Third Party Audits

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.

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

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

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

We perform structured audits before supplier selection, acquisitions, or regulatory submissions to identify compliance gaps.

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:

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

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

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

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

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:

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 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

Third Party Audits