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Good Manufacturing Practices (GMP) Certification in India

Q: Is GMP Certification mandatory in India?

Yes, GMP Certification is mandatory for certain product categories in India. It is especially true for pharmaceutical manufacturers under the Drugs and Cosmetics Act, 1940, and its rules (like Schedule M). This ensures product safety and quality for consumers.

Q: Can I get GMP Certification completely online?

While much of the application and documentation preparation can be done online, the audit process for GMP Certification usually requires a physical inspection of your manufacturing facility. This on-site visit is crucial to verify compliance with the actual practices.

Q: What are the consequences of not having GMP Certification?

Not having GMP Certification can lead to serious problems. These include legal penalties, fines, and even suspension or cancellation of your manufacturing license. Your products might be banned from sale. It also harms your business reputation and customer trust.

Q: How can I check or verify a GMP Certificate?

To verify a GMP certificate, you can often check with the issuing authority. For WHO-GMP certificates, sometimes a public database or official records can be accessed through the CDSCO or state FDA websites. You would typically need the certificate number and company details.

Q: Are there any special GMP schemes for startups or small businesses?

While the core GMP standards apply to all, the government has provided more time for Small and Medium Enterprises (SMEs) to adopt the latest revised Schedule M. There aren't "special" GMP standards, but supportive schemes for MSMEs might help with funding for upgrades.

Q: What is the validity period of a GMP Certificate?

A GMP certificate in India is generally valid for 3 years. However, continuous compliance is needed. Regular surveillance audits are often conducted within this period. This ensures the company consistently follows the Good Manufacturing Practices.

Q: What is the difference between a GMP Certificate and an ISO certificate?

GMP Certification is specific to manufacturing practices in certain industries (like pharma, food, cosmetics) and focuses on product safety and quality. ISO certification (like ISO 9001) is a broader quality management system that can apply to any industry and focuses on overall business processes and customer satisfaction. GMP is often mandatory, while ISO is generally voluntary.

Ensure your products meet export-quality standards with GMP Certification in India. Get expert-led assistance in documentation, audits, and compliance. Start your GMP certification process with RegisterKaro today.

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Frequently Asked Questions (FAQs)

Who issues GMP certificates in India?

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In India, GMP certificates are primarily issued by the respective State Drug Licensing Authorities. For exports, the Central Drugs Standard Control Organization (CDSCO) issues WHO-GMP certificates. These bodies ensure that manufacturing units meet the required quality and safety standards.

Is GMP Certification mandatory in India?

Can I get GMP Certification completely online?

What are the consequences of not having GMP Certification?

How can I check or verify a GMP Certificate?

Are there any special GMP schemes for startups or small businesses?

What is the validity period of a GMP Certificate?

What is the difference between a GMP Certificate and an ISO certificate?

Why Choose RegisterKaro for Obtaining GMP Certification?

At RegisterKaro, we simplify the GMP certification process, ensuring a smooth and stress-free experience for your business.

Expert Guidance: Our team makes the process easy by breaking down complex steps into manageable tasks.
End-to-End Support: From paperwork to audit preparation, we handle every detail, ensuring everything is in order.
Transparent Pricing: No hidden fees, just clear, upfront costs with a detailed breakdown.
Efficient Service: Designed for busy entrepreneurs, our quick and hassle-free service allows you to focus on your business.

Why Choose RegisterKaro for Obtaining GMP Certification?

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