SOP for Data Logger Management in Pharma

Standard Operating Procedure for Data Logger Management

1. Purpose

To provide a standard operating procedure for procedure for management of data logger in warehouse.

2. Scope

The scope of this SOP is applicable for following activity in warehouse at [company name]:

  • Management of Data Logger
  • Monitoring and management of downloaded data from Data Logger
  • Sending Data Logger data to customer
  • Placement of Data Logger in to shipment
  • Tracking the Data Logger for availability, calibration, re-conciliation and Destruction

3. Responsibility

Warehouse person:

Ordering data logger

Maintaining minimum stock of data logger

Periodic calibration of data logger

Storage of Data logger

Download and review data from data logger

Issuance of data logger as per shipment requirement

Keep track of data logger (if re-usable)

Warehouse and Packing supervisor:

Placement of Data Logger in line with recommendation made during shipment mapping study

Maintain the record of data logger placement in the shipment

Quality Assurance Person:

To verify Data Logger placement at the time of placement of data logger or before the shipment

To review the data logger data to identify excursions

Supply Chain Department

To get the data logger from customer incase customer wants to use their own data logger

Warehouse head: Overall responsibility to ensure compliance to the procedure

4. Definitions

Not applicable

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5. Procedure

I. Procurement of data logger:

1. Warehouse person shall maintain the minimum stock of data logger as per average monthly planning of shipments.

2. Required number of data logger shall be ordered in advance considering supply lead time. There should be more than one data logger supplier to have a backup plan.

3. When the new data loggers receive at warehouse, warehouse person shall verify the physical condition of data logger, calibration status, and calibration certificate. In case data logger having any damage it shall be returned to the supplier back.

4. Minimum calibration validity should be six months at the time of receipt.

5. Data measuring range should be ensured according to the shipment condition.

6. Data logger should have capability measure mean kinetic temperature. Data can be viewed in the form of graph, value, summary and statistics.

7. Data logger should have good accuracy of level. This can be 0.5 Deg. C or less.

8. Data logger should have capability to generate data in non-editable format for usage. Additional functionality for extract data in spread sheet can be acceptable, just to enable data analysis in case if needed.

9. On satisfactory verification, data logger receipt shall be documented with unique identification number, make and model of data logger, serial number of data logger, calibration certificate number and validity of data logger.

II. Storage of data logger:

1. Data logger shall be stored at controlled room temperature.

III. Usage of data logger:

1. As per the shipment requirement, data logger shall be taken from the stored location and necessary issuance entry shall be made in respective logbook.

2. Before the shipment, and before usage of data logger, it shall be stored at the temperature similar to the shipment temperature to ensure that at the time of placement of data logger in the shipment, momentary spike of temperature can be avoided.

3. Place the data logger with calibration status considering delivery time. Data logger should be valid up to expected delivery of consignment to customer

4. Placement of Data Logger in line with recommendation made during shipment mapping study. In case of any specific requirement by customer, additional data logger can be placed as per locations suggested by customer.

5. Data logger capacity should be ensured before selecting the data logger to assure that it will not consume all the memory and stop recording during transit. It can be decided based on capability of logging time points as well as frequency of data logging.

6. While configuration of data logger, it shall be ensured that data should not be overwritten when storage is full.

7. Data logger shall be used with valid calibration status.

8. In case of customer specific data logger needs to be used, respective customer procedure shall be requested and followed while usage of data logger [OR customer procedure can be adopted in the SOP].

9. While using the customer data logger, same precautions should be ensured which is applicable for own organization.

10. Record for customer specific data logger should be maintained.

11. At the time of shipment, data logger shall be configured as per user manual. [Procedure can be embedded in the SOP]

12. Warehouse, Packing and QA Person shall be available at the time of data logger placement in the shipment. [data logger shall be placed by either warehouse of packing person depending on company’s policy or feasibility of operations.]

13. The placement of data logger shall be recorded in the logbook.

14. Data logger shall be placed as per defined location for the product/ shipment.

IV. Data logger data management:

1. Depending on the agreement with customer, data shall be either reviewed by customer or by company by asking data logger data from customer or asking data logger back and download by warehouse.

2. At the time of receipt of data logger from customer, check for the data logger condition. It should not have any damage.

3. Download the data as per procedure specified in the user manual of data logger.

4. Review the data logger data for any excursion. In case of any excursion noted, warehouse person shall inform to QA person. Based on the review, in case of any excursion noted it shall be investigated and product quality impact shall be assessed.

5. Warehouse person and QA person shall verified the details as below:

i. Excursion against set points for temperature

ii. Date and time

iii. Data logger serial number

6. After review of data logger report by warehouse it shall be dully signed and date.

V. Periodic calibration of Data Logger:

1. Calibration of data logger shall be done calibration due date. Frequency of data logger calibration shall be one year after first re-calibration. First re-calibration shall be done as per certificate received from vendor.

VI. Procedure disposal of data logger:

1. Data logger shall be discarded in following conditions:

i. Found damaged

ii. If not working condition

iii. After completion of 3 years from manufacturing date or recommendation by data logger manufacturer.

2. Data logger shall be discarded as per procedure of disposal of electronic goods.

VII. Handling of customer Data Logger:

1. Customer shall send the data logger to plant as per customer directly or through logistic department. It shall be received with the adequate calibration validity and calibration certificate.

2. At the time of receipt, data logger should be verifying physically for any damage and calibration status.

3. Details of receipt shall be maintained in the log book.

6. Frequency

During data logger receipt

During shipment

7. Formats

  • Format for data logger order and procurement:
Data logger make:
Range of temperature:
Range of RH:
Minimum validity:
Statistics required:
Number of data point storage:
Settable frequency in minutes:
Any other user requirement:
User requirement documented by:
Verified by:
  • Format for data logger management:
Date of Receipt:
Serial No.:
Make and Model:
Calibration Date:
Due Date:
Expiry Date:
Date of Discard:
Reason for Discard:
Discarded by:
Sr. No.Data logger Used byShipment dateProductBatch No.Data logger placement atName of Customer / ConsigneeData logger Start TimePlaced byVerified by
Data logger received back to plant onVerification of physical conditionReceived and verified byData logger data downloaded onData downloaded byReviewed byVerified by
  • Format for maintenance of customer specific data logger:
Customer name
Date of Receipt
Data logger ID No.
Physical condition
Calibration due on
Make and model
Received by
Verified by
Shipment  Date
Product name
Batch No.
Data logger Start Time
Data logger placed by
Verified by
  • Format for data logger calibration management:
Sr. No.Data Logger Identification No.Make and ModelCalibration Done OnCalibration Due OnCertificate numberRemarks
  • Format for product specific requirement of data logger:
Sr. No.Product NameCustomerCountry NameData Logger type and makeLocation For Placement of data logger as per mapping requirementShipment ConditionTolerance of temperatureTolerance of RH (if applicable)
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