Validation is a crucial stage that ensures that all your systems, processes, equipment, activities, and procedures generate consistent outcomes as intended and meet the required compliance levels. At Alsitype Pharma Technologies, we go beyond mere compliance by applying a risk-based approach to validation focused on reducing overall business risk and improving product quality.
Services offered to pharmaceutical manufacturing facilities, warehouses, and laboratories include:
- Qualification of facilities, utilities and equipment- Installation Qualification (IQ), Operation Qualification (OP) and Performance Qualification (PQ) for clean rooms, warehouses, pharmaceutical waters, clean steam, compressed air, autoclaves, stability chambers, manufacturing and packing equipment etc. as applicable
- Manufacturing process validation- Risk-based approach with Stage 1 Process Design, Stage 2 Process Qualification (PQ) and Stage 3 Continued Process Validation (CPV)
- Analytical method validation- To ensure your analytical testing procedures are suitable for their intended use
- Cleaning validation- To ensure the robustness of cleaning procedures to remove product, detergent and other residues in your manufacturing equipment and therefore prevent cross-contamination
- Computerised System Validation (CSV)- To ensure that computer-based systems perform as intended in adherence GAMP5
We also provide transport validation and GMP temperature mapping services.