Professional Documents
Culture Documents
Agenda 1. Qualification of stability chambers 2. Calibration of equipment of stability chambers 3. Maintenance of stability chambers
Qualification
1. Qualification of stability chambers 1.1 General aspects 1.2 URS, analysis of local conditions 1.3 Qualification: DQ, IQ, OQ, PQ 1.4 periodic Re-Qualification
define good Team-Members, experts where needed QA, Engineer, technician, system owner (teamleader) the team determines your success
approach: planning doing reporting using professional project management Tool (MS-Project) define milestones arrange periodical status- meetings
Qualification
1. Qualification of stability chambers 1.1 General aspects 1.2 URS, analysis of local conditions 1.3 Qualification: DQ, IQ, OQ, PQ 1.4 periodic Re-Qualification
define usage very precisely (which kind of samples will be stored?) define climatic condition -nominal value, according ICH Q1A, WHO (e.g. accelerated conditions: 40C 2C / 75 % r.H. 5 % r.H.) - limits, according ICH Q1A, - additional conditions (e.g. Humidity in 5C-Cells is not recommended, but very important)
define location, shape and area needed define equipment (shelves, drawer needed?) define safety and enviromental aspects (fire detector) define security requirements (on-line monitoring, locking system) define budget define basis and scale of qualification
Find the best location (building) for stability chambers consider flow line (Short way, minimal horizontal moving) infrastructure (water, air condition, additional deconstruction) safety and enviromental aspects (energy saving) security requirements (available access control-systems)
Qualification
1. Qualification of stability chambers: 1.1 General aspects 1.2 URS, analysis of local conditions 1.3 Qualification: DQ, IQ, OQ, PQ 1.4 periodic Re-Qualification
Qualification overview
1.Phase MQP DQ
2.Phase IQ
3.Phase OQ
4.Phase PQ MQR
DQ: Design Qualification MQP: Master-Qualification Plan MQR: Master-Qualification Report IQ: Installation Qualification OQ: Operational Qualification PQ: Performance Qualification
Qualification
Qualification
1. Qualification of stability chambers: 1.1 General aspects 1.2 URS, analysis of local conditions 1.3 Qualification: DQ, IQ, OQ, PQ 1.4 periodic Re-Qualification 2. Calibration of equipment: 3. Maintenance of stability chambers:
Start running climatic chamber Strategy: Review of qualification status after a pre-defined time period write and approve Re-Qualification-Plan check all relevant parameters (i.e. MSR) is the change documentation complete? Repeat the Temperatur- and Humidity- Room-Mapping write and approve PQ-Report before writing the Final Report End re-qualified climatic chamber
Calibration
1. Qualification of stability chambers 2. Calibration of equipment of stability chambers 3. Maintenance of stability chambers
Calibration concepts