Validation
Qualification of equipment and utilities enable to demonstrate that the installation conforms to the design (IQ), that its operation complies with the supplier’s specifications (OQ), and that its performance meets the user requirements (PQ). Similarly, process validation demonstrates the reproducibility and the efficacy of a process.
Validapro Biosciences personnel include experts with many years of experience in validation/qualification, and an extensive portfolio of diverse projects such as:
- Validation Master Plans
- Manufacturing and packaging equipment qualification
- Sterile and non-sterile liquid dosage forms (tanks, mixers, freeze-dryers, etc.)
- Solid dosage forms (blenders, granulators, coating machines, drying ovens, tablet presses, etc.)
- Packaging (filling machines / hoppers, thermoforming machines, counting devices, labelling equipment, cartoners, etc.)
- Laboratory equipment qualification
- Walk-in cold rooms, freezers, refrigerators, incubators, stability chambers
- Analytical instruments (chromatography, spectrometry, etc.)
- Utilities qualification
- HVAC (Ventilation / Air treatment and conditioning systems)
- Water systems (purified water, WFI, clean steam)
- Gases (compressed air, nitrogen, etc.)
- Qualification of controlled environments
- Cleanrooms (ISO classification)
- Isolators / Confinement equipment (manufacture of sterile and highly toxic products, sterility testing)
- Laminar flow hoods and biological safety cabinets
- Process validation
- Manufacturing and packaging processes (liquids, creams, ointments, tablets, capsules, etc.)
- Cleaning processes (manual and CIP)
- Sterilization processes for pharmaceutical products and medical devices (steam, SIP, dry heat, gamma radiation, etc.)
- Analytical methods