设备确认操作规程(英文)

1、CiplaPatalgangaSTANDARD 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 underg

2、one 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 equipme

3、nt 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 criteria or conditions that have to be met.卑微如蝼蚁、坚强似大象CiplaPatalgangaSTANDARD OPERATING PROCE

4、DURENo.: MT95EQUIPMENT QUALIFICATIONDate of IssueFunctional 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 proceduresf

5、or 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 requirementsdefined in the specification phase are completely covered by the succeedin

6、g specification or implementation phase.Factory Acceptance Test (FAT):Testing conducted at the suppliers factory todetermine whether or not a system specifies it s acceptanceandcritoeriaenable theuser to determine whether or not to accept the system.PREPARED BYAPPROVED BYAUTHORISED BYDepartment Head

7、Unit Quality AssuranceUnit HeadDate :Date :Date :(CQA-56/F3/4)Installation Qualification (IQ): Documented verification that a system is installed according to written and pre-approved specifications.卑微如蝼蚁、坚强似大象CiplaPatalgangaSTANDARD OPERATING PROCEDURENo.: MT95EQUIPMENT QUALIFICATIONDate of IssueSi

8、te Acceptance Test (SAT): An acceptance test at the users site, usually involve the supplier.Operation Qualification (OQ):Documented verification that a system operatesaccording to written and pre-approved specification throughout all specified operating ranges.PLC Validation: Documented verificatio

9、n 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 syst

10、em 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 sy

11、stem.Supplier: Any organisation or individual contacted directly by the user to supply a product or service.卑微如蝼蚁、坚强似大象CiplaPatalgangaSTANDARD OPERATING PROCEDURENo.: MT95EQUIPMENT QUALIFICATIONDate of IssueCritical Equipment: The machine within a system where the malfunctioning or failure of equipm

12、ent 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

13、machine body parts.1.0HEALTH, SAFETY AND ENVIRONMENT: (对验证实施人员的HES 要求 )1.1Personnel involved in qualification / re-qualification / periodic qualification should use appropriate personal protective equipment.1.2Do not touch the moving parts.1.3Electrical isolation should be done before any electric c

14、ontrol panel verification.1.4Read the safety instructions specified in the operation Manual of the machine to be qualified.卑微如蝼蚁、坚强似大象CiplaPatalgangaSTANDARD OPERATING PROCEDURENo.: MT95EQUIPMENT QUALIFICATIONDate of Issue2.0PROCEDURE:2.1Equipment qualification should be based on the following docum

15、entsUser Requirement Specification (URS)Functional Design Specification (FDS)Design Qualification (DQ)Factory Acceptance Test (FAT)Checklist on ReceiptInstallation Qualification (IQ)Operation Qualification (OQ)PLC Validation ( If applicable)Provisional Handover CertificatePerformance Qualification (

16、PQ)Handover CertificateThe flow of the equipment qualification is as followsURSFDSDQFATIQOQPLC Validation (if applicable)SATPQ卑微如蝼蚁、坚强似大象CiplaPatalgangaSTANDARD OPERATING PROCEDURENo.: MT95EQUIPMENT QUALIFICATIONDate of IssueUser Requirement Specification (URS):URS protocol should be approved by the

17、 project team (Users) members and Quality Assurance with Name, Sign and Date.Following points should be considered during the development of URS.? Introduction? Over view? Operation requirements? Constraints? Life cycle? Glossary? References? ApprovalEach URS protocol should be allotted with a proto

18、col no. in the format specified below“ URS/P”Where,卑微如蝼蚁、坚强似大象CiplaPatalgangaSTANDARD OPERATING PROCEDURENo.: MT95EQUIPMENT QUALIFICATIONDate of Issue“ URS” stands for User requirement specification.“ P” stands for equipment / instrument / balance / area abbreviated code.The protocol should also ide

19、ntify with a Version No. Where the version no. changes with every change in the URS.? Title of the URS? Protocol No.? Version No.? Date? Cipla Patalganga? Unit? Page No.A specimen of the header is given below:Protocol No.: URS/PVersion No.:Date:TITLECipla Patalganga Unit:Page x of y卑微如蝼蚁、坚强似大象CiplaP

20、atalgangaSTANDARD OPERATING PROCEDURENo.: MT95EQUIPMENT QUALIFICATIONDate of IssueFunctional Design Specification (FDS):The FDS should be the manufacturer interpretation of URS. FDS should include basic functioning of the equipment with focus on control and critical components specifications and fun

21、ctions.The FDS should be in the form of separate document and should include equipment specification, P&ID diagrams.The FDS protocol / report should be mutually approved by the user and supplier with sufficient technical details based on the techno commercial offer.The supplier is finally select

22、ed and CER is raised.Any changes made after finalisation of DQ should under go change control procedure as per SOP CQA 06.Design Qualification (DQ):卑微如蝼蚁、坚强似大象CiplaPatalgangaSTANDARD OPERATING PROCEDURENo.: MT95EQUIPMENT QUALIFICATIONDate of IssueDesign qualification should be based on the discussio

23、n between the supplier and the user with reference to URS / FDS.Following points should be considered during the development of design qualification.? Purpose? Scope? Responsibility? Project requirement? Critical variables to be met? Process/ Product parameters e.g. Capacity etc.? cGMP consideration

24、se.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)?

25、 Review (Inclusive of follow up action, if any)? Recommendation卑微如蝼蚁、坚强似大象CiplaPatalgangaSTANDARD OPERATING PROCEDURENo.: MT95EQUIPMENT QUALIFICATIONDate of Issue? Signing offAny change in DQ should be through a change control procedure as per SOP CQA-06 and should be documented.Factory Acceptance T

26、est (FAT):The FAT should be conducted at the supplier premises under the users supervision unless agreed upon.The FAT protocol / report should be prepared by the supplieras per Manufacturers format and should be submitted for approval of user.The equipment should be shipped to the site only after ap

27、proval by the user.The FAT protocol / report should include details of the URS and FDS.Any modification, changes needs during the FAT should be documented and intimated to the user and carried out with mutual consent.卑微如蝼蚁、坚强似大象CiplaPatalgangaSTANDARD OPERATING PROCEDURENo.: MT95EQUIPMENT QUALIFICAT

28、IONDate of IssueAll critical parts of equipment should be checked for finish, any damages on receipt for availability as per packing list and order details.All aspects such as utility connections, location suitability, material of construction of critical parts, installation of all monitoring, contr

29、olling, instruments and gauges including their calibration and certification by supplier should be checked and verified.During the installation qualification Area Lux level, Floor drains, piping connections , machine alignment, levelling, P& ID Diagram, Schematic, circuit diagram, tagging, wirin

30、g pheruling, pneumatic connections considered during design qualification are checked and verified.卑微如蝼蚁、坚强似大象CiplaPatalgangaSTANDARD OPERATING PROCEDURENo.: MT95EQUIPMENT QUALIFICATIONDate of IssueOperation Qualification (OQ):During Operation qualification the working of the monitoring and controll

31、ing instruments, gauges and systems like PLC, switches, gauges, motors, pumps etc. are checked and certified.The parameters considered during design qualification are checked and certified.PLC Validation2.1.8.1PLC validation should be carried out by competentexternal approved agency.2.1.8.2PLC valid

32、ation 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

33、ERTL.卑微如蝼蚁、坚强似大象CiplaPatalgangaSTANDARD OPERATING PROCEDURENo.: MT95EQUIPMENT QUALIFICATIONDate of IssueBrief description about equipment operating function and its location should be mentioned in the report. All raw data should be handwritten at site during actual validation.The details of PLC and

34、HMI hardware are checked as per circuit diagram and type of PLC, HMI, its software Version no. details, details of the available digital/ analogue inputs and outputs. Installed switchgear details should be mentioned i.e. SFU, MCB, relays, contactors, push buttons, switch, power supply, Surge protect

35、ion etc.Equipment interlocks, alarms and operation logic should be checked. Details of the PLC Battery conditions should be checked and it s life will be verified appropriately.All PLC validation reports should be handed over by the validation agency to the engineering department for verification wi

36、thin a week after physical verification of the system. Engineering, user department and quality assurance department will verify submitted reportsAny deviation observed should be highlighted and broughtup to the notice of Engineering/ User/QA dept.卑微如蝼蚁、坚强似大象CiplaPatalgangaSTANDARD OPERATING PROCEDU

37、RENo.: MT95EQUIPMENT QUALIFICATIONDate of IssueNo changes should be made in the software or hardware during the course of validation.Site acceptance test (SAT) and Provisional Handover Certificate:SAT should be carried out in conjugation with the supplier and may include checks of critical component

38、s, controls based on the detail Fat, IQ and OQ have been successfully performed.After the equipment goes through the installation and operational qualification procedure, it should be reviewed at each stage by a team of Engineering, Production, Quality Assurance, Quality Control, Safety and Unit Hea

39、d.In few cases the equipment may have to go through a process cycle development and stabilisation phase before subject to validation trials.If any deviation or non conformance to the acceptance criteria should be recorded and informed to concerned supplier. A decision should be taken by user team an

40、d supplier to reject or to proceed for PQ.卑微如蝼蚁、坚强似大象CiplaPatalgangaSTANDARD OPERATING PROCEDURENo.: MT95EQUIPMENT QUALIFICATIONDate of IssueIf SAT is found to be satisfactory, equipment should be provisionally handed over to the concerned department for Performance Qualification.Performance Qualifi

41、cation (PQ):During the Performance Qualification the working of the system as a whole is checked with respect to out put, quality, quantity and any specific requirements as per design qualification.Critical equipment should undergo extensive validation studies to ensure consistent performance depend

42、ing on approved validation protocol.Handover Certificate:After successful Performance Qualification, based on review by the team of Engineering, Production, Quality Assurance, Quality Control, Safety and Unit Head. The equipment is handed over to the concerned department for regular use.卑微如蝼蚁、坚强似大象C

43、iplaPatalgangaSTANDARD OPERATING PROCEDURENo.: MT95EQUIPMENT QUALIFICATIONDate of Issue2.2Equipment Qualification and Requalification protocol consist of the following sections.? Covering page? Table of contents.? Glossary? Pre approval? Design Qualification? Check list on receipt? Installation Qual

44、ification? Operation Qualification? Provisional Handover Certificate? Performance Qualification? Hand over Certificate2.3REQUALIFICATION / PERIODIC QUALIFICATIONAll Major equipment should be requalified after any major change in the equipment or modification.If there are any major changes in critica

45、l parameters of equipment (e.g. RPM of blender, speed of agitator etc.) which has direct impact on the quality, then the revalidation of the process should be done.卑微如蝼蚁、坚强似大象CiplaPatalgangaSTANDARD OPERATING PROCEDURENo.: MT95EQUIPMENT QUALIFICATIONDate of IssueThe requalification need not be perfo

46、rmed for any minor changes in the equipment, For example, few blades of multimill are replaced.NOTE: Minor changes should be recorded in the Machine History Card.If any fixed equipment is shifted from one area to another area. Critical parameters should be checked during requalification. Transfer no

47、te should be made for the equipment. It should be kept along with the requalification record. For relocation of portable equipment requalification is not required.During the transfer of equipment from one unit to another unit requalification as IO, OQ should be conducted based on critical parameters

48、. A such copy of original qualification should be forwarded for reference.While transferring the equipment to other area / units, review should be done for any specific requirements of conditionsFor equipment having no changes requalification time period should be decided based on performance of ann

49、ual review of the equipment. The review of the equipment should be recorded in卑微如蝼蚁、坚强似大象CiplaPatalgangaSTANDARD OPERATING PROCEDURENo.: MT95EQUIPMENT QUALIFICATIONDate of Issuethe Equipment Review Report (Annexure MT95/A1) The requalification time period should not exceed five years.Schedule for re

50、qualification of the major equipment should available at unit level and should be recorded in schedule for requalification Annexure MT95/A2.Schedule for PLC revalidation of the major equipment should be available at unit level and should be recorded in Annexure MT95/A3.Any changes in schedule of equipment qualification should be carried out through deviation.Requalification / Periodic Qualification protoc