Validation-Concept and Procedure - GMPSOP

1 Standard Operating ProcedureTitle: validation concept and Procedure_____Copyright All rights reservedUnauthorized copying, publishing, transmission and distribution of any part of the content by electronicmeans are strictly Criteria Successful Master of of ValidationAccording to GMP definitionValidation is Establishing documented evidence which provides a highdegree of assurance that a specific process will consistently produce a product meeting its pre-determined specifications and quality attributes. Appropriate and complete documentation is recognised as being crucial to the validation Operating procedures (SOPs), manufacturing formulae, detailed batch documentation,change control systems, investigational reporting systems, analytical documentation, developmentreports, validation protocols and reports are integral componentsof the validation philosophy.

2 Allvalidation documentation is prepared and maintained to be readily accessible to Operationspersonnel. The validation documentation provides a source of information for the ongoing operationof the facility and is a resource that is used in subsequent process development or validation activities will incorporate a level of Impact Assessment to ensure that systems, servicesand products directly influenced by the testing have been identified. Additionally, an EHS Audit,incorporating risk assessment activities, are performed by the EHS management on all product linesto address the safety issues involved in the manufacturing revalidation programme will be implemented based on routineequipment revalidationrequirements and on the Change Control is the responsibility of the Project Manager to source appropriate resources, assign responsibilityand obtain agreement to participate in the should include: Skills needed Facilities needed Equipment and technology required Suppliers/contractors and materials Capital funds needed Special resources teams are assembled for a limited or fix duration to deal with new equipment, processes orsystems.

3 Team members can be drawn from single departments, cross-functional divisional areasand contractors. Skills, which do not exist inside the organisation, or for which there is insufficientcapacity, will need to be sourced validation Plan and Reports are reviewed, approved and accepted, as applicable by members ofthe review team identified below as a minimum. It is the responsibility of the individual project teamsto identify appropriate and/or additional reviewers as identified in the individual validation Plan forthat project: Quality Assurance Manager validation ManagerStandard Operating ProcedureTitle: validation concept and Procedure_____Copyright All rights reservedUnauthorized copying, publishing, transmission and distribution of any part of the content by electronicmeans are strictly validation Project Log Form (Form-375) validation Qualification series of Operational Qualification Test Protocols and Raw Data Results (as definedin the validation Operational Qualification Audit Report (for new process lines) series of Performance Qualification Test Protocols and Raw Data Results (asdefined in the validation Plan and during the OQ phase).)

4 validation SOPs(a list of SOP s relating to the process) Changes (Change Request Forms, seeSOP QMS-030). validation Documents are to be clearly identified with numbered pages, with clearunits of measure stated, results/signatures recorded in black or blue pen, andsignatures of persons performing tests and dates conducted are all to be original copies of approved validation documents are the responsibility of theProject Coordinator typically validation Manager. During the validation Project theyare to be kept in a secure place and copies issued to members of the ValidationTeam as required, in a controlled manner, by the Project Coordinator. The originalapproved copies are to be included in the validation Data relating to the execution of Operational and Performance Qualificationtests can consist of result sheets, temperature recordings, etc. Raw Data is the realtime recording of the results obtained and must always be signed and dated by theperson performing the test and then included in the validation file.

5 Operational andPerformance Qualification protocols and the Raw Data relating to them are to befiled in a separate section or volume of the validation file. It is the responsibility ofthe person/s assigned responsibilityfor checking and approving the completedprotocols to ensure that the data presented in the Reports is factual and trulyrepresents the validation effort. The Reports are then presented to the ValidationCommittee for their composite validation Files are to be appropriately numbered and indexed toallow for easy review of the validation effort and are to include a section to recordany changes that are hence made to the validated equipment/process/system, inaccordance withSOP System of validation Project Coordinator is responsible for registering the validation Project with theValidation Dept by filling out aValidation Project Log Form(Form-375).

6 validation Dept is responsible for allocating a uniqueProject No. to eachProject. The same code number will be utilised for the numbering of associateddocumentation relating to that validation file validation plan, IQ, Qualificationtest protocols, validation reports, and other associated documentation and will beused on all validation forms. validation documentation will be numbered accordingto the following designated sequence:Standard Operating ProcedureTitle: validation concept and Procedure_____Copyright All rights reservedUnauthorized copying, publishing, transmission and distribution of any part of the content by electronicmeans are strictly of22 Supplier installation inspections Instrument data Documentation Supplier operating & maintenance & Instrument Lists All process and ancillary equipment and instrumentation must be identified andclearly described as to vendor, model, serial number; instruments must becalibrated according to approved procedures and have calibration certificatesissued.

7 Motors, agitators and pumps must be identified as to vendor and model,electrical requirements, power and/or capacity output. Spare parts lists and preventative maintenance schedules must be of Construction & Lubricants in Potential Product Contact Materials of construction and lubricants in potential product contact must conformto design specifications and be suitable for the intended Verification Utilities must be properly installed and available as specified by themanufacturer s design specifications and in-house Verification SOPs shall be listed and verified to be in place. SOPs should accuratelydescribe the equipment setup and operation. SOPs must be available to support the satisfactory operation, maintenance,cleaning and change control of the equipment. Training records should be available for all personnel operating the All documentation identified as required in the approved protocol must beobtained and filed in the established validation Filing System.

8 See section Change control on all equipment and systems must be instituted in the facilityfrom the start of IQ either using manufacturer s or in-house Change Controlprocedures. Any changes during OQ to system turnover must be made inaccordance to the in-house ChangeControl Procedure . All discrepancies must be satisfactorily resolved prior to system Criteria for Operational QualificationThe OQ must demonstrate that the system operates as intended throughout the specifieddesign, operational or approved acceptance range of the equipment, as criteria for all OQ protocols will be based on the following of Test Instrumentation Indicating and recording Instrumentation utilised to obtain test data required bythe protocol must be calibrated according to approved procedures and traceableISO, AS or British standards and have calibration Operating ProcedureTitle: validation concept and Procedure_____Copyright All rights reservedUnauthorized copying, publishing, transmission and distribution of any part of the content by electronicmeans are strictly of22 Approval of this report by the validation Committee signified that aprovisionalapproval (of a maximum of 6 months duration) has been granted to enable theequipment/system to be utilised for production Qualification (PQ) Test ProtocolsThe Performance Qualification phase consists of the conducting of tests defined inthe validation Plan and during the Operational Qualification phase to determine ifthe equipment/process/system continues to operate in a reliable manner required toattain a specified quality in the process used at performance qualification should be those actually used at thenormal processing.

9 Performance Qualification usually consists of the manufactureof three consecutive production runs that satisfy all of the acceptance ReportThis document summarises all the tests that have been conducted as part of theOperational Qualification (OQ) and the Performance Qualification (PQ). Itaddresses the requirements for the validation programme stipulated and theValidation Plan. Approval of this report by the validation Committee signifies thatfull approval of the equipment/system for routine production use has been validation Report will stipulate the required Revalidation routine performance of tests to check that a validated subject or an element of asubject still does what it is expected to to be conducted during the validation PointsAll validation projects are to be logged with the validation Department. TheValidation Department is responsible for allocating a Project Number that is to bereferenced on all validation DQ, IQ, OQ and PQ Protocols shall define the acceptance criteria withqualification procedures , be reviewed and approved by the persons identified in theValidation Plan prior to checks and testing must be carried out using measuring instruments that areidentified and calibrated according to established methods.

10 All calibrations must validated test methods are to be different steps of the validation Programme (IQ, OQ & PQ) should be followedas identified in the validation qualification test results obtained during the testing must be recorded even thosethat did not meet the acceptance test results must be clearly written up and compared withthe test should be reviewed by the same members of the Project Team whoapproved the Test effective change control Procedure should be operational and encompass thewhole project from the pre-planning stage through to the final acceptance of theprocess validation Work- The validation Programm