Valor follows internationally recognized standards and best practices for Commissioning and Qualification (C&Q) of pharmaceutical facilities, equipment, and systems.
Key Standards and Guidelines Adopted By Valor.
1- ISPE Baseline® Guides (Especially GAMP® 5 and ISPE Baseline Guide Volume 5): Valor leverages ISPE’s Good Practice Guides for C&Q. The ISPE Baseline Guide Volume 5: Commissioning & Qualification (Second Edition) is a core reference, advocating a science- and risk-based approach. GAMP® 5 (Good Automated Manufacturing Practice) provides further guidance for computer system validation, which is also foundational to C&Q.
** 2- EU GMP Annex 15*** (Qualification and Validation):** Valor references EU GMP Annex 15. This annex sets the requirements for qualification and validation of facilities, utilities, equipment, and processes.
3- ASTM E2500 Standard: Incorporate principles from the ASTM E2500 standard, which promotes a science- and risk-based approach to verification of manufacturing systems and equipment.
4- EDA Compliance Validation Matrix for Work Package Development (Non-Sterile Areas):
| Element | EDA Specification | Inclusion in WP Scope |
|---|---|---|
| Room Classification | ISO 8 / Grade D for gowning & weighing | Scope must state cleanroom grade explicitly |
| Particle Limit | ≤ 3,520,000 particles ≥ 0.5 µm/m³ (at rest) | Particle count test to be included if needed |
| Pressure Cascade | 10–15 Pa ±5 between adjacent areas | Scope must reference DP sensor validation |
| ACH Requirement | 15–20 Air Changes per Hour | Verify design & measured ACH |
| Filtration Type | HEPA filters + prefilters + bag filters | Scope must define filter type/integrity check |
| Airflow Directionality | Positive pressure zones for clean-to-less-clean flow | Smoke study/visual airflow checks |
| Filter Integrity Validation | Mandatory (HEPA Leak test) | Must include DOP/PAO testing |
| HVAC System Control | Monitoring, alarms, BMS/SCADA control where applicable | Alarm testing and logging |
Valor adopts a lifecycle approach to C&Q, which may include:
- User Requirements Specification (URS)
- Design Qualification (DQ)
- Factory and Site Acceptance Testing (FAT/SAT)
- Installation Qualification (IQ)
- Operational Qualification (OQ)
- Performance Qualification (PQ)
- Note:C&Q is risk-based, focusing efforts on systems that impact product quality, patient safety, or regulatory compliance. Documentation, traceability, and data integrity are emphasized throughout the process.