What is GMP Certificate & Why is it Required?

what is gmp certificate

GMP is an abbreviation for Good Manufacturing Practice. GMP is a system used on a global level that manages the management of manufacturing, testing, and standard qualities of pharmaceutical products.

Let’s read about GMP. 

What is GMP Certificate?

GMP certificates define the guidelines set to check the quality assurance of pharmaceutical products. This certificate demonstrates that the company follows the quality standard norms to manufacture pharmaceutical products.

Read More: Important Documents in India

What is the Purpose of GMP Certificate?

GMP certificate is provided to those pharmaceutical companies that take all the necessary precautions to prevent the risk of the following accident or error in the production of pharmaceutical items. 

  • Unexpected uncleanness 
  • Incorrect labels on containers 
  • Correct usage of ingredients in the product 

GMP covers many aspects of pharmaceutical products production, like keeping an eye on the materials, details regarding areas and equipment to the training and personal hygiene of the staff working in the warehouse. 

Who Issues GMP Certificate? 

The Commissioner, Food & Drug Administration has legally authorised the Joint Commissioner to sign and issue the GMP certificate under the WHO-GMP certification scheme. 

What do GMP Guidelines Direct the Certification Holders?

WHO (World Health Organisation) has set certain guidelines for good manufacturing practices. The motive of each guideline is to add quality to pharmaceutical product manufacturing. 

Besides, GMP certification empowers organisations to take necessary precautions to prevent contamination, misunderstandings, and mistakes while manufacturing products. 

What are the Benefits of GMP Certification?

GMP certificate is a crucial document for pharmaceutical and medical device manufacturers to assure WHO that they follow all the guidelines that correspond with their legislation.

The benefits of GMP Certification are as follows; 

  • Confirms that the pharmaceutical and medical device manufacturers comply with all the laws and guidelines.
  • The company timely checks the manufacturers and management issues.
  • GMP certificate improves the public image of the company. 
  • The certificate proves that the company takes all necessary precautions to maintain product quality and safety.
  • GMP certificate confirms to the consumer that these particular company products are safe. 
  • Help companies improve quality systems and quality compliance at the manufacturer. 

List of the Documents Required for GMP Certificate

  • Applicant name with confirmed address, telephone, fax, and e-mail
  • Copy of Manufacturing Licence
  • List of approved products
  • Site Master file 
  • Master manufacturing formula
  • Manufacturing process
  • Finished product specification and Method of Analysis
  • Stability study evaluation for three batches (Batch size, Batch No, Date of manufacturing, Date of Expiry, stability study condition)
  • Process validation report for three batches
  • Validation report of the analytical method
  • List of technical staff
  • Technical staff qualification, experience, and approval status
  • List of equipment and instrument
  • List of SOPs and STPs
  • Manufacturing Plant layout
  • Schematic diagram of the water system 
  • Product summary sheet 
  • Proof of safety and effectiveness 

How to Get GMP Certification for Your Company?

  1. Submit your application for a GMP certificate to the concerned department. 
  2. The department will review your application.
  3. Analysis of the agreement details. 
  4. Review submitted documents related to the company. 
  5. Grand a GMP certificate to the company 

Surveillance review confirms that the organisation or company meets the guidelines of GMP certification. Observation review acts every six months or one year from the date of the issued certificate to check the current scenario of the company manufacturing part. 

What are the Consequences of GMP Non-Compliance?

Compliance with good manufacturing practices is crucial to growing in your field. GMP compliance helps pharmaceutical and medical devices to make high-quality products. 

Here is a glimpse of the consequences of GMP Non-Compliance.

  • Customers might not trust you.
  • Consumers might lose confidence in your product. 
  • The Food & Drug Administration can seize a drug and stop production through a court injunction. 
  • The danger of losing licences.
  • Resulting in charges of fraud. 

Consequences for failing to match with GMP guidelines can affect your business and its reputation. 

GMP Certificate Attestation 

Attestation is mandatory to confirm the document is genuine and legal to use in a foreign country. GMP is a commercial document that needs to be verified by the Chamber of Commerce, the Ministry of External Affairs, and the embassy of the applicant’s destination country for their attestations. 

Read More: Commercial Document Attestation

The MEA and many embassies accept documents for attestation through Superb Enterprise Private Limited (SEPL). 

The dedicated team of SEPL completes the administrative tasks necessary to finish the producer for a GMP certificate attestation. 

You can visit the office of SEPL to submit your GMP certificate for attestation from the Chamber of Commerce, MEA, and the concerned embassy. 

Or, 

You can courier your GMP certificate with your passport copy to the nearest office of SEPL to avail of the best and most authentic document attestation services.

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