefit-risk evaluation.

4. Promotes Transparency and Trust
   A robust GVP system fosters accountability and builds trust among healthcare professionals, regulators, and patients.

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GVP and Global Regulatory Bodies

Good Vigilance Practices are codified by several authorities:

• European Medicines Agency (EMA) – EU GVP Modules I-XVI

• U.S. Food and Drug Administration (FDA) – 21 CFR Part 314 & 600

• Health Canada – Guidance on Post-Market Surveillance

• ICH Guidelines – E2E Pharmacovigilance Planning

Companies operating internationally must align their pharmacovigilance systems with multiple regulatory requirements to maintain market authorization.

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Best Practices for Implementing GVP Within GMP Frameworks

• Integrate Quality Management Systems (QMS) across manufacturing and pharmacovigilance functions.

• Train cross-functional teams on pharmacovigilance and GMP requirements.

• Conduct audits and inspections to identify GVP-GMP compliance gaps.

• Leverage digital tools for real-time safety monitoring and reporting.