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

GxP Audits

PharmExpert conducts the full spectrum of GxP audits with a worldwide pool of qualified, independent auditors and a standardized audit life-cycle — from scheduling and execution to reporting and CAPA follow-up. Because we manufacture nothing and sell no products, our findings carry no conflict of interest: you receive an objective assessment of compliance risk, not a sales pitch.

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.

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