IATA CEIV Pharmaceutical Logistics Audit Checklist V1.3 20170904 Clean

IATA Change History
IATA CEIV Pharma Logistics Audit Checklist

File Name Version Date
IATA_CEIV_Audit_Checklist 0.10 06-Aug-2014
IATA_CEIV_Audit_Checklist 0.40 06-Mar-2015
IATA_CEIV_Audit_Checklist 0.50 21-Apr-2015
IATA_CEIV_Audit_Checklist 0.60 28-May-2015
IATA_CEIV_Audit_Checklist 0.70 08-Jul-2015
IATA_CEIV_Audit_Checklist 1.00 13-Jul-2015
IATA_CEIV_Audit_Checklist 1.10 14-Oct-2015
IATA_CEIV_Audit_Checklist 1.20 01-Sep-2016
IATA_CEIV_Audit_Checklist 1.30 04-Sep-2017
TABLE OF CONTENT
1. General Introduction
2. Quality Management
Organization
### and management
Quality
###Management System
Management
### Reviews
Key ###
Performance Indicators
3. Personnel
General
### Information
Responsible
### Person
Other###
Personnel
4. Training
5. Documentation
General
### Requirements for Documentation
Infrastructure
### & Equipment Documentation
Process
### Documentation
6. Infrastructure and equipment
Premises
### & Equipment
Empty###Equipment
Mapping
###
Monitoring
###
IT System
###
Calibration
###
Maintenance
###
7. Complaints and quarantine
Quarantine
###
Complaints
###
8. Supplier Management
9. Self-inspections & Internal Audits
10. Transportation
General
### Information for Road and Air Transport
By Road
### Specifically
By Air
###
Specifically
11. Operations
General
###
Ground
###Transportation
Acceptance
###
Temporary
### Storage
Warehousing
###
Tarmac
###Transportation
Aircraft
###Loading
Aircraft
###Unloading
All the information contained in this document is confidential and privileged. None will be disclosed wit
authorization, unless such information is already of public knowledge. Its use is limited to that pertine
the IATA programs.
Changes Owner
First release IATA
Revised Version IATA
Time and Temperature Task Force and Industry Feedback
Update with Comments from the Industry IATA
Update with Comments from the Industry IATA
Final Version IATA
First Amendment IATA
Second Amendment IATA
Third Amendment IATA
Documentation
Documentation
ad and Air Transport
ential and privileged. None will be disclosed without prior written

blic knowledge. Its use is limited to that pertinent and relevant to
Organization
Party Audited
Location
IATA consultants /assessors
Date
Contact Name
Contact Details
No. ITEMS YES NO N/A
Have the IATA Checklist and set of documents being
1.1 provided upfront and shared with IATA prior to the CEIV
Audit?
Is the IATA Temperature Control Regulations (TCR)
1.2 available?
1.3 Are WHO Guidelines available (specify which ones apply)?
1.4 Are the National Regulations available?

1.5 Is your organization IOSA?
1.6 Is your organization ISAGO?
Is there a quality management system certified by an
1.7 external body (e.g. valid ISO 9001 certification)?
1.8 What is the number of employees?
1.9 What is the volume of pharmaceutical activity?
What is the number (%) of employees involved in each
1.10 steps of the handling process of pharmaceutical
shipments?
What is the service offer for temperature controlled
1.11 pharma shipments?
1.12 What are is the current capacity in square meters?
1.13 Are the premises subcontracted?
In case of storage and/or distribution of pharmaceutical

1.14 goods is the right authorization in place?
1.15 Is a Code of Conduct implemented in your company?

Where does the process starts and ends? Where are the
1.16 handover points?
IATA_CEIV_Audit_ChecklistV1.3_20170904 5 of 60
No. COMPLIANCE
ITEMS
YES NO N/A
2. Quality Management
2.1 Organization and management
Are documents including the current organizational
2.1.1 structure, showing responsibilities and relationships,
published?
2.1.2 Is there a Quality department identified?
2.2 Quality Management System
2.2.1 Is there a Quality management system implemented?
Is there a quality manual, which mentions management's
2.2.2 active commitment to Quality?
Is there a Quality policy and is it signed by senior
2.2.3 management?
Is there a designated person who has authority and
2.2.4 responsibility for ensuring a quality system is implemented
and maintained?
Is there a document control system in place ensuring
2.2.5 proper design, approval, review, and distribution of
necessary documentation?
Is there a CAPA procedure in place, reflecting response
2.2.6 time commitment to Customers and mentioning items
triggering this CAPA process?
2.2.7 Is there a change control system in place?
Are Risk Assessments conducted to assess potential risk to

2.2.8 the defined processes and procedures for handling and
transporting of pharmaceutical shipments?
Is there a defined review frequency of the risk

2.2.9 assessment?
Is there a process for quality agreements and/or SLA when
2.2.10 activities of subcontracted?
Are there quality reports (reviews) available from the
2.2.11 subcontracted activities?
2.3 Management Reviews
Is a formal management review of the Quality
2.3.1 Management System held at least once a year?
Do management reviews consider the overall effectiveness

2.3.2 of the system in achieving quality objectives?
Do management reviews consider findings of internal

2.3.3 audits, recommendations made and corrective actions
taken?
Do management reviews consider customer feedback and
2.3.4 complaints? How is the CAPA process linked with
complaints?
2.3.5 Are the CAPA's reviewed during management reviews?
Are appropriate follow up actions taken after
2.3.6 investigation?
2.3.7 How is the overall capacity managed and reviewed?
2.4 Key Performance Indicators
Are there Pharma related quality KPIs defined? (internal
2.4.1 and external)
Do management reviews consider trends in customer
2.4.2 complaints?
No. COMPLIANCE
ITEMS
YES NO N/A
Do management reviews consider trends in supplier
2.4.3 performance?
2.4.4 Are these indicators communicated and acted upon?
No. COMPLIANCE
ITEMS
YES NO N/A
3. Personnel
3.1 General Information
Is there a Health, Safety and Environment (HSE) policy and
3.1.1 responsible person?
Are there procedures in place ensuring good hygiene
3.1.2 procedure to avoid contamination to the product as well
as to the handling personnel?
Is key personal, involved in activities such as transport,
3.1.3 handling and maintenance, identified via risk
assessments?
Are roles and responsibilities of employees working in key
3.1.4 positions set out in written job descriptions, along with
any arrangements for delegation?
Are any changes in roles and responsibilities timely
3.1.5 reflected in job descriptions?
Are employees dealing with dangerous goods is provided
3.1.6 regular training?
3.2 Responsible Person
Is there a person with the specific responsibility and the

3.2.1 appropriate authority to deal with pharmaceuticals related
quality issues within the company?
Has the responsible person been trained on GDP/Pharma

3.2.2 Handling? Can this be proven by training records?
Is there a job description for the responsible person

3.2.3 detailing roles and responsibilities along with any
arrangements for delegation?
Is there a back-up person and is this reflected in its job
3.2.4 description?
3.3 Other Personnel
3.3.1 Are employees trained on GDP/Pharma Handling?
Is personnel dedicated to pharmaceutical shipments? If
3.3.2 personnel is not dedicated, is there a risk assessment
performed?
Is staff capacity managed to ensure handling requirements
3.3.3 are met?
3.3.4 Are codes of practice and punitive procedures in place?
No. COMPLIANCE
ITEMS
YES NO N/A
4. Training
Has an evaluation been made of all activities to identify
4.1 training needs?
Is there a specific Pharma training program (GDP, IATA
4.2 Regulations,..)?
4.3 Is there training program for new employees?
How are skills gained from training implemented in day-to-
4.4 day performance?
4.5 Is there a training program for key personnel?
4.6 Is there recurrent training updated for all staff?
Does the Training address the policies, processes,
4.7 procedures, and written instructions related to all
operational activities and the quality system?
Are employees trained on Active Temperature Controlled
4.8 Container (ACT) handling?
4.9 Is there a training matrix built ? How is it built?
4.10 How often is staff trained?
Is the training material compliant with the regulatory
4.11 requirements?
Is the training material approved by the responsible
4.12 person?
Are different training materials available for key,
4.13 competent and all staff available?
4.14 Are internal and external course materials documented?
Are employee training and qualification records

4.15 maintained and up-to-date?
4.16 Is there a training database?
4.17 Is there an assessment of the efficiency of the training?
4.18 Is there a process to train the trainers?
Is the personnel of contracted service providers
4.19 adequately trained?
No. COMPLIANCE
ITEMS
YES NO N/A
5. Documentation
5.1 General Requirements for Documentation
Are there written procedures for documentation,

5.1.1 transportation, storage and handling of shipments
including Active Temperature Controlled Container (ACT)?
Is there evidence that documents are laid out in an orderly

5.1.2 manner and with clear and unambiguous content?
How are changed or new SOP's approved? Is there a

5.1.3 procedure in place?
5.1.4 Do SOPs clearly specify job responsibilities?
Are the job responsibilities clearly reflected in the job
5.1.5 descriptions ?
5.1.6 What is the review periods for SOP's?
Is the responsibility for translating customer requirements
5.1.7 or national regulations into internal procedures clearly
assigned?
How are changed or new SOP's converted into trainings? Is
5.1.8 there a procedure?
Are new or updated working instructions dispatched in a
5.1.9 timely manner?
Is there a Health, Safety, Environment (HSE) policy
5.1.10 available related to all relevant health safety and first aid
procedures?
5.2 Infrastructure & Equipment Documentation
5.2.1 Is there a written cleaning program in place?
5.2.2 Are there records for cleaning activities available?
Are cleaning equipment and agents chosen to avoid
5.2.3 contamination of products?
Is there a written procedure for the operation and
5.2.4 maintenance of vehicles and equipment?
Is there a procedure and a maintenance contract available
5.2.5 for the heating/cooling devices?
Do operation procedures detail how each piece of
5.2.6 equipment critical to the processes should be used?
Is there a qualification and acceptance process in place for

5.2.7 new piece of equipment, vehicle or infrastructure?
What is the emergency procedure in case of a failure of a

5.2.8 heating/cooling system?
Is there a reaction and escalation process in case of alarm
5.2.9 for temperature deviation?
In case of an alarm for temperature deviation, is there an
5.2.10 investigation? What is the procedure?
Is there a Risk assessment conducted in order to identify a

5.2.11 piece of equipment, vehicle or infrastructure?
5.3 Process Documentation

Is there a written procedure in place to handle cargo
5.3.1 transportation documentation?
Is the company able to provide traceability in its own
5.3.2 operations?
No. COMPLIANCE
ITEMS
YES NO N/A
Is the company able to provide traceability on product
5.3.3 location, temporary storage conditions, handling
information and destinations?
Are records kept for the duration required by applicable
5.3.4 regulations?
Are procedures in place to precondition the truck, shipping
5.3.5 unit, monitoring devices or the temperature controlled
rooms?
5.3.6 Is there an acceptance procedure for all shipments?
Is there a clear process in place to identify at which
5.3.7 temperature the cargo has to be handled?
Is there an acceptance procedure to check the integrity of

5.3.8 the shipment (damaged, temperature, labeling) ?
Are there appropriate acceptance control procedures in

5.3.9 place with conformity inspection, including the seals?
Is there a defined, controlled and risk assessed process for

5.3.10 non-secured cargo?
Are there written procedures and documentation for
5.3.11 loading of products?
Are there written procedures and documentation for
5.3.12 unloading of products?
Is there a procedure in place for quarantine, recalls,

5.3.13 returns and suspected falsified pharmaceutical products?
If there is a deviation in the temperature notified, what is

5.3.14 the operational procedure ?
Is there a CAPA procedure that shows that irregularities in
5.3.15 the process are investigated?
Is it clear in a procedure that in case of discrepancy

5.3.16 between the transportation temperature on the AWB and
the IATA label, the information on the AWB prevails?
Is there a procedure to handle pharma products

5.3.17 containing or that are classified as dangerous goods,
including radioactive materials?
Is there a communication process in place at each
5.3.18 handover points between stakeholders?
Are Risk assessments performed to assess Critical Control

5.3.19 Points in the process (e.g. inbound, transit, outbound)?
5.3.20 Are checklists used at Critical Control Points?
No. COMPLIANCE
ITEMS
YES NO N/A

6.1 Premises & Equipment
Are the different temperature controlled rooms matching
6.1.1 the service offer?
Are areas where pharmaceutical materials are handled
designed and operated in a way to ensure cleanliness,
6.1.2 appropriate hygiene and a minimization of cross-
contamination risks?
6.1.3 Are premises adequate and in visibly good condition?
Are vehicles and equipment suitable to protect product

6.1.4 and packaging integrity and prevent contamination?
Is there a physical segregated storage area provided for

6.1.5 pharmaceutical shipments? If not is there a risk
assessment performed to avoid a risk of contamination?
Is there site plan and facility floor plans, showing routes

6.1.6 for the flow of materials?
Are there clear identification for
6.1.7 inbound/transit/outbound?
Are facilities temperature and eventually humidity
6.1.8 controlled?
Are specific storage area maintained, monitored and
6.1.9 controlled?
Is there a business contingency procedure to ensure
6.1.10 continuous and safe storage conditions?
Are appropriate action (CAPA) taken when the
6.1.11 temperature requirements are not met?
Has the site implemented security measures to control
6.1.12 access of unauthorized persons?
Are visitors clearly identified? Can visitors go to the
6.1.13 operations? How is this described in a procedure?
Are loading / unloading bays protected for different
6.1.14 environmental conditions?
6.1.15 Is there adequate lighting in the warehouse?
6.1.16 Are shipments stored off the ground?
6.1.17 Are the racking systems in good condition ?
Are dedicated areas available to store dangerous goods
6.1.18 products?
Is adequate spill clean-up equipment available and are

6.1.19 procedures in place for containing/collecting any spillage?
Are waste materials awaiting disposal stored safely and

6.1.20 properly?
Are the premises equipped to avoid infestation by rodents,
6.1.21 birds, insects, and other vermin?
6.1.22 Is there an effective pest control program in place?
Is there a policy concerning food, drinks and smoking on
6.1.23 the premises?
Are vehicles and equipment dedicated in handling of
Pharmaceutical shipments? If not, is there an assessment
6.1.24 and procedure in place to minimize the risk to the
process?
Is there sufficient capacity of vehicles, equipment and

6.1.25 facility? Are procedures to handle peak period defined?
No. COMPLIANCE
ITEMS
YES NO N/A
Is defective equipment taken out of service (e.g. either
6.1.26 removed, disposed of or status labelled)?
Are facilities, vehicles and equipment qualified before
6.1.27 commencing use and after any significant changes, e.g.
repair or maintenance?
Are changes related to infrastructure and equipment

6.1.28 managed in accordance to change control procedures?
Is there a specific area for Active Temperature Controlled

Container (ACT) with sufficient plugs? Is the capacity
6.1.29 addressed in a procedure and/or in a business contingency
plan?
6.2 Empty Equipment
Is the empty equipment checked for airworthiness before
6.2.1 use?
6.2.2 Are all personnel trained to use the qualified equipment?
Are materials stored in compliance with safety

6.2.3 requirements?
No. COMPLIANCE
ITEMS
YES NO N/A
6.3 Mapping
6.3.1 Is a temperature mapping used?
6.3.2 Is the mapping exercise based on a risk assessment?
How are changes in the warehouse infrastructure dealt
6.3.3 with?
Is the mapping done in the extreme seasons (e.g., summer
6.3.4 and winter)?
Is the mapping done when the storage facility is both
6.3.5 empty and full; and when in operations and inactive ? Has
a power failure test been carried out?
6.3.6 Are the temperature mapping results documented?
Is the temperature mapping report used to provide
6.3.7 recommendations in the operations?
6.4 Monitoring
Is it ensured that the storage temperature is always kept
6.4.1 within a defined range and controlled according to
instructions?
Is there a monitoring system in place based on the results
6.4.2 of the mapping exercise?
6.4.3 Has the monitoring system been validated?
Has the monitoring system been clearly defined in a
6.4.4 procedure?
Who has access to the monitoring system? Is this being
6.4.5 described in a procedure?
6.4.6 Are temperature monitoring records kept?
What is the maintenance frequency of the monitoring

6.4.7 system? Is there a written procedure/contract in place?
6.5 IT Systems
Have all computer systems been selected according to
6.5.1 written specifications?
Is there a procedure where these computer systems are
6.5.2 described?
Is there a maintenance contract available that describes
6.5.3 the service for these computer systems?
Does the procedure clearly identify access to the computer
6.5.4 systems for different users with different levels? Have
these persons been trained accordingly?
Is there a contingency procedure in case of systems
6.5.5 failure?
Are backup systems in place? Is there a procedure/contract

6.5.6 with duration of storage, location and availability?
6.5.7 Is there a process for data recovery?

6.6 Calibration
Is there a procedure for calibration of equipment used to
6.6.1 transport and handle pharmaceutical shipment?
Is there a procedure for the calibration of monitoring
6.6.2 equipment?
6.6.3 Is the calibration done based on a risk assessment?
6.6.4 Is there traceability of equipment calibration?
Is the calibration of the suppliers' equipment part of the
6.6.5 contract or quality agreement with the suppliers?
Is there a reaction process in place in case of deviation of
6.6.6 calibration of equipment?
No. COMPLIANCE
ITEMS
YES NO N/A
6.7 Maintenance
6.7.1 Is there a Preventative Maintenance Plan?
6.7.2 Is the maintenance policy covered by written procedures?
6.7.3 Are key equipment identified based on a risk assessment?
6.7.4 Are maintenance records available?

Is there a process in place for monitoring and approving
6.7.5 the quality of maintenance?
No. COMPLIANCE
ITEMS
YES NO N/A
7. Complaints and quarantine
7.1 Quarantine
7.1.1 Is there a quarantine procedure in place?
Is there a physical or computerized process to segregate
7.1.2 quarantine shipments?
7.1.3 Are quarantine shipments appropriately labelled?
Are appropriate follow-up actions taken regarding
7.1.4 quarantine shipments?
Is there a procedure on theft with escalation and
7.1.5 communication processes as well as trend analysis
recorded?
7.2 Complaints
Does the company operate a complaint procedure that
7.2.1 describes actions to be taken?
How are complaints acted upon? Do they trigger a CAPA
7.2.2 process?
Is there a responsible person assigned to handle
7.2.3 complaints?
Are complaints recorded? And investigated to identify the
7.2.4 origin and reason?
Can customers easily receive information to demonstrate
7.2.5 that shipments have complied with the required
temperature conditions?
8. Supplier Management
8.1 Is a list of sub-contractor available and provided?
Does the supplier selection include safety, quality criteria
8.2 and GDP/IATA TCR principles?
Are risk assessment conducted to identify critical
8.3 suppliers?
Are agreements in place with all suppliers and reflect the
8.4 GDP/IATA TCR principles?
Are suppliers provided with information relevant to the job
8.5 to be done?
8.6 Do you audit all your suppliers?
Is there a risk analysis performed to define the frequency
8.7 of the audits of the supplier?
8.8 How do you evaluate the performance of your supplier?
Are responsibilities at handover points defined and

8.9 documented?
How do you ensure your suppliers inform you about
8.10 subcontracting activities?
Do you have the written approval of your customer to sub-
8.11 contract?
Are suppliers provided with appropriate personal
8.12 protective equipment?
Are changes related to supplier management handled in
8.13 accordance to change control procedures?
9. Self-inspections & Internal Audits

Is there a procedure on internal audit and on self-
9.1 inspections?
9.2 Who performs the self-inspections?
9.3 Are there annual plans for audit and inspection ?
No. COMPLIANCE
ITEMS
YES NO N/A
Do Internal auditors have training in auditing and
9.4 evaluation techniques?
9.5 Do you monitor and record self-inspections?
9.6 How are findings solved? Do they trigger a CAPA process?
Is the self-inspection evaluation findings part of the

9.7 management review?
No. COMPLIANCE
ITEMS
YES NO N/A
10. Transportation
10.1 General Information for Road and Air Transport
Is there a contract in place between the contract giver and
10.1.1 contract acceptor defined regarding transportation,
temperature, performance?
10.1.2 Are risk assessments performed for the current lanes?
Is there a route qualification performed when planning
10.1.3 transportation?
Does the route qualification consider transit duration? Is
10.1.4 this specific to the pharmaceutical shipment?
Does the route qualification cover the full route with
10.1.5 unloading, loading and hub locations?
Is the communication structure mentioned in the route
10.1.6 qualification?
Are procedures in place for the operations and
10.1.7 maintenance of all vehicles and equipment in involved in
the transportation process?
Are deviations (e.g. temperature excursions, damages)
10.1.8 reported to the contract giver?
Is there a procedure in place for investigating and handling
10.1.9 temperature excursions?
Can information be provided to customers to demonstrate
10.1.10 that shipment have complied with the temperature
transport conditions?
10.2 By Road Specifically
Are there formal agreements in place with transport
10.2.1 contractors, specifying sealing requirements and checks of
seal integrity before unloading?
Are dedicated vehicles and equipment exclusively used for
10.2.2 pharma shipments? If not is there a risk assessment on the
processes?
10.2.3 Are there procedures in place to prevent contamination?
If non-dedicated equipment is used, are there any specific

10.2.4 cleaning procedures in place?
Is there an inspection made of the transport equipment

10.2.5 cleanliness before loading? Is this recorded?
Are vehicles checked and monitored for special transport

10.2.6 conditions (temperature and eventually humidity)?
Is equipment used for temperature monitoring during

10.2.7 transport maintained and calibrated at regular intervals?
Is temperature mapping carried out under representative

10.2.8 conditions, taking into account seasonal variations?
10.3 By Air Specifically

Has there been a study per aircraft type on Hot & Cold
10.3.1 capabilities with a Risk Assessment included in the study?
Is there a process to maintain recommended cargo hold

10.3.2 temperature setting?
Is procedure in place to ensure space onboard is available?
10.3.3
10.3.4 Are there defined actions in the event of delays?
No. COMPLIANCE
ITEMS
YES NO N/A
11. Operations
11.1 General
Have you performed a risk assessment on your operational
11.1.1 processes?
Is the responsibility of ensuring the shipment is stored
11.1.2 according to instructions, clearly defined?
11.1.3 Is there a process to ensure all deviations are handled?
Is there an inventory management in place? Is it described

11.1.4 in a procedure?
Is there a procedure for stock discrepancies with records of
11.1.5 investigation?
Can information be provided to customers to demonstrate
11.1.6 that shipments have complied with the transportation
temperature conditions?
Are changes related to operations managed in accordance
11.1.7 to change control procedures?
11.2 Ground Transportation
Is ground transportation done in such a way to minimize
11.2.1 the exposure of the shipment to external temperatures
and sunlight?
11.2.2 Is the use of a temperature controlled truck recorded?
11.2.3 Do you check if the temperature setting is defined?
Do you check if there is an electronic temperature
monitoring? And if the set temperature in the truck
11.2.4 matches the required temperature range of the shipping
document?
In case of no use of temperature controlled truck is a risk
11.2.5 assessment and a time tracking performed ?
11.2.6 Is there serviceability checks on equipment ?
Is there a procedure to avoid co-loading with general, non
11.2.7 temperature controlled cargo?
11.3 Acceptance
Are checks performed on received documentations
11.3.1 according to acceptance instructions?
Are checks performed on Active Temperature Controlled
11.3.2 Container (ACT) ?
Are checks performed based on the IATA acceptance
11.3.3 checklist requirements?
Is the temperature indicated on the IATA label checked
11.3.4 against the transportation documents?
Is there a check of the Physical Integrity of the shipping
11.3.5 unit ?
11.3.6 Is there a check and reporting on shipment completeness?
11.4 Temporary Storage

11.4.1 Is there a warehouse Freezer -10°C or colder ?
Is there a warehouse with Refrigerated Room +2°C to
11.4.2 +8°C?
Is there a warehouse with Controlled Room Temperature
11.4.3 +15°C to +25°C?
Is there a warehouse with Extended Room Temperature
11.4.4 +2°C to +25°C?
No. COMPLIANCE
ITEMS
YES NO N/A
11.4.5 How are shipments segregated?
Is the capacity managed in such a way to ensure all
11.4.6 shipments are stored in temperature controlled room?
No. COMPLIANCE
ITEMS
YES NO N/A
11.5 Warehousing
Is there a process for the availability of batteries and dry
11.5.1 ice for active containers?
Is there a process for checking the availability of
11.5.2 refrigerator/freezer storage (where required) ?
Is there a process in place in the defined storage area
11.5.3 (away from doors, heat sources and sunlight)?
11.5.5 Is serviceability check on equipment performed?
Is the time needed to transfer to the Controlled
11.5.6 Temperature storage areas tracked? If not is there a risk
assessment on the processes?
Is the time needed to transfer from the Temperature

11.5.7 storage areas to the ULD pallets preparation area tracked?
If not is there a risk assessment on the processes?
Is the time needed to build-up the ULD pallets tracked? If

11.5.8 not is there a risk assessment on the processes?
Is the time needed to break down of the ULD pallets

11.5.9 tracked? If not is there a risk assessment on the processes?
Is the time needed to transfer to the hand over point

11.5.10 tracked (truck or aircraft)? If not is there a risk assessment
on the processes?
Is the area where ULD's are build or breaking down
11.5.11 temperature controlled? If not is there a risk assessment
on the processes?
11.6 Tarmac Transportation
Is tarmac transportation done in such a way to minimize
11.6.1 the exposure of the shipments to external temperatures
and sunlight?
11.6.2 Is there a high priority ramp handling?
Is the time needed to transfer to the aircraft tracked? If
11.6.3 not is there a risk assessment on the processes?
Is the time needed to transfer from the plane position to
11.6.4 the warehouse tracked? If not is there a risk assessment
on the processes?
Are shipments protected from extreme weather conditions
11.6.5 (e.g. thermal blankets, plastic for rain,….)?
Are there defined actions in the event of delays or
11.6.6 offloads?
11.7 Aircraft Loading
Is aircraft loading done in such a way to minimize the
11.7.1 exposure of the shipments to external temperatures?
Is there a check performed (e.g. damages, temperature,
11.7.2 label) when shipment is loaded ?
Are procedures in place to consider special requests? E.g.

•Do not load near cargo door, if requested
•Cargo hold temperature maintained between + 10°C and
11.7.3 + 25°C
•Notice to Captain (NOTOC) defining hold temperature
setting
11.7.4 Are there procedures to precondition the aircraft?
No. COMPLIANCE
ITEMS
YES NO N/A
Is the time needed to load the aircraft tracked? If not is
11.7.5 there a risk assessment on the processes?
Are there defined actions in the event of delays or
11.7.6 offloads?
11.8 Aircraft Unloading
Is aircraft unloading done in such a way to minimize the

11.8.1 exposure of the shipments to external temperatures?
Is there a check performed (e.g. damages, temperature,

11.8.2 label) when unloading the shipment?
Is the time needed to unload the aircraft tracked? If not is
11.8.3 there a risk assessment on the processes?
POTENTIAL
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RECOMMENDED ACTIONS
RECOMMENDED ACTIONS
RECOMMENDED ACTIONS
RECOMMENDED ACTIONS
RECOMMENDED ACTIONS
RECOMMENDED ACTIONS
RECOMMENDED ACTIONS
RECOMMENDED ACTIONS
RECOMMENDED ACTIONS
Standard or Reg
CEIV for Pharmaceutical Logistics Audit Items IATA
2. Quality Management 17.12
2.1 Organization and management 17.12
2.2 Quality Management System 17.12.1
2.3 Management Reviews 17.12.2+3
2.4 Key Performance Indicators 17.12.1
3. Personnel
3.1 General Information 17.12.5
3.2 Responsible Person 17.8
3.3 Other Personnel 17.12.5
4. Training 17.11
5. Documentation
5.1 General Requirements for Documentation 17.12.4
5.2 Infrastructure & Equipment Documentation 17.12.4
5.3 Process Documentation 17.12.4
6.1 Premises & Equipment 17.12.8
6.2 Empty Equipment 17.12.8
6.3 Mapping 17.8.2; 17.9
6.4 Monitoring 17.8.2
6.5 IT System 17.8.4
6.6 Calibration 17.12.1
6.7 Maintenance
7. Complaints and quarantine 17.12.6
7.1 Quarantine
7.2 Complaints
8. Supplier Management 17.4.1
9. Self-inspections 17.12.9
10. Transportation 17.8
10.1 General Information for Road and Air Transport
10.2 By Road Specifically
10.3 By Air Specifically
11. Operations 17.8
11.1 General 17.8
11.2 Ground transportation 17.8.3; 17.8.4.10
11.3 Acceptance 17.8.2;17.8.4.2.1
11.4 Temporary Storage 17.8.2;17.8.4.5
11.5 Warehousing 17.8.4.5
11.6 Tarmac Transportation 17.8.4.6
11.7 Aircraft Loading 17.8.4.7
11.8 Aircraft Unloading 17.8.4.8
Standard or Regulatory Reference
WHO annex 5 EU GDP SIN Others
Guideline
4
8 1.1
6 1.2
8 1.2
6 1.4
1.4
4
7 2.1 1
6.3 2.2 8.4
7 2.3 1
7.1,7.5 2.4 1.2
14 4 5
14 3.2, 3.3 5
14 4.1 5.2
9 3
9,10 3.2 2
9 3.3
9 3.2.1 annex 1.6
9 3.2.1 annex 1.7
14 3.3.1 annex 1.9
9 3.3 annex 1.7
3.3 annex 1.7
16, 17, 18, 19 6, 5.6 6; 7; 8; 9
9
16
5, 21 7 11
22 8 10
13 9 3.10;3.11
5 annex 1
9 5
11, 13 5.4 annex 1.3+4

9, 11 5.5 2; 3
9, 11,12 5.7 2
13
12
12

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IATA CEIV Pharma Logistics Audit Checklist

ential and privileged. None will be disclosed without prior written

No. ITEMS YES NO N/A

1.3 Are WHO Guidelines available (specify which ones apply)?

1.4 Are the National Regulations available?

In case of storage and/or distribution of pharmaceutical

1.15 Is a Code of Conduct implemented in your company?

Are Risk Assessments conducted to assess potential risk to

Is there a defined review frequency of the risk

Do management reviews consider the overall effectiveness

Do management reviews consider findings of internal

Is there a person with the specific responsibility and the

Has the responsible person been trained on GDP/Pharma

Is there a job description for the responsible person

3.3.4 Are codes of practice and punitive procedures in place?

4.14 Are internal and external course materials documented?

Are employee training and qualification records

Are there written procedures for documentation,

Is there evidence that documents are laid out in an orderly

How are changed or new SOP's approved? Is there a

Is there a qualification and acceptance process in place for

What is the emergency procedure in case of a failure of a

Is there a Risk assessment conducted in order to identify a

5.3 Process Documentation

Is there an acceptance procedure to check the integrity of

Are there appropriate acceptance control procedures in

Is there a defined, controlled and risk assessed process for

Is there a procedure in place for quarantine, recalls,

If there is a deviation in the temperature notified, what is

Is it clear in a procedure that in case of discrepancy

Is there a procedure to handle pharma products

Are Risk assessments performed to assess Critical Control

5.3.20 Are checklists used at Critical Control Points?

6. Infrastructure and equipment

Are vehicles and equipment suitable to protect product

Is there a physical segregated storage area provided for

Is there site plan and facility floor plans, showing routes

Is adequate spill clean-up equipment available and are

Are waste materials awaiting disposal stored safely and

Is there sufficient capacity of vehicles, equipment and

Are changes related to infrastructure and equipment

Is there a specific area for Active Temperature Controlled

6.2.2 Are all personnel trained to use the qualified equipment?

Are materials stored in compliance with safety

What is the maintenance frequency of the monitoring

Are backup systems in place? Is there a procedure/contract

6.5.7 Is there a process for data recovery?

6.7.2 Is the maintenance policy covered by written procedures?

6.7.3 Are key equipment identified based on a risk assessment?

6.7.4 Are maintenance records available?

8.8 How do you evaluate the performance of your supplier?

Are responsibilities at handover points defined and

9. Self-inspections & Internal Audits

9.6 How are findings solved? Do they trigger a CAPA process?

Is the self-inspection evaluation findings part of the

10.2.3 Are there procedures in place to prevent contamination?

If non-dedicated equipment is used, are there any specific

Is there an inspection made of the transport equipment

Are vehicles checked and monitored for special transport

Is equipment used for temperature monitoring during

Is temperature mapping carried out under representative

10.3 By Air Specifically