Temperature Management – Cold Chain Medicinal Products Wholesale Distribution Conference 8 th February 2017 Emer O’Neill MPSI Health Products Distribution Inspections Co-ordinator
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Temperature Management –
Cold Chain Medicinal Products
Wholesale Distribution Conference
8th February 2017
Emer O’Neill MPSI
Health Products Distribution Inspections Co-ordinator
Overview
• Regulatory Framework
• Importance of temperature management
• Key findings from the inspection programme
• Focussed inspections
• Recurring issues
Regulatory Framework
Legislation
procure hold
supply export
wholesale distribution
authorisation (WDA)
Medicinal Products (Control of Wholesale Distribution) Regulations 2007 (as amended)
Medicinal Products (Control of Manufacture) Regulations 2007 (as amended)
EU GDP Guidelines (2013/C 343/01)
Directive 2001/83/EC as amended
Legislation
• Training
• Repair, maintenance and calibration activities
• Immediately transferred to appropriate storage
facilities.
• Returns to saleable stock
• Correct transport conditions
EU GDP Guidelines, Paragraph 2.4, 3.3, 5.4, 6.3, 9.4
Importance of temperature
management
2oC - 8oC
Cold chain products (requiring low temperature
handling)
What is the impact of improper storage on
medicines?
Noticeable Impacts
Discolouration
Changed form – liquid to
solid
Unusual odour
Unnoticeable Impacts
Efficacy lost
Shelf life shortened
Stability altered
Safety compromised
If kept under the right conditions, it should do its job.
Key findings from inspection
programme
30 36
Financial
transactions only
(i.e. Procure &
Supply)
Storage
(i.e. Procure,
Holding &
Supply)
Wholesaler’s Authorisation including the category
cold chain products (requiring low temperature
handling)
Classification of Deficiencies
Financial transactions only
Based on the number of
companies with:
Critical
Major
Other
Financial transactions only
2
4
3
1
INVESITGATION OF EXCURSIONS -
HOLDING SITE
RECORDS AND PROCEDURES TECHNICAL AGREEMENT -
EXCURSIONS NOT REQUIRED TO
BE REPORTED
NOFICATION OF EXCURSIONS
DURING TRANSPORT
No
. o
f d
efi
cie
ncie
s
Other deficiencies
Classification of Deficiencies
Storage
Based on the number of
companies with:
Critical
Major
Other
Storage
11
24
16
19
INVESTIGATION
OF EXCURSIONS
RECORDS AND PROCEDURES VALIDATION OF
STORAGE & TRANSPORT
QUALIFICATION OF
EQUIPMENT
No
of
deff
icie
ncie
sMajor Deficiencies
Storage
20
87 7
RECORDS AND PROCEDURES INVESTIGATION OF EXCURSIONS VALIDATION OF STORAGE &
TRANSPORTATION
MAPPING OF FRIDGE
No
. o
f d
efi
cie
ncie
s
Other Deficiencies
Focussed Inspection Findings
Inclusion criteria
• Authorised wholesale activities
• Activities at the time of selection
• Responsibility for transportation
• Classification of deficiencies
• Type of operator
Classification of Deficiencies
Focussed inspections
Based on the number of
companies with:
Critical
Major
Other
Focussed inspections
2
1
3
RECORDS AND PROCEDURES PROCESS FOR TRANSPORT VALIDATION OF TRANSPORT
No
of
deff
icie
ncie
sMajor Deficiencies
Focussed inspections
3 3
2
RECORDS AND PROCEDURES MNAGAMENT OF TEMPERATIRES OUTSOURCED TRANSPORT
No
of
defi
cie
ncie
s
Other Deficiencies
Recurring Issues
Recurring Issues
19
44
24
21
INVESTIGATION OF EXCURSIONS RECORDS AND PROCEDURES VALIDATION OF STORAGE &
TRANSPORT
QUALIFICATION OF EQUIPMENT
No
of
defi
cie
ncie
s
Validation of transport
Freezer
Fridge
Shippers
Vehicle
Validate
Validation of transport
Freezer
Fridge
Shippers
Vehicle
Validate
Freezer
Conclusion
HPRA Guidance Documents
• Guide to Good Distribution Practice of Medicinal
Products for Human Use
• Guide to Control and Monitoring of Storage and
Transportation Conditions
Conclusion
• Qualify each piece of equipment
• Validate each process
• Investigate excursions
• Document all actions taken!
Temperature Management –
Cold Chain Medicinal Products
text questions to: 0873769292
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