📚 Starter PackPharmaceutical / Ayurvedic Manufacturing
Certification Starter Pack — Pharma & Ayurvedic Manufacturer
GMP compliance is a legal condition of your drug manufacturing licence — it is not optional. This pack maps everything from drug licence to WHO GMP for export, in the order CDSCO and your buyers expect.
Drug licence conditional on GMP complianceWHO GMP required for export to regulated marketsISO 13485 for medical device manufacturers
Legal requirement
Drug licence + Schedule M GMP
CDSCO or State Drug Authority
Export to regulated markets
WHO GMP certificate
CDSCO coordinates WHO inspections
Quality management
ISO 9001 optional
Many pharma companies hold both GMP + ISO 9001
Medical devices
ISO 13485
Separate standard — not ISO 9001 for devices
Your certification roadmap — in the right order
Start at Step 1. Each step builds on the previous. Trying to skip foundational steps delays everything that follows.
Drug Licence + Schedule M GMP★ Mandatory
Your manufacturing licence from CDSCO or State Drug Authority is conditional on GMP compliance. Schedule M (revised 2023) defines the facility, documentation, and process standards. Cannot manufacture legally without this.
Full guide ↗
Batch Manufacturing Records★ Mandatory
A BMR for every production batch. The most scrutinised document in any GMP inspection. Must be contemporaneous, ALCOA+ compliant, and available for the retention period.
Full guide ↗
ISO 9001✓ Recommended
Quality management system. Many pharma companies implement ISO 9001 alongside GMP. Adds process consistency, management review, and supplier management beyond the GMP framework.
Full guide ↗
WHO GMP certificate○ Optional
Required for export to EU, USA, UN agency supply, and most regulated markets. CDSCO coordinates WHO GMP inspections for Indian manufacturers.
Full guide ↗
ISO 13485○ Optional
If you manufacture medical devices (not drugs), ISO 13485 is the relevant QMS standard — not ISO 9001. MDR 2017 requires a QMS for Class B and above.
Full guide ↗
ISO 14001○ Optional
Environmental management. Required by some European buyers and relevant for manufacturers with significant chemical or effluent footprint.
Full guide ↗
All certifications for pharma/Ayurvedic manufacturer
Drug Licence (Schedule M GMP)
★ Mandatory
From CDSCO or State Drug Authority. Conditional on GMP compliance. Schedule M revised 2023.
Read the full guide ↗
WHO GMP Certificate
○ Optional
For export to regulated markets and UN procurement. CDSCO coordinates.
Read the full guide ↗
ISO 13485
○ Optional
QMS standard for medical device manufacturers. Requires DHR, DHF, risk management.
Read the full guide ↗
GreenPro
○ Optional
Eco-label for specific products. Relevant for Ayurvedic and herbal products marketed on sustainability credentials.
Read the full guide ↗
Internal Audit
★ Mandatory
GMP requires internal self-inspections. ISO 9001 requires formal internal audit programme.
Read the full guide ↗
Skill Matrix
★ Mandatory
GMP competence for all manufacturing and QC roles. Training attendance is not sufficient — assessment required.
Read the full guide ↗
Clicarity — Live Job Process Tracker & Bottleneck Identifier
Clicarity tracks your production batches — and that tracking builds the BMR that GMP inspectors ask for.
GMP requires a Batch Manufacturing Record for every production batch: materials used, quantities, operators, equipment, in-process results, and QA release. In Clicarity, every batch is a job. Dispensing captures material name, AR number, quantity dispensed, and double-check sign-off. Processing stages capture critical parameters (temperature, duration, yield). QC captures test results and analyst name. QA release is the final stage sign-off. When a batch splits into different pack formats, each is tracked through its own QC and release independently. When they rejoin, the complete BMR of every format is preserved.
Clicarity is a process tracking tool. It does not provide certification, consulting, or audit services.
Common questions from pharma/Ayurvedic manufacturers
Is GMP certification the same as a drug licence?
GMP is a condition of your drug licence — not a separate certificate for domestic manufacturing. Your CDSCO or State Drug Authority licence is issued after verifying GMP compliance.
Do I need ISO 9001 if I already comply with GMP?
Not mandatory — but many pharma companies pursue ISO 9001 alongside GMP because it adds management review, customer feedback, and continual improvement processes beyond the GMP framework.
What is WHO GMP and when do I need it?
WHO GMP (TRS 986 Annex 2) is required for export to regulated markets (EU, USA) and WHO/UN agency supply. CDSCO coordinates WHO GMP inspections for Indian manufacturers.
Pharma vs medical devices — same certifications?
No. Drug manufacturers need Schedule M GMP and optionally ISO 9001. Medical device manufacturers need ISO 13485 under MDR 2017. Different standards, different regulatory authorities.