“Directly reviewing the overall storage warehouse, planning to overcome the problems, retraining knowledge of GSP, related knowledge and completing the GSP reassessment application as required by the Authority”
Import-export and storage service establishments that satisfy GSP requirements shall be granted certificates of eligibility for pharmaceutical business in the scope of import and export, and services for preserving drugs and medicinal ingredients. As a rule, the Certificate of Eligibility for Pharmacy and the GSP Warehouse Certificate is valid for 3 years the date of issue, so the establishment should proceed to apply for GSP maintenance reassessment first. When the certificate expires in order for the regulator to set up a mission to the establishment to perform the assessment and re-recertify the GSP to the Preservation warehouse..
GMPc Vietnam's GSP reevaluation consulting service includes 6 steps as follows:
+ Step 1: Overall review
Review the entire warehouse and participate in internal inspection to record the current state of existence
+ Step 2: Make a plan to overcome existing problems
List the work to be performed and the records to be prepared for GSP reassessment
+ Step 3: Re-training knowledge about GSP
Training to repeat the theory, combined with GSP practice guidance at the storage warehouse. Besides, GMPc will update the latest regulations on relevant laws.
+ Step 4: Deploying, supplementing, completing documents to prepare for GSP re-evaluation
All documents in 3 years at the factory include:
- Correction report of the previous evaluation
- Legal records
- Human resource and training records
- Records storage activities.
- Document on warehouse cleaning and handling of harmful insects and animals.
- Warehouse appraisal activities.
- Import and export of drugs and materials under Special Control (if any)
- Self-inspection activities of preservation warehouse.
+ Step 5: Submit document to Drug Administration Of Vietnam
Filing for GSP reassessment is the final stage of the preparation for the Establishment to demonstrate to the regulator that within 3 years of obtaining a certificate of eligibility for the import-export pharmacy business. / maintenance services with a GSP certificate, the establishment maintains that it meets the guidelines for the GSP standards and serves as the basis for the regulator to make the decision to set up a reevaluation team for its entity.
+ Step 6: Support when auditing
GMPc accompanies the Unit in welcoming the assessment team to maintain compliance with GSP and continue to support the completion of additional reports until the unit is officially re-certified..
With GMPc, the Unit's GSP reassessment documents will ensure
- Following authorities’ required forms and procedures
- Saving time
- Knowing the focal points that authorities require
- Supporting certification audit through clear and concise articles
"GMPc Vietnam takes pride in being the first consultant that supports Esteem Investors their initial ventures to getting GSP certification"