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Logistics: Customer & Regulatory Expectations versus Daily Reality
Marian Desmet Benoît Cloquet
B&Cemo Conf/MD/26-Jan-2006/Slide 2
1. Logistics: What is it?
Total process of moving goods from a Manufacturer to a Customer
in the most timely and cost-efficient manner possible
Handling and movement of inbound raw materials and other supplies as well as outbound physical distribution
Organisation of any project or operation, including transportation and housing
B&Cemo Conf/MD/26-Jan-2006/Slide 3
2. Clinical Research Regulatory Compliance
YES!
Safe & Effective
B&Cemo Conf/MD/26-Jan-2006/Slide 4
Patients CT Subjects
Declaration of Helsinki/ Hippocratic Oath
Good Medical Practice
GCP …
ContractCT Protocol
Good Lab Technical
Working Principles
National Regulations
(e.g. GBEA)Norms
(CAP, ISO)
2. Clinical Research Regulatory Compliance
B&Cemo Conf/MD/26-Jan-2006/Slide 5
3. Regulatory & Customer Expectations
What do they expect? Compliance?
With what?Really mandatory for a company as B & C
International?
Differences between CustomersDifferent viewpoints & auditing focus
between Auditors
B&Cemo Conf/MD/26-Jan-2006/Slide 6
4. Compliance Approach
Risk Management Approach? Risk for Regulatory Authority Inspections?
Yes
Are the data & systems in support of regulatory submissions?
Integrate principles of GCP and related applicable regulations, incl. validation
B&Cemo Conf/MD/26-Jan-2006/Slide 7
5. Compliance Examples
Laboratory Kit- Tube
missing
- Expired product in tube
- Not delivered at right time
QC Error
Delay Customs
Impact on Result &/or Clinical Trial?
- Some tests not performed- Reliable result?- Test out-of Protocol required time-window
B&Cemo Conf/MD/26-Jan-2006/Slide 8
5. Compliance Examples
Specimen Storage
- 1X/day temperature monitoring- No traceability of removal in- & out in case of specimen transfer (defrosting, cleaning)
Impact on Result &/or Clinical Trial?
- Evidence of specimen storage at appropriate conditions at all times (incl. Transfer)?
B&Cemo Conf/MD/26-Jan-2006/Slide 9
6. Transport Validation Approach at B & C
Pre-testing
- Time of ambient specimen to become
- refrigerated
- frozen at -20°C
- frozen at -80°C
- In-house TempTale Validation
- IQ/OQ/PQ: 1 hour temp. recording
- Inter-TempTale Variability: Accuracy Static Testing: Controlled Conditions Dynamic Testing: Life Transport Test
B&Cemo Conf/MD/26-Jan-2006/Slide 10
6. Transport Validation Approach at B & C:Inter-TempTale Variability
N = 18 Temptales Consecutive conditions Test: 4 1/2 h
1 H 1 H 30’1 H1 H
Room T° 2 – 8°C -20°C -80°C Room T°
B&Cemo Conf/MD/26-Jan-2006/Slide 11
6. Transport Validation Approach at B & C:Inter-TempTale Variability
B&Cemo Conf/MD/26-Jan-2006/Slide 12
6. Transport Validation Approach at B & C: Static Test
• Specimens: 9 (3 X 3) Tubes filled with water
• Additive for “Position” in shipment container
• Labelling for original condition - Refrigerated- -20°C- -80°C
• Probe from TempTale inside tube
• Shipment container: TempTale sensor on Top / Middle / Bottom
B&Cemo Conf/MD/26-Jan-2006/Slide 13
B&Cemo Conf/MD/26-Jan-2006/Slide 14
B&Cemo Conf/MD/26-Jan-2006/Slide 15
Results: Specimen T° at bottom: Stable The less dry ice surrounding the specimen, specimen T° Effect of opening/closing box on specimen T°: Almost nihil Box T° “Top”: - 45°C to - 20°C (evaporation dry ice)
6. Transport Validation Approach at B & C:Static Test
Static Test: Temp. inside Tubes
-100
-80
-60
-40
-20
0
20
-80°C Bottom -80°C Middle -80°C Top
Static Test: Temp. Inside Box
-100
-80
-60
-40-20
0
20
40
Box Bottom Box Middle Box Top0’ 5 ½ D 0’ 5 ½ D
B&Cemo Conf/MD/26-Jan-2006/Slide 16
6. Transport Validation Approach at B & C:Dynamic Test
Main Objective:
Verification of Life Transport Conditions
- 2 specimens (tube with water) - TempTale inside tube
- Shipment container: TempTale on Top / at Bottom
B&Cemo Conf/MD/26-Jan-2006/Slide 17
7. Lessons Learned - Conclusions
Added value of Transport Validation
- Not the opening of transport boxes important, but the level of dry ice
- If specimens need to remain at -80°C, they should be permanently surrounded by dry ice
- Specimens half in/half out dry ice: T° variation between -80°C to -45°C