All types of turnkey projects with scope of Designing, Commissioning, Installation, Validation, Qualification of utilities, Equipments, Systems, Validation Services to Qualify Facilities, Systems and Equipment Qualification is essential to successful process validation, product quality and patient safety.
We have experienced team of validation professionals from Engineering and Pharmacy field who provide qualification and validation documentation of direct impact systems, indirect impact systems with critical components in GMP environments. In addition to validation strategy, we offer a full portfolio of services including Protocol Development, Execution accordance with cGMP, US-FDA, MHRA, Schedule-M, ISO &WHO requirements and compliant Documentation comprising of
- Validation Master Plan,
- All Operational as well as system SOPs of Warehouse, Production, Engineering, Quality control and Quality Assurance Department of all dosage forms.
- Design Qualification (DQ), Impact, and Risk and GAP assessment.
- Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
- PQ batches execution and support for Process validation.
- FAT Inspection of Equipments at vendor’s site.
- SAT Inspection of Equipments at installation site.
- Failure investigation, CAPA, Risk assessment, Deviation and change management documentation.
