PVS : GxP Quality Consulting
Since 2017, we have been providing consultancy, validation and qualification services in the GxP field as well as 'on site' calibration services for measuring instruments for companies operating in the Life Science sector. We address major Swiss companies with dedicated support to meet all quality and regulatory requirements necessary for production activities.
Pharma
Manufacturers of all pharmaceutical forms, finished and active ingredients for specialities and third parties. Sterile liquid and powder productions, non-sterile productions, oral liquid and solid production and packaging activities.
Api & Hpapi
Active and Highly active pharmaceutical ingredients (HAPI) sterile and non-sterile ingredients from synthesis or fermentation, qualification activities on reaction, fermentation, centrifugation, filtration and finishing equipment.
Advanced therapies
Cell banks, stem cells, cryogenic storage and manipulation of biological material.
Oem
Packaging machines, serialisation, aggregation, filling, preparation systems, sterilisation, decontamination, depyrogenation, transfer, CIP/SIP and customised equipment.
Utilities, hvac and warehouses
Qualification of GMP-impacted utilities installations: WFI, Purified Water, Clean Steam, Compressed Air and Process Gases. Qualification and periodic requalification of sterile and non-sterile HVAC systems, biohazard hoods, containment isolators and radiation protection. Mapping and qualification of warehouses or equipment dedicated to temperature and humidity controlled storage.
Quality control
Qualification and periodic retraining of incubators, stoves, biohazard hoods, autoclaves, ovens, pH meters and scales.
Medical device
Manufacturers of medical devices for all forms.
Who we are:
a team of experienced and qualified professionals who, through strategic services, meet the needs of all types and sizes of our customers.Services
We support industry activities in a variety of areasCalibration
On-site calibration activities for instrumentation of:
- Temperature from -100 to +500°C
- Pressure, vacuum and high vacuum
- Humidity
- Speed and flow rate of fluids and gases
- Oxygen and carbon dioxide concentrations
- Redox, pH and conductivity
- Rpm
Hvac and hoods
Initial and periodic qualification activities of classified sterile or non-sterile areas, vertical, horizontal, biohazard and chemical fume hoods. Qualification activities in accordance with GMP standards and up-to-date regulatory references.
- Delta Pressure
- Air Flow Rate and air changes/hours
- Filter integrity test (DOP Test)
- Verification of filter clogging, air speed and flow rate
- Unidirectional flow uniformity check
- Particle counts and recovery test
- Smoke test in laminar and sterile flow departments
Sterilisation and depyrogenation equipment
Initial and periodic qualification of equipment dedicated to thermal or chemical sterilization, sanitization and depyrogenation.
- Risk Analisys e Bracketing studies
- Thermal distribution
- Bowie dick test
- Pressure and vacuum tightness testing
- Periodic requalification with standard loads
Laboratory equipment
Initial and periodic qualification of dedicated equipment within the Quality Control (QC) and Pharmaceutical Development (R&D) laboratories
- Fridges, freezers, ultrafreezers and cold
- Ovens, climatic chambers and incubators
- Autoclaves for sterilization and decontamination
- Glass Washers
- Centrifuges
Temperature-controlled warehouses
- Thermal or thermo-hygrometric mapping of small, medium or large warehouses
- Mapping of cold rooms down to -30°C
- Mapping of stability chambers
Control systems
Initial and periodic qualification activities of the following computerized systems in accordance with reference standards (e.g. CFR21 Part11)
- PLC
- DCS
- SCADA
- Panel PC
- Paperless recorder
Documentation writing
Writing activities on standard templates or customizable to our customers' specific templates of the following documents:
- Validation Master Plan
- Risk Analysis
- Commissioning Protocols, FAT e SAT
- Design Qualification
- Installation Qualification
- Operational Qualification
- Performance Qualification
Commissioning
On behalf of our customers, we carry out commissioning, FAT and SAT activities at machine and plant manufacturers.