GMP Certification

GMP Certification

GMP refers to Goods Manufacturing Practices. GMP Certification is specially developed for the natural and pharmaceutical product manufactures. It’s a group of guidelines that provides you the assurance that your product is safe and proper. It’s mainly dedicated to food manufacturers and drug manufacturers. And GMP provides assurance for produce safe and quality products consistent with the Quality standard. GMP is liable for the security, efficiency, and quality of pharmaceutical products and medical devices.

Procedure to get the GMP Certification

• Application:- This is often the primary step to get the GMP certification, the application covers some basic information of the company. The certification body must accept the application and needs to be recorded or maintain all the knowledge on the GMP database. 

• Review of Application:- The application received will be reviewed by the team to make sure that the compliance requirement is fulfilled. 

• Quote and Agreement:- After the review of documents price quotation should be provided to the client and the Gap Analysis is performed to hide all the clauses and sections of the quality standards and Gap Analysis is completed to see the Gap between company planned things and achieved things. 

• Documentation Review:- Check the document of the organization to make sure that the documentation fulfilled the compliance requirement.

• Stage-1 Audit:- Evaluate your organization’s documented procedure and policies against compliance needs. 
  • Review:- Review the documentation of your management system to make sure that the compliance requirement are contented. 
  • Corrective action:- Corrective action is taken when the non-conformity occurs. 
  • Verification:- Verify the documentation of the organization as per the quality requirements. 

• Stage-2 Audit:- In the stage-2 audit, the auditor verifies that the organization implement consistent with its documentation. And if the auditor of the certification body identifies the non-conformities then the he give the chance to correct the non-conformities. 
  • Review:– Review the implementation process consistent with the organizations document. 
  • Corrective Action:- If there’s any non-conformity occurs then the corrective action has been taken.
  • Verification:- Verify work instruction and implementation process is being followed by the employees. 

• Granting of Certification:- The Certification Body will issue a certificate of compliance, which is valid for 3 years. 

• Surveillance Audit: – Surveillance audit conduct to make sure that the organization meets the wants of the management system. Surveillance audit must be performed every six months or one year from the date of the issued certificate. 

• Re-Certification:- Re-certification is that the process, which is completed at the end of three years period. 
  • Review:- Review the documentation and implementation process of your management system to make sure that the compliance requirement is contented. 
  • Corrective Action:- Recheck the non-conformity, if the other problem occurs then CB give the chance to the organization to resolve the non-conformity. 
  • Verification:- The documentation of the organization and the compliance requirement are compared.

Benefits of GMP Certification

• Improves brand value or image within the market 
• Provide guidelines on the way to produce safe and quality products. Develops customer satisfaction by delivering the safe and quality product and services. 
• Develops motivation and teamwork between the workers of the organization.