GMP refers for the goods manufacturing practices. GMP Certification is mainly developed for the natural and pharmaceutical product manufactures. It is a set of guidelines that gives you the assurance that your product is safe and correct. It is mainly dedicated for the food manufactures and medication manufactures and GMP provides assurance for produce safe and quality products according to the Quality standard. GMP is responsible for the safety, efficiency and quality of pharmaceutical products and medical devices.
Benefits of GMP Certification
Improves brand value or image in the market
Provide guideline on how to produce safe and quality products.
Develops customer satisfaction by deliver the safe and quality product and services.
Develops motivation and team work between the employees of the organization.
Process to get the GMP Certification
Application:- This is the first 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 b record or maintain all the information on the GMP database.
Review of Application:- The application received shall be reviewed by the team to ensure that the compliance requirement have been fulfilled.
Quote and Agreement:- After the review of documents we provide the price quotation to the client and performs the Gap Analysis to cover all the clauses and section of the quality standards and Gap Analysis is done to check the Gap between company planned things and achieved things.
Documentation Review:- check the document of the organization to ensure that the documentation fulfilled the compliance requirement.
Stage-1 Audit:- Evaluate your organizations documented procedure and policies against the compliance requirement.
Review:- Review the documentation of your management system to ensure that the compliance requirement have been contented.
Corrective action:- Corrective action is deal with the non conformity. It has taken when the non conformity occurs.
Verification:- Verify the documentation of the organization as per the standard requirements.
Stage-2 Audit:- In stage-2 audit, the auditor verifies that the organization implement according to its documentation and if the auditor of certification body identifies the non conformities then the auditor give the opportunity to correct the non conformities.
Review:- Review the implementation process according to the organizations document.
Corrective Action:- If there is any non conformity occurs then the corrective action has been taken.
Verification:- Verify work instruction and implementation process are being followed by your employees.
Granting of Certification:- The Certification Body will issue a certificate of compliance, which is valid for three years.
Surveillance Audit: – Surveillance audit conduct to ensure that the organization meets the requirements of the management system. Surveillance audit must be performed in every six month or one year from the date of issued certificate.
Re-Certification:- Re-certification is the process, which is done at the end of three years period.
Review:- Review the documentation and implementation process of your management system to ensure that the compliance requirement have been contented.
Corrective Action:- Recheck the non conformity, if any other problem occurs then CB give the opportunity to the organization to resolve the non conformity.
Verification:-Compare the documentation of the organization with the compliance requirement.