GDP Compliance

Absolute Quality Certification (Thailand) Co., Ltd.

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 warehouse and distribution centers dedicated for 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.

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 b 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 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.