1.1The objective of this policy is to provide an outline of the steps necessary to validate the computer systems in the certified pharmaceutical production facility.
2.0 SCOPE
2.1 This policy is applicable to all HAPL and contractor facilities producing clinical supplies or marketed products.
3.0 DOCUMENTATION REQUIREMENTS
2.0 SCOPE
2.1 This policy is applicable to all HAPL and contractor facilities producing clinical supplies or marketed products.
3.0 DOCUMENTATION REQUIREMENTS
3.1 Validation Protocol (see attached outline).
4.0 PROCEDURES
4.1 The validation protocols for each system should be initiated by the department manager who is responsible for the operations controlled by the computer in conjunction with the appropriate HAPL Systems representatives.
4.2 Technical input should be given by the in-house experts (System) on the computer system and by the hardware and software suppliers
4.3 The protocol should be reviewed and commented on by the appropriate representatives of Systems, Production, and QA/QC.
4.4 The protocol should be approved by the site Technical Director prior to installation and operation of the Computer system.
4.5 The system Installation Qualification (IQ) and initial testing Operational Qualification (OQ) should be performed by an approved contractor and/or in-house expert(s), as á appropriate, and monitored by QA/QC.
4.6 Performance qualification (PQ) and validation testing may be performed by contractors and/or HAPL personal monitored by QA/QC.
4.7 System documentation should be reviewed and approved by QA/QC and the G.M.(P) before the system is considered validated for production (Validation Certificate).
4.8 Basis of Design
4.8.1 Description of what the system is supposed to do. This information is usually contained in internal documents that back up Capital Appropriation Request (CAR) or Purchase submissions.
4.9 System Specifications
4.9.1 The information is the Basis of Design documents is used to develop proposal/purchase specifications such as control and/or recording of time temperature and volume for processes. These are the requirements of the computer systems performance that can be measured against.
4.10 Operating Procedure (SOPs)
4.10.1 Listing of procedures required for computer system operation and control of data. This included supplier manuals and training materials.
4.11 Training Records
4.11.1 Operations, maintenance personnel, and their supervisors should have their training appropriately documented.
4.12 Installation Qualification
4.12.1 Checklist of the specifications and purchase order against components and parts delivered and/or installed at part of the computer system. This included as-built drawings, maintenance and warranty documentation.
4.13 Performance Qualification
4.13.1 Specific performance measured against the specifications listed in Item #2. This means that the computer system is checked out in isolation from other systems or operations. If the computer system controls á production operation then the computer and the process should be checked out individually and collectively for proper performance.
4.14 Validation Testing
4.14.1Testing of the specified parameters in simulated or actual operating conditions. The tests should be predetermined including acceptance criteria The computer hardware (HW) including Operating Software should be checked out using supplied provided diagnostic programs. Applications software (SW) written specifically for á particular function should be appropriately functionally tested and verified prior to installation and validation testing.
4.15 Maintenance
4.15.1 Maintenance scheduled for validated systems should be set up as part of the protocol.
4.16 Change Control
4.16.1 Change control files should be established for á periodic, at least annual review of all changes to ensure that the system remains in á state of control. Computer systems that are not maintained in á state of control and/or which have significant changes should be revalidated.
4.16 Summary Report and Management Approval
4.16.1 Á summary report of the data analysis and QÁ audit of the computer system validation documentation should be written by the protocol project manager. Approval should be signed and dated for the authorisation of the protocol and the approval of the validated system to be operated in á production facility by:
Name Title Date
4.0 PROCEDURES
4.1 The validation protocols for each system should be initiated by the department manager who is responsible for the operations controlled by the computer in conjunction with the appropriate HAPL Systems representatives.
4.2 Technical input should be given by the in-house experts (System) on the computer system and by the hardware and software suppliers
4.3 The protocol should be reviewed and commented on by the appropriate representatives of Systems, Production, and QA/QC.
4.4 The protocol should be approved by the site Technical Director prior to installation and operation of the Computer system.
4.5 The system Installation Qualification (IQ) and initial testing Operational Qualification (OQ) should be performed by an approved contractor and/or in-house expert(s), as á appropriate, and monitored by QA/QC.
4.6 Performance qualification (PQ) and validation testing may be performed by contractors and/or HAPL personal monitored by QA/QC.
4.7 System documentation should be reviewed and approved by QA/QC and the G.M.(P) before the system is considered validated for production (Validation Certificate).
4.8 Basis of Design
4.8.1 Description of what the system is supposed to do. This information is usually contained in internal documents that back up Capital Appropriation Request (CAR) or Purchase submissions.
4.9 System Specifications
4.9.1 The information is the Basis of Design documents is used to develop proposal/purchase specifications such as control and/or recording of time temperature and volume for processes. These are the requirements of the computer systems performance that can be measured against.
4.10 Operating Procedure (SOPs)
4.10.1 Listing of procedures required for computer system operation and control of data. This included supplier manuals and training materials.
4.11 Training Records
4.11.1 Operations, maintenance personnel, and their supervisors should have their training appropriately documented.
4.12 Installation Qualification
4.12.1 Checklist of the specifications and purchase order against components and parts delivered and/or installed at part of the computer system. This included as-built drawings, maintenance and warranty documentation.
4.13 Performance Qualification
4.13.1 Specific performance measured against the specifications listed in Item #2. This means that the computer system is checked out in isolation from other systems or operations. If the computer system controls á production operation then the computer and the process should be checked out individually and collectively for proper performance.
4.14 Validation Testing
4.14.1Testing of the specified parameters in simulated or actual operating conditions. The tests should be predetermined including acceptance criteria The computer hardware (HW) including Operating Software should be checked out using supplied provided diagnostic programs. Applications software (SW) written specifically for á particular function should be appropriately functionally tested and verified prior to installation and validation testing.
4.15 Maintenance
4.15.1 Maintenance scheduled for validated systems should be set up as part of the protocol.
4.16 Change Control
4.16.1 Change control files should be established for á periodic, at least annual review of all changes to ensure that the system remains in á state of control. Computer systems that are not maintained in á state of control and/or which have significant changes should be revalidated.
4.16 Summary Report and Management Approval
4.16.1 Á summary report of the data analysis and QÁ audit of the computer system validation documentation should be written by the protocol project manager. Approval should be signed and dated for the authorisation of the protocol and the approval of the validated system to be operated in á production facility by:
Name Title Date
Systems -------------- ----------------- ------------
Production -------------- ----------------- ------------
QA/QC -------------- ----------------- ------------
G.M.(p) --------------- ----------------- -------------
4.16.2 The following people have read this SOP and are currently following these procedures in the laboratory.
Production -------------- ----------------- ------------
QA/QC -------------- ----------------- ------------
G.M.(p) --------------- ----------------- -------------
4.16.2 The following people have read this SOP and are currently following these procedures in the laboratory.
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