D-2000 Elite HPLC System ManagerQualification ProtocolValidation No.：QC-V AL-151-01Suzhou Homesun Wanqing Pharmaceutical Co., LtdOct, 2010P r o t o c o l C o n f i r m a t i o nTABLE OF CONTENTS1.STATEMENT (1)2.SCOPE (1)3.REFREENCE DOCUMENTS (1)4.GLOSSARY (1)5.RESPONSIBILITIES (2)6.INSTALLATION QUALIFICATION (IQ) (3)7.OPERATION QUALIFICATION (OQ) (7)8. PERFORMANCE QUALIFICATION (PQ) (9)9. ATTACHMENT (11)1.StatementThe objective of this protocol is to define the main requirements and processes for qualification of D-2000 Elite HPLC System Manager used in the laboratory analysis. D-2000 Elite HPLC System Manager is a chromatography data system supported by Hitachi used to control the Techcomp LC2000 HPLC instrument which also supported from Hitachi, the software can execute analyzer’s input automatically including establishing analytical method, executing method program, collecting sample response, acquiring data, reprocessing data and initiating electronic records. Techcomp LC2000 HPLC located in laboratories (including QC laboratory and in-process control laboratory), have been completed IQ, OQ, PQ test and approved for use. In order to prove that D-2000 Elite HPLC System Manager is appropriate for GMP requirements on laboratory computerized system, QC department will execute the qualification.2.ScopeThis protocol applies to D-2000 Elite HPLC System Manager used to control Techcomp LC2000 HPLC.This protocol does not apply to LC2000 HPLC Qualification, it only contains applicable software qualification. The instrument qualifications are performed according to QC-V AL-105-01.Chromatography Data System Qualification and HPLC Qualification constitute good operation and maintenance in HPLC application.3.Reference Documents3.1GAMP Good Practice Guide: Validation of Laboratory Computerized Systems, 2005.3.2PDA technical report 31, ‘Validation and Qualification of Computerized Laboratory DataAc quisition Systems’, June 1999.3.3GMP Regulations (e.g. – 21 CFR 211.194, 91/356/EEC Ch 6, and ICH Q7A 6.6)3.4ICH Q7A – Good Manufacturing Practices for Active Pharmaceutical Ingredients, Chapter5.4 Computerized Systems4Glossary4.1 Computerized System: Computer system (hardware and software, including infrastructure)with associated functions and controlled process (equipment, users, procedures), in its operating environment4.2 Data backup: Copy of the data on a different medium (for example floppy disk, cartridge,CD-Rom) to allow data retrieval in case of a failure of the main storage medium.4.3 Data archival: Removal of some system data onto more durable and high capacity storagemedia (tapes, optical digital disks), necessary when the data is no longer required for routine work and data volumes are too great for the main storage medium.4.4 Audit trail: An audit-trail is a computer -generated recording of changes to GMP recordsindicating who created or changed the data, when, and if needed, why.4.5 Electronic Record (or Electronic Data): Combination of information in digital form that ismaintained by a computerized system and used for a GMP regulated activity.4.6 Applicable program: A document folder registered in D-2000 Elite HSM used to establishand storage analytical method, sample table, data and report. For example, create an applicable program <Sample A>, then authorized analyst could establish analytical method, sample table in this program, Moreover the analyst could use the method and sample table to initial origin data and report,5Responsibilities5.1System Administrator: To install the software per the user requirements, draft the validationprotocol and implement the validation, maintain the system to correct errors. Complete the protocol and generate a paper report for review and approval.5.2QC management (QC supervisor or manager): To ensure that the system is in compliancewith regulatory requirements and that the validation process is kept consistent with the protocol.5.3QA management (QA supervisor or manager: To ensure that documentation (includingprotocol and report) are consistent with applicable GMP regulations and to verify that the process comply with regulatory requirement.6Installation Qualification (IQ)Installation Qualification (IQ) must be performed to assure that the hardware and software components of the system are installed properly, and that the required documentation is available.6.3Verification of sensorsFor controlling the HPLC instrument from the PC, it is required to provide the USB interface board (IFB) and install the IFB driver software. Install the Analog Input Device (AID) and connect it with PC and HPLC per the following figure (see page 4):6.4Verification of instrumentsMake sure HPLC has been performed with IQ, OQ, PQ. Qualification meets the acceptance criteria, all instruments being used within the expiry dates.6.5Verification of software version6.6Verification of software installation procedureExecute D-2000 Elite HSM (HPLC System Manager) installation according to D-2000 Elite HSM Installation Manual, record the whole process to assure main sequence and detailed operation of installation maintaining consistency with vendor requirement.6.8Verify the configuration of backup systems6.9 IQ should be completed and approved for systems prior to commencing the OQ. Anydeviation should be recorded. A Summary Table should be created confirming that the IQ was performed according to plan and/or explaining any deviations discovered and their resolution or follow-up actions.Deviation description:Deviation resolution or follow-up action:IQ Conclusion:7 Operation Qualification (OQ)Operational Qualification (OQ) must be performed by User Representatives to assure testing of the system functions. OQ must focus on the GMP related function(s) of the system.7.17.3 Testing the defined user profiles“D-2000 Elite Group Security Protection ” Function has defined 3 groups for D-2000 Elite users with different levels. The function runs bind to <Microsoft Windows XP user and group management>Function, D-2000 user groups are created by Windows XP Administrator.7.4Testing the analytical method management functionsD-2000 Elite HSM could create a new analytical method in applicable program. In order to validate that the software could correctly execute the analyst’s setup. The checker will create a simulated analytical method in D-2000 Elite HSM, record the setup process and the related response. Document the execution procedure by pasting image in sequence to prove the validity for the analytical method setup process.7.5Testing the sample table management functionsD-2000 Elite HSM could create a new sample table in applicable program. In order to validate the software could correctly execute the analyst’s setup. The checker will create a simulated sample table in D-2000 Elite HSM, record the setup process and the related response. Document the execution procedure by pasting image in sequence to prove the validity for the sample table setup process.7.6 OQ should be completed and approved for systems prior to commencing the PQ. Anydeviation should be recorded. A Summary Table should be created confirming that the OQ was performed according to plan and/or explaining any deviations discovered and their resolution or follow-up actions.Deviation description:Deviation resolution or follow-up action:OQ Conclusion:8Performance Qualification (PQ)Performance Qualification (PQ) must be performed by instrument users to verify the performance of the system. This activity may be performed in actual environment. PQ must focus on the GMP related steps of the supported process.8.1Verification of authorized users and their corresponding rightsAfter installation of D-2000 Elite HSM in windows, three levels of applicable individuals with different rights were authorized to ensure laboratory data security.In OQ test (section7.2), The users “A”, “B”, “C”, “D”, “E”, “F”were simulated set up.Define “A”, “D”as administrator, “B”, “E”as developer, “C”, “F”as operator to test the rights with different grades. Record the results in the following chart.8.2Testing of sample and analytical method preparation8.3Testing of data acquisitionPlace sample (prepared in Section 8.2) in sample rack, prime the column to allow the chromatographic system to be stabilized, then start sample injection and data acquisition.Paste the observed data acquisition image to demonstrate that the system could execute D-2000 Elite HSM well. No error or deviation occurs.8.4 Testing that an operator can not delete raw data.After the raw data is created by D-2000 Elite HSM, perform the challenge to delete rawdata. Paste the image to document the process and result.8.5 Testing the full traceability of performed analytical methods (audit trail).Change the analytical method and save the updated method. Paste the images to document the process and result.8.6 Testing the full traceability of data creation and reprocessing (audit trail). Select a raw data and reprocess the data, Paste the images to document the result.8.7 Testing or documenting the traceability of equipment used (audit trail).Paste the images to document the traceability information.8.8 Testing data backup and retrievalBackup data into another medium and perform the data retrieval. Paste the images todocument the process and results.8.9 Testing of results printout and comparison of the printout with the screen image.8.10 Testing that all critical parameters and data that can influence the result are printed out.8.11 Testing that the system will not allow any user to alter data in print and thus to printerroneous results.8.12 Manual re-calculation of automated resultsManually measure the T and W h/2, then calculate the theoretical plates. The manualcalculated results are compared to that generated by D-2000 Elite HSM.The number of theoretical plates, N, is a measure of column efficiency, it is calculated byequation:Where T is the retention time of the substance and W h/2 is the width of the peak at its halfheight.Deviation description:Deviation resolution:PQ Conclusion:9Attachment。
