Pharmaceutical and Life Sciences businesses must comply with this area so new systems or processes can be fully validated in accordance with regulatory requirements.
RB Plant helps clients by writing and executing validation protocols which they can inherit into their internal procedures for future projects, thus freeing up time to focus on core activities.
We carry out:
- 100% coverage of all protocols to achieve regulatory compliance.
- Protocol and procedures documentation.
- Design Qualification and GMP reviews.
- Installation Qualification (IQ).
- Operational Qualification (OQ).
- Performance Qualification (PQ).
- Validation master planning.
- Process validation.
- Prospective, retrospective and routine validation studies.
- Software validation to GAMP 5
- Construction auditing.
- Wet and dry commissioning.
- Validation training.
- Factory and site acceptance test witnessing.