Temperature Mapping Protocols

1.0 OBJECTIVE

The Objective of this protocol is to ensure that the temperature-controlled transport vehicle is capable to maintaining the required temperature condition throughout the transit duration from plant to customer depot and also provide detailed steps to conduct transport validation and to evaluate the product integrity and effect of environmental condition as temperature during the transport on the quality of finished pharmaceutical product dispatched.

2.0 SCOPE

This Protocol is applicable to all product manufactured and supplied in Refrigerated Vehicle

6.0 PROCEDURE FOR TRANSPORT VALIDATION

• The Validation team for the transportation study shall be consists of personnel from QA, engineering warehouse, and marketing/Sales
• QA shall ensure that persons carrying out the transport validation must be trained on respective operations and procedures
• QA shall ensure that the data logger use for the transport validation shall be calibrated and record the details in Annexure-3
• Warehouse person shall inform QA about the details such as the introduction of new transporter, name of the transporter, Vehicle Number, and Vehicle size, product details such as product name, batch number and the number of packed shippers at least for one day in the advance before the dispatch and also record the details in Annexure -4
• QA shall verify the products and transport details and evaluate that transport validation is required or not
• If temperature validation study is applicable on the transport vehicle, QA shall communicate to all concerned person from the site and depot/marketing department regarding the same.
• Warehouse person shall arrange the shipper /pallets/Drums of the products which is under transport validation
• QA person along with warehouse person shall perform the visual inspection of all the containers to be shipped for cleanness and any defects and records the observations and record the observations in Annexure-5
• If the transport container is dirty and damaged, then wait until unless it is cleaned and rectified
• QA shall ensure that packed products are complying with the approved specification.
• The Vehicle container shall be preconditioned at least 30 minutes before the loading of finished product start to maintained the required temperature.
• QA/Eng. person shall calculate the dimensions of Vehicle container and dived the area in equal grid
• Arrange a minimum of three data logger for each grid in case of without palletization and four data loggers in case of with palettization
• QA shall check the battery level of each datalogger, preferably the battery level shall be 100 % but shall not less than 50 % level.
• In case of lower level of battery, then replace the battery before placement of data loggers
• Warehouse/QA person set the program of data logger to 10 minutes frequency interval to take the reading in the data logger.
• Data loggers shall be place while loading of shippers and same shall be recorded in Annexure -6
• The shipper/Pallet contains the data logger shall be Marked as "CONTAINS DATA LOGGER”.

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1.0 Purpose

The purpose of this protocol is to provide the procedure and acceptance criteria for temperature and relative humidity (in %) in manufacturing/Warehouse Storage area. Successful execution of this protocol and successive report compilation shall provide sufficient data to establish that the air handling systems connected to the rooms or equipments installed in the rooms are capable of continuously maintaining desired conditions of temperature and relative humidity and performing as intended and are in a state of control.

2.0 Scope

Scope of this protocol is limited to Temperature and %RH mapping of the following rooms of Manufacturing and Warehouse area.

5.0 Qualification Test, Procedures and Acceptance Criter

5.1 Pre-Requisites

5.1.1 Impart training to all personnel involved in the qualification exercise and record the details in Annexure I. Attach a copy of training record to the report.

5.1.2 Ensure that all instruments to be used in mapping exercise are in calibrated state, record the details in Annexure I and attach copy of calibration certificates to the report. The instruments shall have valid calibration of atleast three points and shall have accuracy of NMT ±0.5ºC / 3.0% RH. Calibration range of the instruments shall be inclusive of acceptance criteria of the staging / storage area.

5.1.3 If services of external agency are being taken, ensure that the agency is in agreement with the organization.

5.1.4 All recordings shall be on Annexure I only and any raw data generated during the execution shall be attached alongwith the report.

5.2 Empty Staging Room Temperature / Relative Humidity Mapping

5.2.1 Empty room heat distribution study shall be performed only when any modification is performed any identified room. Empty room heat distribution study is to be performed after successful completion of prerequisite. Procedure for Mapping is as follows:

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1.0 OBJECTIVE

The objective of this Performance Qualification protocol is to provide documented verification that the RM Quarantine, RM AC Quarantine, RM Store of Warehouse when operated within established parameters, performs consistently and in accordance with its intended use and meets predetermined requirements. Performance qualification study shall be carried out to establish the following parameters:

• To ensure that the uniform temperature distribution is achieved at different locations of the area under monitoring;

• To identify the worst-case location for positioning of temperature monitoring devices for routine monitoring;

• To determine minimum time taken for temperatures to exceed the standard limits in the event door opening;

The purpose of Performance Qualification (PQ) of Room RM Quarantine, RM AC Quarantine, RM Store of Warehouse is to provide documented evidence which demonstrates to a high level of assurance that the areas meet current Standards and company requirements.

2.0 SCOPE

This protocol is applicable to the Performance qualification of RM Quarantine, RM AC Quarantine, RM Store of Warehouse.

A Validation Summary report will be generated at the end of Qualification to summarize the Qualification results for the Performance qualification. This report will include but not be limited to:

• Qualification Results of Performance Qualification.

• A summary of discrepancies

• Qualified Parameters

6.0 PERFORMANCE QUALIFICATION RATIONALE

6.1 Temperature/RH Mapping:

To ensure that the uniform temperature/RH distribution is achieved at different locations of the area under monitoring and to identify the worst case location for positioning of temperature monitoring devices for routine monitoring.

6.1.1Selection of Data Logger:

• All the data loggers must have a NIST-traceable at least 3-point calibration completed and valid.

• Calibration range of data loggers should cover the standard temperature range being studied.

• Accuracy of data loggers should NMT ± 0.5°C for temperature and NMT ±3% for RH at each calibration point.

• Calibration certificate of each logger shall be verified and attached with protocol prior to mapping.

• All data logger shall have sufficient memory for entire duration of mapping.

• Data recording interval shall be set at 10 min.

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