PHARMA DEVILS

QUALITY ASSURANCE DEPARTMENT

TRANSPORT VALIDATION STUDY FOR BULK PRODUCTS FROM SITE TO SITE

TRANSPORT VALIDATION STUDY

FOR
BULK PRODUCTS FROM SITE TO SITE

Route of Transportation: Road

 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

TRANSPORT VALIDATION STUDY FOR BULK PRODUCTS FROM SITE TO SITE

APPROVAL
Signing the Transportation verification study approval section indicates agreement with the methodology and
requirements for transportation testing of Bulk products from Site 1 location to Site 2 via Road routes.

Prepared By Designation Signature Date

Quality Assurance-Receiving unit (RU)

Reviewed By Designation Signature Date

Quality Assurance-Receiving unit (RU)

QC-Receiving unit (RU)

Production-Receiving unit (RU)

Warehouse- Receiving unit (RU)

Reviewed By Designation Signature Date

Quality Assurance - Sending unit (SU)

QC - Sending unit (SU)

Warehouse - Sending unit (SU)

Approved By Designation Signature Date

Quality Assurance Manager (RU)

Authorized By Designation Signature Date

Site Head (RU)

Contract giver
 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

TRANSPORT VALIDATION STUDY FOR BULK PRODUCTS FROM SITE TO SITE

ABBREVIATIONS USED IN THIS DOCUMENT

GMP Good Manufacturing Practice

SOP Standard Operating procedures

RU Receiving Unit

SU Sending Unit

QA Quality Assurance

RM Raw materials

PM Packaging Materials

NIST National institute of standards and testing

BMR Batch Manufacturing Record

BPR Batch Packaging Record

QC Quality Control
 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

TRANSPORT VALIDATION STUDY FOR BULK PRODUCTS FROM SITE TO SITE

LIST OF CONTENTS

CONTENTS Page No.

APPROVAL ................................................................................................................................. 2
ABBREVIATIONS USED IN THIS DOCUMENT ............................................................... 3
LIST OF CONTENTS ......................................................................................................... 4
INTRODUCTION ........................................................................................................................ 5
OBJECTIVE....................................................................................................................5
SCOPE .......................................................................................................................................... 5
TRANSPORT STUDY RATIONALE ......................................................................................... 6
RESPONSIBILITIES ................................................................................................................... 6
PROCESS STEPS ........................................................................................................................ 7
TRANSPORTATION STUDY METHODOLOGY .................................................................... 8
ANALYSIS OF RESULTS ........................................................................................................ 11
ACCEPTANCE CRITERIA ....................................................................................................... 11
TRANSPORTATION STUDY CONSIDERATIONS ............................................................... 11
REPORT AND APPROVALS ................................................................................................... 12
LIST OF ATTACHMENTS ....................................................................................................... 12
ANNEXURE 1- SIGNATURE LOG ......................................................................................... 13
ANNEXURE 2- SHIPMENT/DATA LOGGER DETAIL ...................................................... 14
ANNEXURE 3- TRANSPORTATION STUDY INCIDENT FORM ....................................... 15
ANNEXURE 4: PRODUCT DISPOSITION STATEMENT .................................................... 16
ANNEXURE 5: DATA LOGGER PLACEMENT LOCATION DIAGRAM...........................17
 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

TRANSPORT VALIDATION STUDY FOR BULK PRODUCTS FROM SITE TO SITE

INTRODUCTION:
Bulk product manufactured for Site shall be subjected to transport verification study as defined in this document. Site is
committed to comply with GDP by ensuring that Bulk product (Container) are verified through proper transport process
verification. This is an important part of the overall site Quality Management process to demonstrate the products are
produced consistently in compliance with GMP & GDP. The temperature will be monitored during transfer to ensure
that the container is not exposed to extreme conditions which could compromise the quality and efficacy of the
products.

OBJECTIVE:
The objective of this study is collection & evaluation of data to establish that by using correct distribution practices the
Bulk product will not be exposed to temperature outside the required storage conditions as demonstrated by stability
data.

SCOPE:
The scope of this study is limited to one transportation verification run for Bulk product manufactured in Site 1 and
transfer to Site 2 for customer by road route to cover the temperature mapping during its transit from one location to
other.
This study is applicable for single container (1st shipment) verification run as initial transport validation study with three
continuous runs through specified route of transportation (Road).
Trails can be performed on batches intended for commercial use.
The verification trial involves including temperature monitoring through 9 locations (data logger placed in such way it
cover all the area) within a load. Upon completion of this study all loads will be routinely monitored from at least 2
locations within the load (As per customer recommendation after verification study in 1st container).
Transferring condition may not exceed 25ºC as per product requirement.
 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

TRANSPORT VALIDATION STUDY FOR BULK PRODUCTS FROM SITE TO SITE

TRANSPORT STUDY RATIONALE:

It is intended that the Bulk Product for Site 1 are transported in temperature controlled containers. The temperature
and humidity (if required) will be monitored during transferring to ensure the material is not exposed to extreme
condition which could compromise the quality and efficacy of the product. The Bulk product will test before
transport and after transport in order to determine if there is any changes physical &/or chemical Characteristics of
the product (as per FG test specification) as a result of transport method as well as to provide a comparison of
results for such product that are subjected to transport conditions. This study will generate data to demonstrate the
effectiveness of this control across the load. Upon completion of this study routine monitoring will ensure that
control is maintained. The conditions will be within the range that is demonstrated as acceptable by stability
studies. Thereby providing assurance that the efficacy, quality and safety of the product is unaffected by its
transportation.

RESPONSIBILITIES:
1) Unit-1 Operations – Responsible for production of Bulk product as per pre established process and shipments
planned for this transportation verification study
2) Unit-1 Quality control – Responsible for analysis of Bulk products pre-shipment and
Generate test report.
3) Unit-1 warehouse –Responsible for executing the transportation study and communication of information to
shipment receipt at destination.
4) Container receipt at Unit-2 –To remove the data loggers from Shipment, download and transfer information
to Quality team at Unit 1.
5) Unit-2 Quality control – Responsible for analysis of the received Bulk products upon receipt and report.
6) Unit-1 Quality Assurance – Responsible for placing data loggers into shipments, executing the transportation
study & to review the uploaded information, deal with excursions using the standard response in Annexure-4 &
any incident as per Annexure-3. Ensure appropriate conclusions are drawn from the data to meet the objectives of
this study, finalise the closeout report.
7) QA – Unit-2 – To review and approve study protocol and the final report.
 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

TRANSPORT VALIDATION STUDY FOR BULK PRODUCTS FROM SITE TO SITE

PROCESS STEPS:
Step No. Action Responsibility
1. ➢ To ensure that the Bulk products are produced with approved Unit-1- Production
materials.
➢ To produce shipments planned for this transportation study.

2. ➢ To ensure that all RM is tested as per specification and released for Unit-1 – Quality
production. control
➢ To analysis the Bulk products pre-shipment and generate testing
report.
3. ➢ To check and ensure the storage condition of container during QA & warehouse –
transportation from respective product requirements. Unit-1
➢ To ensure that the data loggers are calibrated before insertion into the
shipments.
➢ To follow the SOP for Handling of temperature data loggers QA
➢ Place the data loggers at defined locations as per Annexure-5.
➢ To record data logger details at the time of dispatch on the data sheet
Annexure- 2 of this document.
➢ Communicate the details to all concerned after shipping.
4. ➢ Upon receiving the shipment in Unit-2 the information from data Shipment receipt at
loggers should be downloaded and forward reports to Quality destination
assurance, Unit-1.
➢ Post shipment detail shall be recorded as per Annexure-II.
5. ➢ Post shipment analysis and reporting Unit-2 Quality

6. ➢ To oversee execution of this transportation study. Unit-2- QA

➢ To review the uploaded information & deal with excursions if any
using the standard response in Annex 4.
➢ Ensure appropriate conclusions are drawn from the data.
➢ To meet the objectives of this study, finalise the closeout report.
➢ Finalise the study, draw conclusions and recommendations for future.
 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

TRANSPORT VALIDATION STUDY FOR BULK PRODUCTS FROM SITE TO SITE

TRANSPORTATION STUDY METHODOLOGY:

Calibrated data loggers shall be used for temperature monitoring during transportation verification study. The data
loggers named as “Log Tag”, model “USRIC – 16” single used temperature recorders shall be used for temperature
monitoring. For example/ to describe the methodology, handling procedure for “Log Tag USRIC – 16 single used
temperature recorders” is described below:
The USRIC-16 is a single use USB temperature recorder that can be directly plugged into the computer for
configuration and generation of PDF reports. Configuring and evaluating the data generated by the USRIC-16 requires
installation of LogTag Analyzer software version 3.1.1.
Log Tag Analyzer software installation
Download & install the software on your computer using/ clicking the given link. Save the ‘ltanalyzer_25r16.exe’ file
on your computer in desired destination folder.
Installing the USRIC-16
Step 1: Start the Log tag Analyzer software.
Step 2: Remove protective cap on the USRIC-16 and insert into USB port on computer. The device drivers will be
installed on your computer.
Step 3: Click ‘Close’. The USRIC-16 is now ready for configuration, using Log Tag Analyzer
USRIC-16 Configuration
Note: USRIC-16 configuration possible only after installation of the Log tag Analyzer.
Note: Do not unplug the USRIC-16 from the computer during configuration
1. Open the Log Tag Analyzer software. Click ‘LogTag’ and choose ‘Configure’

2. The following window opens with various configuration options. File setting & Advanced options are also available
for customization
 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

TRANSPORT VALIDATION STUDY FOR BULK PRODUCTS FROM SITE TO SITE

Configuration panel

Advanced Configuration panel

Enter the desired options to accept the new values.

This returns you to the standard configuration dialogue.
3. Click ‘Configure’ to upload configuration data to USRIC-16. Remove device from USB hub and replace protective
cap.
 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

TRANSPORT VALIDATION STUDY FOR BULK PRODUCTS FROM SITE TO SITE

Starting the USRIC-16

Using the configuration options, users can decide when the device starts recording temperature.
- via Push button start: Press the START/MARK button to start recording temperature immediately. When pre-start
logging is enabled USRIC-16 starts recording as soon as it is unplugged from the USB port and the device continues to
record data till the START/MARK is pressed. This way you do not lose
readings even if you forget to start the unit.
- via Date/Time start: Using this option the USRIC-16 can be configured to record temperature readings at the date and
time (local time) specified by user.
Data Retrieval from USRIC-16
If you have used the ‘File/Advanced setting’ during configuration to Generate files, then files (pdf/ltd/csv) will be
created every time you plug the recorder into the USB port.
1. Plug USRIC-16 in to USB port on computer.
2. The device will appear as a new mass storage device with the USRIC-16 serial number as the device name.
3. Open the mass storage device to view files.
4. PDF files can be views using PDF viewer, LTD files need Log Tag Analyzer software and CVS files can be
imported to spreadsheet program like MS ExcelTM
5. The files are not automatically stored in your computer and need to be manually copied and pasted into file location
of your choice.
6. The USRIC-16 can be unplugged directly and does not require specific procedure to stop or un mount the device.
7. Every time the device is plugged into the computer, the files are generated, this action ceases when the battery is
exhausted.
Data Interpretation
The data generated from the USRIC-16 appears as a chart or data list.
These data loggers shall be calibrated, with an internal memory and clock to record data every 5 /15 / 30 minute during
transit. Temperature alarm will be enabled for quick identification if temperature exceeds the limits. Data loggers shall
be placed in shipments.
Shipment upon arrival at the destination country shall be
• Visually inspected to ensure no damages & record the detail as per Annexure-I of QA.
• Information from data loggers will be downloaded.
Results shall be compared with the initial release testing data to see if any variance is evident.
 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

TRANSPORT VALIDATION STUDY FOR BULK PRODUCTS FROM SITE TO SITE

ANALYSIS OF RESULTS:
The shipment will be tested before shipping and post shipping condition shall be verified in order to determine if
there are any changes of the product as a result of the road shipment mode, to provide a comparison of the results
that are subjected to transport conditions. The temperature will be monitored during shipping to ensure that the
shipment is not exposed to extreme conditions which could compromise the quality and efficacy of the products.
Temperature mapping data will be reviewed by Unit-1 Quality Assurance which will be supported by the pre
shipment and post shipment detail & temperature mapping reports. Any incident shall be raised as per the
Annexure- 3 of this study protocol if necessary.
Upon completion of verification run, a separate final summary report shall be prepared, reviewed and approved by
QA.

ACCEPTANCE CRITERIA :
Data logger charts should be reviewed for shipment by Unit-1 QA.
• Shipments are clearly acceptable in case of No damage of corners & faces, No sign of any water
soaking, No smudging of labels or label peel off.
• Shipments are clearly acceptable if temperature is not exceeding 250 C during its transit from Unit 1
to destination countries. However exception of +/- 20C to above said (270C) for less than 24 hrs is also
acceptable. If the temperature excursion is greater than 24 hrs. outside of 270C then deviation should
be raised and investigated.
• In case of any excursion in temperature, QA should review the post shipment analysis report against
the stability data of the product and raise product disposition statement as per Annexure 4 of this
protocol before disposition for further distribution or disposal of product is made.

TRANSPORTATION STUDY CONSIDERATIONS:

1. Bulk Product must be shipped in good conditions (No damage condition).
2. Products must be transported in the agreed manner for that product. In all cases temperature controlled
transport (containers) is required.
3. Products before shipping should be verified by analytical testing and should comply with our release
specifications.
4. Post shipment detail shall be verified & should comply with pre shipping condition.
5. Product shall be monitored by using calibrated data loggers which will be capable of monitoring
Temperature during its full journey.
6. Finally all data captured during this study will be analysed and presented in the final report.
 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

TRANSPORT VALIDATION STUDY FOR BULK PRODUCTS FROM SITE TO SITE

REPORT AND APPROVALS:
Separate summary report shall be prepared for verification run based on the findings of this transportation verification
study. The report will summarize the results and review of the documentation. All the filled annexures shall be attached
with report. The transportation study summary report will indicate the status of the transportation via container shipping
freight of products from Unit-1 to Unit-2.

LIST OF ATTACHMENTS:
The attachments used in this study will be used to document the results of the transport study.
Annexure 1- Signature log
Annexure 2 – Shipment/Data Logger detail
Annexure 3 – Transportation study incident form
Annexure 4 - Product disposition statement
Annexure 5 – Data logger placement diagram
 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

TRANSPORT VALIDATION STUDY FOR BULK PRODUCTS FROM SITE TO SITE

ANNEXURE 1- SIGNATURE LOG
Objective of this document is to record details of all personal involved in the execution of this transportation
verification study. Individuals should record their name, sign, department and Initials/date in the table below.
Signatories indicate that they have read and understand this transport study and their assumed responsibilities.
Name Signature Department Initials/Date

This page may be copied as required.

 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

TRANSPORT VALIDATION STUDY FOR BULK PRODUCTS FROM SITE TO SITE

ANNEXURE 2 - SHIPMENT/DATA LOGGER DETAIL
Data logger shall place in such way that it covers all the area, within a load as per location diagram.
Following detail shall be recorded at the time of dispatch:
Data logger ID./Sr No. Calibration status Location Container No.

Checked By Verified By
(Sign & date) (Sign & date)
This page may be copied as required.
 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

TRANSPORT VALIDATION STUDY FOR BULK PRODUCTS FROM SITE TO SITE

ANNEXURE 3 - TRANSPORTATION STUDY INCIDENT FORM

Incident No: Batch No.: Date:
Description of Incident:

Impact on Quality of product:

Corrective actions taken: (By/Date)

Preventative actions, if any:

Completed Product disposition statement as per Annexure 5 attached (Required)

This page may be copied as required.

Documented by: ________________________ Date: _____________

Reviewed by: _____________________ Date: _____________

 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

TRANSPORT VALIDATION STUDY FOR BULK PRODUCTS FROM SITE TO SITE

Annexure 4: PRODUCT DISPOSITION STATEMENT
The following temperature excursion information has been received from _________________Date ____________

Product Information:
Products:
Batch (es):
Expiry date:
Country of deliver:
Temp tale numbers:
Delivery Number(s):

Temperature data:
Minimum temperature from Temp tale data:
Maximum temperature from Temp tale data:
Time in hours above allowable upper limit (270C for less/more than 24 hours):

Based on the stability data available, it has been concluded that the product has been adversely affected/ not affected by
the temperature excursion mentioned above.

Decision: The above mentioned batch (es) should be released /not released for further distribution.

Name: Position:

Signed: Date:

This page may be copied as required.

 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

TRANSPORT VALIDATION STUDY FOR BULK PRODUCTS FROM SITE TO SITE

Annexure 5: Data Logger Placement location Diagram

Data logger shall be placed as in required quantity & record the location as below mentioned diagram