Location: USA/Canada/Malaysia/Indonesia
Area: N/A
Project Cost: Confidential
Share:
PharmEng provided technology transfer and start up services, qualification services, and cGMP expertise to help the client conduct three international technology transfers and start-up projects.
PharmEng also completed validation activities that involved transfer of processes, equipment, and facilities from the parent site to a recipient site, while meeting the client’s quality requirements on time and within budgets.
Responsibilities:
- Quality System Gap Remediation
- Technology Transfer & Start Up
- Facility & Utilities Qualification
- New Clean Room Complexes HVAC System
- Manufacturing Area HVAC System
- Cleaning Validation
- Computer Validation
- Equipment Validation
- Process Validation
- Quality Assurance
- ISO 13485 Quality System
- DIN/510(K) Submission
- Export Certificate
- SOPs Development
Location:
USA/Canada/Malaysia/Indonesia
Area:
N/A
Project Cost:
Confidential
Bio-containment level:
Share:
