Compliance & Validation
Qualification & Validation
- Validation master plans (VMP)
- Risk analyses
- Qualification: DQ / IQ / OQ / PQ
- Cleaning and process validation
- Prospective and retrospective qualification
- Manufacturing and cleaning processes
- Microbiological, chemical and physical analytical methods
Implementation of QM and QA-systems / QC-management
- Workshops, planning, concepts, coordination, drawing up SOP´s Development
GMP consulting
- Auditing (facilities, rooms, processes, documentation, quality control, QS systems, hygiene, storage, logistics, personnel)
- Auditing and consultancy for computerized systems
- Preparation of FDA and authority inspections
- Auditing and coaching for suppliers and contractors (package unit suppliers, raw material suppliers, pharmaceutical contract manufacturers)
- Qualification and validation master planning
- Risk analyses and workshops
- GMP reviews of engineering concepts/design documentation, existing process facilities and clean rooms
Training / Workshops
- GMP basic data, risk analyses (FMEA, FTA, ….), qualification of clean room and clean utilities
- GMP compliant documentation and maintenance
- Computer system validation
- Integrated engineering and qualification
- Cleaning and process validation
- Hygiene production concepts
Test Services
Cleanroom test regarding to GMP Guideline & cleanroom standard include:
- Air Volume Test (CFM)
- Differential Pressure Test (ΔP)
- Particle Counting Test
- Temp / Humidity Test
- Airflow & Air change
- Airflow visualization test
- Filter Leakage integrity test
- HVAC system Balancing Test (TAB)
