PHARMA DEVILS

MICROBIOLOGY DEPARTMENT

TRANSPORT VALIDATION PROTOCOL

TRANSPORT VALIDATION
PROTOCOL
 PHARMA DEVILS
MICROBIOLOGY DEPARTMENT

TRANSPORT VALIDATION PROTOCOL

1.0 CONTENTS
Sr. No. SECTION TITLE PAGE No.
NA Cover Page 1
1.0 Content 2
2.0 Protocol Pre-Approval 3
3.0 Objective 4
4.0 Scope 4
5.0 Responsibility 4-5
6.0 Training 5
7.0 List of Instruments 5
8.0 Procedure 5-7
9.0 Acceptance Criteria 7
10.0 Deviation (If Any) 8
11.0 Change Control (If Any) 8
12.0 Document to be attached 8
13.0 Conclusion 8
14.0 Recommendation 8
15.0 Abbreviations 9
 PHARMA DEVILS
MICROBIOLOGY DEPARTMENT

TRANSPORT VALIDATION PROTOCOL

2.0 PROTOCOL PRE-APPROVAL:

Signing of this Pre-approval page of Transport Validation Protocol indicates agreement with the
process approach described in this protocol. This protocol of Transport Validation has been prepared,
reviewed, approved and authorized by the following persons for execution.

PREPARED BY:

DESIGNATION NAME SIGNATURE DATE

EXECUTIVE
(QUALITY ASSURANCE)

REVIEWED BY:

DESIGNATION NAME SIGNATURE DATE

Sr. EXECUTIVE/ASSISTANT
MANAGER
(QUALITY ASSURANCE)
HEAD
(PRODUCTION)
HEAD
(QUALITY CONTROL)
HEAD
(ENGINEERING)

APPROVED BY:

DESIGNATION NAME SIGNATURE DATE

HEAD
(QUALITY ASSURANCE)
 PHARMA DEVILS
MICROBIOLOGY DEPARTMENT

TRANSPORT VALIDATION PROTOCOL

OBJECTIVE:

The objective of the Transport Validation Protocol is to summarize the philosophy, intentions and
approach to perform validation activities in accordance WHO-TRS 961. The Transport Validation shall
ensure that qualifications are done efficiently and consistently throughout the organization policy and
meet regulatory, quality and business requirements.

3.0 SCOPE:
The scope of this protocol describes the steps to be taken to carry out temperature mapping of the
specified Product from Start to Destination point with data logging frequency of 30 minutes. Transport
Validation in such a manner that transport temperatures meet local regulatory requirements at the
sending and receiving sites and/or so that temperature excursions above or below the manufacturer’s
labeled storage temperature range do not adversely affect product quality. Product stability data must
demonstrate the acceptable temperature excursion time during transport

4.0 RESPONSIBILITY:
The Validation Group, comprising of a representative from each of the following Departments,
Shall be responsible for the overall compliance of this Protocol
Department Responsibility
A) Shall prepare & Review the Transport Validation protocol as per the
Quality Regulatory guideline.
B) Execution of the Transport Validation protocol with FG department:
Assurance verification of components calibration records of instrument,
C) Verification of test & results.
D) Shall compile the data & prepare summary report.
E) Protocol shall be approved by the QA prior and after the execution.
F) Shall review the executed protocol to check the compliance and
corrective action for any discrepancies found. Also shall prepare the
summary and conclusion of the study
A) Responsible for trouble shooting (if occurred during execution).
Engineering B) To affix recording instruments/sensors and then monitoring of the area under
study at different locations/levels.
To affix FG Store in
recording A) Support Validation team for Transport Validation Activity.
A) Reviewing of Transport Validation protocol for correctness, completeness
Quality Control and technical excellence.
B) Analyzed the Transport Validation Samples.
 PHARMA DEVILS
MICROBIOLOGY DEPARTMENT

TRANSPORT VALIDATION PROTOCOL

5.0 TRAINING:
Provide the training to a team for the execution of protocol before execution of the transport validation
and data shall be recorded.

6.0 LIST OF INSTRUMENT:

During Transport validation Data Logger used for Temperature mapping, that should be calibrated and
Validity of data logger shall be valid.

7.0 PROCEDURE:
To ensure that the Product can be safely transported within the transport temperature profile defined
for each product and that compliance can be demonstrated to the regulatory authorities and other
interested parties.
8.1 When pharmaceutical products are stored at manufacturing sites or medical shops, it is recommended
to maintain the controlled environment then it is also important to transit these products in specified
controlled conditions.
8.2 Increase temperature can reduce the efficiency of the drug products. Transportation of these items has
risk of temperature variation due to different factors; therefore it is required to validate the whole
transportation process.
8.2.1 The Head QA shall decide the product for Transport Validation activity. After approval from Head
QA, QA officer/Executive with FG Store Officer/Executive shall ready all the related documents.
8.2.2 FG Officer call for Transporter. Transport practices comply with all relevant local legislation and
Regulations.
8.2.3 QA officer/Executive select the Product Shippers and Put the Calibrated Data loggers, in side it and
packed properly and affixed the label on shippers ‘SHIPPER WITH DATA LOGGER’ and same
shall be recorded in BPR also.
8.2.4 FG officer/Executive shall kept this shipper in four corner and center define in figure No. 1 of the
Vehicles. Vehicles should be properly locked; Vehicle driver should be trained for handling the data
loggers during transit. Vehicle Drivers are informed about the perishability of the product and the
maximum acceptable transport time.
8.2.5 This protocol describes the steps to be taken to carry out temperature mapping of the specified
Product from Start to Destination point with data logger frequency of 30 minutes.
8.2.6 Risk assessment for different factors during transport as failure of data loggers, vibration, delay
 PHARMA DEVILS
MICROBIOLOGY DEPARTMENT

TRANSPORT VALIDATION PROTOCOL

during transit and other factors that can happen during the transit, should be done.
8.2.7 The samples required for Analysis shall be collected from destination point (selected shippers) and
same shall be documented.
8.2.8 The Reconciliation of the Transport Validation Product shall be reported in Report. Transit Route
and Transit time shall be recorded in Validation Report.
8.2.9 All the Validation Batches Details Shall be recorded in Validation Report.

Data Logger 1 Packed Shippers Data Logger 3

S1 S3

Door
S5

S2 S4

Data Logger 2 Data Logger 5 Data Logger 4

Fig. No. 1

Location of Data Loggers:

S.No. LOCATION FOR Data Logger Data Logger No.

1. Right Corner of Vehicle S1
2. Left Corner of Vehicle S2
3. Near Main Entry Door (Right) S3
4. Near Main Entry Door ( Left) S4
5. Middle of Vehicle S5
 PHARMA DEVILS
MICROBIOLOGY DEPARTMENT

TRANSPORT VALIDATION PROTOCOL

8.0 ACCEPTANCE CRITERIA:

The temperature of the Finished Product shall be not more than defined storage condition (as per
the Specified in Batch Manufacturing and Batch Packing Record). The Validation samples of
Finished Product shall be tested as per the latest version of Finished Product Specification.

9.0 DEVIATION (If Any):

During Transport validation of define Product any deviation occurred, shall be investigate and to
be addressed in Transport Validation report.

10.0 CHANGE CONTROL (If Any):

During Transport validation of define Product any changes occurred, shall be investigate and to be
addressed in Transport Validation report.

11.0 DOCUMENTS TO BE ATTACHED:

During Transport validation of define Product validation related documents shall be attached
for the reference purpose.

12.0 CONCLUSION:
A summary report shall be prepared to summarise the results of the Validation Studies. On the
basis of evaluation of results, a conclusion shall be drawn to state the transport validation.

13.0 RECOMMENDATION
After completion of Transport Validation activity if any recommendation suggest by the Validation
team shall be recoded in Transport Validation Report.
 PHARMA DEVILS
MICROBIOLOGY DEPARTMENT

TRANSPORT VALIDATION PROTOCOL

14.0 ABBREVIATIONS:

S. No. Abbreviated Form Full Extended Form

1. TVP Transport Validation Protocol
2. WHO-TRS World Health Organization-Technical Report Series
3. QA Quality Assurance
4. QC Quality Control
5. RA Regulatory Affair
6. FG Finished Goods
7. QA Quality Assurance
8. QC Quality Control
9. RA Regulatory Affaire
10. °C Degree Celsius
11. Sign Signature
12. No. Number