Transportation Vendor Audit Questionnaire

In the fast-paced world of pharmaceuticals, where precision and timeliness are paramount, every step of the supply chain must be meticulously scrutinized to ensure the safety and efficacy of life-saving medications. Among the crucial components of this supply chain is transportation. Given the sensitive nature of pharmaceutical products, ensuring that transportation vendors meet stringent quality standards is non-negotiable. This is where Transportation Vendor Audit Questionnaires play a pivotal role.

Transportation Vendor Audit Questionnaires serve as a comprehensive tool to evaluate and assess the capabilities, processes, and compliance of transportation vendors within the pharmaceutical industry. These questionnaires are tailored to address specific concerns and requirements unique to pharmaceutical transportation, such as temperature control, security protocols, adherence to regulatory standards, and risk mitigation strategies.

Maintaining the integrity of pharmaceutical products during transit is a top priority. Temperature-sensitive medications, for instance, must be transported under strict temperature controls to prevent degradation or loss of efficacy. Audit questionnaires delve into vendors' temperature monitoring systems, transportation equipment, and contingency plans to ensure that products remain within specified temperature ranges throughout the journey.

The pharmaceutical industry operates within a heavily regulated environment governed by stringent standards and guidelines. Transportation vendors must adhere to various regulations, including Good Distribution Practices (GDP), Good Manufacturing Practices (GMP), and international transportation regulations. Audit questionnaires meticulously examine vendors' compliance with these regulations, verifying proper documentation, training protocols, and adherence to quality management systems.

Risk management is a critical aspect of pharmaceutical transportation. From route optimization to security measures, transportation vendors must implement robust risk mitigation strategies to safeguard shipments against potential threats such as theft, contamination, or delays. Audit questionnaires assess vendors' risk assessment procedures, contingency plans, and insurance coverage to ensure adequate safeguards are in place.

Beyond compliance and risk management, transportation vendor audit questionnaires also contribute to enhancing operational efficiency and cost-effectiveness. By identifying areas for improvement, streamlining processes, and fostering transparency and communication between pharmaceutical companies and transportation vendors, these questionnaires help optimize supply chain operations, minimize disruptions, and ultimately reduce costs.

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Transportation Vendor Audit 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

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)
1.4	Other (please specify): ………………………………………………………………………………………………………………… ………………………………………………………………………………………………………………… ………………………………………………………………………………………………………………… …………………………………………………………………………………………………………………
1.5	Percentage of your company Business in the Pharmaceutical Industry / Other main activities	….. % …………………………
2	Materials Handled	Yes	No	N/A
2.1	Active Pharmaceutical Ingredients (APIs)
2.2	Excipients
2.3	Fine chemicals
2.4	Radioactive
2.5	Flammables
2.6	Controlled drugs (Schedule 1 to 5)
2.7	Others (specify) ……………………………………………………………………
3	Quality System & Quality Management	Yes	No	N/A
3.1	Is there a quality management system implemented?
3.2	Is there a third-party certification of the quality system (Covered 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?

3.7	Does the company have a written procedure on internal audits and audits of contracted services? If yes, please briefly describe the process followed: …………………………………………………………………………………… …………………………………………………………………………………… …………………………………………………………………………………… ……………………………………………………………………………………
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?
3.11	In case of emergency does the company have a written procedure for deliveries outside normal business hours and does the company offer this 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?
4.2	Have all (including administrative) personnel, involved in handling and transporting medicinal products, been made aware of the potential risks to human health?
4.3	For new personnel employed or contractors, please indicate the checks performed on the individual, in particular any security checks : …………………………………………………………………………………… …………………………………………………………………………………… ……………………………………………………………………………………
4.4	Is there a specific qualification required for employees responsible for key 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?

4.10	Are internal and external training courses documented? (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?
4.15	Are there procedures in place ensuring good hygiene of the personnel 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?
4.17	Is initial and ongoing GDP training provided? Are training sessions recorded? Is there a training evaluation system?
5	Transportation	Yes	No	N/A
5.1	Does the company have a dedicated fleet of vehicles for the transportation of medicinal products?
5.2	Do the vehicles have dual temperature capabilities?
5.3	If the company possesses any vehicles that have temperature controlled chambers, has any validation study been performed and documented to ensure optimal operating conditions, taking into consideration any environmental variables?
5.4	Do the vehicles have temperature controlling, monitoring and reporting devices?
5.5	If yes to 5.4, are these devices serviced and calibrated?   Please specify frequency of maintenance and calibration: …………………………………………………………………………………… ……………………………………………………………………………………
5.6	Are the vehicles locations tracked via GPS?
5.7	Are transportation vehicles cleaned on a frequent basis and are records available to view on request? Please specify frequency of cleaning and any additional information: …………………………………………………………………………………… …………………………………………………………………………………… ……………………………………………………………………………………..
5.8	Are transportation vehicles serviced on a frequent basis and are records available to view on request? Please specify frequency of servicing and any additional information: …………………………………………………………………………………… …………………………………………………………………………………… ……………………………………………………………………………………..

5.9	Are Transportation/distribution records kept for each shipment? Please specify the records that are retained and the archive period for these records: …………………………………………………………………………………… …………………………………………………………………………………… ……………………………………………………………………………………
5.10	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? Please specify: …………………………………………………………………………………… …………………………………………………………………………………… ……………………………………………………………………………………
6	Transportation (Medicinal Products Requiring Special Conditions)	Yes	No	N/A
6.1	Does your company transport scheduled drug products such as narcotics or psychotropics?
6.2	If yes, do you maintain a safe and secure means of transportation in accordance with requirements laid down by your country medicines regulatory authority?
6.3	Briefly describe the security measures in place at your company to ensure secure transportation of scheduled drug products: …………………………………………………………………………………… …………………………………………………………………………………… ……………………………………………………………………………………
6.4	Briefly describe the customer checks performed and documented at time of delivery of a scheduled drug product: …………………………………………………………………………………… …………………………………………………………………………………… ……………………………………………………………………………………
6.6	Does your company transport radioactive or highly leachable toxic products?   If yes, please specify the safety precautions taken when transporting these types of products: …………………………………………………………………………………… …………………………………………………………………………………… …………………………………………………………………………………… …………………………………………………………………………………… ……………………………………………………………………………………
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
7.1c	Do you re-label the product? Palette label? Container label? If yes, do you edit labels in your facilities?

7.2	Does the company utilise transportation hubs? If yes and products are unloaded at hubs, what is the maximum storage period? …………………………………………………………………………..
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?
7.5	Briefly describe how the quality of medicines is assured during unloading, storing and loading at hubs? …………………………………………………………………………………… …………………………………………………………………………………… …………………………………………………………………………………… ……………………………………………………………………………………
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?
9.2	Is there a system in place to ensure that returned goods are placed in a separate location in the vehicle storage chamber (separate from saleable product)?
10	Additional Comments

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