Sharon Yarkoni 08, March 2016 - IPL Forum · 2012. 7. 1. · Process- PDA Technical Reports PDA TR...
Transcript of Sharon Yarkoni 08, March 2016 - IPL Forum · 2012. 7. 1. · Process- PDA Technical Reports PDA TR...
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Shipping validation, from customer
prospective
Sharon Yarkoni
08, March 2016
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Agenda
Good Distribution Practice the three main streams.
USP 1079,1197, 1083
PDA 39, 46, 52, 53,72
Regulatory bodies requirements.
Risks involved in shipping and distribution
Risks involved during transportation.
Case study.
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cGDP – is based of 3 main streams:
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Chapter Outline
Good Storage & Distribution Practices for
Drug Products.
Introduction, Definitions, Scope
Background Information
Responsibilities
Labeling Information
Quality Management System
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Chapter Outline
Good Distribution Practices for
Pharmaceutical excipients.
Quality Organization & Documentation
Premises, Storage, Repackaging & Stability
Returned Goods, Dispatch, Transport, Importation,
Traceability
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Chapter Outline
Good Distribution Practices – Supply Chain
Integrity
Importation, Supply Chain Risk Management, Effective Supplier Partnerships, Supply Chain Quality System
Counterfeit Drugs & Medical Devices
Best Practices to Combat Counterfeit Drugs & Medical Devices
Theft
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Summary of , &
Chapter
Coverage
QMS
Environmental
Control
Importation
Counterfeit
Traceability
DP
Yes
Yes
No
No
No
EXCP; DS; DP;
MD
Yes
No
Yes
Yes
Yes
EXCP
Yes
Yes
Yes
Yes
Yes
EXCP = Excipients; DS = Drug Substance; DP = Drug Products
MD = Medical Devices
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Regulatory Guidance- EU GDP Article 84 of Directive 2001/83/EC on the
Community code relating to medicinal products for
human use is under revision for public consultation
Reason: 1994 GDP no longer adequate
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Regulatory Guidance-Mexico Ministry of
Health (MOH)
“The cold chain report must correspond to the
temperature of the product, not to the external one.”
Mexican MOH “COFEPRIS” only allows use of data
loggers they do not allow use of electronic or chemical
indicators
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Process- PDA Technical Reports
PDA TR 39 (revised 2007) Guidance for Temperature-
Controlled Medicinal Products: Maintaining the Quality of
Sensitive Medicinal Products Through the Transportation
Environment.
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Process- PDA Technical Reports
PDA TR 46 Last Mile: Guidance for Good Distribution
Practices for Pharmaceutical Products to the End User.
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Process- PDA Technical Reports
PDA TR 52 Guidance for Good Distribution Practices
(GDPs) for the Pharmaceutical Supply Chain.
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Process- PDA Technical Reports
PDA TR 53 Guidance for Industry: Stability Testing to
Support Distribution of New Drug Products.
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Standards
IATA INFORMATION NOTICE: time and temperature
sensitive label to become mandatory 1 July 2012.
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Transport process involves:
Variance ambient temperature.
Modes of transportation.
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Shipping systems
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Temperature monitoring devices
There are different types of data loggers for different temperature
conditions such as 2-8°C, -30°C, RT etc.
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Cooling material
Dry ICE- changes from a solid to a gas at −78.5 °C
Ice Packs-can be pre cooled to 2-8 °C, -30 °C
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Transport process involves:
Transit duration (since the product left production site until it gets to the
final costumer).
Route (where do I send my product, how many stops on the way).
Material handling (temperature sensitive products, light sensitive etc.)
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Risks during storage and distribution
Mix up of products
Mix up of batches
Contamination
High temperature/high humidity
Light
Freezing
Pests
Distribution of non released products
Using of inappropriate vehicles
Damage to product
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Risks during Transportation
Shipment of wrong product
Shipment to wrong destination
Inappropriate handling/loading
Damage in transit
Loss in transit
Temperature deviation
Mixing of batches
Breakdown of pallets
Late delivery
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Qualification versus Validation
high degree of documented testing that demonstrate with a -Qualification
that a specific process will meet its pre determined acceptance assurance
criteria.
Validation- documented testing performed under highly controlled conditions
produces a result meeting consistentlythat demonstrates that a process
pre determent acceptance criteria.
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Shipping Qualification
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Shipping Qualification
Physical
Challenge
Thermal Study
Packaging Integrity
Tests
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Case study- protocol
Maximum load-
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Case study- protocol
Minimum load-
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Case study- protocol
Pallet configuration
Minimum Load shipping carton
Maximum Load shipping carton
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Case study- protocol
Specifications:
For the duration of the shipment the temperature in direct vicinity of the
product should not exceed -20ºC. Temperature limitations to the air
temperatures outside the shipper are not specified.
The maximum duration for the complete shipment is not to exceed 72hours.
The expected average duration of an individual shipment is 36 hours.
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Case study- report
Executive summary:
A series of 12 shipments were carried out
Each shipment included Maximum and Minimum configuration
Different vial formats (5 ml and 1or 2 ml ) were investigated separately
The recorded data was compared to data available from summer shipments
of 2008, 2009
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Case study- report
The complete cold chain consist of total of 8 legs:
Packaging and storage at manufacturer
Road transport manufacturer to Ben gurion Airport
Freight handling at Tel Aviv airport
Air transport Tel Aviv to Frankfurt
Freight handling at Frankfurt airport
Air transport Frankfurt to Memphis
Freight handling at Memphis airport
Road transport Memphis airport to Distribution warehouse
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Case study- report
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Case study- report Ambient temperature (summer profile):
duration Temperature
measured
Leg
16-18 11°C to 23°C Packaging and storage at Mfr
0.5-1.5 3°C to 27°C
Road transport Mfr to BGA
1.5-4 Controlled area Freight handling at BGA
5-6.5 -15°C to 18°C
Air transport BGA-Frankfurt
1.5-2 -10°C to 12°C
Freight handling at Frankfurt airport
10-12 -19°C to 20°C
Air transport Frankfurt to Memphis
6.5-32.5 0°C to 20°C
Freight handling at Memphis airport
0.5-5 -1°C to 25°C
Road transport Memphis airport to
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Case study- report
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Case study- report
Historic Data:
Series of 30 shipments from summer 2008-2009 were analyzed
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Case study- report
Historic Data:
Series of 30 shipments from summer 2008-2009 were analyzed
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Case study- report
Conclusions and recommendations:
Temperature is fully within range during the entire shipment (both minimum
and maximum).
The shipping configuration selected for the minimum and maximum load in
this study meets the defined temperature specification.
All collected data in this study as well as the historical data analyzed is fully
compatible with the requirements.
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Case study- report
The maximum shipping period of 72 hours can be exceeded by one hour
without undue thermal risk to the product.
The most critical phase in the transport length is fount at the Memphis
airport (the product was held for 6-32 hours prior to release, probably
customs release).
The location chosen for the data logger needs to be at the side wall on the
upper level in order to measure the most critical temperature during the
shipment.
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Case study- Physical challenge
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Case study- Physical challenge
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Case study- Physical challenge
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Case study- Physical challenge
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Stability & Packaging Integrity
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Stability indicating test methods
Performed after each thermal study to ensure that the shipment didn’t
impact the quality of the product.
Specific protocol was prepared to determine the tests to be performed
Package Integrity
Visual Inspection performed to ensure that the shipment didn't impact the
product.
Sterility test performed to ensure that the shipment didn't impact the
integrity of the product.
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Thank You!
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