VENDOR AUDIT QUESTIONNAIRE

TRANSPORTATION

This questionnaire applies to contract transportation services who may collect product, transport, store and
deliver to customers.
All information provided in this questionnaire will be treated as strictly confidential. An evaluation of this
questionnaire will be performed by …………………..
Based on the information provided a decision will be made on whether to audit the site referenced in this
questionnaire.

Name

Address

Internet Address
Name of Parent
Organization (if any)
Correspondent:
Name / title

Phone Number
Fax Number
E-Mail address

Vendor Approval:
Name Position Date

Remark: see Glossary section at the end of the questionnaire in case of doubt about meaning of certain terms
 Quality Questionnaire – Transportation

1 Company Activity Yes No N/A

1.1 Distributor (a wholesaler who takes title to the property of the goods)
1.2 Transportation ( a courier service that collects and delivers product)

1.3 Broker (an agent who buys or/and sells for a principal on a commission
basis without having title to the property)

Other (please specify):

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1.4
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Percentage of your company Business in the Pharmaceutical Industry ….. %

1.5
/ Other main activities …………………………

2 Materials Handled Yes No N/A

2.1 Active Pharmaceutical Ingredients (APIs)

2.3 Medicinal products
2.4 Excipients
2.5 Fine chemicals
2.6 Radioactive
2.7 Flammables
2.8 Controlled drugs (Schedule 1 to 5)

2.9 Others (specify)

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3 Quality System & Quality Management Yes No N/A
3.1 Is there a quality management system implemented?

Is there a third party certification of the quality system (example, covered

3.2 by ISO 9001:2008 certification or other)?
Please provide copies of current version

3.3 Does the company hold a wholesale dealer licence or a GDP certificate
of compliance? Please provide copies of current version.

3.4 Does your company have a written policy including management's active
commitment to Quality?

3.5 Are there written standard operating procedures (SOPs) in place that
describe operations to be performed by the personnel?

3.6 Is there a quality manual and written procedures describing Good

Distribution Practices related processes?

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 Quality Questionnaire – Transportation
Does the company have a written procedure on internal audits and audits
of contracted services?
If yes, please briefly describe the process followed:
3.7 ……………………………………………………………………………………
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3.8 Does the company operate a documented system for quarantining

suspect product?

3.9 Does the company have a formal system for documenting and
investigating incidences that impact on the product quality?

3.10 Is there a procedure for internal audits of the quality management system
including an audit plan?

In case of emergency does the company have a written procedure for

deliveries outside normal business hours and does the company offer this
3.11 service?
……………………………………………………………………………………
…………………………………………………………………………………….

3.12 Is a formal management review of the Quality Management System held

at least once a year?

3.13 Is there a document control system in place ensuring proper design,

approval, review, and distribution of necessary documentation?
4 Organisation & Personnel Yes No N/A

4.1 Has the company a sufficient number of qualified employees for these
operations?

Have all (including administrative) personnel, involved in handling and

4.2 transporting medicinal products, been made aware of the potential risks
to human health?

For new personnel employed or contractors, please indicate the checks

performed on the individual, in particular any security checks :
4.3 ……………………………………………………………………………………
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Is there a specific qualification required for employees responsible for key

4.4 activities in Safety, Health, Environment and Quality?
If yes, please specify : ………………………………………………………….

4.5 Are the health and safety responsible persons providing regular training
to employees dealing with hazardous materials?
4.6 Have job descriptions been made and regularly updated?
4.7 Has an evaluation been made of all activities to identify training needs?
4.8 Is initial and ongoing general training provided?
4.9 Are employee training and qualification records maintained?

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 Quality Questionnaire – Transportation
Are internal and external training courses documented?
4.10 (Documentation of training should include records of training
effectiveness.)
4.11 Are contracted service providers included in the training program?
4.12 Are contractors provided with information relevant to the job to be done?
4.13 Are contractors provided with appropriate training if necessary?
4.14 Are contractors provided with appropriate personal protective equipment?

Are there procedures in place ensuring good hygiene of the personnel

4.15 where exposure to material in open containers may occur (e.g.
monitoring of health conditions, wearing of protective clothes etc.)?

4.16 Is there a person with the specific responsibility and the appropriate
authority to deal with GDP issues in the company?
Is initial and ongoing GDP training provided?
4.17 Are training sessions recorded?
Is there a training evaluation system?

5 Transportation Yes No N/A

Does the company have a dedicated fleet of vehicles for the

5.1
transportation of medicinal products?
5.2 Do the vehicles have dual temperature capabilities?
If the company possesses any vehicles that have temperature controlled
chambers, has any validation study been performed and documented to
5.3
ensure optimal operating conditions, taking into consideration any
environmental variables?
Do the vehicles have temperature controlling, monitoring and reporting
5.4
devices?
If yes to 5.4, are these devices serviced and calibrated?

5.5 Please specify frequency of maintenance and calibration:

……………………………………………………………………………………
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5.6 Are the vehicles locations tracked via GPS?
Are transportation vehicles cleaned on a frequent basis and are records
available to view on request?
5.7 Please specify frequency of cleaning and any additional information:
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Are transportation vehicles serviced on a frequent basis and are records
available to view on request?
5.8 Please specify frequency of servicing and any additional information:
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 Quality Questionnaire – Transportation
Are Transportation/distribution records kept for each shipment?
Please specify the records that are retained and the archive period for
5.9 these records:
……………………………………………………………………………………
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Is there a written procedure detailing the process to be followed in the
event of an unexpected occurrence such as vehicle breakdown (engine
or storage chamber temperature control failure) or non-delivery?
5.10 Please specify:
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Transportation (Medicinal Products Requiring Special Conditions)

6 Yes No N/A

6.1 Does your company transport scheduled drug products such as narcotics
or psychotropics?
If yes, do you maintain a safe and secure means of transportation in
6.2 accordance with requirements laid down by your country medicines
regulatory authority?
Briefly describe the security measures in place at your company to
ensure secure transportation of scheduled drug products:
6.3 ……………………………………………………………………………………
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Briefly describe the customer checks performed and documented at time
of delivery of a scheduled drug product:
6.4 ……………………………………………………………………………………
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Does your company transport radioactive or highly leachable toxic
products?

If yes, please specify the safety precautions taken when transporting

6.6 these types of products:
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6.7 Is a Material Safety Data Sheet (MSDS) provided with each order?
7 Premises (Distribution Warehouses and Hubs) Yes No N/A
7.1 Do you conduct physical handling of the product such as:
7.1a - Warehousing and Storage for greater than 24 hours
7.1b - Repackaging
Do you re-label the product?
- Palette label?
7.1c
- Container label?
If yes, do you edit labels in your facilities?
Does the company utilise transportation hubs?
7.2 If yes and products are unloaded at hubs, what is the maximum storage
period? …………………………………………………………………………..

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 Quality Questionnaire – Transportation
7.3 Have you performed a GDP audit of the hubs used by your company?
7.4 Is a Quality Agreement in place with these hubs used by your company?
Briefly describe how the quality of medicines is assured during unloading,
storing and loading at hubs?
7.5 ……………………………………………………………………………………
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8 Complaints – Recalls Yes No N/A

8.1 Does the company operate a complaint procedure that describes actions
to be taken?
8.2 Does the complaint procedure contain recall criteria?

8.3 Is there a procedure ensuring that customers are informed in the event of
serious quality problems?

8.4 Are complaints recorded and investigated to identify the origin and
reason?

8.5 Does the company have a procedure in place for prevention of counterfeit
products entering the supply chain?
9 Returned Goods Yes No N/A

9.1 Are returned products handled according to written procedures?

Is there a system in place to ensure that returned goods are placed in a

9.2 separate location in the vehicle storage chamber (separate from saleable
product)?
Additional Comments
10
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10.1
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 Quality Questionnaire – Transportation

GLOSSARY

Customer
The organization receiving the product (drug product) once it has left the control of the distribution
warehouse.
Drug (Medicinal) Product
The dosage form in the final immediate packaging intended for marketing (ICH Q7)
Good Distribution Practices (GDP)
That part of quality assurance that ensures that the quality of a pharmaceutical product in maintained by
means of adequate control of the numerous activities which occur throughout the transportation process.
Procedure
Written, authorized instruction for performing specified operations;
Record
Documents stating results achieved and/or providing evidence of activities performed. The medium may be
paper or electronic.
Relabelling
The process of sticking a new label on the material.
Repackaging
The action of changing the packaging of the material (e.g.: replacement of a box, division of material in
small containers, etc).
Traceability
Ability to determine the history, application or location that is under consideration, for example, origin of
materials and parts, possession history or distribution of the product after delivery.

Material Safety Data Sheet (MSDS)

It is intended to provide personnel with procedures for handling substance in a safe manner, and includes
information such as physical data, toxicity, health effects, first aid, reactivity, storage, disposal, protective
equipment, and spill-handling procedures

Scheduled Drug Products

Controlled substances are drugs or other substances that are controlled under national or international law.
These substances are classified into “schedules,” depending on how hazardous they are. The schedule the
drug is placed under depends on it’s medical use, it’s potential for abuse, and it’s safety or how easily
people become dependent on it

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