设备确认操作规程(英文).doc

Cipla PatalgangaSTANDARD OPERATING PROCEDURENo.: MT95EQUIPMENT QUALIFICATION Date of IssueVersion No.: 06Effective Date Supersedes16.10.2007Page 13 of 13PURPOSE: 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 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 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 its acceptance criteria and to enable the user 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 specifications.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.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 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 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 operation 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 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 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 development 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. in the format specified below“URS/P”Where, “URS” stands for User requirement 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 below: 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/PTITLECipla PatalgangaVersion No.:Unit:Date: Page x of y2.1.2 Functional Design Specification (FDS):2.1.2.1 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 functions. 2.1.2.2 The FDS should be in the form of separate document and should include equipment specification, P&ID diagrams.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 procedure 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. Purpose Scope Responsibility Project requirement Critical variables to be met Process/ Product parameters e.g. Capacity etc. cGMP considerations e.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 agreed parameters (Deviation if any). Justification for acceptance (if any deviation) Review (Inclusive of follow up action, if any) Recommendation Signing off2.1.3.3 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 by 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 should 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 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 qualification 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 During 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. 2.1.8 PLC Validation 2.1.8.1 PLC validation 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 instruments 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 and 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 protection 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 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 should 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 have 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 have 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 to 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):2.1.10.1During 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.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 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.2.2 Equipment Qualification and Requalification protocol consist of the following 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 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 revalidation 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 area 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 one 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 conditions2.3.7 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.2.3.8 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 Any changes in schedule of equipment qualification should be carried 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 verification 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 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 compiled 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