Download ppt - Logistics: Customer & Regulatory Expectations versus Daily Reality Marian Desmet Benoît Cloquet

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


2. Clinical Research Regulatory Compliance

YES!

Safe & Effective


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


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


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


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


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)?


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


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°


6. Transport Validation Approach at B & C:Inter-TempTale Variability


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




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


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


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