Third Party Audits

Third Party Audits

Third Party GMP Audits and Pharmaceutical Compliance Audits in India

Third party audits protect your organisation from hidden compliance risks within supply chains and manufacturing partnerships. We conduct independent audits on your behalf to ensure auditees remain aligned with GMP and regulatory expectations. Our audits support API, biotechnology, and pharmaceutical operations facing USFDA, EU GMP, MHRA, TGA, EDQM, MFDS, COFEPRIS, HEALTH CANADA and PMDA scrutiny.

We do not conduct superficial reviews. We examine systems, documentation, validation practices, and data integrity controls in depth. Our objective remains clear. We help you maintain supplier reliability and regulatory confidence.

We bring APIC-certified auditors with strong experience in active pharmaceutical ingredient manufacturing and global compliance standards. Our auditors understand process validation, impurity control, deviation management, and quality risk systems. This expertise allows us to assess technical areas beyond surface-level documentation checks. When weaknesses appear, we identify root causes and recommend structured corrective actions. Strong audit findings prevent regulatory exposure before inspections arise.

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Our audit process includes pre-audit planning, on-site evaluation, and detailed reporting. We review quality manuals, batch records, laboratory controls, and change management systems. We assess facility conditions, equipment qualification, and environmental monitoring practices. Each observation is documented clearly with risk classification and corrective recommendations. This structured approach supports transparent supplier communication.

We also assist in supplier qualification and requalification programmes. Our audit reports help you make informed sourcing decisions. When suppliers understand audit expectations, compliance behaviour improves. Our third party audits strengthen regulatory readiness across your supply chain. By identifying risks early, we protect approvals, maintain product quality, and preserve long-term compliance stability.

What CPC Offers

Supplier GMP Compliance Audits

Supplier GMP Compliance Audits

We conduct detailed on-site audits to assess quality systems, validation practices, documentation controls, and overall GMP compliance.
APIC Certified API Audits

APIC Certified API Audits

Our APIC-certified auditors evaluate API manufacturing controls, impurity management, process validation, and regulatory alignment.
Pre-Approval and Due Diligence Audits

Pre-Approval and Due Diligence Audits

We perform structured audits before supplier selection, acquisitions, or regulatory submissions to identify compliance gaps.
Corrective Action and Follow-Up Reviews:

Corrective Action and Follow-Up Reviews:

We support observation response planning, verify corrective actions, and monitor supplier improvements to maintain compliance stability.

How Can We Help You?

We protect your supply chain through independent third party audits that strengthen compliance and reduce regulatory risk. Our audits provide clear insight into supplier quality systems and operational controls.

We work closely with your teams to ensure audit findings translate into corrective action and sustainable compliance stability.

Independent GMP Compliance Audits:

Independent GMP Compliance Audits:

We conduct structured supplier audits to evaluate quality systems, validation practices, and documentation control against global GMP standards.

APIC Certified API Evaluations

APIC Certified API Evaluations

Our APIC-certified auditors assess API manufacturing processes, impurity control, and regulatory compliance across critical production areas.

Risk-Based Due Diligence Reviews

Risk-Based Due Diligence Reviews

We perform pre-selection audits to identify compliance risks before partnerships, acquisitions, or regulatory submissions.

Corrective Action Verification and Monitoring:

Corrective Action Verification and Monitoring:

We review remediation plans, verify corrective measures, and monitor ongoing improvements to sustain supplier compliance confidence.

Chemical Third Party Audits Support

Chemical Third Party Audits Support

  • GMP Compliance Audit for Chemical Manufacturing Sites
  • Process Safety and Hazard Control System Evaluation
  • Raw Material Supplier Qualification Audits
  • Impurity Control and Analytical Laboratory Assessment
  • Data Integrity and Documentation System Review
  • Change Control and Deviation Management Audit
  • Stability Study Compliance Verification
  • Effluent and Environmental Control Audit
  • Pre-Approval Audit for Regulatory Submissions
  • Corrective Action Follow-Up and Compliance Monitoring
Biotech Third Party Audits Support:

Biotech Third Party Audits Support:

  • Biotechnology Facility GMP Audit
  • Cleanroom and Contamination Control Assessment
  • Cell Culture and Fermentation Process Review
  • Environmental Monitoring System Evaluation
  • Batch Record and Data Integrity Audit
  • Validation and Qualification Documentation Review
  • Technology Transfer Compliance Audit
  • Quality Risk Management System Assessment
  • Pre-Inspection Mock Audit and Gap Identification
  • CAPA Verification and Ongoing Compliance Follow-Up
Pharmaceutical Third Party Audits Support

Pharmaceutical Third Party Audits Support

  • Pharmaceutical Manufacturing Site GMP Audit
  • Batch Manufacturing Record and Documentation Review
  • Laboratory Control and OOS Investigation Assessment
  • Validation Master Plan and Qualification Audit
  • Supplier Qualification and Vendor Audit Support
  • Data Integrity and Electronic System Review
  • Change Management and Deviation Control Audit
  • Product Quality Review System Assessment
  • Regulatory Readiness Pre-Inspection Audit
  • Corrective Action Implementation Verification and Monitoring

Frequently Asked Questions

A third party audit is an independent assessment conducted by external GMP and regulatory experts to evaluate a pharmaceutical company’s quality systems, manufacturing processes, documentation practices, and regulatory compliance. These audits help identify gaps before inspections by regulatory authorities.

GMP third party audits provide an unbiased review of compliance with Good Manufacturing Practices. They help pharmaceutical companies identify risks, strengthen quality systems, improve operational performance, and reduce the chances of regulatory observations during inspections.

Most pharmaceutical companies conduct independent audits annually or before major regulatory inspections. The frequency may vary based on product risk, regulatory requirements, manufacturing complexity, and previous audit findings.

Third party audits simulate regulatory inspections and identify potential compliance gaps. They help companies address deficiencies, improve documentation, strengthen GMP systems, and enhance readiness for USFDA, EU GMP, MHRA, and other regulatory inspections.

A vendor audit evaluates suppliers, contract manufacturers, and service providers to ensure they meet quality and regulatory standards. A GMP audit focuses on assessing a pharmaceutical company’s internal manufacturing operations, quality systems, and compliance with GMP requirements.

Third party pharmaceutical audits should be conducted by experienced GMP consultants, regulatory experts, and qualified auditors with extensive knowledge of pharmaceutical manufacturing, quality systems, and global regulatory requirements.

Audit findings create an opportunity to improve systems before regulators identify issues. GMP GAP Assessment Consultant in India services help prioritise actions and strengthen compliance performance.