Pharmaceutical Development
Product Support
- Forming a link between client and machine supplier
- Support of prototype development
- Life-Cycle Management support
Scale-up-Support
- Design transfer from test phase to production phase
- Implementation of individual requirements
Process Support
- Analysis of current process workflows
- Establishment of GMP-conform process workflows
- Interface Management
Compliance Support
- Structuring of technical, process and quality management documentation
- Qualification and validation of production- and control-plants and systems
- GMP training of employees
Process-based Risk Management
Risk-Assessment
- Establishment of a risk analysis strategy
- Risk analysis of GMP plants
- Risk analysis of computer systems
QbD-Assessment
- Process development via the QbD approach that helps implementing ICH quality guidelines Q8 and Q9
- Application of the QbD risk analysis as combination of probability
and severity of the considered risk - Adaption to the relevant risk
Top-Down-Strategy
- Analysis of existing process workflows
- Establishment of a top-down risk management
- Specification of problems
PQR – Product Quality Review
- Refurbishment of existing data
- Establishment of product quality review for easy process specifications verification
Quality Management
Qualification Support
- Preparation of qualification documentation
- Implementation of initial qualifications
- Employees and plant qualification
Validation Support
- Preparation of validation documentation
- Validation of document management software
- Validation of monitoring systems
Life-Cycle Management
- Support of the prototype development
- Support of the whole Life-Cycle Management process
- Establishment of documentation software
Audits
- Audit preparation
- Audit execution
Project Management
Process Buildup
- Buildup of new processes and operations
- Analysis of existing processes
- Expansion and reconstruction of existing processes
Project Management Assessment
- Analysis of existing process workflows considering optimizing potentials
- Planning of process optimization
- Implementation of process optimization
Phase Conception
- Demonstration of process phases
- Structuring of process phases
- Implemention of process phases
