IATA Change History

IATA CEIV Pharma Logistics Audit Checklist

File Name Version Date Changes Owner
IATA_CEIV_Audit_Checklist 0.10 06-Aug-2014 First release IATA
IATA_CEIV_Audit_Checklist 0.40 06-Mar-2015 Revised Version IATA
IATA_CEIV_Audit_Checklist 0.50 21-Apr-2015 Time and Temperature Task Force and Industry Feedback
IATA_CEIV_Audit_Checklist 0.60 28-May-2015 Update with Comments from the Industry IATA
IATA_CEIV_Audit_Checklist 0.70 08-Jul-2015 Update with Comments from the Industry IATA
IATA_CEIV_Audit_Checklist 1.00 13-Jul-2015 Final Version IATA
IATA_CEIV_Audit_Checklist 1.10 14-Oct-2015 First Amendment IATA
IATA_CEIV_Audit_Checklist 1.20 01-Sep-2016 Second Amendment IATA
IATA_CEIV_Audit_Checklist 1.30 04-Sep-2017 Third Amendment IATA
IATA_CEIV_Audit_Checklist 1.40 07-Sep-2018 Fourth Amendment IATA
IATA_CEIV_Audit_Checklist 1.50 01-Sep-2019 Fifth Amendment IATA

TABLE OF CONTENT
1. General Introduction
2. Quality Management
2.1 Organization and management
2.2 Quality Management System
2.3 Management Reviews
2.4 Key Performance Indicators
3. Personnel
3.1 General Information
3.2 Responsible Person
3.3 Other Personnel
4. Training
5. Documentation
5.1 General Requirements for Documentation
5.2 Infrastructure & Equipment Documentation
5.3 Process Documentation
6. Infrastructure and equipment
6.1 Premises & Equipment
6.2 Empty Equipment
6.3 Mapping
6.4 Monitoring
6.5 IT System
6.6 Calibration
6.7 Maintenance
7. Complaints and quarantine
7.1 Quarantine
7.2 Complaints
8. Supplier Management
9. Self-inspections & Internal Audits
10. Transportation
10.1 General Information for Road and Air Transport
10.2 By Road Specifically
10.3 By Air Specifically
11. Operations
11.1 General
11.2 Ground Transportation
11.3 Acceptance
11.4 Temporary Storage
11.5 Warehousing
11.6 Tarmac Transportation
11.7 Aircraft Loading
11.8 Aircraft Unloading

All the information contained in this document is confidential and privileged. None will be disclosed without prior written
authorization, unless such information is already of public knowledge. Its use is limited to that pertinent and relevant to
the IATA programs.
All the information contained in this document is confidential and privileged. None will be disclosed without prior written
authorization, unless such information is already of public knowledge. Its use is limited to that pertinent and relevant to
the IATA programs.
 Organization
Party Audited
Location
IATA consultants /assessors
Date
Contact Name
Contact Details

POTENTIAL
No. ITEMS YES NO N/A COMMENTS /OBSERVATIONS RECOMMENDED ACTIONS
IMPROVEMENTS

1. General Introduction
Have the IATA Checklist and set of documents being
1.1 provided upfront and shared with IATA prior to the CEIV
Audit?

1.2 Is the IATA Temperature Control Regulations (TCR)

available?

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

1.4 Which current National and or local Regulations apply? Are

these available?
1.5 Is your organization IOSA?
1.6 Is your organization ISAGO?

1.7 Is there a quality management system certified by an

external body (e.g. valid ISO 9001 certification)?

1.8 Has your organization completed any CEIV certification

Program?

1.9 Has your organization completed other qualification(s)?

1.10 What is the number of employees?

1.11 What is the volume of pharmaceutical activity?
What is the number (%) of employees involved in each
1.12 steps of the handling process of pharmaceutical
shipments?

1.13 What is the service offer for temperature controlled

pharma shipments?
1.14 What are is the current capacity in square meters?
1.15 Do you own or subcontract the premises?

1.16 In case of storage and/or distribution of pharmaceutical

goods is the right authorization in place?

1.17 Is a Code of Conduct implemented in your company?

1.18 Where does the process starts and ends? Where are the
handover points?

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 No. COMPLIANCE COMMENTS / OBSERVATIONS NON COMPLIANCE POTENTIAL RECOMMENDED ACTIONS
ITEMS IMPROVEMENTS
YES NO N/A Major Minor

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?

2.2.2 Is there a quality manual, which mentions management's

active commitment to Quality?

2.2.3 Is there a Quality policy and is it signed by senior

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?

2.2.9 Is there a defined review frequency of the risk assessment?

2.2.10 Is there a process for quality agreements and/or SLA when

activities of subcontracted?

2.2.11 Are there quality reports (reviews) available from the

subcontracted activities?
2.3 Management Reviews
2.3.1 Is a formal management review of the Quality
Management System held at least once a year?

2.3.2 Do management reviews consider the overall effectiveness

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?

2.3.6 Are appropriate follow up actions taken after investigation?

2.3.7 Is the overall capacity managed and reviewed?

2.4 Key Performance Indicators
2.4.1 Are there Pharma related quality KPIs defined? (internal
and external)

2.4.2 Do management reviews consider trends in customer

complaints?

2.4.3 Do management reviews consider trends in supplier

performance?
2.4.4 Are these indicators communicated and acted upon?

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 No. COMPLIANCE COMMENTS / OBSERVATIONS NON COMPLIANCE POTENTIAL RECOMMENDED ACTIONS
ITEMS IMPROVEMENTS
YES NO N/A Major Minor

3. Personnel
3.1 General Information
3.1.1 Is there a Health, Safety and Environment (HSE) policy and
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?

3.1.3 Is key personal, involved in activities such as transport,

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?

3.1.5 Are any changes in roles and responsibilities timely

reflected in job descriptions?

3.1.6 Are employees dealing with dangerous goods provided

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?

3.2.2 Has the responsible person been trained on GDP/Pharma

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?

3.2.4 Is there a back-up person and is this reflected in its job

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?

3.3.3 Is staff capacity managed to ensure handling requirements

are met?

3.3.4 Are codes of practice and punitive procedures in place?

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 No. COMPLIANCE COMMENTS / OBSERVATIONS NON COMPLIANCE POTENTIAL RECOMMENDED ACTIONS
ITEMS IMPROVEMENTS
YES NO N/A Major Minor
4. Training
Has a training needs analysis (TNA) been made for all el problema dice que el programa es robusto lo que
4.1 indica que se hizo a partir de un analisis de necesidades
functions in the organization ?
Si de capacitacion
el problema dice que el programa es robusto lo que
4.2 Is there a training matrix built? How is it built? indica que se hizo a partir de un analisis de necesidades
de capacitacion
Si
4.3 Is a procedure in place to identify how often should
employee be trained? Si
4.4 Is there a Pharma training program (GDP, IATA
Regulations,..)? Si
4.5 Is there a training program for new employees? Si

4.6 Is a procedure in place to demonstrate skills gained from

training are implemented in day-to-day performance?
No
4.7 Is there a training program for key personnel? No
4.8 Is there recurrent training updated for all staff? Si
4.9 Have the two key personnel successfully completed the
CEIV Pharma training? No
4.10 Have the two competent personnel successfully completed
the CEIV Pharma training? No
4.11 In the case of re-certification were the key personnel
trained on CEIV Pharma refresher training?
In the case of re-certification are the competent personnel
4.12 currently employed by the company and performing the
pharmaceutical operational function?
Does the Training address the policies, processes,
4.13 procedures, and written instructions related to all
operational activities and the quality system?

4.14 Are employees trained on Temperature Controlled

Containers (TCC) with-in the last two years?

4.15 Is the training material compliant with the regulatory

requirements?

4.16 Is the training program and material approved by the

responsible person?

4.17 Are different training materials available for key,

competent and all staff available?

4.18 Are internal and external course materials documented?

4.19 Are employee training and qualification records

maintained and up-to-date?
4.20 Is there a training database?
4.21 Is there an assessment of the efficiency of the training?
4.22 Is there a process to train the trainers?

4.23 Is the personnel of contracted service providers adequately

trained?

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 No. COMPLIANCE COMMENTS / OBSERVATIONS NON COMPLIANCE POTENTIAL RECOMMENDED ACTIONS
ITEMS IMPROVEMENTS
YES NO N/A Major Minor

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)?
Si El problema dice "manejo", para mi manejo incluye todo

Are documents setting out the procedures and the work

5.1.2 instructions clear, unambiguous and sufficiently detailed to
enable their correct application by appropriate staff?
Si
5.1.3 Is a procedure in place describing how changes or new
SOP's are approved? No
5.1.4 Do SOPs clearly specify job responsibilities? No
5.1.5 Are the job responsibilities clearly reflected in the job
descriptions? SI
5.1.6 Is a procedure in place describing the review periods for El problema no lo especifica
SOP's? No
Is the responsibility for translating customer requirements El problema no especifica que haya una persona que
5.1.7 or national regulations into internal procedures clearly levante losprocedimientos tomando en cuenta la
assigned? No normativa o requisitos del cliente
5.1.8 Is a procedure in place to ensure changes or new SOP's are Queda a criterio del gerente de operación si el cree que
converted into training? No se necesita entrenamiento

Are new or updated working instructions dispatched in a No hay un procedimiento que especifique como se
5.1.9 actualiza ni cuanto tiempo se tiene para entregar las
timely manner?
No nuevas instrucciones de trabajo
Is there a Health, Safety, Environment (HSE) policy
5.1.10 available related to all relevant health safety and first aid
procedures? No No existe una politica formal
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?
5.2.3 Are cleaning equipment and agents chosen to avoid
contamination of products?

5.2.4 Is there a written procedure for the operation and

maintenance of vehicles and equipment?

5.2.5 Is there a procedure and a maintenance contract available

for the heating/cooling devices?

5.2.6 Do operation procedures detail how each piece of

equipment critical to the processes should be used?

5.2.7 Is there a qualification and acceptance process in place for

new piece of equipment, vehicle or infrastructure?

5.2.8 Is a procedure in place describing the emergency

procedure in case of a failure of a heating/cooling system?

5.2.9 Is there a reaction and escalation process in case of alarm

for temperature deviation?
Is an investigation carried out in case of an alarm for
5.2.10 temperature deviation and is this is this described in a
procedure?

5.2.11 Is there a Risk assessment conducted in order to identify a

piece of equipment, vehicle or infrastructure?

5.3 Process Documentation

5.3.1 Is there a written procedure in place to handle cargo
transportation documentation?

5.3.2 Is the company able to provide traceability in its own

operations?
Is the company able to provide traceability on product
5.3.3 location, temporary storage conditions, handling
information and destinations?

5.3.4 Are records kept for the duration required by applicable

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?
5.3.7 Is there a clear process in place to identify at which
temperature the cargo has to be handled?

5.3.8 Is there an acceptance procedure to check the integrity of

the shipment (damaged, temperature, labeling) ?

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 No. COMPLIANCE COMMENTS / OBSERVATIONS NON COMPLIANCE POTENTIAL RECOMMENDED ACTIONS
ITEMS IMPROVEMENTS
YES NO N/A Major Minor

5.3.9 Are there appropriate acceptance control procedures in

place with conformity inspection, including the seals?

5.3.10 Is there a defined, controlled and risk assessed process for

non-secured cargo?

5.3.11 Are there written procedures and documentation for

loading of products?

5.3.12 Are there written procedures and documentation for

unloading of products?

5.3.13 Is there a procedure in place for quarantine, recalls,

returns and suspected falsified pharmaceutical products?

5.3.14 Is an operational procedure in place in case a deviation in

the temperature is notified?

5.3.15 Is there a CAPA procedure that shows that irregularities in

the process are investigated?

Is there a procedure that in case of discrepancy between

5.3.16 the transportation temperature on the AWB and the IATA
label, the information on the AWB prevails?

Is there a procedure to handle pharma products containing

5.3.17 or that are classified as dangerous goods, including
radioactive materials?

5.3.18 Is there a communication process in place at each

handover points between stakeholders?

5.3.19 Are Risk assessments performed to assess Critical Control

Points in the process (e.g. inbound, transit, outbound)?

5.3.20 Are checklists used at Critical Control Points?

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 No. COMPLIANCE COMMENTS / OBSERVATIONS NON COMPLIANCE POTENTIAL RECOMMENDED ACTIONS
ITEMS IMPROVEMENTS
YES NO N/A Major Minor

6. Infrastructure and equipment

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

6.1.4 Are vehicles and equipment suitable to protect product

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?

6.1.6 Is there site plan and facility floor plans, showing routes for
the flow of materials?

6.1.7 Are there clear identification for

inbound/transit/outbound?

6.1.8 Are facilities temperature and eventually humidity

controlled?

6.1.9 Are specific storage area maintained, monitored and

controlled?

6.1.10 Is there a business contingency procedure to ensure

continuous and safe storage conditions?

6.1.11 Are appropriate action (CAPA) taken when the

temperature requirements are not met?

6.1.12 Has the site implemented security measures to control

access of unauthorized persons?

6.1.13 Are visitors clearly identified? Can visitors go to the

operations? How is this described in a procedure?

6.1.14 Are loading / unloading bays protected for different

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?

6.1.18 Are dedicated areas available to store dangerous goods

products?

6.1.19 Is adequate spill clean-up equipment available and are

procedures in place for containing/collecting any spillage?

6.1.20 Are waste materials awaiting disposal stored safely and

properly?

6.1.21 Are the premises equipped to avoid infestation by animals

(e.g. rodents, birds, insects, as well as domestic animals)?

6.1.22 Is there an effective pest control program in place?

6.1.23 Is there a policy concerning food, drinks and smoking on
the premises?

Are vehicles and equipment dedicated in handling of

6.1.24 Pharmaceutical shipments? If not, is there an assessment
and procedure in place to minimize the risk to the process?

6.1.25 Is there sufficient capacity of vehicles, equipment and

facility? Are procedures to handle peak period defined?

6.1.26 Is defective equipment taken out of service (e.g. either

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?

6.1.28 Are changes related to infrastructure and equipment

managed in accordance to change control procedures?

Is there a specific area for Active Temperature Controlled

6.1.29 Container (ACT) with sufficient plugs? Is the capacity
addressed in a procedure and/or in a business contingency
plan?
6.2 Empty Equipment
6.2.1 Is the empty equipment checked for airworthiness before
use?

6.2.2 Are all personnel trained to use the qualified equipment?

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No. COMPLIANCE COMMENTS / OBSERVATIONS NON COMPLIANCE POTENTIAL RECOMMENDED ACTIONS
ITEMS IMPROVEMENTS
YES NO N/A Major Minor
6.2.3 Are materials stored in compliance with safety
requirements?

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No. COMPLIANCE COMMENTS / OBSERVATIONS NON COMPLIANCE POTENTIAL RECOMMENDED ACTIONS
ITEMS IMPROVEMENTS
YES NO N/A Major Minor
6.3 Mapping
6.3.1 Is a temperature mapping used?
6.3.2 Is the mapping exercise based on a risk assessment?
6.3.3 Is a procedure in place describing how changes in the
warehouse infrastructure are dealt with?

6.3.4 Is the mapping done in the extreme seasons (e.g., summer

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?
6.3.7 Is the temperature mapping report used to provide
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?

6.4.2 Is there a monitoring system in place based on the results

of the mapping exercise?
6.4.3 Has the monitoring system been validated?

6.4.4 Has the monitoring system been clearly defined in a

procedure? si
6.4.5 Is a procedure in place describing who has access to the
monitoring system?
6.4.6 Are temperature monitoring records kept?

6.4.7 Is procedure/contract in place describing the maintenance

frequency of the monitoring system?
6.5 IT Systems
6.5.1 Have all computer systems been selected according to
written specifications?

6.5.2 Is there a procedure where these computer systems are

described?

6.5.3 Is there a maintenance contract available that describes

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?

6.5.5 Is there a contingency procedure in case of systems

failure?

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

with duration of storage, location and availability?

6.5.7 Is there a process for data recovery?

6.6 Calibration
6.6.1 Is there a procedure for calibration of equipment used to
transport and handle pharmaceutical shipment?

6.6.2 Is there a procedure for the calibration of monitoring

equipment?
6.6.3 Is the calibration done based on a risk assessment?
6.6.4 Is there traceability of equipment calibration?

6.6.5 Is the calibration of the suppliers' equipment part of the

contract or quality agreement with the suppliers?

6.6.6 Is there a reaction process in place in case of deviation of

calibration of equipment?
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?

6.7.5 Is there a process in place for monitoring and approving

the quality of maintenance?

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 No. COMPLIANCE COMMENTS / OBSERVATIONS NON COMPLIANCE POTENTIAL RECOMMENDED ACTIONS
ITEMS IMPROVEMENTS
YES NO N/A Major Minor
7. Complaints and quarantine
7.1 Quarantine
7.1.1 Is there a quarantine procedure in place?

7.1.2 Is there a physical or computerized process to segregate

quarantine shipments?
7.1.3 Are quarantine shipments appropriately labelled?
7.1.4 Are appropriate follow-up actions taken regarding
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
7.2.1 Is a complaint procedure in place describing actions to be
taken?

7.2.2 Is a procedure in place describing how the complaints are

acted upon? Are complaints triggering a CAPA process?

7.2.3 Is there a responsible person assigned to handle

complaints?

7.2.4 Are complaints recorded? And investigated to identify the

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?

8.2 Does the supplier selection include safety, quality criteria

and GDP/IATA TCR principles?

8.3 Are risk assessment conducted to identify critical suppliers?

8.4 Are agreements in place with all suppliers and reflect the
GDP/IATA TCR principles?

8.5 Are suppliers provided with information relevant to the job

to be done?
8.6 Do you audit all your suppliers?

8.7 Is there a risk analysis performed to define the frequency

of the audits of the supplier?

8.8 Is a procedure in place to evaluate the performance of

your supplier?

8.9 Are responsibilities at handover points defined and

documented?

8.10 Is a procedure in place to ensure your suppliers inform you

about subcontracting activities?

8.11 Do you have the written approval of your customer to sub-

contract?

8.12 Are suppliers provided with appropriate personal

protective equipment?

8.13 Are changes related to supplier management handled in

accordance to change control procedures?

9. Self-inspections & Internal Audits

9.1 Is there a procedure on internal audit and on self-
inspections?
9.2 Are self-inspections performed by dedicated staff?

9.3 Are there annual plans for audit and inspection? Are they
based on risk assessments?

9.4 Are internal audits carried out by appropriately trained and

competent auditors?

9.5 Are self-inspections and audits monitored and recorded?

Are non-conformities identified during self-inspections and

9.6 audits shared with the responsible person and triggering a
CAPA process?

9.7 Is the self-inspection evaluation findings part of the

management review?

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 No. COMPLIANCE COMMENTS / OBSERVATIONS NON COMPLIANCE POTENTIAL RECOMMENDED ACTIONS
ITEMS IMPROVEMENTS
YES NO N/A Major Minor

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?

10.1.3 Is there a route qualification performed when planning

transportation?

10.1.4 Does the route qualification consider transit duration? Is

this specific to the pharmaceutical shipment?

10.1.5 Does the route qualification cover the full route with
unloading, loading and hub locations?

10.1.6 Is the communication structure mentioned in the route

qualification?
Are procedures in place for the operations and
10.1.7 maintenance of all vehicles and equipment involved in the
transportation process?

10.1.8 Are deviations (e.g. temperature excursions, damages)

reported to the contract giver?

10.1.9 Is there a procedure in place for investigating and handling

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?

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

cleaning procedures in place?

10.2.5 Is there an inspection made of the transport equipment

cleanliness before loading? Is this recorded?

10.2.6 Are vehicles checked and monitored for special transport

conditions (temperature and eventually humidity)?

10.2.7 Is equipment used for temperature monitoring during

transport maintained and calibrated at regular intervals?

10.2.8 Is temperature mapping carried out under representative

conditions, taking into account seasonal variations?

10.3 By Air Specifically

10.3.1 Has there been a study per aircraft type on Hot & Cold
capabilities with a Risk Assessment included in the study?

10.3.2 Is there a process to maintain recommended cargo hold

temperature setting?

10.3.3 Is procedure in place to ensure space onboard is available?

10.3.4 Are there defined actions in the event of delays?

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 No. COMPLIANCE COMMENTS / OBSERVATIONS NON COMPLIANCE POTENTIAL RECOMMENDED ACTIONS
ITEMS IMPROVEMENTS
YES NO N/A Major Minor

11. Operations
11.1 General
11.1.1 Have you performed a risk assessment on your operational
processes?

11.1.2 Is the responsibility of ensuring the shipment is stored

according to instructions, clearly defined?

11.1.3 Is there a process to ensure all deviations are handled?

11.1.4 Is there an inventory management in place? Is it described

in a procedure?

11.1.5 Is there a procedure for stock discrepancies with records of

investigation?
Can information be provided to customers to demonstrate
11.1.6 that shipments have complied with the transportation
temperature conditions?

11.1.7 Are changes related to operations managed in accordance

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
11.2.4 monitoring? And if the set temperature in the truck
matches the required temperature range of the shipping
document?

11.2.5 In case of no use of temperature controlled truck is a risk

assessment and a time tracking performed?
11.2.6 Is there serviceability checks on equipment?

11.2.7 Is there a procedure to avoid co-loading with general, non-

temperature controlled cargo?
11.2.8 Are there defined actions in the event of delays?
11.3 Acceptance
11.3.1 Are checks performed on received documentations
according to acceptance instructions? No
11.3.2 Are checks performed on Active Temperature Controlled
Container (ACT)?

11.3.3 Are checks performed based on the IATA acceptance

checklist requirements?

11.3.4 Is the temperature indicated on the IATA label checked

against the transportation documents?

11.3.5 Is there a check of the Physical Integrity of the shipping

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?

11.4.2 Is there a warehouse with Refrigerated Room +2°C to +8°C?

11.4.3 Is there a warehouse with Controlled Room Temperature

+15°C to +25°C?

11.4.4 Is there a warehouse with Extended Room Temperature

+2°C to +25°C?
11.4.5 Are shipments segregated following a process?

11.4.6 Is the capacity managed in such a way to ensure all

shipments are stored in temperature controlled room?

Page 14 IATA_CEIV_Pharmaceutical Logistics Audit Checklist_V1.5_20190901_Final

 No. COMPLIANCE COMMENTS / OBSERVATIONS NON COMPLIANCE POTENTIAL RECOMMENDED ACTIONS
ITEMS IMPROVEMENTS
YES NO N/A Major Minor
11.5 Warehousing
11.5.1 Is there a process for the availability of batteries and dry
ice for active containers?

11.5.2 Is there a process for checking the availability of

refrigerator/freezer storage (where required)?

11.5.3 Is there a process in place in the defined storage area

(away from doors, heat sources and sunlight)?
11.5.4 Are there defined actions in the event of delays?
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?

11.5.8 Is the time needed to build-up the ULD pallets tracked? If

not is there a risk assessment on the processes?

11.5.9 Is the time needed to break down of the ULD pallets

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? No
11.6.2 Is there a high priority ramp handling?

11.6.3 Is the time needed to transfer to the aircraft tracked? If 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? No
11.6.5 Are shipments protected from extreme weather conditions
(e.g. thermal blankets, plastic for rain,….)?

11.6.6 Are there defined actions in the event of delays or offloads?

11.7 Aircraft Loading

11.7.1 Is aircraft loading done in such a way to minimize the

exposure of the shipments to external temperatures?

11.7.2 Is there a check performed (e.g. damages, temperature,

label) when shipment is loaded?

Are procedures in place to consider special requests? E.g.

•Do not load near cargo door, if requested
11.7.3 •Cargo hold temperature maintained between + 10°C and
+ 25°C
•Notice to Captain (NOTOC) defining hold temperature
setting

11.7.4 Are there procedures to precondition the aircraft?

11.7.5 Is the time needed to load the aircraft tracked? If not is

there a risk assessment on the processes?

11.7.6 Are there defined actions in the event of delays or offloads?

11.8 Aircraft Unloading

11.8.1 Is aircraft unloading done in such a way to minimize the

exposure of the shipments to external temperatures?

11.8.2 Is there a check performed (e.g. damages, temperature,

label) when unloading the shipment?

11.8.3 Is the time needed to unload the aircraft tracked? If not is

there a risk assessment on the processes?
11.8.4 Are there defined actions in the event of delays?

Page 15 IATA_CEIV_Pharmaceutical Logistics Audit Checklist_V1.5_20190901_Final

 Standard or Regulatory Reference
CEIV for Pharmaceutical Logistics Audit Items IATA WHO annex 5 EU GDP SIN Others
Guideline
1. General Introduction 4
2. Quality Management 17.12 8 1.1
2.1 Organization and management 17.12 6 1.2
2.2 Quality Management System 17.12.1 8 1.2
2.3 Management Reviews 17.12.2+3 6 1.4
2.4 Key Performance Indicators 17.12.1 1.4
3. Personnel 4
3.1 General Information 17.12.5 7 2.1 1
3.2 Responsible Person 17.8 6.3 2.2 8.4
3.3 Other Personnel 17.12.5 7 2.3 1
4. Training 17.11 7.1,7.5 2.4 1.2
5. Documentation
5.1 General Requirements for Documentation 17.12.4 14 4 5
5.2 Infrastructure & Equipment Documentation 17.12.4 14 3.2, 3.3 5
5.3 Process Documentation 17.12.4 14 4.1 5.2
6. Infrastructure and equipment 9 3
6.1 Premises & Equipment 17.12.8 9,10 3.2 2
6.2 Empty Equipment 17.12.8 9 3.3
6.3 Mapping 17.8.2; 17.9 9 3.2.1 annex 1.6
6.4 Monitoring 17.8.2 9 3.2.1 annex 1.7
6.5 IT System 17.8.4 14 3.3.1 annex 1.9
6.6 Calibration 17.12.1 9 3.3 annex 1.7
6.7 Maintenance 3.3 annex 1.7
7. Complaints and quarantine 17.12.6 16, 17, 18, 19 6, 5.6 6; 7; 8; 9
7.1 Quarantine 9
7.2 Complaints 16
8. Supplier Management 17.4.1 5, 21 7 11
9. Self-inspections 17.12.9 22 8 10
10. Transportation 17.8 13 9 3.10;3.11
10.1 General Information for Road and Air Transport
10.2 By Road Specifically
10.3 By Air Specifically
11. Operations 17.8 5 annex 1
11.1 General 17.8 9 5
11.2 Ground transportation 17.8.3; 17.8.4.10
11.3 Acceptance 17.8.2;17.8.4.2.1 11, 13 5.4 annex 1.3+4
11.4 Temporary Storage 17.8.2;17.8.4.5 9, 11 5.5 2; 3
11.5 Warehousing 17.8.4.5 9, 11,12 5.7 2
11.6 Tarmac Transportation 17.8.4.6 13
11.7 Aircraft Loading 17.8.4.7 12
11.8 Aircraft Unloading 17.8.4.8 12