Standard Operating Procedure SOP

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					Title     Standard Operating Procedure SOP
Version   Status                                    Date          Page
1.0       Commercial in Confidence                  16-Aug-2006   1 of 8




           Standard Operating Procedure SOP




                                     Document No:      SOP_0101
                                     Prepared by:      David Brown
                                     Date:             16-Aug-2001
                                     Version:          1.0
Title         Standard Operating Procedure SOP
Version       Status                                  Date          Page
1.0           Commercial in Confidence                16-Aug-2006   2 of 8



                                 Document Approval

Name                    Role             Date           Signature
David Brown             Author




                                 Document Control


Version       Author             Date           Description
1.0           David Brown        16-Aug-2006    First draft.
Title                Standard Operating Procedure SOP
Version              Status                                                                  Date                          Page
1.0                  Commercial in Confidence                                                16-Aug-2006                   3 of 8



                                                                 Table of Contents



1      Introduction .................................................................................................................................... 4
    1.1 Purpose ...................................................................................................................................... 4
    1.2 Scope .......................................................................................................................................... 4
    1.3 Definitions.................................................................................................................................. 4
    1.4 Responsibility ............................................................................................................................ 4
2      Procedure ........................................................................................................................................ 6
    2.1 SOP Manuals............................................................................................................................. 6
    2.2 SOP Logs ................................................................................................................................... 6
    2.3 SOP Master Document Retention ........................................................................................... 6
    2.4 SOP Development ..................................................................................................................... 6
      2.4.1 Identification of SOP Requirement ..................................................................................... 6
      2.4.2 Establish SOP team ............................................................................................................. 7
      2.4.3 Develop SOP....................................................................................................................... 7
    2.5 SOP Implementation ................................................................................................................ 8
    2.6 SOP Maintenance ..................................................................................................................... 8
Title     Standard Operating Procedure SOP
Version   Status                                Date            Page
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1          Introduction

1.1        Purpose
           The purpose of this Standard Operating Procedure (SOP) is to
           document the procedure and standards for developing,
           documenting and issuing SOPs.

1.2        Scope
           Department/Section: Client, IT, Validation Group
           This SOP will apply to all SOPs produced to govern computer
           system related processes.

1.3        Definitions
           SOP – Standard Operating Procedure, a description of the
           processes and standards that must be employed to undertake a
           specific set of activities.
           Validation – defined at its simplest, is demonstrating that a
           computer system operates as it purports to, and that it will
           continue to do so.
           Project Team - The group of associates that come together for a
           specific purpose. The group maybe composed of business clients,
           Support, Validation, and other areas necessary to the successful
           completion of a project.
           Client – the business system owner is typically the ‘line’ manager
           responsible for the business process where the computer system
           will be used.
           Validation Group – the group responsible for ensuring that
           computer systems are implemented and maintained in a validated
           state.
           IT Group – the group responsible for development, operation, and
           maintenance of computer systems.

1.4        Responsibility
           Overall responsibility for the development and maintenance of an
           appropriate set of SOPs rests with the Quality Manager.
           It is the responsibility of each employee or associate to be aware of
           the SOPs that are relevant to their work, and to undertake their
           work in accordance with the appropriate SOPs.
Title     Standard Operating Procedure SOP
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           In addition, managers are responsible for monitoring their staff’s
           compliance with relevant SOPs, and for overseeing any remedial
           action where activities are failing to meet the quality standards
           required.
Title     Standard Operating Procedure SOP
Version   Status                                Date            Page
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2          Procedure
           This section describes the procedures that are to be used in the
           development, implementation and maintenance of SOPs.

2.1        SOP Manuals
           The Quality Manager will ensure that each member of staff is issued
           with an SOP Manual. This manual will contain a complete set of all
           current, approved SOPs. The Quality Manager is responsible for
           ensuring that a process is in place for keeping these manuals up-
           to-date.
           Each SOP manual will be uniquely numbered and a log kept of SOP
           Manual issues (see section 2.2 below).

2.2        SOP Logs
           The Quality Manager will be responsible for maintaining a number
           of logs in respect to SOPs:
              Master SOP Log – a record of all SOPs issued or under
               development; including a history of approved versions for each
               SOP.
              SOP Manual Log – a record of the individuals holding SOP
               Manuals; including unique manual number, name and location
               of manual holder, and original issue date.
              SOP Update Log – a record of all updates to the SOP Manual;
               including returns from individuals to confirm that they have
               updated their Manuals correctly and understood the procedures
               issued.

2.3        SOP Master Document Retention
           The Quality Manager will be responsible for maintaining a master
           set of SOPs. This comprises the original signed hard-copy SOPs.
           All approved SOPs will be held on file, even in the event that they
           are superseded or retired.

2.4        SOP Development

2.4.1      Identification of SOP Requirement
           Any member of staff may identify the need for a new SOP, or for an
           existing SOP to be amended. Requests for a new or amended SOP
           should be directed to the Quality Manager. Such requests should
Title     Standard Operating Procedure SOP
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           contain a brief description of the SOP requirement and justification
           for the need.
           In consultation with others as appropriate, the Quality Manager will
           determine whether or not a new SOP or SOP change is required. In
           the event that a new SOP is required, the Quality Manager will
           assign the SOP a unique number and update the Master SOP Log
           accordingly.

2.4.2      Establish SOP team
           The Quality Manager will nominate a suitably qualified team to
           undertake the SOP development work.
           As a first step, and with the Quality Manager, the team will:
              confirm the scope of the SOP development work;
              confirm that the nominated team is appropriate for the task at
               hand; and
              agree who needs to review and sign-off the SOP.

2.4.3      Develop SOP
           The team will design the procedures for the SOP. Where a change
           is being made to an existing SOP, this work can be restricted to the
           scope of the requested change.
           During the development of procedures, the team will consider:
              procedures already mandated by other related SOPs;
              changes that might be required to other SOPs as a result of
               development of the new/amended SOP;
              requirements and constraints imposed by pharmaceutical
               regulation on validation and the development of computer
               systems;
              training requirements resulting from the new procedures; and
              any constraints on when the new SOP can be implemented.
           Any identified relationships or impacts on existing SOPs should be
           notified to the Quality Manager.
           The new procedures should be documented in a draft SOP, and
           circulated for review. Review comments should be addressed to
           the satisfaction of the reviewers.
           Once an SOP has been finalised, it should be circulated to the
           previously agreed approvers for sign-off. The approvers should be
Title     Standard Operating Procedure SOP
Version   Status                                  Date            Page
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           asked to provide a paper signature on a hardcopy of the SOP.
           Once all of the required signatures have been obtained, the
           hardcopy document should be sent to the Quality Manager for
           filing.
           The SOP team should notify the Quality Manager of any training
           requirements that have been identified or if there are any
           constraints on the date from which the SOP can be made effective.

2.5        SOP Implementation
           Once an approved SOP has been received by the Quality Manager,
           the following steps should be taken by him/her to ensure the
           implementation of the SOP:
              update the Master SOP Log;
              prepare and issue updates to SOP manuals;
              facilitate the provision of any training required as a result of the
               new SOP; and
              if required, initiate reviews of any existing SOPs impacted by the
               new/amended SOP.

2.6        SOP Maintenance
           On at least an annual basis, the Quality Manager should
           commission a review of each implemented SOP:
              to ensure that it is still relevant and up-to-date; and
              to identify any significant improvements that could be made to
               the defined procedures.
           Where changes are required to an SOP, the SOP should be updated
           using this procedure.
           In the event that it is identified that an SOP can be withdrawn, the
           Quality Manager will:
              arrange for the removal of references to the redundant SOP in
               any other SOPs;
              organise a recall of the retired procedure from the issued SOP
               Manuals; and
              update the Master SOP Log.

				
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