Setup of a pharmaceutical manufacturing facility and obtaining manufacturing authorization for unit-dose packaging
AVANTALION supported a pharmaceutical company in setting up a new manufacturing facility and in obtaining manufacturing authorization under section 13 of the German Medicinal Products Act.
Business Process Management
Qualification & Validation
Computer System Validation
A pharmaceutical company set up a manufacturing facility in Germany for unit-dose packaging of solid dosage forms.
Within the process of obtaining the manufacturing authorization under section 13 of the German Medicinal Products Act, the quality management system needed to be established and expanded, the manufacturing facilities qualified and the processes as well as the ERP system validated.
AVANTALION managed the PMO.
As part of a comprehensive business process management effort, AVANTALION supported the pharmaceutical company in modelling and validating the manufacturing processes and ERP system.
AVANTALION provided the pharmaceutical company with the support to qualify the manufacturing facilities (including various prototypes), to prepare the required GMP documentation and to coordinate communication with vendors.
Within quality management, AVANTALION was responsible for optimizing risk management and the defect and change management system.
The facilities were qualified and the ERP system and processes validated. Risk-based approaches were taken and all steps were documented in compliance with GMP.
The defect and change management system was implemented in line with requirements and adopted across all areas.
The inspection was passed without critical defects and the manufacturing authorization was granted.
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