Validation Services
Pania Validation Group can offer you following validation services:
Validation Services
- Validation Master Plan (VMP)
- Equipment cleaning validation
- Clean room cleaning validation
- Sterile and non-sterile process validation
- Microbiological validation for sterile lines
- Media fill for sterile lines
Qualification Services
Development of URS/ Risk assessment/ DQ/ IQ/ OQ/ PQ protocol, execution and repot for following equipment and systems:
Solid dosage form equipment:
- Blister Machine
- Tablet Press machine
- Capsule filling Machine
- Negative isolators
- Down flow booth
- Blender
- Tablet coater
- Mix and granulation machine
Systems & utilities:
- Hygienic HVAC
- Clean room (EU class A,B,C,D)
- Cold room
- Warehouse (Temperature mapping)
- Pharmaceutical gases (Compressed air, Nitrogen & other gases)
- Pharmaceutical water purification systems ( Purified generator and distribution, Water for injection generator and distribution, Clean steam generator and distribution)
Sterile filling equipment:
- Autoclave & oven (including microbiological validation)
- Positive and negative pressure isolators
- Compounding vessel
- Sterile filling line
- Laminar air flow & Hoods
