Onsite Execution in the Field of GMP for Quality Assurance in the Life Sciences
As a GMP service provider, gempex offers consulting and implementation of GMP requirements as well as longer-term support in pharmaceutical/biotechnological quality assurance at the customer's site. Are peak loads occurring? Does a personnel bottleneck need to be covered at short notice? Sabbatical or parental leave replacements cannot be filled internally?
Through the flexible and immediate availability of qualified and trained employees, gempex ensures ongoing production and provides up-to-date GMP know-how. GMP compliance and product quality are maintained.
Established GMP Know-How and Competence in Quality Assurance
With 20 years of experience in onsite support, gempex knows what it takes. The team can provide support for all quality assurance tasks, e.g. for
- Qualification of technical facility and equipment items
- Qualification documentation such as DQ, IQ, OQ, PQ protocols and reports, SOPs, URS
- Risk analyses
- FAT/SAT support
- Coordination of qualification, calibration and maintenance activities
- Review of technical documents and drawings
- Processing and monitoring of changes and deviations
- Periodical reviews and batch record reviews
- Process, method and cleaning validation
- Data integrity
- Method transfer
GMP-Experienced Employees and Quick Response Time
The entire selection process of potential candidates usually has to go very quickly. Due to its own project work, gempex knows exactly which qualification profiles are required and which skills the employee must bring with it. Individual training and regular interaction with in-house GMP experts provide a good basis for supporting the customer in its balance between cost-effectiveness and quality requirements. And through the strategic combination of compliance consultancy, project management and onsite execution, the customer not only gets manpower but also up-to-date GMP know-how on top.