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Good Manufacturing Practices Certificate- An Overview

A good manufacturing practices certificate is a regulatory mandate required by businesses engaged in the production and manufacturing of pharmaceuticals, F&B, medical equipment, dietary supplements, and cosmetics.

The Joint Commissioner of the CDSCO (Central Drugs Standard Control Organisation), Mumbai, India, is the national certifying authority that issues the GMP certification for individuals and businesses. You can also obtain state-wide approval through your respective state FDA.

Corpbiz’s seasoned consultants with experience in health and cosmetic compliance will help provide documentation and after registration compliance support to streamline the GMP certification process.

Good Manufacturing Practices Certificate
Good Manufacturing Practices (GMP)

What are Good Manufacturing Practices (GMP)?

Good manufacturing practices (GMP) are a standard mandate that ensures that products, namely food, medications, cosmetics, and medical equipment, maintain a prescribed quality standard.

With strict adherence to the said standards, businesses avoid any potential risks and guarantee quality products to the consumers.

Benefits of GMP Certificate Registration in India

Explore the following benefits of GMP certificate registration in India:

Benefits of GMP Certificate Registration in India
Market Credibility

Market Credibility

With a GMP license, your products demonstrate that they follow the rules and guidelines as per the World Health Organization (WHO) & and the Central Drugs Standard Control Organisation (CDSCO). This level of adherence enhances the product’s credibility in the market.

Customer Trust

Customer Trust

GMP registration guarantees product safety for the end users. Strict practices are implemented throughout the manufacturing process until the final product to ensure public safety. A product is perceived to be more reliable if it demonstrates product safety to the customer.

Compliance Regulation

Compliance Regulation

After obtaining a good manufacturing practices certificate registration, you can ensure 100% compliance with global and Indian regulations, avoiding penalties and fines.

Business Expansion

Business Expansion

Your gateway to the international market opens once you obtain a GMP certification. The GMP certificate registration is optimal for global market exposure and business growth.

Decrease in Product Rejection

Decrease in Product Rejection

A product with a GMP license has fewer chances of product rejection and recalls because it certifies the product’s quality, which guarantees customer satisfaction.

Eligibility Criteria for GMP Certification for Individuals in India

The eligibility criteria for GMP certification for individuals and businesses are as follows:

  • The applicant must demonstrate the effectiveness of their manufacturing facility, such as cleanliness, factory layout, environmental conditions, and infrastructure.
  • You must establish a robust product recall system in case there’s a bad batch and the company needs to recall all of it to safeguard consumer safety.
  • All companies must maintain timely records, including quality control reports, an industrial machinery equipment list, and logistics. The records must be maintained and retained for 5 to 10 years as per the registration requirements.
  • All employees, especially the technical staff involved in quality control and assurance, must receive appropriate training, knowledge, and skills to warrant utmost product security.
  • All machines, manufacturing facilities, and equipment should meet the standards of the GMP certification for individuals and businesses.

Checklist: Who can Obtain a GMP License?

  • Pharmaceutical startups and corporations.
  • Medical equipment businesses are also eligible for GMP certification.
  • Restaurants, cafes, food delivery businesses, and food production factories.
  • Businesses engaged in the manufacturing of dietary and nutritional supplements.
  • Cosmetic & personal care companies, including Spas.
Checklist: Who can Obtain a GMP License?
Documents Required for GMP Certificate Registration

Documents Required for GMP Certificate Registration

The list of documents required for GMP certificate registration is as follows:

  • Name and address of the applicant with ID proof.
  • A copy of the industrial trade license.
  • A list of approved products.
  • Form TRS 823 - for site inspection.
  • A detailed report on the manufacturing formula and process.
  • A summary of the final product specification with an analysis report.
  • A list of equipment and instruments used for manufacturing.
  • The layout of the industrial plant.
  • Product’s stability evaluation report in accelerated and real time for the 3 latest batches.
  • A statement on batch size & number, date of manufacture, and expiry.
  • A list of all the technical staff with their qualification and employment experience.
  • Detailed report on standard operating procedures (SOPs) and standard test procedures (STPs).
  • A diagram of the water supply system, explaining the circulation loop.
  • Product summary sheet as per Format B.
  • A proof of safety and the product’s effectiveness as per Rule 158B of the Drugs & Cosmetics Rules of 1945.
  • A notarized affidavit, confirming compliance with the Drugs & Cosmetics Act of 1940 and the Drugs & Magic Remedies (Objectionable Advertisements) Act of 1954.

How to Get GMP Certification for Individuals in India?

Discover how to obtain GMP certification for individuals in India as described below:

  • Application Submission – After obtaining the login credentials, you’re required to upload all mandatory documents to our website.
  • GAP Analysis – Our seasoned consultants will conduct a GAP analysis to ensure the documentation meets your business goals.
  • Document Review – We’ll examine the documents to certify that they meet the standards specified by the good manufacturing practices compliance guidelines.
  • Audit – As a part of your compliance with regulations, Corpbiz’s auditors will conduct an audit to evaluate your company’s standards and implement corrective measures to align them with GMP requirements.
  • Application Filing to GMP Authority – After completing the audit, we’ll move forward with application and document submission to the GMP authority.
  • Evaluation & Inspection – Once the authority has received your application, they will send an officer to your manufacturing plant or factory to conduct a physical inspection.
  • Grant of Certificate – The GMP issuing authority will issue the certificate if they don’t find any irregularities with your company’s manufacturing process or documents.

Features of a Good Manufacturing Certificate in India

The features of the Good Manufacturing Certificate in India are as follows:

  • The certification ensures product quality and consumer safety.
  • A Good Manufacturing Practices Certificate helps companies comply with domestic and global regulations.
  • It is valid for a maximum of three years.
  • GMP certification for individuals acts as both a cost-effective and waste-reducing tool.
  • The process requires various inspections and process checks for all equipment and machinery.
  • More focused on risk mitigation processes.
  • The certification mandates that companies must provide proper training to all technical staff.

Timeline for Obtaining Good Manufacturing Practices Certificate

The Central Drugs Standard Control Organization (CDSCO) usually takes around 2 to 3 months to allot a GMP license. The overall timeline for obtaining the good manufacturing practices certificate is as follows:

  • Gather Documents & Conduct GAP Analysis: 2–4 Weeks
    You are required by the CDSCO or state FDA to gather mandatory documents and conduct the GAP analysis. This phase will take at least 2 to 4 weeks.
  • Application Submission: 1–2 Days
    Apply for the good manufacturing practices certificate in 1 to 2 days to the relevant authority, namely the Food and Drug Administration (FDA) or CDSCO.
  • Audit & Inspection: 4–8 Weeks
    Government officials will take at least 4 to 8 weeks to inspect your documents and manufacturing site for the Good Manufacturing certificate.
  • Issuance of Certificate: 2–4 Weeks
    After evaluation and providing corrective measures, if applicable, the authority will issue the GMP certificate in 2 to 4 weeks.

Compliance After GMP Certificate for Individuals & Business

Go through the following compliance after GMP certification for individuals and businesses:

  • Continuous Monitoring Our associates will help you monitor and review your systems as per the latest governmental regulations, so you are 100% top quality and safety.
  • Record Maintenance To sustain transparency and accountability, you must maintain records of your machines, equipment, and quality control after the Good Manufacturing Certificate.
  • Periodic Audits As part of your annual compliance review, we’ll assist you in conducting internal and external reviews.
  • On-the-Job Training All businesses with GMP certification must provide training to their tech employees to ensure they receive up-to-date information on GMP license processes.
  • Machinery & Equipment Upgrade To minimize the risk of product failure or license cancellation, you must conduct regular inspections of your equipment after obtaining a Good Manufacturing Certificate.
  • GMP License Renewal The GMP certification is valid for three years, so we’ll help you renew the license within the prescribed deadline to avoid penalties and revocation.

Why Trust Corpbiz for GMP Certification in India?

24/7 Customer Support

24/7 Customer Support

Your progress is most important to us. Therefore, our business executives work around the clock to solve all of your queries.

10+ Years of Experience

10+ Years of Experience

We’ve been in the compliance industry for over a decade, but don’t take our word for it. With a 4.3 Google rating, we are one of the top-most preferred brands by Indian entrepreneurs.

Network of 200+ Local Consultants

Network of 200+ Local Consultants

Our consultants are spread throughout the country, namely Delhi, NCR, Gurugram, Pune, Mumbai, Kolkata, Hyderabad, Surat, Ahmedabad, Indore, Kanpur, Coimbatore, Lucknow, & Chandigarh.

Expert Compliance Team

Expert Compliance Team

Our consultants have proven experience as legal and health compliance experts. We currently house 200+ regulatory associates.

Full Documentation Support

Full Documentation Support

From collecting your documents to examining before final submission to the authority, we ensure a seamless process.

No Hidden Cost

No Hidden Cost

Corpbiz's pricing policy is 100% transparent with no hidden costs. You pay for what you see on our website.

Frequently Asked Questions on GMP License

A Good Manufacturing Practices Certificate is a regulatory mandate, which is compulsory for quality and safety purposes. It was formed by the World Health Organization (WHO) in 1968. India adopted the framework in 1988 under Schedule M of the Drugs and Cosmetics Rules of 1945.

Corpbiz will help you with CGMP Certification through the following:
  • Conduct audits to check for problem areas in your compliance system via GAP analysis.
  • Our legal associates will prepare the mandatory documents required for application submission.
  • We’ll provide training modules and online lectures to your employees as part of our GMP compliance services.
  • Our seasoned consultants will provide post-enrolment guidance to ensure continuous compliance with the Good Manufacturing Practices Certificate.

The advantages of a good manufacturing practices certificate are as follows:
  • It enhances brand identity in the consumer market.
  • The certification guarantees 100% customer satisfaction, which will help your product gain a competitive advantage in the market.
  • The regulation helps you establish a business presence in top economies.
  • With registration, you can identify issues and mitigate potential quality risks.
  • Constant monitoring can help you update your processes as per business trends, increasing your revenue.

The process for obtaining CGMP certification is as follows:
  • Pre-assessment of the compliance system.
  • Conduct a GAP analysis for quality assurance systems, equipment checks, and facility records.
  • Then, apply to the relevant authority with supporting documents.
  • The authorities will visit the site for inspection and to examine the documents.
  • After review, the concerned governmental agency will issue the certificate.

The requirements for a GMP license in India are as follows:
  • The company incorporation certificate for the business set up.
  • Factory or establishment unit with an utmost clean environment, meaning no room for contamination.
  • Records of product manufacturing for the final batch.
  • Qualified and experienced workforce.
  • Quality control department with assessment systems.
  • A pre-approved system for product recall.
  • Basic business license, such as industrial and manufacturing approvals.
  • Product testing methods with documented results.

The documents important to obtain a good manufacturing practices certificate are as follows:
  • Identification of the applicant with proof of address of the principal place of business.
  • Complete list of your product line that you wish to cover through the GMP license.
  • An engineer or architect designed the blueprint of your factory or warehouse facility.
  • An original copy of the business incorporation certificate.
  • A list of all the equipment and machinery for product manufacturing.
  • A site master file with details on quality management system, employees, number of facilities, documents, production process, quality control system, and licenses and approvals.
  • Manufacturing trade license by the respective municipal corporation.
  • Standard operating procedures (SOPs)
  • Raw materials and semi-finished goods are used to prepare goods.
  • Local environmental permits with a waste management system.

A GMP WHO certification is valid for at least three years from the official registration. The validity can differ as per the authority’s decision.

The CDSCO (Central Drugs Standard Control Organisation), Mumbai, is the national certifying authority for granting the GMP WHO certification.

Read the following key consequences of not obtaining a GMP certificate:
  • Loss of customer support:
    By adopting safe practices, you earn the trust of your customers. Noncompliance with the Good Manufacturing Practices Certificate can lead to distrust among customers.
  • Bad reputation:
    Non-adherence can lead to safety violations and damage your reputation. Buyers won’t purchase your products if they don’t trust them.
  • Criminal action:
    The issuing authority, the FDA, reserves the right to seize all your products if you don’t comply with their regulations. They may also impose temporary or permanent stay orders through court action, disrupting your operations.
  • Risk to Public Health:
    A product without GMP certification can lead to serious health consequences, including potentially fatal diseases.
  • Trade License Cancelations:
    Failure to follow the safety standards set by the GMP certification can result in the FDA canceling your business license.

If you want to renew the GMP certification for individuals, then you should apply to the relevant authority, namely the state FDA or CDSCO, before the expiration of the license. The process includes the submission of documents and site inspection.

About the Author


NE
Neha Dawra

Legal Researcher

Written by Neha Dawra. Last updated on May 28 2026, 08:21 AM

Neha Dawra has 4+ years of experience in legal research and intellectual property advisory. Her expertise lies in analyzing IP laws, drafting structured legal content, and simplifying complex registration procedures into clear, simple insights.

 

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