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Independent, conflict-free GxP audits across the global supply chain.

Comprehensive Supplier Qualification & GxP Audits

PharmExpert provides independent, risk-based supplier qualification and GxP audits across the global pharmaceutical, healthcare and life sciences supply chain.

Audits cover APIs, Key Starting Materials (KSMs), intermediates, excipients, CMO/CDMOs, packaging materials, contract laboratories, warehousing, transportation and logistics (GDP), medical devices, nutritional supplements, cosmetics and EHS — conducted in accordance with applicable global regulatory requirements and industry standards.

Every engagement is backed by a verifiable audit-report database, harmonized report templates, and lead auditors qualified to WHO, EU GMP, US FDA and PIC/S expectations. Whether you need a single supplier audit or a global qualification program across dozens of sites, we scale the team to your timeline without compromising rigor.

From Raw Materials to Distribution, We Deliver Independent Audit Expertise to Strengthen Quality, Compliance, and Supply Chain Confidence.

01

GMP Audits

Independent Good Manufacturing Practice audits of API, intermediate and finished-dosage-form manufacturers against WHO, EU, US FDA and PIC/S expectations.

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02

GCP Audits

Good Clinical Practice audits of investigator sites, sponsors, CROs and vendors against ICH E6(R2/R3) and applicable national regulations.

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03

GDP Audits

Good Distribution Practice audits of warehouses, cold-chain operations, transport providers and wholesale dealers to protect product quality through the supply chain.

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04

GLP Audits

Good Laboratory Practice audits of non-clinical safety studies and test facilities against OECD GLP Principles and 21 CFR Part 58.

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05

GVP Audits

Pharmacovigilance system audits against EU GVP Modules, assessing QPPV oversight, the PSMF and the end-to-end safety system.

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06

FAT Audits

Factory Acceptance Test audits that verify equipment and systems meet specification at the vendor's site before shipment and installation.

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Standards & Frameworks
  • EU GMP (Parts I & II, Annexes)
  • US FDA 21 CFR Parts 210 & 211
  • ICH Q7 (API GMP)
  • ICH Q9 / Q10
  • WHO TRS GMP guidelines
  • PIC/S Guide to GMP
  • ICH E6(R2) and E6(R3) Good Clinical Practice
  • ICH E8(R1)
  • US FDA 21 CFR Parts 50, 54, 56 & 312
  • EU Clinical Trials Regulation (536/2014)
  • Declaration of Helsinki
  • EU GDP Guidelines (2013/C 343/01)

Talk to a gxp audits specialist

Tell us about your challenge and we'll propose a scoped, independent engagement — with a transparent quote.

Request an Audit +91 70468 82130