Built for the standard
export markets actually check.
WHO-GMP certification is often the difference between a domestic-only manufacturer and one that can supply regulated export markets. ValiCore's quality system architecture follows WHO's Pharmaceutical Quality System model directly — not retrofitted after the fact.
What is WHO-GMP certification, and is it mandatory in India?
WHO-GMP is the World Health Organization's Good Manufacturing Practice framework, currently anchored in TRS 986 (2014, core principles and model quality assurance system) and TRS 1044 (2022, updated annexes including sterile products and R&D facilities), with TRS 1052 (2023) covering excipients specifically. It is not mandatory for domestic Indian manufacturing — revised Schedule M is the mandatory domestic standard — but WHO-GMP certification is typically required for manufacturers pursuing WHO prequalification, which many export markets and international procurement bodies (including UN agencies) require before they'll purchase from a facility.
Built for
What goes wrong without it
Domestic-only quality systems don't translate
A quality system built purely to satisfy domestic Schedule M inspection may miss WHO-GMP-specific expectations around supplier and distributor participation in the quality system — a scope WHO's PQS model explicitly names.
Export documentation reconstructed per shipment
Rebuilding batch and quality documentation from scratch for each export certification request is slow and inconsistent — the records should already exist in exportable form.
Sterile/R&D-specific annexes overlooked
TRS 1044's 2022 update specifically revised the sterile products and R&D facility annexes — manufacturers in these categories working from older WHO guidance may be building against outdated expectations.
What ValiCore actually does here
PQS spanning suppliers and distributors
Supplier qualification and change control extend the quality system beyond the plant floor — matching WHO's explicit requirement that PQS participation include suppliers and distributors, not just internal QA.
WHO TRS 986Batch records built for export documentation
Electronic batch records with e-signature release, structured for the documentation rigor export certification and prequalification reviews expect.
Validation aligned to current WHO annexes
IQ/OQ/PQ and cleaning validation workflows applicable across standard, sterile, and R&D facility contexts, reflecting TRS 1044's 2022 updates.
WHO TRS 1044Supplier qualification & approved vendor list
Formal supplier qualification records and an approved vendor list — a named WHO-GMP expectation, not an optional extra.
Audit-ready export documentation on demand
Batch, calibration, QC, and validation records exportable in standard formats — no per-shipment scramble to assemble a documentation package.
Regulations this addresses
Related modules
Frequently asked questions
Revised Schedule M was explicitly designed to align with WHO TRS 986, so their core requirements — Pharmaceutical Quality System, risk management, lifecycle quality — overlap substantially. Schedule M is India's mandatory domestic standard, enforced by CDSCO. WHO-GMP certification is a separate certification process, typically pursued by manufacturers targeting export markets or WHO prequalification, and it involves its own assessment even for a facility that's already Schedule M-compliant.
It depends on the destination market. Many export markets and international procurement bodies (particularly UN agencies and WHO prequalification-dependent buyers) require WHO-GMP certification or equivalent as a condition of purchase, even where the destination country's own regulator might accept other GMP certifications. For manufacturers targeting these channels, WHO-GMP certification is effectively a market-access requirement.
WHO Prequalification is a program that assesses the quality, safety, and efficacy of priority medicines (particularly for HIV, malaria, TB, and other conditions of global health importance), enabling UN agencies and other qualified procurers to purchase from prequalified manufacturers. WHO-GMP certification of the manufacturing site is typically a prerequisite for a product to be considered for prequalification.
See ValiCore
live in your lab.
Book a free 30-minute demo. We’ll walk through the modules your team will use, answer your compliance questions, and give you a clear picture of what implementation looks like for your lab.
Book your free demo
30 minutes. No credit card. We’ll respond within 4 business hours with a calendar invite tailored to your time zone.
Book my free demo35 working modules · Founder-led onboarding · 14-day go-live guarantee