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Regulatory Compliance

Ayurvedic Factory
Compliance

Implementing comprehensive cGMP procedures, SOPs, regulatory documentation and audit-ready quality systems for Ayurvedic and Unani pharmaceutical manufacturing facilities.

Ayurvedic Factory Compliance
📋
cGMP Audit Ready
DGDA · AYUSH · Export
Why Compliance Matters

Built on Trust,
Verified by Audit

Ayurvedic factory compliance is more than a regulatory checkbox — it is the ethical foundation on which every safe, effective medicine is built. Every SOP, every batch record and every quality check protects patient health.

Dr. Dulal has implemented compliance systems at 80+ Ayurvedic and Unani manufacturing organisations — preparing facilities for DGDA, AYUSH, WHO-GMP and international export inspections.

1
cGMP Implementation
Current Good Manufacturing Practice across all production zones — material, personnel and process flow.
2
SOP Development
Comprehensive Standard Operating Procedures for every production, QC and warehouse activity.
3
Documentation Systems
Site Master File, batch records, validation protocols and regulatory dossiers — all audit-ready.
4
Audit Preparation
Pre-audit assessments, gap analysis, corrective action plans and inspection-readiness training.
Six GMP Procedures

Process-by-Process
Compliance Frameworks

Every Ayurvedic manufacturing process — from herbal extraction through final packaging — operates under detailed cGMP procedures with documented controls, in-process checks and validated parameters.

⚗️
Procedure 01

Extraction Process

Standardised extraction protocols for herbal raw materials — covering Soxhlet, percolation, maceration and reflux methods.

Solvent selection & ratios
Temperature & time control
Yield optimization protocols
Concentration & drying SOPs
🌀
Procedure 02

Granulation Process

Wet and dry granulation procedures for tablet and capsule manufacturing — controlled by precise SOPs and in-process checks.

Binder selection & preparation
RMG/FBD operating parameters
Particle size & flow testing
In-process moisture control
💊
Procedure 03

Tablet Compression

Tablet manufacturing protocols ensuring weight uniformity, hardness, friability and disintegration time within pharmacopoeial limits.

Punch & die selection
Compression force calibration
Hardness & friability checks
Coating & polishing SOPs
🥄
Procedure 04

Ointment Manufacturing

Ayurvedic ointment, cream and gel manufacturing — vacuum mixing, homogenization and aseptic filling under controlled environments.

Base preparation & mixing
Active ingredient incorporation
Vacuum homogenization
Aseptic filling & sealing
🍶
Procedure 05

Liquid Manufacturing

Asava, Arista, syrup and suspension production — fermentation, distillation, filtration and bottle filling under cGMP conditions.

Fermentation control & monitoring
Distillation parameters
Membrane filtration
Bottle filling & capping
📦
Procedure 06

Packaging & Storage

Primary and secondary packaging operations — strip, blister, alu-alu, bottle and cartoning — with environmental controls.

Packaging material qualification
Online printing & coding
Tamper-evident sealing
Warehouse FIFO & FEFO
Documentation Systems

Complete Audit-Ready Records

Full documentation infrastructure — every SOP, batch record, validation protocol and regulatory file — prepared and maintained to international standards.

📜
Site Master File
Complete facility documentation
📋
Master SOPs
Standard Operating Procedures
📝
Batch Records
BMR & BPR documentation
🔍
Validation Protocols
IQ, OQ, PQ documents
🧪
QC Specifications
Raw material & finished goods
📊
Stability Studies
Real-time & accelerated
⚖️
Regulatory Files
DGDA, AYUSH, export dossiers
🎓
Training Records
Personnel qualification logs
Compliance Philosophy

"Compliance is not paperwork — it is patient safety written into every batch, every record, every decision."

— Dr. Shahinoor Rahman Dulal

The Audit Journey

From Gap Analysis
to Certification

A structured four-stage process takes your facility from initial gap analysis through full inspection-readiness and certification.

🔍
Stage 1
Gap Analysis
Comprehensive assessment of existing systems against cGMP requirements.
📝
Stage 2
SOPs & Documents
Drafting and implementing master SOPs, batch records and validation protocols.
🎓
Stage 3
Training & Implementation
Hands-on team training across production, QC, warehouse and quality assurance.
Stage 4
Audit & Certification
Mock audits, corrective actions, and final regulatory inspection support.
📋 Audit-Ready Compliance

Need Compliance
Expertise?

Whether preparing for a first regulatory audit or upgrading existing systems — Dr. Dulal brings 20+ years of cGMP, DGDA, AYUSH and WHO-GMP compliance experience across South Asia and Turkey.

📊
Gap Assessment
Detailed audit-readiness report
📚
SOP Library
Production, QC & warehouse procedures
🛡️
Audit Support
Pre-audit, on-site & post-audit help