設(shè)備確認(rèn)操作規(guī)程英文

1、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 manufactur

2、ing 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 specifica

3、tion 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.Functional Design Specification (FDS): Functional design specification is a document that specifies in a complete, precise, variable manner, the requirement d

4、esign, 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

5、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 its acceptance criteria and to enable the u

6、ser to determine whether or not to accept the system. PREPARED BYAPPROVED BY AUTHORISED BY Department HeadUnit Quality Assurance Unit Head Date :Date : Date :(CQA-56/F3/4)Installation Qualification (IQ): Documented verification that a system is installed according to written and pre-approved specifi

7、cations.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: Document

8、ed 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 verificat

9、ion 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 dire

10、ctly with the system. Supplier: Any organisation or individual contacted directly by the user to supply a product or service.Critical Equipment: The machine within a system where the malfunctioning or failure of equipment will have direct impact on product quality. Where product is in direct contact

11、 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: (對(duì)驗(yàn)證實(shí)施人員的HES要求)1.1 Personne

12、l involved in qualification / re-qualification / periodic qualification should use appropriate personal protective equipment.1.2 Do not touch the moving parts.1.3 Electrical isolation should be done before any electric control panel verification. 1.4 Read the safety instructions specified in the ope

13、ration Manual of the machine to be qualified.2.0PROCEDURE: 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 R

14、eceipt2.1.6 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 ®

15、 FAT ® IQ ® OQ ® PLC Validation (if applicable) SAT® PQ 2.1.1 User Requirement Specification (URS):2.1.1.1 URS protocol should be approved by the project team (Users) members and Quality Assurance with Name, Sign and Date.2.1.1.2 Following points should be considered during the d

16、evelopment of URS.Ø IntroductionØ Over viewØ Operation requirementsØ Constraints Ø Life cycleØ GlossaryØ ReferencesØ Approval2.1.1.3 Each URS protocol should be allotted with a protocol no. in the format specified below“URS/P”Where, “URS” stands for User requi

17、rement specification.“P” stands for equipment / instrument / balance / area abbreviated code. 2.1.1.4 The protocol should also identify with a Version No. Where the version no. changes with every change in the URS.2.1.1.5 The URS protocol header should consist of the following details as mentioned b

18、elow:Ø Title of the URSØ Protocol No.Ø Version No.Ø DateØ Cipla PatalgangaØ UnitØ Page No.A specimen of the header is given below:Protocol No.: URS/PTITLECipla PatalgangaVersion No.:Unit:Date: Page x of y2.1.2 Functional Design Specification (FDS):2.1.2.1 The FDS s

19、hould be the manufacturer interpretation of URS. FDS should include basic functioning of the equipment with focus on control and critical components specifications and functions. 2.1.2.2 The FDS should be in the form of separate document and should include equipment specification, P&ID diagrams.

20、2.1.2.3 The FDS protocol / report should be mutually approved by the user and supplier with sufficient technical details based 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 under go change control pr

21、ocedure as per SOP CQA 06.2.1.3 Design Qualification (DQ):2.1.3.1 Design qualification should be based on the discussion between the supplier and the user with reference to URS / FDS.2.1.3.2 Following points should be considered during the development of design qualification.Ø PurposeØ Sco

22、peØ ResponsibilityØ Project requirement Ø Critical variables to be metØ Process/ Product parameters e.g. Capacity etc.Ø cGMP considerations e.g. MOC of individual parts, finish of contact partsØ Critical parameters e.g. Instrumentation, limits,Ø SafetyØ Locati

23、on suitabilityØ References Ø Documents to be attached.Ø Any changes made against the formally agreed parameters (Deviation if any).Ø Justification for acceptance (if any deviation)Ø Review (Inclusive of follow up action, if any)Ø RecommendationØ Signing off2.1.3.3

24、Any change in DQ should be through a change control procedure as per SOP CQA-06 and should be documented.2.1.4 Factory Acceptance Test (FAT):2.4.1 The FAT should be conducted at the suppliers premises under the users supervision unless agreed upon.2.4.2 The FAT protocol / report should be prepared b

25、y the supplier as per Manufacturers format and should be submitted for approval of user.2.4.3 The equipment should be shipped to the site only after approval by the user.2.4.4 The FAT protocol / report should include details of the URS and FDS.2.4.5 Any modification, changes needs during the FAT sho

26、uld be documented and intimated to the user and carried out with mutual consent.2.1.5 Checklist on Receipt:2.1.5.1 All critical parts of equipment should be checked for finish, any damages on receipt for availability as per packing list and order details.2.1.6 Installation Qualification (IQ):2.1.6.1

27、 All aspects such as utility connections, location suitability, material of construction of critical parts, installation of all monitoring, controlling, instruments and gauges including their calibration and certification by supplier should be checked and verified.2.1.6.2 During the installation qua

28、lification Area Lux level, Floor drains, piping connections , machine alignment, levelling, P& ID Diagram, Schematic, circuit diagram, tagging, wiring pheruling, pneumatic connections considered during design qualification are checked and verified.2.1.7 Operation Qualification (OQ):2.1.7.1 Durin

29、g Operation qualification the working of the monitoring and controlling instruments, gauges and systems like PLC, switches, gauges, motors, pumps etc. are checked and certified.2.1.7.2 The parameters considered during design qualification are checked and certified. PLC Validation 2.1.8.1 PLC validat

30、ion should be carried out by competent external approved agency.2.1.8.2 PLC validation should be carried out during SAT or subsequently within three months based on level of checks carried out during SAT. Validation should be done according to pre-approved protocol and report. All reference instrume

31、nts being used for validation should be certified by approved agencies like IDEMI and ERTL.2.1.8.3 Brief 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.2.1.8.4 The details of PLC a

32、nd 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 prot

33、ection etc. 2.1.8.5 Equipment interlocks, alarms and operation logic should be checked. Details of the PLC Battery conditions should be checked and its life will be verified appropriately.2.1.8.6 All PLC validation reports should be handed over by the validation agency to the engineering department

34、for verification within a week after physical verification of the system. Engineering, user department and quality assurance department will verify submitted reports2.1.8.7 Any deviation observed should be highlighted and brought up to the notice of Engineering/ User/QA dept.2.1.8.8 No changes shoul

35、d be made in the software or hardware during the course of validation.2.1.9Site acceptance test (SAT) and Provisional Handover Certificate:2.1.9.1 SAT should be carried out in conjugation with the supplier and may include checks of critical components, controls based on the detail Fat, IQ and OQ hav

36、e been successfully performed.2.1.9.2 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 Head.2.1.9.3 In few cases the equipment may h

37、ave to go through a process cycle development and stabilisation phase before subject to validation trials. 2.1.9.4 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 and supplier to reject or t

38、o proceed for PQ.2.1.9.5 If SAT is found to be satisfactory, equipment should be provisionally handed over to the concerned department for Performance Qualification.2.1.10Performance Qualification (PQ):.1During the Performance Qualification the working of the system as a whole is checked with respec

39、t to out put, quality, quantity and any specific requirements as per design qualification.2.1.10.2 Critical equipment should undergo extensive validation studies to ensure consistent performance depending on approved validation protocol.2.1.11 Handover Certificate:After successful Performance Qualif

40、ication, 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.2.2 Equipment Qualification and Requalification protocol consist of the following sections.Ø Coveri

41、ng pageØ Table of contents.Ø GlossaryØ Pre approvalØ Design QualificationØ Check list on receiptØ Installation QualificationØ Operation QualificationØ Provisional Handover CertificateØ Performance QualificationØ Hand over Certificate2.3 REQUALIFICATI

42、ON / PERIODIC QUALIFICATION2.3.1 All Major equipment should be requalified after any major change 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 direct impact on the quality, then the r

43、evalidation of the process should be done.2.3.3 The requalification need not be performed 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.2.3.4 If any fixed equipment is shifted from one are

44、a to another area. Critical parameters should be checked during requalification. Transfer note should be made for the equipment. It should be kept along with the requalification record. For relocation of portable equipment requalification is not required.2.3.5 During the transfer of equipment from o

45、ne unit to another unit requalification as IO, OQ should be conducted based on critical parameters. A such copy of original qualification should be forwarded for reference.2.3.6 While transferring the equipment to other area / units, review should be done for any specific requirements of conditions2

46、.3.7 For equipment having no changes requalification time period should be decided based on performance of annual review of the equipment. The review of the equipment should be recorded in the Equipment Review Report (Annexure MT95/A1) The requalification time period should not exceed five years.2.3

47、.8 Schedule for requalification of the major equipment should available at unit level and should be recorded in schedule for requalification Annexure MT95/A2.2.3.9 Schedule for PLC revalidation of the major equipment should be available at unit level and should be recorded in Annexure MT95/A3.2.3.10

48、 Any changes in schedule of equipment qualification should be carried out through deviation.Requalification / Periodic Qualification protocol consist of the following sections:Ø Covering pageØ Table of contents.Ø GlossaryØ Pre approvalØ Over viewØ Pre requisiteØ Pr

49、eventive Maintenance verification Ø Major breakdown verificationØ System descriptionØ Physical verificationØ Calibration verification of critical componentsØ Calibration verification of calibration standards usedØ Safety features verificationØ Control panel verific

50、ationØ Interlocks/controls verificationØ Performance evaluationØ Documentation verificationØ Post approvalØ Hand over certificate 2.4 Protocol Approval:2.4.1 All protocols are approved by Quality Assurance and Unit Head prior to their implementation i.e. after they are compi

51、led by a team of Production, Engineering, Quality Control and Safety.2.4.2 Each protocol should be allotted with a protocol number in the format specified bellow “QUALI/X”Where, “QUALI” stands for qualification“X” stands for equipment / instrument / balance / area abbreviated code 2.4.3 The protocol should also be identified with a Version No., where the version no. changes with every change in the Qualification, Requalification and Periodic Qualifica