sop for Transport Validation
1.0 PURPOSE:
1.1 To lay down a procedure for transit study to ensure that the high level of product quality is maintained throughout the distribution network.
2. SCOPE: This procedure is applicable to products manufactured and dispatched to various locations.
3. RESPONSIBILITY:
It is the joint responsibility of Head Stores, Purchase & Dispatch, Engineering and Head Quality Control in coordination with Quality Assurance department.
4.0 DISTRIBUTION:
4.1 Quality Assurance
4.2 Quality Control
4.3 Production
4.4 Ware house
4.5 Dispatch & Purchase
4.6 Engineering
5.0 DEFINITION & ABBREVIATION(S):
5.1 Definitions
5.1.1 Validation: A documented program that provides a high degree of assurance that a specific
process, method, or system will consistently produce a result meeting pre-determined acceptance criteria.
5.2 Abbreviations
5.2.1 SOP : Standard Operating Procedure
5.2.2 QA : Quality Assurance
5.2.4 No. : Number
6.0 PROCEDURE
6.1 Identify the product consignment/Batch number that needs to be evaluated for transit study by preparing a schedule for a year at the beginning.
6.2 Risk Assessment shall be performed based on the following points, but not limited to:
6.1.1 Nature of the products (solids, semisolids, liquids)
6.1.2 Labeled storage requirements and associated warnings
6.1.3 Sensitivity of product to extremes of temperature
6.1.4 Likely period of exposure to temperatures outside the labeled storage requirements.
6.1.5 Maximum and minimum temperatures that may be experienced by the product.
6.1.6 Nature of the transportation stages in the chain and number of drop-off points in delivery chain.
6.1.7 Support available (service providers)
6.3 The study shall be well planned in advance and shall be approved, communicate to all concerned departments and persons.
6.4 A protocol shall be prepared for each individual study. Protocol Numbering shall be given as follows TVP/XX/YYY/00,
”TVP” indicates, transport validation protocol, ”XX” indicates year 20 (for 2020)
“YYY” indicates serial number (001, 002. )
00 indicates the revision number Protocol prepared as per Format No.
The transit study protocol should describe the following:
6.5 Product shall be packed as per the simulated/intended for commercial packaging configuration of the product.
6.6 Samples sufficient for analysis in duplicate shall be withdrawn in advance for analysis and shall be stored as per recommended storage condition of respective product (Protected sample).
6.7 Data logger shall be programmed for the time interval of data acquisition and feed other required parameters.
6.8 The data logger shall be cleaned to avoid any remote possibility of contamination and shall be placed in pre identified container along with product, in such a way that it undergoes similar environmental condition experienced by the product.
6.9 The shipper/box/drum containing data logger shall be clearly identified with label as “CONTAINING DATALOGGER”.
6.10 If more than one product is sent in one consignment, data logger can be placed in any one container /pack with proper identified label.
6.11 Procedure to be followed by recipient ( to whom the procedure shall be communicated in advance via e- mail/Telecom/Courier ):
6.11.1 The recipient, on receipt shall examine the pack for physical condition and remove the data logger from the identified container.
6.11.2 If any abnormalities/damage observed, the recipient shall communicate the same to study initiator.
6.11.3 The recipient shall collect the required quantity of sample as indicated in the respective communication and shall arrange to send to initiator of the study, along with the data logger.
6.11.4 The recipient shall provide brief information about samples and data logger received on, physical condition of the consignment / container or any information as indicated in individual protocol.
6.12 After receiving the sample and data logger, initiator shall check the samples for physical observation and retrieve the data of temperature and humidity from the data logger.
6.13 The study initiator shall arrange to analyse the transit samples along with the control sample drawn initially and stored as per recommended storage condition of respective product.
6.14 Data shall be compiled in transit study report, reviewed and summary shall be prepared. As per Format No.: Format No.
6.15 A protocol shall be prepared for each individual study. Protocol Numbering shall be given as follows TVR/XX/YYY/00,
”TVR” indicates transport validation Report, ”XX” indicates year 20 (for 2020)
“YYY” indicates serial number (001, 002. ) and 00 is the revision number.
6.16 In case of acceptance criteria are not met, detailed investigation shall be conducted and conclusion shall be indicated the course of action to be taken for recon ducting the study or any recommendations on the packaging configuration.
6.17 Transit study of particular product shall perform for three seasons (summer, rainy and winter) as per the customer requirement.
7.0 References
In-house
