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:
It is the web version of the FSSAI & Ayush GMP - Basic Compliance Action Plan, Salmon Attitude, March 2026, Version 1.0. The source document contains 17 compliance areas spanning facility design, equipment, raw materials, utilities, hygiene, manufacturing controls, sanitation, storage, quality control, documentation, recalls, training, packaging/labelling and licensing.
- 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.
Compliance Coverage
The underlying action plan covers 17 practical compliance areas:
Location & Surroundings · Building & Facility Design · Equipment & Utensils · Raw Material Standards & Control · Water, Steam & Utilities · Personal Hygiene & Worker Health · Manufacturing & Process Control · Cleaning & Sanitation · Pest Control · Waste Management · Storage & Warehousing · Quality Control & Laboratory Testing · Documentation & Records · Recall & Complaint Handling · Training & Competency · Packaging & Labelling · Licensing & Registration.
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). Managing these records within an audit-ready platform like Stream ensures immutable version control and automated retention tracking.
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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