TABLE OF CONTENTS
- Table Content
- Protocol Pre-Approval
- Objective
- Scope
- Responsibility
- Training
- List of Instruments
- Procedure
- Acceptance Criteria
- Deviation (If Any)
- Change Control (If Any)
- Document to be attached
- Conclusion
- Recommendation
- Abbreviations
PROTOCOL PRE-APPROVAL
Signing this Pre-approval page of the Transport Validation Protocol signifies agreement with the process outlined in the document. The Transport Validation Protocol has been prepared, reviewed, approved, and authorized by the individuals listed below for implementation.
PREPARED BY:
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Designation |
Name |
Signature |
Date |
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Executive (Quality Assurance) |
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Designation |
Name |
Signature |
Date |
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Assistant Manager (Quality Assurance) |
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Head (Production) |
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Head (Quality Control) |
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Head (Engineering) |
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APPROVED BY:
|
Designation |
Name |
Signature |
Date |
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Head (Quality Assurance) |
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OBJECTIVE
The objective of the Transport Validation Protocol is to outline and approach for conducting validation activities in accordance with WHO-TRS 961. The Transport Validation aims to ensure that qualifications are performed efficiently and consistently in alignment with organizational policies, while also meeting regulatory, quality, and business requirements.
SCOPE
This protocol outlines the procedures for conducting temperature mapping of the specified product from the starting point to the destination, with data logging at 30-minute intervals. Transport Validation is designed to ensure that transport temperatures comply with local regulatory requirements at both the sending and receiving sites, and that any temperature excursions outside the manufacturer’s labeled storage range do not compromise product quality. Additionally, product stability data must demonstrate the acceptable duration of temperature excursions during transport.
RESPONSIBILITY
The Validation Group, consisting of representatives from each of the following departments, will be responsible for ensuring the overall compliance with this protocol.
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Department |
Responsibility |
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Quality Assurance |
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Engineering |
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FG Store |
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Quality Control |
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TRAINING
Provide the training to a team for the execution of protocol before execution of the transport validation and data shall be recorded.
LIST OF INSTRUMENT
During Transport validation Data Logger used for Temperature mapping, that should be calibrated and Validity of data logger shall be valid.
PROCEDURE
To ensure that the product can be safely transported within the specified temperature profile and that compliance with regulatory requirements and the expectations of interested parties can be demonstrated:
- When pharmaceutical products are stored at manufacturing sites or medical facilities, maintaining a controlled environment is crucial. It is equally important to transport these products under specified controlled conditions.
- Elevated temperatures can reduce the efficacy of pharmaceutical products. Transportation poses a risk of temperature fluctuations due to various factors, making it necessary to validate the entire transportation process.
- The Head of QA will determine the product for Transport Validation activities. Once approved by the Head of QA, the QA Officer/Executive, along with the FG Store Officer/Executive, will prepare all relevant documents.
- The FG Officer will arrange for a transporter. Transport practices must comply with all relevant local legislation and regulations.
- The QA Officer/Executive will select the product shippers, place calibrated data loggers inside, properly pack the shippers, and label them as "SHIPPER WITH DATA LOGGER." This action will also be recorded in the BPR.
- The FG Officer/Executive will position the shippers in the four corners and the center of the vehicle as defined in Figure 1. The vehicle must be properly locked, and the driver trained in handling data loggers during transit. Drivers should also be informed about the product's perishability and the maximum allowable transport time.
- This protocol outlines the steps for conducting temperature mapping of the specified product from the starting point to the destination, with data logging at 30-minute intervals.
- A risk assessment should be conducted to address potential issues during transport, such as data logger failure, vibration, delays, and other possible factors.
- Samples required for analysis will be collected from the destination point (selected shippers) and documented accordingly.
- The reconciliation of the Transport Validation Product will be documented in the report. The transit route and time will also be recorded in the Validation Report.
- All details of the validation batches will be documented in the Validation Report.
Location of Data Loggers:
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Sr.
No. |
Location
For Data Logger |
Data
Logger No. |
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1. |
Right Corner of Vehicle |
S1 |
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2. |
Left Corner of Vehicle |
S2 |
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3. |
Near Main Entry Door (Right) |
S3 |
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4. |
Near Main Entry Door (Left) |
S4 |
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5. |
Middle of Vehicle |
S5 |
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.
DEVIATION
During Transport validation of define Product any deviation occurred, shall be investigate and to be addressed in Transport Validation report.
CHANGE CONTROL
During Transport validation of define Product any changes occurred, shall be investigate and to be addressed in Transport Validation report.
DOCUMENTS TO BE ATTACHED
During Transport validation of define Product validation related documents shall be attached for the reference purpose.
CONCLUSION
A summary report shall be prepared to summaries the results of the Validation Studies. On the basis of evaluation of results, a conclusion shall be drawn to state the transport validation.
RECOMMENDATION
After completion of Transport Validation activity if any recommendation suggest by the Validation team shall be recoded in Transport Validation Report.
ABBREVIATIONS
TVP: Transport Validation Protocol
WHO-TRS: World Health Organization-Technical Report Series
QA: Quality Assurance
QC: Quality Control
RA: Regulatory Affair
FG: Finished Goods
QA: Quality Assurance
QC: Quality Control
RA: Regulatory Affaire
°C: Degree Celsius
Sign: Signature
No.: Number
ALSO READ: SOP for Transport Validation
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