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Template for Mapping of the Environmental condition

  • Template for Mapping of the Environmental condition
  • Objective
  • The objective of this validation study is to provide a document evidence of Temperature and Relative Humidity distribution in Ware House area against predetermined acceptance criteria.
  • Scope
  • The validation study of the Temperature and Relative Humidity distribution in Ware House area shall be carried out for one year on once in quarterly to check the seasonal variations also.
  • Responsibility
  • Quality Assurance : Preparation of validation protocol and report; review of validation data; verify the activity during recording;
  • Functional area : To check the protocol and report, arrangement & Setting of electronic thermo hygrometer or data logger as per given locations; perform the validation activity as per the protocol; preparation of validation report along with QA.
  • Engineering : To Check the Protocol, Report and provide support with equipments facility and manufacturing conditions.
  • Head -Functional Area : Approval of Protocol and Report With respect to its intended purpose and to make evaluation on compiled data.
  • Head -Quality Assurance: Approval of Protocol and Report correctness and adequacy of the text and   the experiment, regulatory compliance, correctness of the data and compliance of the protocol.
  • Head-Engineering :To approve the Protocol and report and ensure the conditions provided to the area is as per Design.
  • Validation Team members
  • Validation team shall comprise of the representatives from following functions:
  • Ware House
  • Engineering
  • Quality Assurance
  • The personnel involved in validation activity shall put the information.
  • Abbreviations
  • NMT : Not More Than
  • SOP : Standard Operating Procedure
  • Temp : Temperature
  • RH : Relative Humidity
  • Pre-requisites for Validation
  • Equipment/Instrument
  • The following instruments are to be used for Mapping of the Environmental Conditions (Temperature and Relative Humidity) in ——– Area.
S. No. Instrument Name Make Range
  • SOP of the Electronic Datalogger.
  • SOP of the Electronic thermo hygrometer.
  • Documents
  • Note:   List of instruments used in the mapping process shall be prepared as per the format attached as Annexure- and shall be made a part of validation report.
  • Acceptance Criteria
  • Area description, Environmental conditions and Acceptance criteria shall be followed.
  • Procedure
  • Area should be in operation for at least 24 hours prior to performing this test.
  • All lights in the subjected area should be kept ‘ON’ during the testing.
  • The electronic thermo-hygrometer or Dataloggers are to be placed at various test spots in the room/ area at the top level, middle level and bottom level of the room.
  • Record the Temperature & Relative humidity for 7 days at the time interval of 1 hour for each room for 8 hrs.
  • Repeat the exercise quarterly as per seasonal basis, once in the recommended months of
  • November, December & January (Winter Season)
  • February, March & April (Spring Season)
  • May, June & July (Summer Season)
  • August,September & October (Monsoon Season)
  • After completion of one year, report shall be prepared on the basis of results obtained.
  • Summarize the results for seasonal wise in temperature and RH.
  • Re-validation
  • Revalidation shall be considered and done if required when any of the following conditions occur or prevail:
  •  Any deviation to this protocol and thereupon investigation shall be recorded.

Image result for temperature mapping

  • Deviations and Investigations
  • When ever a major change have been done in the area.
  • Validation Report
  • Based on the outcome from this validation study, a report shall be prepared by Functional department and Quality Assurance. The validation report shall be reviewed and then approved by functional head, QA and engineering departments. Validation Report shall include following:
  • Cover page of the Report
  • Validation Report Approval Sheet
  • Validation Report Summary and conclusion
  • Distribution
  • Quality Assurance, Production, Quality Control,Warehouse
  • History
    Date Revision Number
    Reason for Revision
    00 New SOP

 

 

 

 

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