GMP Certification in India
Ensure your products meet global-quality standards with Good Manufacturing Practices (GMP) Certification. At Tax Pal Solutions, we provide end-to-end support—from documentation to audits and compliance—to help your business achieve safe, reliable, and export-ready products.
What is GMP Certification?
- GMP stands for Good Manufacturing Practice.
- It is a system of mandatory guidelines and quality controls for producing safe and consistent products.
- Applicable for pharmaceuticals, food, cosmetics, and dietary supplements.
- Ensures clean facilities, proper equipment, trained staff, and documented production processes.
- Helps businesses comply with laws and gain consumer trust.
GMP vs cGMP
| Aspect | GMP | cGMP |
|---|---|---|
| Meaning | Follows basic manufacturing rules | Uses up-to-date methods and technology |
| Scope | Ensures safety and quality | Meets latest international standards |
| Application | Domestic and general compliance | Global exports & regulatory approvals |
Main Goals of GMP
- Safety – Ensure products do not harm consumers.
- Quality – Maintain batch-to-batch consistency.
- Legal Compliance – Follow Indian & international laws.
- Efficiency – Reduce errors, waste, and recalls.
Why Your Business Needs GMP Certification
- Build Customer Trust – Demonstrates safe manufacturing practices.
- Access Global Markets – WHO GMP or cGMP needed for exports.
- Regulatory Compliance – Avoid fines, bans, and legal issues.
- Operational Efficiency – Streamlines processes and prevents costly mistakes.
- Government Tenders – Essential for supplying hospitals or government projects.
Types of GMP Certifications in India
| Certification | Industry | Details |
|---|---|---|
| WHO-GMP | Pharmaceuticals | Global standard for export-oriented pharma |
| 🇮🇳 chedule M | Pharmaceuticals | Mandatory for domestic pharma under CDSCO |
| Food GMP | Food & Beverages | Hygiene & safety as per FSSAI |
| Cosmetics GMP | Cosmetics | Schedule M-II & ISO 22716:2007 compliance |
| AYUSH GMP | Ayurvedic, Unani, Siddha | Schedule T guidelines under Ministry of AYUSH |
GMP Certification Process
- Preparation & Gap Analysis – Assess your facility against GMP norms.
- Documentation & Application – Collect business, technical, and product-related documents.
- Submit to Certifying Body – CDSCO, FSSAI, ISO, or Ministry of AYUSH depending on product type.
- On-Site Audit – Inspectors check facility, staff, documents, and machinery.
- Certificate Issuance – After compliance, receive your GMP certificate.
Documents Required
Essential Business Documents
- Business registration (MSME/Udyam, LLP Agreement, etc.)
- Manufacturing/factory license
- GST Certificate
- Site plan & proof of premises
- Pollution control NOC & Fire Safety Certificate
Technical Documents
- SOPs & validation reports
- Quality control procedures & maintenance logs
- CAPA records & internal audit reports
- Pest control & hygiene protocols
Product & Personnel Documents
- Product list, labels & packaging
- Raw material supplier details
- Employee training & hygiene records
- Material Safety Data Sheets (MSDS)
GMP Certification Cost
| Factor | Estimated Cost (₹) |
|---|---|
| Small Food/Cosmetic Unit | 50,000 – 5,00,000 |
| Large Pharma Manufacturer | 30,00,000+ |
| Influencing Factors | Business size, product type, consultant fees, audit scope |
Timeline
| Step | Duration |
|---|---|
| Facility Preparation | 1–3 months |
| Documentation | 1–2 months |
| Application Submission | 1–2 weeks |
| Audit Preparation | 2–4 weeks |
| On-Site Audit | 1–2 weeks |
| Certificate Issuance | 1–3 weeks |
| Total: 3–12 months depending on complexity |
Certificate Validity & Renewal
- Valid for 3 years in India.
- Surveillance audits every 6–12 months to ensure ongoing compliance.
- Renewal involves another full audit before expiry.
DSCO & Schedule M
- Schedule M – Mandatory Indian GMP guidelines under the Drugs & Cosmetics Act, 1940.
- WHO-GMP – Internationally recognized, voluntary for domestic pharma unless exporting.
- Alignment of Schedule M with WHO-GMP ensures smooth export compliance.
GMP Certificate
- Confirms adherence to GMP standards for pharma, food, or cosmetics.
- Required for exports, legal compliance, and market trust.
- Can be downloaded online via CDSCO, FSSAI, or AYUSH portals once approved.
Why Choose Tax Pal Solutions?
- 500+ MCA-certified experts
- 10,000+ trusted reviews
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- Expert guidance on documentation, audits, and compliance
Certification
