"Directly inspecting the pharmaceutical/veterinary medicine factory to analyze the gaps of existing system and make a plan to overcome the shortcomings combined with GMP training and finalizing registration dossier for GMP WHO assessment as authorities' requirements"
Pharmaceutical/veterinary medicine manufacturing facilities in compliance with GMP WHO regulations are granted a WHO GMP Certificate. According to regulations, the WHO GMP certificate is valid for 3 years (or 5 years for veterinary medicine) the date of issue, so the facility needs to submit an application for WHO GMP re-evaluation before the certificate is expired, accordingly the Authority can set up a inspection team for assessment and renewed WHO GMP certification for the facility.
The WHO GMP re-evaluation Consultancy Service designed by GMPc Vietnam consists of 6 steps as follows:
+ Step 1: Overall review
Review the entire facility and also internal inspection to analyze the gaps of existing system.
+ Step 2: Planning for Problems Solving
List the tasks and documents that need to be prepared for the GMP re-evaluation.
+ Step 3: WHO GMP training
Combination of theoretical lectures and practical WHO GMP on-job training with the update of latest regulations about related laws.
+ Step 4: Supplement and finalizing registration dossier for the GMP revaluation
All record documents for 3 years at the facility include:
- Remedy report of the previous assessment
- Personnel and training records
- Production activities records
- Quality control activities records
- Preservation activities records
- Quality management system
- Legal records
+ Step 5: Submit the registration dossier to Adminstrative Department
Application for WHO GMP revaluation is the last step of the preparation process which proved to the authorities that after 3 years of obtaining GMP certificate, the facilities remained to meet WHO GMP regulations, and more important, the authorities will base on it to set up an inspection team for facility re-evaluation.
+ Step 6: Defend against the inspection team
GMPc accompanies the facility in welcoming the GMP inspection team and continues to support the finalizing of additional reports until the facility is officially re-certified.
With GMPc services, your GMP revaluation dossier will be ensured in:
- Gain the sympathy the authorities when receiving and evaluating
- Saving time because the dossiers are responsive the start
- Equip the necessary knowledge for the workforce to take control the presentation to GMP inspection team.
- Confident presenting with definite report.
"GMPc Vietnam is the first Consultant committed to accompany customers until the date of receiving WHO GMP certification"