GDP Temperature Control and Monitoring Audit Checklist

A specialized checklist for auditing GDP compliance in temperature control and monitoring systems within pharmaceutical distribution, focusing on cold chain management and temperature-sensitive product integrity.

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About This Checklist

Temperature control and monitoring are critical aspects of Good Distribution Practice (GDP) in the pharmaceutical industry. This specialized GDP Temperature Control and Monitoring Audit Checklist is designed to help pharmaceutical companies ensure the integrity and efficacy of temperature-sensitive products throughout the distribution chain. By focusing on key areas such as cold chain management, temperature mapping, data logging, and alarm systems, this checklist enables auditors to thoroughly assess compliance with GDP temperature requirements. Regular use of this checklist can significantly reduce the risk of temperature excursions, protect product quality, and enhance overall GDP compliance in pharmaceutical distribution operations.

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Industry

Healthcare

Standard

GDP - Good Distribution Practice

Workspaces

Pharmaceutical Warehouses and Cold Storage Facilities

Occupations

Quality Assurance Specialist
Cold Chain Manager
Warehouse Supervisor
Temperature Mapping Technician
GDP Compliance Auditor
1
Is the temperature monitoring system operational?

Select the current status of the temperature monitoring system.

To ensure that the monitoring system is functioning correctly to maintain temperature integrity.
2
What is the maximum temperature deviation recorded?

Provide the maximum deviation in degrees Celsius.

To assess the compliance of temperature control within acceptable limits.
Min0
Target2
Max5
3
Is the alarm system functional and tested regularly?

Select the status of the alarm system.

To ensure prompt alerts during temperature excursions.
4
Is the temperature mapping documentation available and up to date?

Provide details about the temperature mapping documentation.

To verify that the temperature mapping is current and compliant with GDP requirements.
5
Are personnel trained in cold chain management procedures?

Select the compliance status regarding personnel training.

To ensure that staff are knowledgeable about handling temperature-sensitive products.
6
How often is the temperature monitored?

Provide the frequency of temperature monitoring in minutes.

To assess the adequacy of temperature checks to maintain product integrity.
Min0
TargetEvery 30 minutes
Max60
7
Are incident reporting procedures documented and accessible?

Describe the incident reporting procedures for temperature excursions.

To confirm that there is a clear process for reporting temperature excursions.
8
Is there a scheduled maintenance program for cold chain equipment?

Select the status of the maintenance program for cold chain equipment.

To ensure that all equipment used in cold chain management is properly maintained.
9
Was immediate action taken during the last temperature excursion?

Indicate whether immediate action was taken.

To evaluate responsiveness to temperature deviations and ensure corrective actions are implemented.
10
What was the impact of the last temperature excursion on product integrity?

Provide details regarding the impact assessment conducted after the temperature excursion.

To understand how temperature deviations affect the quality of products.
11
When did the last temperature excursion occur?

Enter the date of the last recorded temperature excursion.

To track the frequency and timing of temperature excursions for trend analysis.
12
Were follow-up actions completed after the last excursion?

Select the status of follow-up actions regarding the last excursion.

To ensure that all necessary corrective measures are taken post-excursion.
13
Is the distribution route validated for temperature control?

Select the validation status of the distribution route.

To ensure that the transportation route maintains the required temperature for products.
14
What criteria are used for selecting carriers for temperature-sensitive products?

Describe the criteria used for selecting carriers.

To ensure that carriers meet the necessary requirements for maintaining product integrity.
15
How many temperature monitoring devices are utilized during transportation?

Provide the number of temperature monitoring devices used.

To assess the adequacy of monitoring devices employed to ensure compliance.
Min1
TargetAt least 2
Max10
16
When was the last audit conducted on the carrier?

Enter the date of the last audit performed on the carrier.

To track and ensure regular audits of carriers for compliance with cold chain standards.
17
Is the temperature in the storage area continuously monitored?

Select the compliance status regarding temperature monitoring in the storage area.

To ensure that the storage environment maintains the required temperature for pharmaceutical products.
18
How many temperature sensors are installed in the storage area?

Indicate the number of temperature sensors installed.

To evaluate the adequacy of temperature monitoring devices in place.
Min1
TargetMinimum 2
Max20
19
Is the storage procedure documentation complete and accessible?

Provide details about the storage procedure documentation.

To confirm that there are written procedures for proper storage of temperature-sensitive products.
20
When was the last temperature audit conducted in the storage area?

Enter the date of the last temperature audit performed.

To ensure regular evaluation of temperature control measures in the storage environment.

FAQs

Typically, pharmaceutical products require monitoring of ambient (15-25°C), refrigerated (2-8°C), and frozen (<-15°C) temperature ranges, depending on the specific product requirements.

Temperature monitoring devices should be calibrated at least annually, or more frequently if recommended by the manufacturer or required by regulatory bodies.

A temperature mapping study should include placement of data loggers in various locations within storage areas, consideration of seasonal variations, and assessment under both loaded and empty conditions.

This checklist provides a comprehensive framework for evaluating temperature control systems, helping to identify gaps in cold chain management and implement necessary improvements to maintain product quality.

The checklist should cover various temperature monitoring systems including data loggers, real-time monitoring systems, alarm systems, and manual temperature checks in storage areas and during transportation.

Benefits

Ensures thorough evaluation of temperature control systems in pharmaceutical distribution

Helps identify potential weaknesses in cold chain management

Facilitates compliance with GDP temperature monitoring requirements

Reduces risks associated with temperature-sensitive product degradation

Supports continuous improvement in temperature control practices