Pharma GxP Audit Services

Ensuring compliance with GxP, ISO, and FDA regulations is critical for pharmaceutical, biotechnology, medical device, and cosmetic industries. X Pharma Plus offers comprehensive GxP audit services, including vendor evaluation, audits, mock audits, targeted assessments, and regulatory audit findings closure, to help organizations maintain robust quality systems and regulatory adherence.

Pharma GxP Audit Services – Overview

Quality in pharma and life sciences is defined by strong GxP practices implemented throughout the product lifecycle.

Organizations face challenges in:

Vendor Evaluation

Verifying compliance of multiple vendors to select the most suitable partner.

Vendor Audits

Assessing existing vendors as part of continual improvement.

GxP Compliance

Adhering to manufacturing (GMP), distribution (GDP), clinical trials (GCP), laboratory (GLP), and process automation (GAMP) standards.

X Pharma Plus supports organizations with tailored GxP compliance consulting, guiding them to interpret and apply GxP guidelines across operational areas and ensuring systems are audit ready.

Services

“End-to-end Pharma GxP Audit Services ensuring adherence to GMP, GLP, and GCP guidelines through systematic evaluation and compliance assurance.”

Multi-site project management under a single audit plan.
Auditing across many areas, including GMP, GCP, GLP, and GAMP.
Vendor evaluation and audit services aligned with US FDA, EU, and emerging market regulations.
Preparing factual and actionable audit reports with clear findings.

Streamlined vendor management and audit processes.
Experienced auditors with subject matter expertise.
Comprehensive coverage of all critical process areas.
Ability to provide end-to-end audit services: planning, execution, reporting, and closure.
Ensures organizations remain audit-ready and compliant with evolving GxP requirements.

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Pharma GxP Audit Services