Pharmaceutical Supplier Qualification & Procurement Consulting.
Build a GMP-compliant supply chain — vendor audits, AVL management, CMO qualification, and procurement SOPs that hold up in any FDA or EU GMP inspection.
PHARPRO pharmaceutical procurement consulting covers the full supplier lifecycle: initial risk classification, qualification audits, quality agreement drafting, approved vendor list (AVL) development, contract manufacturer (CMO) qualification, and contract testing laboratory qualification. Aligned with FDA 21 CFR Parts 210/211, EU GMP Chapter 7, and ICH Q10. Based in Amman, Jordan - serving pharmaceutical companies in Jordan, UAE, Saudi Arabia, Egypt, and globally.
Complete supplier qualification support
From first-time vendor assessments to full AVL remediation — every engagement ensures your supply chain can withstand regulatory scrutiny.
Supplier Qualification Programmes
Risk-based qualification programmes for raw material suppliers, API manufacturers, excipient vendors, and packaging suppliers — documented to FDA and EU GMP standards.
GMP Vendor Audits
Structured on-site or remote GMP audits of suppliers, contract manufacturers, and contract laboratories — with formal audit reports, risk ratings, and CAPA follow-up.
Approved Vendor List (AVL) Management
Development, remediation, and ongoing management of your Approved Vendor List — including re-qualification schedules, change notification procedures, and periodic review SOPs.
Contract Manufacturer (CMO) Qualification
Full qualification of contract manufacturing organisations — regulatory status check, GMP audit, technical capability review, quality agreement drafting, and ongoing oversight.
Contract Laboratory Qualification
Qualification of external testing laboratories — GLP/GMP compliance review, method transfer documentation, technical audit, and quality agreement alignment with 21 CFR Part 211.
Quality Agreements & Procurement SOPs
Drafting and review of quality agreements with suppliers and CMOs, plus procurement SOPs covering supplier selection, qualification, re-qualification, and disqualification procedures.
How pharmaceutical supplier qualification works
A four-step risk-based process that builds a GMP-compliant, inspection-ready supply chain — from first assessment to AVL approval.
Supplier Risk Classification
All suppliers are classified by criticality — based on the nature of the supplied material, the supplier's regulatory status, and your specific regulatory markets. Risk classification determines audit depth, qualification requirements, and re-qualification frequency.
Questionnaire & Document Review
PHARPRO issues a structured supplier questionnaire and reviews returned documentation — quality agreements, regulatory certificates, SOPs, validation summaries, and COA records — to identify gaps before committing to an audit visit.
GMP Vendor Audit (Remote or On-site)
A structured audit is conducted against the applicable regulatory framework. PHARPRO issues a formal audit report with findings classified by risk (critical / major / minor) and supports CAPA responses where required.
AVL Approval & Quality Agreement
Qualified suppliers are formally approved and entered on your Approved Vendor List. PHARPRO drafts or reviews quality agreements aligned with EU GMP Chapter 7, FDA requirements, and ICH Q10 before signature.