Programme
Validation Inventory
Canonical register of facilities, utilities, equipment, processes, methods, systems and controlled calculations requiring qualification or validation.
- Inventory items
- 15
- Restricted
- 15
- Revalidation required
- 2
- Active controls
- 1
15 of 15 items shown
| ID / Item | Type | Department | GxP criticality | Validation status | Intended use | Current restriction | Next review | Active project | Temporary control | Owner |
|---|---|---|---|---|---|---|---|---|---|---|
| analytical procedure | QC | GxP Critical | In Validation | Assay of CBD isolate | Technical review is pending. | 18 Aug 2026 | AV-CBD-ASSAY-001 | None | Mara König | |
| computerised system | QC | GxP Critical | Planned | Laboratory readiness workflow | URS and GxP risk assessment remain open. | 18 Aug 2026 | CSV-PRISM-001 | None | Mara König | |
| cleaning procedure | Production | GxP Critical | In Validation | Nutsche filter cleaning | Dirty hold time at 72 hours remains open. | 18 Aug 2026 | CV-NUTSCHE-002 | None | Mara König | |
| data migration | IT | GxP Critical | Temporary Controlled Use | Migrated qualification records | Dual review required for migrated qualifications. | 18 Aug 2026 | DM-COMP-001 | None | Mara König | |
| laboratory instrument | QC | GxP Critical | Conditionally Qualified | Qualitative identity testing | Qualitative identity testing only. | 23 Jul 2026 | EQ-HPLC-02 | Active | Mara König | |
| hold-time requirement | Production | GxP Critical | In Validation | Wet cake hold up to 48 hours | 48-hour provisional limit; 72-hour point pending. | 18 Aug 2026 | HT-CBD-WETCAKE-001 | None | Mara König | |
| utility | Engineering | GxP Critical | Revalidation Required | Production Room 2 environmental control | Air-balance modification requires requalification. | 18 Aug 2026 | HVAC-GMP-01 | None | Mara König | |
| packaging process | Production | GxP Critical | Planned | CBD API drum packaging | Seal-integrity challenge remains open. | 18 Aug 2026 | PKV-CBD-API-001 | None | Mara König | |
| manufacturing process | Production | GxP Critical | In Validation | CBD crystallisation process | Three PPQ batches remain planned. | 18 Aug 2026 | PV-CBD-CRYST-003 | None | Mara König | |
| utility | Engineering | GxP Critical | Qualified | Purified water supply | Increased return-loop TOC monitoring. | 18 Aug 2026 | PW-001 | None | Mara König | |
| room | Engineering | GxP Critical | Planned | Production Room 2 airflow pattern | Smoke study scheduled after air-balance modification. | 18 Aug 2026 | HVAC-GMP-01 | None | Mara König | |
| spreadsheet | QC | GxP Critical | Revalidation Required | Residual solvent dilution calculation | Independent second-person verification required pending formula revalidation. | 18 Aug 2026 | SV-CALC-014 | None | Mara König | |
| storage configuration | Warehouse | GxP Critical | Restricted | Finished goods storage | Logger excursion risk assessment pending. | 18 Aug 2026 | TM-WH-001 | None | Mara König | |
| transport configuration | Logistics | GxP Critical | Qualified with Restriction | Summer transport lane | Winter route remains unqualified. | 18 Aug 2026 | TQ-ZW-CH-001 | None | Mara König | |
| utility | Production | GxP Critical | Qualified with Restriction | Points of use 1–3 | Point-of-use 4 pending PQ. | 18 Aug 2026 | UT-N2-001 | None | Mara König |