Agilent Solutions for achieving 21 CFR 11 Compliance on Atomic Spectroscopy Instrumentation

Transcription

1 Agilent Solutions for achieving 21 CFR 11 Compliance on Atomic Spectroscopy Instrumentation Jon Talbott, PhD Application Scientist Page 1

2 Spectroscopy Products currently supported with Compliance Solutions 1. ICP-MSs (7800, 7900, 8900 and older units) 2. ICP-OES (5110) 3. GFAAs and Flame AAs (240Z, 480, 240FS)

3 Spectroscopy Products currently supported with Compliance Solutions - continued 4. Cary Win UV-Vis Spectrometers (8453 and Cary 60) 5. Dissolution Instruments UV Dissolution UV Fiber Optic (Cary 60 w/ Multicell shown) 5. MicroLab

4 Agilent ICPMSs: 3 Features for «Pharma» Applications 1) Matrix tolerance 2) Interferences removal 3) Wide Dynamic range Ultra High Matrix Introduction System (UHMI) Octopole Reaction System (ORS 3 ) Helium Mode Wider Dynamic Range Able to analyze high total dissolved solids (up to 25%) Reduces sample prep time and error Better long-term stability He mode removes all polyatomic interferences Easy to use - He collision mode only Effective for a wide range of sample types 11 orders of dynamic range Simplifies method development Easy sample prep. Improves productivity

5 ICP-OES Agilent 5110: Benefits for USP <232> <233> 1) Matrix tolerance 2) Synchronous Axial and Radial Viewing 3) Interference removal Vertical Torch Able to analyze high total dissolved solids ( > 25%) Dichroic Spectral Combiner Background Correction and Interference Removal FBC Fitted Background Correction FACT Spectral Deconvolution

6 Compliance for Elemental Impurities, Why Needed? USP Heavy Metal Chapters Current and Planned Heavy Metals Limit Test <231> <232> will eventually replace other metals General Chapters Is being replaced with: <232> Elemental Impurities (Limits) <233> Elemental Impurities (Procedures) Lead Arsenic Mercury <251> <211> <261> Related method <2232> applies to dietary supplements only <2232> Elemental Impurities in Dietary Supplements Terminology changing: Heavy Metals Elemental Impurities Page 7 September 26, 2017

7 PDE Limits depend upon Route of Entry USP/ICH Oral PDE Limits ICH Class Element Symbol ICH (ug/day) Oral PDE Class 1 Arsenic As 15 Cadmium Cd 5 Mercury Hg 30 Lead Pb 5 Class 2A Cobalt Co 50 Nickle Ni 200 Vanadium V 100 Class 2B Silver Ag 150 Gold Au 100 Iridium Ir 100 Osmium Os 100 Palladium Pd 100 Platinum Pt 100 Rhodium Rh 100 Ruthenium Ru 100 Thalium Tl 8 Selenium Se 150 Class 3 Barium Ba 1400 Chromium Cr Copper Cu 3000 Lithium Li 550 Antimony Sb 1200 Tin Sn 6000 Molybdenum Mo 3000 PDE s apply to final products Drug Substances Excipients Does not apply to vaccines Does not apply to veterinary products Does not apply to dietary supplements Testing is based on risk-based assessment Compliance is required with all the limits throughout the life of the product Confidentiality Label September 26,

8 What is FDAs 21 CFR Part 11 Compliance Chpt about? Regulations for Pharma, Food, CROs, anyone sending Sx data to the FDA It is just 4 pages of the Code of the Federal Register!

9 What is FDA 21 CFR Part 11 Compliance Chpt about? Legalese to address Electronic Records (Sample DATA in electronic format) Their management, storage, authenticity, integrity, confidentiality and retrieval Validation of Systems (Instrument IQ/OQ/PQ) Limiting Access to systems to authorized individuals (User Access Control) Protection of Records (Data) Secure Time Stamped Audit Trails Records shall not obscure preciously recorded information (version control) Authorized Individuals Electronically signed Data SOPs, Training

10 FDA 21 CFR Part 11 Compliance Chpt: Summary of Four Key Categories of Criteria 1. Instrument Qualification Procedures and Documentation Instrument design qualification (DQ), lifecycle management, Installation and Operational Qualification (IQ/OQ) for analytical instruments + Software and Performance Qualification (PQ) 2. Access control of instrument and data processing limited to authorized individuals, esignature with audit trail of user log-on/log-off and actions User Access Control (UAC) on Agilent ICP-MSs Spectroscopy Configuration Manager (SCM) on ICP-OESs 3. Electronic records management, secure data storage, version control, archival and retrieval of data records SDA (Spectroscopy Database Administrator) Data Store OpenLab ECM (Enterprise Content Manager) 4. Physical access control (e.g. lab access), standard operating procedures Making the lab compliant is the responsibility of the user, using the tools and software the vendor provides

11 Graphical Representation of Key Categories of Agilent Solutions for 21 CFR Part 11 Compliance 1st Category 2nd Category 3rd Category Application software + 4 Qs Access Control Data Management + + Control the instrument for data acquisition and processing ICPExpert or MassHunter Manage groups, projects, users and user profiles, e-sigs and Audit Trail SCM or UAC Administration of databases and data, records integrity, security and retention SDA, OpenLab ECM

12 Agilent Solution for First Category of 21 CFR 11-4 Qs: Design Qualification, Installation and Operational Qualification (IQ/OQ) PQ is customer s responsibility Agilent s compliance products and services includes Installation Qualification and Operational Qualification for Hardware and Software, Documentation of IQ/OQ

13 IQ/OQ (Installed correctly/ Work as expected) Hardware & Software IQ checks if the system is installed correctly prior to initial utilization: Operating environment Physical connection Safety Functional parameters OQ defines functional tests and compares them against Agilent specifications. IQ/OQ performed jointly with customer representative

14 Example OQ Tests for ICP-MS

15 Example OQ Tests for ICP-OES

16 Agilent Solution for First Category of 21 CFR 11 - Design Qualification, Installation and Operational Qualification (IQ/OQ) Agilent s compliance products and services includes Installation Qualification and Operational Qualification for Hardware and Software, Documentation of IQ/OQ

17 21 CFR Part 11 2 nd Category of Criteria User Access Control & Electronic Signatures Application software Access Control Data Management + + Control the instrument for data acquisition and processing ICPExpert or MassHunter Manage groups, projects, users and user profiles, esigs and Audit Trail UAC or SCM Administration of databases and data, records integrity, security and retention SDA, DS or OpenLab

18 User Access Control SW on ICP-MSs for 21CFR11 Compliance - Access Control of Instrument/SW, esignature and Audit Trail MassHunter User Access Control (UAC) functionality provides: Password protection for user access to ICP-MS MassHunter Flexible, multi-level configurable access to MassHunter functions (defined by user levels, Admin, ECM Mgr, SDAAdmin, SDAApprover, Mgr and Operator) Audit trail - Record of user(s) logon/logoff to operating system (supported OS function) and MassHunter logon; audit trail also records user actions as defined in ATM (Audit Trail Map)

19 ICP-MS MassHunter User Access Control for Audit Trail and some of esignature ICP-MS MassHunter Audit Trail Page 22

20 User Access Control with OpenLab ECM on ICPMSs A Second level of UAC exists Systems with OpenLab ECM ECM is the most comprehensive solution for protecting, storing and accessing your data Not only is there MassHunter User Access Control (UAC) Users and their access roles/privileges are also set up in OpenLab ECM Users must log on to ECM AND UAC for access to ICP-MS MassHunter Different User roles/privileges/ Access rights are also set up in ECM Note Network Domain

21 21 CFR Part 11-2 nd Category for OESs, UV-Vis User Access Control & Electronic Signatures Application software Access Control Data Management + + Control the instrument for data acquisition and processing ICPExpert or MassHunter Manage groups, projects, users and user profiles, esigs and Audit Trail UAC or SCM Administration of databases and data, records integrity, security and retention SDA, DS or OpenLab

22 25 Spectroscopy Configuration Manager What is it? 1. User Access Control Manager for all other Spectroscopy instrumentation (OES, AA, UV, Dissolution) click 2. Allows set up Groups, Programs, Users, User Profiles (access rights) and even Stations 3. Network capable/scalable 4. Audit trail contained within

23 Potential SCM Configurations Network configurable and Scalable There are 5 Scenarios (configurations) for Compliance SCM software. Configuration depends upon customer wishes at installation. Application Application Application SCM Application SDA SCM Application SDA SCM SDA SCM SDA SDA SCM Scenario 1 Scenario 2 Scenario 3 Scenario 4 Scenario 5 In contrast, UAC SW for ICPMS is not configurable as a network (Client/Server) and is not scalable

24 Spectroscopy Configuration Manager (SCM) User Profile set up and are similar to Audit Trail Map access rights (Actions) in UAC Profile capabilities different depending upon the Instrument Select the applications which a User can access by adding x next to each application. Note: For Cary WinUV software the Color, Fabric Protection and Sunglasses Applications are not 21 CFR 11 compliant.

25 21 CFR Part 11 3 rd Category of Criteria Electronic Records Mgmt, Storage & Security Application software Access Control Data Management + + Control the instrument for data acquisition and processing ICPExpert or MassHunter Manage groups, projects, users and user profiles, esigs and Audit Trail UAC or SCM Administration of databases and data, records integrity, security, retention and retrieval SDA, DS or OpenLab

26 Agilent Compliance Products for ICPOES & ICP-MS Recommended for: Large/global Pharma Mid Regulated (CRO) Small Regulated OpenLab ECM OpenLab Data Store SDA All MS DB options need UAC OpenLAB ECM 3.5 Supports 7800, 7900 ICP-MS, and 8900 ICP-QQQ Accepts data files from 5110 with Scheduler but still not compliant (versioning missing) OpenLAB Data Store A Supports 7800, 7900 ICP-MS, and 8900 ICP-QQQ Spectroscopy Database Administrator A Supports 7800, 7900 ICP-MS, and 8900 ICP-QQQ Supports 5110 ICP-OES (different SDA) Page 29 ICP-MS MassHunter Compliance Solutions

27 Agilent Solution for 3rd Category of 21CFR11 Compliance Electronic Records Management, esig, Version, Archive Database provides secure storage of Data SDA and ECM Provide Database Management functions: Creation/ Attaching / Detaching / Archiving / Retrieval of a database An attached database is online and a detached database is offline and cannot be accessed by users Version Control on file save/upload Includes Database Viewer Audit Trail for databases Batch approval in SDA Database backup/upload Admin functions Control of database access rights SDA log Page 30 SDA Database Management pane

28 SDA Database Viewer for more esignature ICP-MS MassHunter with SDA includes a Database viewer for data management. Batch data is secured using ssizip checksum protected file ICP-MS SDA Database Viewer for batch approval, upload, etc.. Version numbers can be seen Batch Properties, Audit and Approval logs are available Page 32 April 11, 2013

29 SDA Database Viewer showing Versioning, Secure Data Storage ICP-MS SDA Database Viewer for batch approval, upload, etc.. 13 Versions of the DA Method Post processed shown here Sitting on this batch Page 33

30 OpenLAB ECM Provides Secure Content Management for all files from all Instruments ECM maintains all electronic data regardless of source: Search function is really cool Analytical data from mulitple techniques and suppliers Chromatographic result data Master methods, and sequence and report templates Pictures and graphic images PDF documents und formulars Microsoft Office files Electronic reports

31 OpenLAB Data Store Compliance Functions Server-based solution for ICP MS Compliance Efficient Data Storage and Retrieval Centralized Storage for ICP MS MassHunter (rev B.01.03) Efficient search and retrieval of files Local Language Support (English, Chinese & Japanese) Security Comprehensive data security Access for registered users with roles Integration to OpenLAB Shared Services/Control Panel Data Integrity and Traceability Maintain file revision and history Comprehensive Audit Trails Trail of who has what item Trail of when an item was received 21 CFR Part 11 Compliant Built to support FDA regulations Data Integrity and Traceability Electronic Signatures Archival Capabilities Server OpenLAB Data Store OpenLAB Shared Services 2 MS instrument connections

32 Agilent Compliance Products for ICP-MS Functional Comparison ECM SDA OpenLAB ECM Data Store for MS SDA for ICP - MS General Specs International Language support (From A.01.02) Multi Vendor Support Integrated Search & Retrieve # of Instruments supported No limit Up to 15 1 Server Required (Enhanced Security) Automated Uploads Integrated (free) Database Compliance e-signature PDF Signature Audit Trails File Revisions Integration OpenLAB CDS (From A.02.01) MassHunter (Before A.02.01, only ICP MS) (ICP MS) OpenLAB ELN Third-party LIMS and ELN

33 Summary of 21 CFR Part 11 Compliance Solutions 1. Software and hardware design validation Agilent excels in IQ/OQ for both hardware and software Agilent consistently ranked #1 for compliance services 2. User Access Control ICP-MS add-on User Access Control for ICP-MS MassHunter OR SCM for all other Atomic line and Spectroscopy products provides fully flexible solution, with configurable access levels 3. Electronic records Mgmt 3 DB options: SDA, Data Store or OpenLab ECM (Enterprise Content Manager) 4. ICP-MS MassHunter User Access Control add-on functionality and SDA/Data Store/OpenLAB ECM software provides full compliance with 21 CFR Part 11 Electronic records and version management done by SDA/OpenLAB ECM Data security is ensured through use of secure (encrypted, non-editable) files Databatch information (raw data and reports) is secured and versioned All back-up and archival functions are performed in SDA/OpenLAB ECM Page 40

34 Agilent 42 Restricted