FSSAI & Ayush GMP
Basic Compliance Action Plan
A consolidated checklist for Food Business Operators under FSSAI Schedule 4 and Ayush GMP Rules 2008 (amended). Also covers nutraceutical, health supplement, functional food, and Ayurvedic/Siddha/Unani (ASU) drug manufacturers.
Scope & Methodology
This document is a consolidated working reference based on:
- FSSAI Schedule 4 Regulations
- FSSAI Health Supplements & Nutraceuticals Regulations 2022
- Ayush GMP Rules 2008 (amended)
- Drugs & Cosmetics Act 1940
- Ayurvedic Formulary of India (AFI) and Pharmacopoeia of India (API)
Regulatory Disclaimer: Always verify with the latest FSSAI and Ayush notifications. Consult a qualified regulatory expert for your specific business category and product portfolio before implementation.
Key: Standard sections apply to all FSSAI-licensed FBOs. Highlighted Amber Boxes denote specific Ayurvedic (ASU) requirements under Ayush GMP Rules 2008.
1. Location & Surroundings
Applies to all FBOs (Parts I-V) and all ASU manufacturers. Physical location must meet hygiene and safety conditions before operations begin.
Pollution-Free Zone
Unit must be away from smoke, chemical fumes, offensive odours, industrial pollutants, and chemical hazards.
Action: Scout sites away from industrial areas, garbage dumps, heavily polluted roads, and chemical storage zones; photograph surroundings within 50m.
Flood / Water Risk
Premises must not be prone to flooding or stagnant water accumulation.
Action: Check municipal flood maps; ensure adequate drainage and elevation before signing any lease.
Sanitary Surroundings
No proximity to open drains, sewage lines, or pest breeding grounds.
Action: Conduct site visit checklist before signing; record and photograph all surroundings.
Adequate Space & Internal Roads
Enough room for people and equipment movement to avoid cross-contamination. Good internal roads and access paths for material movement and emergency vehicles.
Action: Plan floor layout in advance. Ensure paved roads within premises; maintain clear emergency exit routes.
2. Building & Facility Design
Walls, Floors, Ceilings
Must be smooth, non-absorbent, washable, damp-free, and free from flaking paint or plaster.
Action: Use ceramic tiles or food-grade epoxy coating; inspect and repair cracks annually; maintain a repair log.
Unidirectional Flow & Zone Segregation
Materials and personnel must flow in one direction (Receiving → Storage → Prep → Processing → Packaging → Dispatch). Dedicated areas for raw material, processing, quarantine, and storage.
Action: Mark flow with floor arrows. Use physical partitions; post zone-entry rules at entrances.
Drainage, Ventilation & Doors
Efficient drains with grease traps. Exhaust fans and shatter-proof lighting mandatory. Doors fitted with insect-proof screens (< 1.5mm).
Action: Install wire mesh covers on drains. Use self-closing or air-curtain doors; seal gaps < 10mm at floor level.
Ayurvedic / ASU - Additional Zone Requirements
- Pulverizing/Grinding Section: Dedicated room. Must have dust extraction system (cyclone separator) to prevent cross-contamination and fire hazard.
- Extraction/Decoction (Kashayam): Separate area for aqueous and solvent-based extraction. SS-lined vessels and ventilation hoods required.
- Fermentation Area (Asava/Arishta): Separate, temperature-controlled room ($25-30^{\circ}C$). Use certified earthen or SS vessels as per AFI.
- Bhasma / Kupipakwa Section: Separate, clearly demarcated area for metallic/mineral processing with strict containment and fume hoods.
- Taila / Ghrita Section: Dedicated heating area with fire safety. Use stainless steel jacketed boilers.
3. Equipment & Utensils
Food-Grade / Drug-Grade Materials
All product-contact surfaces must be non-toxic, rust-free, non-reactive (SS316 preferred); no crevices that trap residue.
Action: Audit all equipment; obtain supplier certificates; inspect for dead spots weekly.
Calibration & Maintenance Records (PPM)
Weighing scales, thermometers, and process instruments must be calibrated. Planned Preventive Maintenance schedule required.
Action: Set up quarterly calibration schedule. Create Equipment Maintenance Log per machine.
Dedicated Equipment for High-Risk
Separate dedicated equipment required for allergens, probiotics, or high-potency ingredients.
Action: Label equipment clearly (e.g., 'Allergen Only'); verify cleaning before changeover; document in BPR.
4. Raw Material Standards & Control
FSSAI / Ayush-Registered Vendors Only
All raw materials must be purchased from FSSAI-registered or Ayush-approved suppliers. Certificate of Analysis (COA) required for each batch.
Action: Maintain an Approved Vendor List (AVL). QC officer to verify COA against product spec before GRN is raised.
Incoming Temperature & Expiry Verification
Chilled items at $\le5^{\circ}C$; frozen at $\le-18^{\circ}C$. Minimum 70% shelf life remaining at receipt.
Action: Use infrared thermometer at loading bay; train staff to reject items with <70% shelf life.
FIFO/FEFO & Allergen Segregation
Always rotate stock. Allergen-containing materials (soy, dairy, tree nuts, gluten) stored separately.
Action: Label incoming stock with receipt date. Designate labelled allergen bays with physical barriers.
Ayurvedic / ASU - Raw Material Control
- Botanical Identification: Every herbal raw material must be botanically identified by microscopy, morphology, and/or TLC before use.
- Pesticide & Contaminant Testing: Herbal materials must pass tests for pesticide residues, heavy metals, aflatoxins, and microbial load per API/WHO guidelines.
- Rasa Shastra (Minerals/Metals): Mineral and metallic raw materials must undergo classical Shodhana (purification) before use in Bhasma or Sindoor. Document every stage: Shodhana → Marana → Amritikarana.
5. Quality Control, Documentation & Training
Quality Control & Lab Testing
Finished product tested for purity, potency, microbiological limits, heavy metals, and contaminants. Products must be supported by stability data justifying claimed shelf life.
Action: Create finished product specification sheet per product. Conduct accelerated and real-time stability studies per ICH Q1A guidelines.
Documentation & BMR/BPR
Master Formula Record (MFR) for each product. Batch Manufacturing Record (BMR) and Batch Packing Record (BPR) compulsory for each batch. Retain for product shelf life + 1 year (min 5 years for ASU).
Action: QC manager to review and sign off BMR/BPR before batch release. Create a Deviation Log and Change Control Register.
Training & Competency
All staff must receive induction and GMP training. 1 certified Food Safety Supervisor required for every 25 food handlers.
Action: Maintain Training Register per employee. Send eligible staff for FSSAI-approved FSS certification.
6. Packaging, Labelling & Licensing Summary
Packaging & Labelling Requirements
Must state product name, category, complete ingredient list, lot/batch number, MFG/EXP date, and storage conditions. Nutraceuticals must include 'Not intended to diagnose, treat, cure, or prevent any disease' disclaimer.
Action: Verify 8 major allergens declared in bold. Ensure current Ayush licence number (Mfg. Lic. No...) is printed on all ASU labels.
| Business Category | Applicable Licence / Rule |
|---|---|
| Nutraceuticals & Health Supplements | FSSAI Central Licence (Part II + FSSAI Nutraceutical Regulations 2022) |
| Ayurvedic/Siddha/Unani (ASU) Drugs | Ayush Manufacturing Licence + Drugs & Cosmetics Act 1940 + Ayush GMP |
| Combined ASU + Nutraceutical Unit | FSSAI Central Licence + Ayush Manufacturing Licence (must be separate) |
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