WHO-GMP Certification & CoPP
WHO-GMP certification and Certificate of Pharmaceutical Product support for pharmaceutical and AYUSH facilities — the quality systems, documentation and inspection readiness that turn your plant into an export-qualified asset.
Where this usually starts
- International buyers or distributors are asking for WHO-GMP certification or a CoPP before they will sign.
- You are building or upgrading a facility and want it designed to certification standard the first time.
- Your documentation exists on paper but would not survive a regulatory inspection tomorrow.
- An inspection went badly and you need the CAPA closed and the certificate secured.
What we handle
Gap analysis & pre-inspection audit
A frank assessment of premises, equipment, people and paperwork against WHO-GMP expectations — with findings ranked by what an inspector will actually flag.
Documentation system build-out
Quality manual, Site Master File, SOPs and batch documentation written for your actual operations — usable by your team, not shelf-ware.
Validation & qualification
Validation Master Plan, equipment qualification and process validation protocols scaled to your product range and facility size.
Quality systems
Deviation handling, CAPA, change control and risk management set up as working systems with trained owners — the part inspectors probe hardest.
Mock inspection & inspection support
A full dress rehearsal before the real inspection, then on-ground support during the authority visit itself.
CoPP & post-inspection closure
CoPP applications for your target export markets, plus CAPA responses and follow-up until the certificate is in hand.
How the engagement runs
Assess
Gap audit of the facility and quality systems, with a costed, prioritised roadmap to certification.
Build
Close facility gaps and stand up the documentation and quality systems, in parallel workstreams.
Validate & train
Execute validation, train your team on the systems, and run a mock inspection to pressure-test readiness.
Certify
Authority inspection support, CAPA closure and CoPP issuance for the markets you sell into.
What you receive
Questions founders ask us
What is WHO-GMP certification and who issues it?
It certifies that your facility meets WHO Good Manufacturing Practice standards. In India it is granted by the state drug or AYUSH authority after inspection — WHO itself does not inspect your plant. For buyers and foreign regulators it is the baseline signal that your manufacturing can be trusted.
What is a CoPP and why do buyers keep asking for it?
A Certificate of Pharmaceutical Product, issued in the WHO format, confirms that a specific product is manufactured at a WHO-GMP certified facility and can be sold in the country of origin. Most product registrations in Asia, Africa, the Middle East and the CIS require one per product — no CoPP, no dossier.
How long does WHO-GMP certification take?
It depends almost entirely on your starting point. A facility with decent infrastructure but weak documentation is usually a few months of system-building before inspection; one needing civil or equipment changes takes longer. The gap audit gives you a realistic timeline in the first weeks, before you commit spend.
Is WHO-GMP enough for every export market?
No — it opens most emerging and semi-regulated markets, but the US, EU, UK and Australia run their own GMP inspections or recognition routes. We map your target markets first so you invest in the certification level your actual pipeline needs, and not more.
Where do facilities most often fail the inspection?
Rarely on machinery — usually on the quality system: deviations that were never logged, CAPAs without evidence of closure, documentation that does not match what operators actually do, and data-integrity gaps. That is why we build working systems and rehearse the inspection rather than just handing over documents.
Trusted by brands we are proud to work with
From heritage Ayurveda houses to global FMCG leaders, teams rely on AIDNI to move products through regulation and into market.
Planning WHO-GMP certification or need a CoPP?
Tell us about your facility, product range and target export markets. We will respond with a realistic assessment of where you stand and what certification will take.
AIDNI Business Consultancy
Ahmedabad · Dubai · Global Network
+91 98981 AIDNI (24364)
·
www.aidni.me