Transcription of Performance Qualification Protocol - GMPSchool
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Performance Qualification Protocol - GMPSchool
Performance QualificationProtocol #: PQP- xxx Ver 01 Gismo Heat SealerPage 1 of 6 SeerPharma Pty Ltd Page # 1 Performance Qualification ProtocolPrepared March 2008 TitleHeat Sealer ValidationProductsSterile Gizmos Codes 12345 through 12789 Equipment/ process to be Validated:Supplier Co., Model xyz, ABC Manufacturing EquipmentRegister: MER 98-1248 / Heat Sealing process : SOP 20-12-14 Equipment NumberPPCN 98-364 Approval of the Validation ProtocolSign here after reviewing and approving the document, standards and schedulesTitleNameSignatureDateWritten By:Approved By:Validation CoordinatorLaboratory ManagerTechnical/ Quality AssuranceManagerProcess EngineerPerformance QualificationProtocol #: PQP-xxx Ver 01 Gismo Heat SealerPage 2 of 618/12/07 Page # 21 Section 1: PurposeSupplier Co. has developed a new and improved heat sealer, which should improve process flowand reduce setup time.
Performance Qualification Protocol #: PQP-xxx Ver 01 Gismo Heat Sealer Page 2 of 6 18/12/07 Page # 2 1 Section 1: Purpose Supplier Co. has developed a new and improved heat sealer, which should improve process flow
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