Preparation of CGMP/ ISO 22716 registration dossier
| 03/07/2021 4293
Preparation of intitial ( or re-evaluated) CGMP/ ISO 22716 registration dossier
" Direct Guidance on creating and finalizing the registration dossier for CGMP/ ISO 22716 certification as authorities' requirements."
Preparing intitial (or re-evaluated) registration dossier for CGMP/ ISO 22716 certification is the final stage before the certified facilities can put into operation.
This dossier concludes various types of documents that covers entire process preparation stage to business activities, and also indicates how the design, construction, operation of the facility in compliance with GMP regulations.
Registration dossier for GMP ceritication is submitted to DAV (Drug Administration of Vietnam) for first stage of evaluation. The assigned officer will review, and in case of complete dossier, they will approve the decision of set-up inspection team.
With GMPc services, your GMP registration 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 CGMP ASEAN certification"