设备确认操作规程(英文)

Patalganga STANDARD OPERATING PROCEDURENo.: MT95EQUIPMENT QUALIFICATIONDate of Issue盛年不重来，一日难再晨。

及时宜自勉，岁月不待人。

PURPOSE:To provide a formal methodology to be followed during qualification of equipment.SCOPE:Applicable to qualification of new equipment, re-qualification of equipment, which has undergone major modification, relocation of equipment and Periodic Qualification as per schedule in Pharma manufacturing department.RESPONSIBILITY:Production, Engineering, Safety, Quality Control and Quality Assurance staff. DEFINITION:Qualification: Documented verification that the environment and equipment are appropriate for the designated function.User Requirement Specification (URS): A Requirement specification that describes what the equipment or system is suppose to do, thus containing at least set of criteriaor conditions that have to be met.Patalganga STANDARD OPERATING PROCEDURENo.: MT95EQUIPMENT QUALIFICATIONDate of Issue Functional Design Specification (FDS): Functional design specification is a document that specifies in a complete, precise, variable manner, the requirement design, behaviour or other characteristics of a system or component and often the procedures for determining whether these provisions have been satisfied.Specification that is offered by manufacturing based on URS and are agreed mutually.Design Qualification (DQ): Formal and systematic verification that the requirements defined in the specification phase are completely covered by the succeeding specification or implementation phase.Factory Acceptance Test (FAT): Testing conducted at the suppliers factory to determine whether or not a system specifies it’s acceptance criteria and to enable the user to determine whether or not to accept the system.Installation Qualification (IQ): Documented verification that a system is installed according to written and pre-approved specifications.Patalganga STANDARD OPERATING PROCEDURENo.: MT95EQUIPMENT QUALIFICATIONDate of Issue Site Acceptance Test (SAT): An acceptance test at the users site, usually involve the supplier.Operation Qualification (OQ): Documented verification that a system operates according to written and pre-approved specification throughout all specified operating ranges.PLC Validation: Documented verification that PLC Hardware are as per original drawing, Digital and Analog Input and Output are connected as per PLC Architecture and functioning according to written and pre-approved specification throughout all specified operating ranges.Performance Qualification (PQ): Documented verification that a system is capable of performing or controlling the activities of the processes, it is required to perform or control, according to written and pre-approved specifications, while operating in its specified operating environment.User (s): The person, or persons, who operate or interact directly with the system. Supplier: Any organisation or individual contacted directly by the user to supply a product or service.Patalganga STANDARD OPERATING PROCEDURENo.: MT95EQUIPMENT QUALIFICATIONDate of Issue Critical Equipment: The machine within a system where the malfunctioning or failureof equipment will have direct impact on product quality. Where product is in direct contact with machine body parts.Non-critical Equipment: The machine within a system where the malfunctioning or failure of equipment will not have direct impact on product quality. Where product is not in direct contact with machine body parts.1.0 HEALTH, SAFETY AND ENVIRONMENT: (对验证实施人员的HES要求)1.1 Personnel involved in qualification / re-qualification / periodic qualificationshould use appropriate personal protective equipment.1.2 Do not touch the moving parts.1.3 Electrical isolation should be done before any electric control panelverification.1.4 Read the safety instructions specified in the operation Manual of themachine to be qualified.Patalganga STANDARD OPERATING PROCEDURENo.: MT95EQUIPMENT QUALIFICATIONDate of Issue2.0 PROCEDURE:2.1 Equipment qualification should be based on the following documents2.1.1 User Requirement Specification (URS)2.1.2 Functional Design Specification (FDS)2.1.3 Design Qualification (DQ)2.1.4 Factory Acceptance Test (FAT)2.1.5 Checklist on Receipt2.1.6 Installation Qualification (IQ)2.1.7 Operation Qualification (OQ)2.1.8 PLC Validation ( If applicable)2.1.9 Provisional Handover Certificate2.1.10 Performance Qualification (PQ)2.1.11 Handover CertificateThe flow of the equipment qualification is as followsURS → FDS → DQ → FAT → IQ → OQ → PLC Validation (if applicable)SAT→ PQPatalganga STANDARD OPERATING PROCEDURENo.: MT95 EQUIPMENT QUALIFICATIONDate of Issue2.1.1 User Requirement Specification (URS):2.1.1.1 URS protocol should be approved by the project team(Users) members and Quality Assurance with Name, Signand Date.2.1.1.2 Following points should be considered during thedevelopment of URS.➢Introduction➢Over view➢Operation requirements➢Constraints➢Life cycle➢Glossary➢References➢Approval2.1.1.3 Each URS protocol should be allotted with a protocol no. inthe format specified below“URS/P”Where,Patalganga STANDARD OPERATING PROCEDURENo.: MT95 EQUIPMENT QUALIFICATIONDate of Issue “URS” stands for Use r requirement specification.“P” stands for equipment / instrument / balance / areaabbreviated code.2.1.1.4 The protocol should also identify with a Version No. Wherethe version no. changes with every change in the URS.2.1.1.5 The URS protocol header should consist of the following detailsas mentioned below:➢Title of the URS➢Protocol No.➢Version No.➢Date➢Cipla Patalganga➢Unit➢Page No.A specimen of the header is given below:Patalganga STANDARD OPERATING PROCEDURENo.: MT95 EQUIPMENT QUALIFICATIONDate of Issue2.1.2 Functional Design Specification (FDS):2.1.2.1 The FDS should be the manufacturer interpretation ofURS. FDS should include basic functioning of theequipment with focus on control and critical componentsspecifications and functions.2.1.2.2 The FDS should be in the form of separate documentand should include equipment specification, P&IDdiagrams.2.1.2.3 The FDS protocol / report should be mutually approvedby the user and supplier with sufficient technical detailsbased on the techno commercial offer.2.1.2.4 The supplier is finally selected and CER is raised.2.1.2.5 Any changes made after finalisation of DQ should undergo change control procedure as per SOP CQA 06.2.1.3 Design Qualification (DQ):Patalganga STANDARD OPERATING PROCEDURENo.: MT95 EQUIPMENT QUALIFICATIONDate of Issue2.1.3.1 Design qualification should be based on the discussionbetween the supplier and the user with reference toURS / FDS.2.1.3.2 Following points should be considered during thedevelopment of design qualification.➢ Purpose➢ Scope➢ Responsibility➢ Project requirement➢ Critical variables to be met➢ Process/ Product parameters e.g. Capacity etc.➢ cGMP considerationse.g. MOC of individual parts, finish of contact parts➢ Critical parameters e.g. Instrumentation, limits,➢ Safety➢ Location suitability➢ References➢ Documents to be attached.➢ Any changes made against the formally agreedparameters (Deviation if any).➢ Justification for acceptance (if any deviation)➢ Review (Inclusive of follow up action, if any)➢ RecommendationPatalganga STANDARD OPERATING PROCEDURENo.: MT95 EQUIPMENT QUALIFICATIONDate of Issue➢ Signing off2.1.3.3 Any change in DQ should be through a change controlprocedure as per SOP CQA-06 and should bedocumented.2.1.4 Factory Acceptance Test (FAT):2.4.1 The FAT should be conducted at the supplier’s premisesunder the users supervision unless agreed upon.2.4.2 The FAT protocol / report should be prepared by the supplieras per Manufacturers format and should be submitted forapproval of user.2.4.3 The equipment should be shipped to the site only afterapproval by the user.2.4.4 The FAT protocol / report should include details of the URSand FDS.2.4.5 Any modification, changes needs during the FAT should bedocumented and intimated to the user and carried out withmutual consent.Patalganga STANDARD OPERATING PROCEDURENo.: MT95 EQUIPMENT QUALIFICATIONDate of Issue2.1.5 Checklist on Receipt:2.1.5.1 All critical parts of equipment should be checked forfinish, any damages on receipt for availability as perpacking list and order details.2.1.6 Installation Qualification (IQ):2.1.6.1 All aspects such as utility connections, location suitability,material of construction of critical parts, installation of allmonitoring, controlling, instruments and gauges includingtheir calibration and certification by supplier should bechecked and verified.2.1.6.2 During the installation qualification Area Lux level, Floordrains, piping connections , machine alignment, levelling,P& ID Diagram, Schematic, circuit diagram, tagging,wiring pheruling, pneumatic connections consideredduring design qualification are checked and verified.Patalganga STANDARD OPERATING PROCEDURENo.: MT95 EQUIPMENT QUALIFICATIONDate of Issue2.1.7 Operation Qualification (OQ):2.1.7.1 During Operation qualification the working of themonitoring and controlling instruments, gauges andsystems like PLC, switches, gauges, motors, pumps etc.are checked and certified.2.1.7.2 The parameters considered during design qualificationare checked and certified.2.1.8 PLC Validation2.1.8.1 PLC validation should be carried out by competentexternal approved agency.2.1.8.2 PLC validation should be carried out during SAT orsubsequently within three months based on level ofchecks carried out during SAT. Validation should be doneaccording to pre-approved protocol and report. Allreference instruments being used for validation should becertified by approved agencies like ‘IDEMI’ and ‘ERTL.Patalganga STANDARD OPERATING PROCEDURENo.: MT95 EQUIPMENT QUALIFICATIONDate of Issue2.1.8.3 Brief description about equipment operating function andits location should be mentioned in the report. All rawdata should be handwritten at site during actual validation.2.1.8.4 The details of PLC and HMI hardware are checked as percircuit diagram and type of PLC, HMI, its software Versionno. details, details of the available digital/ analogue inputsand outputs. Installed switchgear details should bementioned i.e. SFU, MCB, relays, contactors, pushbuttons, switch, power supply, Surge protection etc.2.1.8.5 Equipment interlocks, alarms and operation logic shouldbe checked. Details of the PLC Battery conditions shouldbe checked and it’s life will be verified appropriately.2.1.8.6 All PLC validation reports should be handed over by thevalidation agency to the engineering department forverification within a week after physical verification of thesystem. Engineering, user department and qualityassurance department will verify submitted reports2.1.8.7 Any deviation observed should be highlighted and broughtup to the notice of Engineering/ User/QA dept.Patalganga STANDARD OPERATING PROCEDURENo.: MT95 EQUIPMENT QUALIFICATIONDate of Issue2.1.8.8 No changes should be made in the software or hardwareduring the course of validation.2.1.9 Site acceptance test (SAT) and Provisional HandoverCertificate:2.1.9.1 SAT should be carried out in conjugation with thesupplier and may include checks of critical components,controls based on the detail Fat, IQ and OQ have beensuccessfully performed.2.1.9.2 After the equipment goes through the installation andoperational qualification procedure, it should be reviewedat each stage by a team of Engineering, Production,Quality Assurance, Quality Control, Safety and Unit Head.2.1.9.3 In few cases the equipment may have to go through aprocess cycle development and stabilisation phase beforesubject to validation trials.2.1.9.4 If any deviation or non conformance to the acceptancecriteria should be recorded and informed to concernedsupplier. A decision should be taken by user team andsupplier to reject or to proceed for PQ.Patalganga STANDARD OPERATING PROCEDURENo.: MT95 EQUIPMENT QUALIFICATIONDate of Issue2.1.9.5 If SAT is found to be satisfactory, equipment should beprovisionally handed over to the concerned departmentfor Performance Qualification.2.1.10 Performance Qualification (PQ):2.1.10.1 During the Performance Qualification the working of thesystem as a whole is checked with respect to out put, quality,quantity and any specific requirements as per designqualification.2.1.10.2 Critical equipment should undergo extensive validationstudies to ensure consistent performance depending onapproved validation protocol.2.1.11 Handover Certificate:After successful Performance Qualification, based on reviewby the team of Engineering, Production, Quality Assurance,Quality Control, Safety and Unit Head. The equipment ishanded over to the concerned department for regular use.Patalganga STANDARD OPERATING PROCEDURENo.: MT95EQUIPMENT QUALIFICATIONDate of Issue 2.2 Equipment Qualification and Requalification protocol consist of thefollowing sections.➢Covering page➢Table of contents.➢Glossary➢Pre approval➢Design Qualification➢Check list on receipt➢Installation Qualification➢Operation Qualification➢Provisional Handover Certificate➢Performance Qualification➢Hand over Certificate2.3 REQUALIFICATION / PERIODIC QUALIFICATION2.3.1 All Major equipment should be requalified after any majorchange in the equipment or modification.2.3.2 If there are any major changes in critical parameters of equipment(e.g. RPM of blender, speed of agitator etc.) which has directimpact on the quality, then the revalidation of the process should be done.Patalganga STANDARD OPERATING PROCEDURENo.: MT95 EQUIPMENT QUALIFICATIONDate of Issue 2.3.3 The requalification need not be performed for any minor changes in the equipment, For example, few blades of multimill arereplaced.NOTE: Minor changes should be recorded in the Machine History Card.2.3.4 If any fixed equipment is shifted from one area to another area.Critical parameters should be checked during requalification.Transfer note should be made for the equipment. It should bekept along with the requalification record. For relocation ofportable equipment requalification is not required.2.3.5 During the transfer of equipment from one unit to another unitrequalification as IO, OQ should be conducted based on criticalparameters. A such copy of original qualification should beforwarded for reference.2.3.6 While transferring the equipment to other area / units, reviewshould be done for any specific requirements of conditions2.3.7 For equipment having no changes requalification time periodshould be decided based on performance of annual review of theequipment. The review of the equipment should be recorded inPatalganga STANDARD OPERATING PROCEDURENo.: MT95 EQUIPMENT QUALIFICATIONDate of Issue the Equipment Review Report (Annexure MT95/A1) Therequalification time period should not exceed five years.2.3.8 Schedule for requalification of the major equipment shouldavailable at unit level and should be recorded in schedule forrequalification Annexure MT95/A2.2.3.9 Schedule for PLC revalidation of the major equipment should beavailable at unit level and should be recorded in AnnexureMT95/A3.2.3.10 Any changes in schedule of equipment qualification should becarried out through deviation.Requalification / Periodic Qualification protocol consist of the following sections:➢Covering page➢Table of contents.➢Glossary➢Pre approval➢Over view➢Pre requisite➢Preventive Maintenance verificationPatalganga STANDARD OPERATING PROCEDURENo.: MT95EQUIPMENT QUALIFICATIONDate of Issue ➢Major breakdown verification➢System description➢Physical verification➢Calibration verification of critical components➢Calibration verification of calibration standards used➢Safety features verification➢Control panel verification➢Interlocks/controls verification➢Performance evaluation➢Documentation verification➢Post approval➢Hand over certificate2.4 Protocol Approval:2.4.1 All protocols are approved by Quality Assurance and Unit Headprior to their implementation i.e. after they are compiled by a teamof Production, Engineering, Quality Control and Safety.2.4.2 Each protocol should be allotted with a protocol number in theformat specified bellow“QUALI/X”Where,Patalganga STANDARD OPERATING PROCEDURENo.: MT95 EQUIPMENT QUALIFICATIONDate of Issue “QUALI” stands for qualification“X” stands for equipment / instrument / balance / area abbreviatedcode2.4.3 The protocol should also be identified with a Version No., wherethe version no. changes with every change in the Qualification,Requalification and Periodic Qualification of equipment.2.4.4 The Qualification, Requalification and Periodic Qualificationprotocol header should consist of the following details asmentioned below➢Title of the protocol➢Protocol No.➢Version No.➢Department➢Area➢Page No.A specimen of the header is given below:Patalganga STANDARD OPERATING PROCEDURENo.: MT95EQUIPMENT QUALIFICATIONDate of Issue2.4.5 Frequency for Periodic QualificationFor Critical Equipment: Once in 3 years of its previousqualification (Initial qualification / requalification)For Non Critical Equipment: Once in 5 years of its previousqualification (Initial qualification / requalification)Note: The period of periodic qualification should be determinedbased on review of history of preventive maintenance, breakdown,calibration data and criticality of process.3.0 ABBREVIATIONS:URS User Requirement SpecificationFDS Functional Design SpecificationDQ Design QualificationFAT Factory Acceptance TestIQ Installation QualificationSAT Site Acceptance TestPatalganga STANDARD OPERATING PROCEDURENo.: MT95EQUIPMENT QUALIFICATIONDate of Issue OQ Operation QualificationPQ Performance QualificationNo. NumberP&ID Piping and Instrumentation DiagramCER Capital Expenditure RequisitionCGMP current Goods Manufacturing PracticesPLC Programmable Logic Controller.MOC Material of Construction材质i.e. That ise.g. For exampleIDEMI Institute for Design of Electrical Measuring InstrumentsERTL Electronics Regional Testing LaboratoryPLC Programmable Logic ControllerHMI Human Machine InterfaceSFU Switch Fuse UnitMCB Miniature Circuit Breaker4.0 REFERENCES:CQA-06 Change ControlPatalganga STANDARD OPERATING PROCEDURENo.: MT95EQUIPMENT QUALIFICATIONDate of Issue5.0 ANNEXURES:MT95/A1 Equipment Review Report (MT95/F1)MT95/A2 Schedule for Requalification/Periodic (MT95/F2)QualificationMT95/A3 Schedule for PLC Revalidation /Periodic (MT95/F3)Validation。