good distribution practices awareness training masterclass gdp antwerpen 5 march 2015 claude...
TRANSCRIPT
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
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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
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Cold chain management and monitoring
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?
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Cold chain management and monitoring
Possible patient effect• Out-of-spec temperature during transport could lead
to instable medicine• Instable medicine could harm patient
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Cold chain management and monitoring
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
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Cold chain management and monitoring
Noticed in time?• It was noticed before the package reached the
patient
• Product was placed in quarantine• Where: in a LSP
(Logistic Service Provider)
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Cold chain management and monitoring
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!
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Cold chain management and monitoring
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!
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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!
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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
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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
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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
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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
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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!
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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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Cornea bank in Switzerland
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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Cornea bank in Switzerland
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
Cornea bank in Switzerland
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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