GDP COMPLIANCE
Good Distribution Practices (GDP) Certification for Pharmaceuticals demonstrates your dedication to good distributive practices and quality in every aspect of your service.
Good Distribution Practices (GDP) is a quality system for warehouses and distribution centers dedicated to medicines. Internationally accepted pharmaceutical GDP regulations stipulate that distributors of pharmaceutical products must align their operations with the standards. The scheme ensures that consistent quality management systems are in place throughout your entire supply chain, from the early delivery of raw materials to the manufacturing plants to the final shipment of finished drugs to the end user. An independent assessment of compliance against international GDP requirements is the most effective way to establish that your quality management system aligns with GDP guidance.
The process to get the GDP Certification
- Application:- This is the first step to get the GDP certification, the application covers some basic information of the company. The certification body must accept the application and needs to record or maintain all the information on the GDP database.
- Review of Application:- The application received shall be reviewed by the team to ensure that the compliance requirements have been fulfilled.
- Quote and Agreement:- After the review of documents we provide the price quotation to the client and perform the Gap Analysis to cover all the clauses and sections of the quality standards 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 fulfills the compliance requirement.
- Stage-1 Audit:- Evaluate your organization’s documented procedure and policies against the compliance requirement.
- Review:- Review the documentation of your management system to ensure that the compliance requirements have been met.
- Corrective action:- Corrective action deals with the nonconformity. It is taken when nonconformity 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 implements according to its documentation, and if the auditor of the certification body identifies the nonconformities then the auditor allows correcting the nonconformities.
- Review:- Review the implementation process according to the organization’s document.
- Corrective Action:- If there is any nonconformity 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: A surveillance audit is conducted to ensure that the organization meets the requirements of the management system. A surveillance audit must be performed every six months or one year from the date of issued certificate.
- Re-Certification:- Re-certification is the process, that 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.
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