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
– Risk analysis of computer systems
– 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
