Slide 1 - EUROTHERM DANMARK by pengtt

VIEWS: 10 PAGES: 34

									Introduction to GAMP4
                                                            2




                    IF IT‟S NOT DOCUMENTED IT‟S A RUMOUR!




Eurotherm Life Sciences Group
                                                                             3



                       GAMP Guide History

  1994 – UK Pharmaceutical Industry Computer System Validation
     Forum set up (now known as the GAMP forum)
  1994 – First draft issued
  1995 – Version 1
  1996 – Version 2
  1998 – Version 3
  2001 – Version 4
  With GAMP4, the target audience has been expanded from just
  pharmaceuticals to the whole healthcare industry including biotechnology
  and medical devices. The scope has been expanded to cover automated
  systems within Good Clinical Practice (GCP), Good Laboratory Practice
  (GLP) and Good Distribution Practice (GDP) in addition to the original
  Good Manufacturing Practice (GMP) environment.

Eurotherm Life Sciences Group
                                                                                   4



                       Lots of Nasty Acronyms

   GCP                  Good Clinical Practice
   GDP                  Good Distribution Practice
   GLP                  Good Laboratory Practice
   GMP                  Good Manufacturing Practice
   GxP                  All of the above!! Sometimes cGxP with „c‟ for „current‟

   URS                  User Requirements Specification
   VMP                  Validation Master Plan

   IQ                   Installation Qualification
   OQ                   Operational Qualification
   PQ                   Performance Qualification

   SOP                  Standard Operating Procedure




Eurotherm Life Sciences Group
                                                                                        5



                       Jargon for „project‟ activities
   GAMP4 – “Good Automated Manufacturing Practice” as defined in the GAMP4
   Guide for Validation of Automated Systems. A set of guidelines for both users and
   suppliers – MORE LATER!
   Validation – “Establishing documented evidence which provides a high degree of
   assurance that a specific process will consistently produce a product meeting its
   pre-determined specifications and quality attributes”
   Installation Qualification [IQ] – “Documented verification that a system is
   installed according to written and pre-approved specifications”.
   Operational Qualification [OQ] - “Documented verification that a system
   operates according to written and pre-approved specifications 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.


Eurotherm Life Sciences Group
                                                                                       6



                       Jargon continued…

   Calibration – “The set of operations which establish, under specified conditions,
   the relationships between values indicated by a measuring instrument, or values
   represented by a material measure or a reference material, and the corresponding
   values of a quantity realised by a reference standard.”

   Change Control – “A formal process by which qualified representatives of
   appropriate disciplines review proposed or actual changes to a computer system.
   The main objective is to document the changes and ensure that the system is
   maintained in a state of control.”
   Life Cycle Concept
   Life Cycle Concept – “An approach to computer system development that begins
   with identification of the user's requirements, continues through design, integration,
   qualification, user validation, control and maintenance, and ends only when
   commercial use of the system is discontinued.”
   21 CFR part 11
   21 CFR part 11 – FDA regulation covering the use of electronic records and
   electronic signatures – MORE LATER!


Eurotherm Life Sciences Group
                                                                           7



                       Validation

      What is validation?
      “Establishing documented evidence which provides a high degree
      of assurance that a specific process will consistently produce a
      product meeting its pre-determined specifications and quality
      attributes”
      What needs to be validated?
      Pharmaceutical Process which produce drugs for the human and
      animal Consumption.

      What is validated?
      • Process
      • Ensures that the process does what it supposed to do backed with
        documentary proof.

      Who is responsible for validation?
      The manufacturer is responsible for obtaining the validation.


Eurotherm Life Sciences Group
                                                                                8



                      Validation..


        What could be our responsibility?
        • Provide a system with documentary evidence that satisfies the Users
          requirement specification.
        • The system documentary evidence will be integrated into the overall
          process documentation which will be submitted for the process
          validation.




Eurotherm Life Sciences Group
                                                                            9



                      Principle of validation


        • Document what is to be done
        • Document how it is to be done
        • Do it
        • Produce documented evidence that it was done in accordance with
          the “how”
        • Demonstrate that it remains in a state of control




Eurotherm Life Sciences Group
                                                                     10


                        Where Does Process Validation begin?



       • Validate the API process beginning at the point where the
         structure of the active ingredient become evident.
       • Secondary Process
       • Packaging
       • Includes
             • Storage
             • Utilities
             • HVAC




Eurotherm Life Sciences Group
                                                                                 11



                       GAMP4 Structure
 Principles and Framework                            Appendices
 - objectives of the Guide                           Management activities
 - overview of validation                            - validation planning/reporting
                                      GAMP
 - validation lifecycle              principles
                                                     - risk assessment
 - IT systems                      and framework     - project change control, etc
 - process control systems                           Development activities
 - benefits of validation          APPENDICES        - specification
 - good practice definitions        Management       - code production
                                   Development
 - glossary                          Operation
                                                     - testing
 - source material.                                  Operating activities
                                                     -service level agreements
                                 GOOD PRACTICE       - performance monitoring
                                    GUIDES           - archive, etc



                                TRAINING MATERIALS




Eurotherm Life Sciences Group
                                12




Eurotherm Life Sciences Group
                                                                                       13


                                                         Ongoing
                       GAMP Lifecycle                    Operation
                                                                      Customer
       User                                            Process        responsibility
    Requirements                                     Qualification

        Functional                              Operational
       Specification                            Qualification
                                                                     Joint
                                                                     responsibility
    Software Hardware                         Installation
     Design   Design                         Qualification

                                            Integrated
                                              Testing
                                                                     Eurotherm
                                Hardware   Module                    responsibility
                                  Build    Testing

                           Configuration
                             / coding

Eurotherm Life Sciences Group
                                                                                   14



                       GAMP and Traceability
                                  Update requirements documentation

              Functional        Document                   Operational
             Specification        Control                  Qualification


          Software    Hardware Document                  Installation
                                                                           FAULT
           Design      Design                           Qualification
                                 Control
                                                      Integrated        Re-Test
                                                        Testing

                                 Hardware            Module
                                   Build             Testing

                                Configuration         Update configuration
             Configuration        / coding
                   Control

Eurotherm Life Sciences Group
                                                                                                  15



                     GAMP4 Lifecycle – Planning and Definition
     Supplier Assessment (appendix M2)
     Validation planning
   PLANNING AND DEFINITION (appendix M1)                                             D T C    D
       User Requirements Specification (Appendix D1)
                                      Validation                                     e  r h   o
      Hierarchy of Validation Master Plans and individual system audit. s a a
          Risk both preliminary assessment
     Covering Assessment (Appendix M3) and detailed
                                         Plan                       supplier                  c
              to specify:
        Has Design Review and Traceability Matrix (Appendix M5)                      i  c n   u
           Covering risk assessment as planning validation process.
      Makes recommendations for auditpart of theand execution and alsog e g
      Validation Plans including:                                                             m
        •Operational requirements for both postal andRisk Assessmentetc) Typically, ea
              Covering Vendorchecklists (process control, calculations, how much
      contains exampledesign review planning (preliminary
                                              User              deliverables.        n a      e
      •GxP criticalityassessment during URS generation to identify
           Initial risk Preliminary
                         assessment        Requirement            + Critical            b     n
        •Data requirements (capacity,and which areas are critical to GxP R i C
              review is required at supplier audits.
      assessment) audits and fullthe end of each specification stage.
                        Assessment          access, archive, etc)
           validation effort is required Specification           Parameters                   t
      •validation strategy to cover the revised lifecycle model                      e  l o
        •Interfacesquality, safety, review process to be meaningful, av formal
              In order for the environmental plant)
           product     (operator, other equipment, protection, or business              i n   M
      •formal list of validation deliverables
                                           Specification through to design documentation
              traceability of user requirements
           continuity.                                                               i  t t   a
        •Environment (layout, physical)Approval                                      e y  r   n
      •formal acceptance criteria for is required. thephase andtraceability matrix
              and tests carried out each lifecycle example An
           Review of (timescales, compatibility with other equipment, etc) w development o    a
        •Constraints the risk assessment during
              format is provided.
                                                              design
                                                                                       M l    g
      •formal detail ensure that choiceandsupplier / implementation method a
           stage (to of change control of document management                                 e
        •Life Cycle (development Supplier Detailed
      procedures to be followed / test requirements, deliverables, etc)                 t     m
           has not introduced additional risks)
                                           Assessment
                                                                                        r     e
              Change Control be created at
           Review of the risk (Appendix M8) completion of the design review i
      •formal list of SOP‟s toassessmentor updated                                            n
                                                                                        x     t
            prior to validation testing (to ensure thatauthorisation, completion
               Change request, disposition and any validated state
      •Actions and procedures required to maintain theproblems identified or and
            work-arounds                   have not
      after approval implementedDESIGN AND introduced additional risks).
      KEY: handover from project to ongoing operation
            Once the
      User Responsibilitysystem is in ongoing operation, risk assessment should
                                         DEVELOPMENT
      Joint Responsibility
            form part of the ongoing change control strategy.
               Document
      Supplier Responsibility Management (Appendix M10)
            The appendix also describes an example risk assessment process
               Production, approval, issue, change, withdrawal, records and
            used to identify risks, categorise according to severity and likelihood
               storage
            and determine appropriate mitigation strategies.
Eurotherm Life Sciences Group
                                                                                                        16



                       GAMP4 Lifecycle – Design and Development
                                         Supplier                                            D T C      D
                                         Quality                                             e  r h     o
    DESIGN AND DEVELOPMENT
      Functional Specification (Appendix D2)M6)
    Quality and Project Planning       (Appendix
                                          Plan                                               s  a a     c
        Hardware Design Specification (Appendix D3)                                          i  c n     u
      Specification include: to (AppendixAcceptance Test from URS and needs gto e g
           needs to replies Functional
    PlanSoftware Design / Module Design Specifications (Appendix D4)
                                     technical requirements                                             m
            Test Specifications Design
        Needs to include:                       D6)
                                                Specification                                n a e      e
    •User quality requirements (eg procedure references)
              Software Production (Appendix D5)
      include: to include: Specification
          Need                                                                                  b       n
                       include:
            Need to System (main computer, storage, peripherals,
        •Computermodule needs to address:                                                    R  i C     t
      •Functional requirements (process control, calculations, etc) undertaken, l o
    •Supplier quality system (certification details, activities to be
              Each                           IQ                                              e
        interconnections)
       Hardware                                                                                 i   n   M
          proceduresHardware
      •Data               controlling these,
          Software Design Specificationresponsibilities for
    and Test requirements (capacity, Protocol archive, etc) eachIntegration Test
                          Design           access,
                                                              Software
                                                               Design
                                                                                 Software
                                                                                activity)    v
        •Inputs andof Tests (instruments used, accuracy, isolation, range, timing) t
            •Scope (eg Gantt chart)
                        Outputs                                                              i  t       a
    •Project•Identification (name, equipment, plant) specification, history)
     Specification
                Plan   Specification
      •Interfaces (operator, other version, controlling
          •System Description (split into modules / interaction of modules)
                                            OQ
                                                            Specifications        Spec       e y    r   n
                                                                                                    o   a
        •Environment and Test Plan Protocol
            •Overview (temperature, (procedure for test execution, ordering of w M l
                                          humidity, EMC, etc)                                tests,
    •Project•Traceability (commenting of etc) maintainability) Software Module
                 organisation (contacts, project team Software andcross reference to
      •Non-Functional Attributes (availability,
          •System Data (files, databases,                       deletions, titles, interface a
                                                 additions /names                                       g
            personnel required,
    to QA) change source) etc)
        •Electrical Supplies (filtering, loading, earthing, UPS, etc) Test                              e
                                                               Module
                                                                                                t       m
          •Module Descriptions (hardware, software, test equipment, test
            •Test Requirements              PQ              Specifications    Specifications
                                                                                                r       e
    •Deliverable items (format, media)
              •Programming Standards      Protocol                                              i       n
            software/data, documentation)
                 Produce                                                Produce                 x       t
    •Activities (milestones, start/end dates for activities, allocation of
          •Test  Hardware                                              Software
    personnel) Scripts (unique reference, traceability to specification, pre-
        Software Module Design Specification
            Source code instructions, data ensure that programming standards are
          requisites, test review attempts toto sub-programs)
        •Module Overview (function, split intobe recorded, acceptance criteria, post
            applied and
          test actions) that modules are in accordance with specifications.
        •Module Data (files, databases, etc)
      KEY:
      User Responsibility       DEVELOPMENT
         •Sub-Program Descriptions (language,
      Joint Responsibility       TESTING AND             standards, functions, parameters,
      Supplier Responsibility   SYSTEM BUILD
         etc)
         •Sub-Program Data (locally declared items)
Eurotherm Life Sciences Group
                                                                                        17



                        GAMP4 Lifecycle – Testing, Build, Acceptance
                                                                           C    DT C    D
                                                                           o    er h    o
 DEVELOPMENT TESTING
                        Hardware                     Software Module       n    sa a    c
 AND SYSTEM BUILD
                       Acceptance                        Testing           f    ic n    u
                         Testing                                           i    ge g    m
         Testing (Appendix D6)                                             g    na e    e
                                                                           u     b      n
         Test procedure (documented in specification) needs to address: r
                                        Integration                           R  i C    t
                                                                           a  e  l  o
                                                                           t  v  i  n   M
                                                                           i  i  t  t   a
         •Pre-requisites (availability of documentation, test equipment, test
                                                                           o data r
                                                                              e y       n
                                          Software
         etc)                            Integration                       n w      o   a
                                           Testing                               M l    g
          •Testing Philosophy (witnessing requirements, documentation and  M     a      e
                                                                           a     t      m
          retention of results, indelible recording of results, etc)       n     r      e
    DESIGN REVIEW                                                          a     i      n
          •Test Script Execution (what happens if acceptance criteria are met / not
    AND ACCEPTANCE                         Factory                         g     x      t
                                         Acceptance
          met?)                            Testing
                                                                           e
                                                                           m
          •Test Results File (completed tests, documentation of test incidents /
                                                                           e
                                                                           n
          faults, etc)                                                     t
      KEY:
      User Responsibility          COMMISSIONING
      Joint Responsibility             AND
      Supplier Responsibility      QUALIFICATION



Eurotherm Life Sciences Group
                                                                                            18



                         GAMP4 Lifecycle – Commissioning, Qualification
                                                                                C   T   C   D
    COMMISSIONING AND                                                           o   r   h   o
    QUALIFICATION                        Installation                           n   a   a   c
                                        Qualification                           f   c   n   u
     Installation Qualification [IQ] – “Documented verification that a systemi      e   g   m
                                                                                g   a   e   e
     is installed according to written and pre-approved specifications”.        u   b       n
                                         Operational                            r   i   C   t
                                        Qualification                           a   l   o
     Operational Qualification [OQ] - “Documented verification that a           t   i   n   M
     system operates according to written and pre-approved specifications i
         Validation Reporting (appendix M7)                                         t   t   a
                                                                                o   y   r   n
     throughout all specified operating ranges”.
                                        Performance                             n       o   a
         New material detailing best practice for validation reporting for both
                                        Qualification                               M   l   g
         individual lifecycle phases and the final validation report.           M   a       e
     Performance Qualification [PQ] – “Documented verification that a           a   t       m
     system is capable of performing or controlling the activities of the       n   r       e
                                      Validation Report                         a   i       n
     processes it is required to perform or control, according to written and g     x       t
     pre-approved specifications, while operating in its specified operating e
                                                                                m
     environment.                                                               e
                                                                                n
       KEY:                                                                     t
      User Responsibility              ONGOING
      Joint Responsibility            OPERATION
      Supplier Responsibility



Eurotherm Life Sciences Group
                                                                                       19



                       GAMP4 Lifecycle –Ongoing Operation
 Appendix O5 – PerformanceReview
    Appendix O1 – Periodic Monitoring
    ONGOING OPERATION
 Guideline for parameters to be monitored (eg disk utilization, response times) and
    Guideline for establishing whether validated state is being maintained (checking
                       to mechanisms.
 appropriate notificationO8 plus Service Level changes in environment, legislation,
    operation of O2Change        assessing Periodic Review Performance
                     Control      Agreement                    Monitoring
               procedures, personnel)
    operating – Record Retention, Archiving and Retrieval
 Appendix O6
     Appendix O2 – Service Level AgreementsRecovery
                   System Security Record Retention Backup and   Business
 Guideline to address retention (security, indexing, availability during full retention
                                                                 Continuity
                                                                  Planning
 period, etc) of all GxP records. Particular requirements for electronic record archival
     Procedure for defining support requirements and agreeing support provisions
      retrieval.
 and between user and supplier (including control of fault reporting, workarounds /
     patches / – Backup spares / consumables,
 Appendix O7 upgrades, and Recovery Retirement routine calibration, support for
    RETIREMENT
     software tools / hardware / infrastructure etc)
 Guideline for data and software backups to guard against physical loss or accidental
     Appendix O3 – Automated System Security
 deletion.
     Guideline for ensuring control, integrity, availability and confidentiality of data.
 Appendix O8 – Business Continuity Planning
     Appendix O4 – Operational of business continuity planning including risk
 Guideline covering broad issuesChange Control
 assessment; disaster recovery procedures; contingency planning; emergency
     Guideline for review, risk assessment, authorization, documentation and re-test
      KEY:
      User Responsibility
 response planning; training; and rehearsal of the continuity plan. emergency repairs
     of changes. Allows exclusion of like-for-like replacement and
      Joint Responsibility
     (though emergency repairs must undergo the same
 Appendix O9 – EU Guideline on Computerized Systemsreview and control „after the
      Supplier Responsibility

     event‟).
 APV Specialist section interpretation of the Annex 11 „Computerized Systems‟
Eurotherm Life Sciences Group
                                                                           20



                       GAMP Hardware and Software Categories



     - Risk of failure increases with the progression from standard to
     bespoke.

     - Many systems are built up multiple components of various
     categories.

     - Validation strategy needs to reflect this in order to ensure that
     effort is correctly focused.




Eurotherm Life Sciences Group
                                                                             21



                      GAMP Software Categories (1)

      CATEGORY 1 – Operating Systems

      VALIDATION APPROACH - Record version (include service
      pack). The Operating System will be challenged indirectly by the
      functional testing of the application.


                                PROCESS CONTROL SYSTEM EXAMPLES

                                Instrument operating system is usually not
                                separable from firmware – see category 2

                                Most SCADA or DCS workstation software
                                runs on one of the Microsoft Windows ®
                                operating systems


Eurotherm Life Sciences Group
                                                                                       22



                       GAMP Software Categories (2)
            CATEGORY 2 – Firmware

            VALIDATION APPROACH
            - For non-configurable firmware record version. Calibrate instruments as
            necessary. Verify operation against user requirements.
            - For configurable firmware record version and configuration. Calibrate
            instruments as necessary and verify operation against user requirements.
            - Manage custom (bespoke) firmware as Category 5 software


                                    PROCESS CONTROL SYSTEM EXAMPLES

                                    Instrument firmware including set-up
                                    parameters.

                                    3-Term Controllers, Recorders, etc


Eurotherm Life Sciences Group
                                                                                 23



                       GAMP Software Categories (3)

      CATEGORY 3 – Standard Software Packages

      VALIDATION APPROACH
      - Record version (and configuration of environment) and verify operation
      against user requirements.
      - Consider auditing the supplier for critical and complex applications.

                                   PROCESS CONTROL SYSTEM EXAMPLES
                                   Provided that „off the shelf‟ solutions are
                                   purchased rather than creating bespoke
                                   toolkits:
                                   Historical data viewers
                                   Statistical analysis packages
                                   Configuration management tools
                                   Application development tools
                                   Diagnostic tools

Eurotherm Life Sciences Group
                                                                             24



                      GAMP Software Categories (4)

      CATEGORY 4 – Configurable Software Packages

      VALIDATION APPROACH
      - Record version and configuration, and verify operation against
      user requirements.
      - Normally audit the supplier for critical and complex applications.
      - Manage any custom (bespoke) programming as Category 5.

                                PROCESS CONTROL SYSTEM EXAMPLES

                                Control schemes configured from library
                                blocks
                                Simple mimics
                                Recipes



Eurotherm Life Sciences Group
                                                                     25



                       GAMP Software Categories (5)



      CATEGORY 5 – Custom (Bespoke) Software

      VALIDATION APPROACH
      - Audit supplier and validate complete system .



                                PROCESS CONTROL SYSTEM EXAMPLES

                                Sequence Function Charts
                                Custom reporting using SQL queries
                                Complex mimics running scripts



Eurotherm Life Sciences Group
                                                                      26



                      GAMP Software Categories Spreadsheets / Tools


      Special Considerations for Spreadsheets

      Can fall into category 3, 4 or 5 depending on use.
      Examples:
      Category 3 – used purely to generate a paper document
      Category 4 – more complex application involving templates
      Category 5 – spreadsheet application using custom macros

      Application Development and Diagnostic Tools

      Can be bespoke or off-the-shelf
      Validation requirements depend on software category and on
      whether the tool directly supports the business process (eg
      application builder) or only supports the development or
      management of applications (eg configuration management tool)

Eurotherm Life Sciences Group
                                                                              27



                       GAMP Hardware Categories


      CATEGORY 1 – Standard Components

      VALIDATION APPROACH
      - Record model, version, serial number. Verify correct installation /
      connection. Apply change control.


      CATEGORY 2 – Custom Built Components

      VALIDATION APPROACH
      - As for standard components but also require a design
      specification and acceptance test. Supplier may be audited.




Eurotherm Life Sciences Group
                                                         28



                        The Eurotherm GAMP Offering


                    AIM – to understand how Eurotherm
                     interprets the GAMP lifecycle and
                       software / hardware categories




Eurotherm Life Sciences Group
                                                                   29



                       Example Architecture 1 – Control System

                                       Ethernet


         Eurotherm
         Suite
         Server /
         Viewer




                                                            ALIN




         Visual
         supervisor



                                                     Profibus




         2500 I/O




Eurotherm Life Sciences Group
                                                                                                30



                        Example Categorisation 1 – Control System
                                HARDWARE          SOFTWARE


                                PC         PC                   GAMP4 SOFTWARE CATEGORIESY
                                            Windows NT
                                                                1 – Operating System
                                             Eurotherm Suite
                 Eurotherm
                 Suite                       Database,          2 - Firmware
                 Viewer                      Security,
                                             Alarming,
                                                                3 – Standard Software Package
                                             Mimics,
                                             Trending.
                                                                4 - Configurable Software Package

                                                                5 - Custom Software

                                T800       T800
                 Visual                    Continuous Control
                 supervisor                                     GAMP4 HARDWARE CATEGORIES
                                           and mimics
                                                  Sequencing    1 – Standard Components

                                                                2 - Custom Built Components

                   2500 I/O     2500       2500




Eurotherm Life Sciences Group
                                                                          31



                          Example Architecture 2 – Graphic Recorders




                                                               Ethernet




             PC viewer                               Data PC
              running                                running
            Bridge 5000                              Review




                                  5180V    5180V




Eurotherm Life Sciences Group
                                                                                             32



                       Example Categorisation 2 – Graphic
                       Recorders

            Remote PC                                         PC
             Windows NT                                        Windows NT
                                                               (inc ftp server)

               Bridge 5000                                      Review

                                                                 Review
                                   5180V          5180V
                                                                 configuration
                                   Config         Config



                    Recorder configurations shown as category 4

                    Also available treated as category 2 for simple
                    configurations only (no user screens, no maths channels)
 Software
 Categorisation
 1 – operating system 2 - parameterised firmware 3 – „off the shelf‟   4 - configured   5 - coded


Eurotherm Life Sciences Group
                                                                                                       33


                             Project Deliverables Compared

                                               PLANNING
       Category 2 Graphic Recorder               AND         Category 4 / 5 Visual Supervisor
                                               DEFINITION
                                                                         Quality Plan

           Standard Functional Spec                               Functional Specification
               Standard IQ Spec              SPECIFICATIO     Hardware       IQ           Module
                                              N, DESIGN,      DS + TS       Spec          FS +TS
                                             CONSTRUCTIO
                                                                             OQ
                                                   N
         Produce               Produce                       Produce        Spec            Produce
         Hardware            Configuration                   Hardware                       Software

                                                              Hardware Test        SW Module Test
                                             DEVELOPMENT
                                              TESTING AND
                                             SYSTEM BUILD
                Internal Test                                           Integrated Test

                                             DESIGN REVIEW          Factory Acceptance
                                             & ACCEPTANCE

           Installation Qualification        COMMISSIONING        Installation Qualification
                                                 AND
                                             QUALIFICATION
              COMPLETION OF QUALIFICATION AND ONGOING OPERATION (TO CUSTOMER
              PROCEDURES)

Eurotherm Life Sciences Group
End Slide

								
To top