We own a validation divison, which includes a number of experienced validation engineers who deep know-how with work and equipment validation processes in a GMP environment for pharma and biotechnology factories.
The company’s engineers have great experience in validation work for all existing process manufacturing equipment, supporting systems (such as HVA, PW, WFI, PS, CA), QC and validation of clean rooms at any level of cleanliness and storage chambers (refrigeration, freezing, thawing, incubators, stability chambers, storerooms, etc.).
- Writing of policy procedure - QRM - Quality Risk Management.
- Conducting a risk analysis process using FMEA methodology for manufacturing processes, systems and changes.
- Writing of work procedures for equipment validation policy and providing a VMP - Validation Master Plan document
- Writing characterization documents - URS - User Requirement Specifications & BOD - Basic Of Design
- Writing and performing the following validation documents:
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- DQ - Design Qualification
- FAT - Factory Expectant Tests
- SAT - Site Expectant Tests
- IQ – Installation Qualification
- OQ – Operation Qualification
- PQ – Performance Qualification
- CIP – Cleaning Validation
- SIP – Sterilization Validation
- PPV - Product Process ValidationQ – Installation Qualification
- OQ – Operation Qualification
- PQ – Performance Qualification
- CIP – Cleaning Validation
- SIP – Sterilization Validation
- PPV - Product Process Validation
