Compliance with Guide-0069 Throughout a

Complex Distribution Model

Rania Al-Ammar, Regional Director, Commercial Quality

Hospira, a Pfizer company
 Case Study: Hospira Canada (a Pfizer
company) journey towards applying evolving
Canadian requirements for temperature
control of drugs during transportation
The Journey
Phase I:

- Educating all stakeholders on Guide 00-69 requirements

- Segmentation of product portfolio
- Completion of a holistic gap assessment (inbound and outbound shipments)

Phase II:

- Implemeting enhancements following a risk based staggered approach

- Investing in stability data to manage T0 excursions
- Initiating shipping studies to validate effectiveness of controls

Phase III:

- Post temperature studies adjustments

- Strenghtening of third party oversight (quality agreements, audits, etc)
- Applying lessons learned during new product launches
Complex & Diversified stakeholders network

Distribution Distribution
HSP hub (EU) hub (US)
Europe

HSP India

3PL I (3 sites)
hospitals
HSP US HSP Canada

CPDN (3 sites) pharmacies

wholesalers
HSP APAC 3PL II (6
sites)

3rd Party
3rd Party 3rd Party
Mfg.
Mfg. APAC Testing
EUROPE

4
Product portfolio segmentation:
Wide range of products with varied To requirements

Cold chain
Large volume parenterals
Small volume injectables

Controlled Room Temperature

Large volume parenterals
Small volume injectables

Sets and device accessories

INBOUND SHIPMENTS
Gap Assessment methodology

Compile Classify Categorize

A list of products products by Mfg shipments by
received from site, Transit DC, container
sister sites & shipping route protection
Third party sites (Air/ Ocean/ method, validated
(> 350 SKUs) land) shipping trucks,
qualified reefers,
dry boxes
INBOUND SHIPMENTS:
Gap Assessment Results

Products shipped
No gaps identified.
using
Envirotainers.

International Remediation required. Move to Air and

monitor via TMDs
Shipments via
Ocean

Shipments from US Remediation required. Implement To

monitoring between :
using Reefers Mfg site & Global DC, Global DC & Local DC
OUTBOUND SHIPMENTS
Gap Assessment methodology

Determine shipment
Classify delivery risk (low, medium,
Determine shipment
Map all delivery Classify
points delivery
by shipping risk (low, medium,
high) based on
Map allfordelivery
points each third points
methodby shipping
(ambient high) based
availability of on
points for each third
party logistic partner method (ambient
services/heated availability
temperature of
control
party logistic
services/heated
services/courier) temperature
during transport control
partner
services/courier) during transport
services
services
OUTBOUND SHIPMENTS
Gap Assessment results

Cold chain products fully compliant Risk identified for CRT products (risk level
throughout the complete distribution increases as delivery points become
network (using of validated shippers ) remote)

Controlled transport available Heated transport available Controlled/Heated transport unavailable

Continuous Improvements initiatives

Strengthen control over inbound shipments:

1) Establish contact with every Mfg plant and update shipping SOPs to
include TMD for every Canadian shipment.
2) Invest in TMD technology and education of Third Party Logistics staff to
ensure Temperature download upon shipment receipt
3) Update release procedures to include review of To data throughout the
supply chain.
 Continuous Improvements initiatives

Strengthen control over shipments to Wholesalers

1) All shipments of refrigerated products contracted to an
approved validated refrigerated shipments contractor
2) All shipments of ambient products contracted to an approved
ambient transport services company
3) Close oversight of transportation companies through Quality
agreements and on-site quality audits
 Continuous Improvements initiatives

Strengthen control over shipments to customers

1) Develop a shipping matrix by product type/by destination and train
3PL
2) Request that Third Party Logistics use ambient services where
available (heated services are permitted only if ambient service
unavailable)
3) Ban the use of non heated courier
4) Ensure adequate quality agreements with all carriers
5) Perform monthly reviews of all shipments to ensure 3PL did abide
by agreed upon directives
Investing in stability data

Compile all existing stability data to support disposition decisions on product

involved in temperature excursions

Build a stability matrix determining impact of any temperature excursion

outside of the labeled storage conditions on product quality

Initiate additional studies on old drug molecules to determine temperature

sensitivity and stability if exposed to temperatures outside the labeling
storage conditions
 Shipping studies initiation

The temperature
Protocols
developped for
Training 3PLs
& monitoring
studies allowed us to
winter and
summer studies
of shipments :
select samples
identify areas of
representative concern and adjust
of all
destinations our shipping
practices accordingly.
Plan Do The studies were
developed to mimic
the worst case winter
and summer
Identify
lanes at risk
Act Check Review data scenarios and were
and change received and
shipping compare executed 2 years in a
practices to results to
ensure further predetermined row.
controls AQL

Adjustments were
implemented based
on study results
Post shipping studies adjustments

Communicated with 3PL to revalidate the shipping lanes used for each destination and
confirm drug products distribution network

Implemented a shipping matrix for use by third party logistics providers as a guide for selection of
transportation methods when coordinating drug shipments to customers .

Prohibited use of couriers for drug products as we could not find any courier service provider
offering temperature protection

For remote areas where no other transportation means exist, identified controls required to ensure
product protection (such as validated pack-outs, freeze watch, thermal blankets, etc)

Disqualified carriers that could not guarantee shipment protection as part of the quality
agreements
Strengthening our Third party oversight

Ensure adequate
quality agreements
with all carriers

Perform monthly
reviews of all On-site audits of
shipments to ensure 3 PLs with focus on
3PL follow upon Guide -0069
transportation compliance
matrix requirements
Applying lessons learned during new
product launches
As part of our New Product Launch preparedness planning, ensure
compliance with Guide-0069 as a pre-requisite:

- Temperature cycling studies data is available

- Adequate shipping lane monitoring activities are defined and documented
- Outbound shipment requirements to wholesalers and /or direct customers
are developed and clearly communicated to the 3 PLs
- Quality agreements are developed with new carriers/ distribution
companies
1. Complying with Guide 0069 is a journey. Length
and magnitude of this journey depends on the
number of products handled, the complexity of
the supply chain and the distribution network
model

2. In order to implement a comprehensive and

compliant GDP management system, you should
understand your baseline, engage with your
supply chain team and follow a risk based
approach to ensure product is protected
throughout its movement.