Good Distribution Practices Awareness training Masterclass GDP Antwerpen 5 March 2015 Claude Goldszmidt Senior IT & Equipment Compliance Consultant and

Good Distribution PracticesAwareness training

Masterclass GDP Antwerpen 5 March 2015

Claude GoldszmidtSenior IT & Equipment Compliance Consultant

and Rescop Academy Trainer

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• Some basic rules

• Practical examples: case studies

• Case: Cold chain

• Case: Vaccine

• Example: Cornea bank

• Existing tools

Index

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Some basic Rules

• Every Distribution company must have a permanently available Responsible Person (RP)

• Quality Management System:

Quality Manual + CAPA system + SLA

• Adequate number of trained personnel

• External audits

• Premises and Equipment Qualification and Validation

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Some basic Rules

• Responsible Person (oversees Quality System)

• Written procedures (SOPs)

• Checking sincerity of suppliers and customers

• Staff Training

• Records/traceability (tracking devices)

• Emergency plans

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Practical examples: case studies

Case study workflow:

• Problem description

• Root-cause

• Possible effect on patient

• Possible consequence for the Company

• Noticed in time

6www.rescop.com 6www.rescop.com 6

Cold chain management and monitoring

Problem• Temperature data loggers did not log any data during

Cold chain truck shipment• Therefore the product quality could not be assured



Root cause• The temperature loggers were not switched on

because both packers expected the other one switched on the temp data loggers.

• SOP exists: It is not allowed to work with 2 persons on one shipment at the same time

• SOP not followed correctly: Why?– Training management– Other possible reasons?



Possible patient effect• Out-of-spec temperature during transport could lead

to instable medicine• Instable medicine could harm patient



Possible Consequences for the Company• Short term impact:

– Extra work for deviation (cost for raising deviation, launching the investigation, closing the deviation)

– Costs for recall (when product already with patient)– When patient safety compromised the company may be

(temporarily) closed by authorities

• Long term impact:– When it happens often the company name could be

damaged, resulting in being forced out-of-business



Noticed in time?• It was noticed before the package reached the

patient

• Product was placed in quarantine• Where: in a LSP

(Logistic Service Provider)



Actual patient effect• Temperature logger installed within the truck: room

temperature exposure (RTE) could be rolled out• Official stability studies with regards to RTE exist• Data from these stability studies could be used:

interest of a LIMS to manage stability studies• Conclusion: no direct impact!



Actual Consequences for the Company• Financial impact:

– Extra work for deviation (cost for raising deviation, launching the investigation, closing the deviation) use of a dedicated registration tool (i.e. RC-QMS)

– Analysis of data: difference with and without a LIMS

• Other shipments could be sent in time to patient• No consequences for the patient: the most

important!


Vaccine

Problem• Customers complained that there were observed

white flocks in the delivered rabies vaccine for dogs• In the leaflet is mentioned that the vaccine must

contain a milky solution without flocks!


Vaccine

Root cause• Product should be stored and maintained at 4-8 C• Product was exposed to temperatures < 0 C causing

the white flocks to form in the product


Vaccine

Possible patient / human safety effect• The vaccine does not work and the dog is not

protected for rabies disease• When the dog bites a human, this might lead to

infection of human


Vaccine

Possible Consequences for the Company• Short term impact:

– Extra work for deviation (cost for raising deviation, launching the investigation, closing the deviation)

– Costs for recall (when product already with patient)– When human safety compromised the company may be

(temporarily) closed by authorities

• Long term impact:– When it happens often the company name could be

damaged, resulting in being forced out-of-business


Vaccine

Noticed in time?• It was noticed multiple times by customers

(veterinarians) that there were white flocks in the vaccine complaints

• There was sufficient temperature logging data available to support that the product was not exposed to too low temperatures at the producer or during transport by the LSP and the exposure happened at the veterinarian


Vaccine

Actual patient effect• The compromised vaccine was not delivered to the

dog• A new vaccine was provided by the national

distributor• Conclusion: no direct impact!


Vaccine

Actual Consequences for the Company• Financial impact:

– Extra work for complaint handling and root cause investigation

• Replacement shipments were made by the local distributor

• No (potential) impact on human safety: the most important!

The Client’s challenge

• Historically no cornea bank in the Geneva catchment area. • Patients needing a cornea transplant had to rely on cornea stocks

located in other Swiss cantons, or even abroad. • Cornea banks exist at Lucerne, Zurich, Berne, Lausanne and Olten.• Beginning 2013, Hôpitaux Universitaires de Genève (HUG) decided

to establish a cornea bank for patients in the Geneva region.• The process of stocking human tissue for transplantation is highly

regulated both at Swiss and international levels. • Swissmedic, the Swiss regulatory agency, sets strict rules at every

step of the process.

Cornea bank in Switzerland

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Logistic service provider answer

• Through extensive interaction with many clients over the years, the LSP observed an increasing and world-wide move towards ever more stringent safety regulations in the life sciences field.

• The LSP wanted to get their competencies, their processes and their infrastructure validated.

• Hence time, effort and resources were allocated to acquire the much sought after Swissmedic certification for transporting, distributing and stocking medicinal products.

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6 selection criteria

1. Swissmedic certification.

2. Adhere to the Good Distribution Practices (GDP) scheme

3. Guaranteed CRT (Controlled Room Temperature)

4. Up-to-date know-how and consulting services.a. Classification

b. Packaging

c. Transport

5. Real Time Shipping Visibility

6. Cost22


The end result

• Geneva’s Cornea Bank is one of only few in Europe who respond to the latest and strictest regulations at all levels of the supply chain.

• When HUG extends its collaboration to include other cornea banks, inside and outside of Switzerland, everything is already in place.

• As Swissmedic certified shippers, the LSP is always up-to-date with the latest regulatory information, they make sure all necessary authorisations are in place, and they deliver on time.

• For shipping biological substances, an ongoing and mutually trusting working relationship between the client and the supplier is absolutely essential.

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Existing tools

Rescop can provide you with:

Quality Management System: RC-QMS• Document Management System for SOPs: RC-DMS• Training Management System: RC-Training• Exception Handling and CAPA: RC-CAPA• Automation Compliance Management Suite: RC-ACMS

– System Management and Electronic Logbook: RC-Logbook– Validation, Qualification and Commissioning: RC-SDLC

• Electronic Laboratory NoteBook: RC-ELN• Laboratory Information Management System: RC-LIMS

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Laboratory Information

ManagementSystem

LIMS

Compliance & Quality Management Software

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ANY QUESTION ?

Thank You

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Documents

Good Distribution Practices Awareness training Masterclass GDP Antwerpen 5 March 2015 Claude Goldszmidt Senior IT & Equipment Compliance Consultant and