【正文】 s SOP requires sound technical justification and must be approved by the site QA manager.RESPONSIBILITIES? For new products, line extensions, and formulation changes, Product Development (PD) or Technical Services (TS) has lead responsibility to assure process validation is conducted and pleted. This includes ensuring that critical processing parameters and acceptable ranges are identified, and required documents are written, including the Performance Qualification (PQ) Protocol and the PQ Report.? Product Supply (PS) has responsibility to write and execute the Installation Qualification (IQ) and Operation Qualification (OQ) protocol. This includes responsibility to prepare the IQ/OQ Report. For existing packing processes, making processes, utilities, facilities, and laboratory equipment used in the manufacture of existing products and changes to these systems, the sites have lead responsibility to assure process validation is conducted and pleted. This includes lead responsibility to write the required documents.? The site QA Manager will assure validation files exist and are kept current.? The Site QA Manger will ensure that a Validation Master plan is available at site.? The Site QA Manager, and Operations Manager or their designee will review and approve all IQ/OQ and PQ protocols and reports.? The PD or TS Section Head or designee will review and approve all PQ protocols and reports for new initiatives.PROCEDURE? Prior to any validation work all the protocols must be approved.? All validation data must be referenced or attached with the final validation report.? All Validation protocols will need to be referenced with a protocol number identifying the specific validation, preferred options would be to abbreviate the plant name or include the site code . Camp。PROCTER amp。 GAMBLEGLOBAL BEAUTYSTANDARD OPERATING PROCEDURE_______________________________________________________________________Title: Process Validation SOP No: GBC007Revision: 3Issue Date: 08/DEC/2022Effective Date: 15/JAN/2022Approval Signatures: Originator: SOF Per Exception GBU12022 Date:M. NairBeauty QA Director SP Riedell Date: 01/DEC/2022PURPOSEThis SOP provides a procedure for qualification and validation of production processes, equipments, utility systems, facilities and laboratory equipment.SCOPE? Cleaning amp。S validations can be referenced as CS0491 xxxx or a making equipment validation as MKG0491XXXX where 0491 is the site ID.? All pleted Validation documents must be appropriately filed for future reference.? Below format and sections describe the detailed requirements for conducting Installation Qualification, Operational Qualification and Performance QualificationInstallation Qualification/Operational Qualification ProtocolThe following format and sections are to be addressed in the development of an IQ/OQ protocol.INSTALLATION QUALIFICATION/OPERATIONAL QUALIFICATION PROTOCOLProject or Equipment NameValidation protocol Number: XXXXDateA. OBJECTIVEState the objective(s) of the equipment qualification.B. SYSTEM DESCRIPTIONProvide a description of the purpose and method of operation for the system being qualified.C. TEST ASSUMPTIONS / BOUNDARIESProvide a brief narrative to describe base assumptions associated with the qualification. Clearly state the boundaries of the system and the operating conditions, which the qualification will evaluate.D. RESPONSIBILITIESIn this section, list the individuals by names who are responsible for conducting each element of the Equipment Qualification.INSTALLATION QUALIFICATION (IQ)Installation Qualification involves establishing documented evidence that process equipment and ancillary systems equipment are constructed and installed to meet design intent. IQ does not typically include operation of the equipment. IQ may only need to be performed once after initial installation. Thereafter, IQ may not be required for each different process validation. All or parts of IQ may need to be repeated following relocation of equipment or major repairs, renovations or modifications to the equipment.E. EQUIPMENT LIST amp。ID39。s name and description. Including equipment numbers from the drawings will be helpful. Instruments can be broken into two categories critical, and noncritical. If critical instruments (., instruments requiring calibration) are listed in the Calibration section, they need not be listed in this section.3. Utility Requirements Discuss here utility requirements including pressed air, treated water, potable water, steam, etc. Hookups to these systems should be verified as part of the test plans.G. INSTALLATION QUALIFICATION TEST PLAN WITH SUCCESS CRITERIADetail here the test plan to verify that the system is constructed and installed according to the design. The test plan should provide sufficient instruction to assure that the task is carried out correctly. Where other systems or procedures are relied upon to provide instruction on how to do a task (lubrication SOP, calibration SOP, PSI Procedure, yellow lining, green tagging, etc.) that document or procedure must be attached to the protocol. SOP39。ll be conducting, prospective, instant run, or concurrent, and the reason(s) why. It may be appropriate to group similar products into families and conduct validation on only one product in the product family. Grouping into families must be based on sound technical justification and that justification must be documented in this section. C. RESPONSIBILITIESList the people who are responsible executing the various sections spelled out in this Performance Qualification ProtocolD. PROCESS DESCRIPTION amp。t have a method number, attach the method procedure to the protocol.6. Critical SubSystemsOutline the critical subsystems, ., purified water, premixes, pre weighs, etc., that inte