Cover sheet

1.

SOP title

2.

SOP number and effective date

3.

Number of any SOP superceded

4.

Author(s) of the SOP

5.

Signatures and titles of those who approved the SOP

6.

History of changes (i.e., previous versions) of the specific SOP

SOP content

1.

Purpose of the SOP

2.

Scope that the SOP covers and in some cases what it does not cover

3.

Flow diagrams that illustrate how some (or all) of the procedures and processes described are to operate and in which order. Various overlays can provide additional information on these flow diagrams.

4.

Forms that will have to be filled out to fulfill the SOPs requirements. Alternatively, the forms may only be referenced by type and not made part of the SOP since forms almost always change more frequently than SOPs.

5.

Responsibilities (e.g., which group is responsible for each step of a SOP)

6.

Lines of communication and distribution of specific documents, products, etc.

7.

Definitions

8.

Procedures

9.

Filing of signed documentation

10.

References to the literature

11.

References to other SOPs and corporate policies

I. Purpose

To describe the process by which SOPs are developed, reviewed, approved, revised, distributed, and maintained within Company X Pharmaceutical Corporation.

II. Scope

This procedure applies to all SOPs developed for implementation within the company. SOPs will be created for those clinical research activities that are subject to compliance with regulatory requirements and that must be performed in a consistent manner to assure patient safety and data integrity.

III. Responsibility

All personnel involved in clinical research activities at the company are responsible for complying with this SOP when preparing, reviewing, approving, revising, distributing, and maintaining SOPs.

IV. Procedure

A. Administration of SOPs

Regulatory Affairs and Compliance (RAC) has responsibility for the central administration of all company SOPs. Note that a Quality Assurance (QA) Department (or another department) could have the role assigned in this example to Regulatory Affairs and Compliance.

B. SOP format, style, and content

1. 
   

   SOPs are prepared according to the standard format, style, and content outlined in this SOP.

   
   
2. 
   

   SOP format

   
   
   
   
   1. 
      

      SOPs contain all the standard headings listed below. Where the heading has no relevance to a particular SOP, the text “N/A” follows the title.

      
      
      
      
      1. 
         

         SOP number: Number to be assigned by RAC according to the SOP Numbering System described in Section IV.C below.

         
         
      2. 
         

         Title.

         
         
      3. 
         

         Purpose: Describes what the procedure is intended to achieve.

         
         
      4. 
         

         Scope: Identifies the range of activities covered by the SOP as well as any limitations or exceptions.

         
         
      5. 
         

         Responsibility: Identifies the title/position of the individuals responsible for assuring compliance to the SOP.

         
         
      6. 
         

         Procedure:

         
         
         
         
         • 
           

           Describes each component task in the procedure.

           
           
         • 
           

           Identifies by job category or title (e.g., project leader, clinical trials monitor) all individuals responsible for performing the specified tasks.

         
         
      7. 
         

         Review and revision: SOPs will be routinely reviewed on a biennial basis or if personnel report that the SOP does not reflect current operations or is no longer consistent with published policies and regulations governing the conduct of clinical trials or other functions covered by the SOP.

         
         
      8. 
         

         Contingencies: Statement that if the SOP cannot be followed this is reported to the Vice President of Regulatory Affairs who arranges to have the SOP revised or takes corrective action if a planned deviation is not in place.

         
         
      9. 
         

         References: Contains:

         
         
         
         
         • 
           

           Related SOPs

           
           
         • 
           

           Any applicable regulations and regulatory guidelines

         
         
      10. 
          

          Definitions: Definitions of words which need clarification in the SOP; if a definition is needed, and one exists in the applicable regulations, that definition is to be used.

          
          
      11. 
          

          Attachments: A list of all attachments with their titles. Supporting documentation can be included in this section.

          
          

          Note: Changes made to supporting documents (e.g., forms) shown as attachments to an SOP require the SOP version to be updated.

          
          
      12. 
          

          History of change: Chronological listing of change history of the SOP—includes version number, SOP sections affected, changes made, and effective date. The effective date in the history of change section should be identical to the effective date in the SOP heading.

      
      
   2. 
      

      RAC provides the following for inclusion with the SOP:

      
      
      
      
      1. 
         

         Effective date (date on which SOP is implemented into practice—occurs no more than 30 days after SOP receives final authorization.)

         
         

         Note: The time between final authorization and the effective date is to allow for training on the SOP.

   
   
3. 
   

   SOP numbering

   
   
   
   
   1. 
      

      SOP numbers consist of a two letter function designator followed by a dash and a chronological three digit number starting with “001” and incrementing by 1 for each new SOP. The function designators are as follows:

      
      

      AD = Administrative

      
      

      RA = Regulatory Affairs and Compliance

      
      

      CL = Clinical Operations

      
      

      MA = Marketing

      
      

      PR = Production, etc.

      
      
   2. 
      

      The initial new SOP is given version number “.00”, with this number placed at the end of the SOP number, e.g., AD-001.00. The first revision of a document shall be given version number “.01”, e.g., AD-001.01. Succeeding revision numbers are labeled “.02”, “.03”, and so forth.

C. Development, review, and approval of SOPs

1. 
   

   Any employee within the company may identify the need for a new SOP or the revision of an existing SOP.

   
   
2. 
   

   All requests for change require the SOP author to consult with Regulatory Affairs and Compliance on the need for the proposed new or revised SOP. This consultation can take place using electronic mail.

   
   
3. 
   

   If Regulatory Affairs and Compliance confirms the need for the new/revised SOP, the SOP author drafts the SOP along with any other supporting documentation.

   
   
4. 
   

   The SOP author is responsible for sending the draft SOP, supporting documentation, and an “Initial Request for SOP Review” (see Attachment A) to Regulatory Affairs for review. a) For a new SOP, write “New” for SOP number and SOP title and “Issue New SOP” for change requested.

   
   
5. 
   

   Regulatory Affairs and Compliance completes its review and signs the “Initial Request for SOP Review” and returns the form, the draft SOP, and supporting documentation to SOP author with revisions and comments, if any.

   
   
6. 
   

   As needed, the SOP author makes revisions and again circulates the revised draft SOP and any supporting documentation for review and comment.

   
   
7. 
   

   Once the final reviewers’ comments are incorporated, the SOP author forwards to Regulatory Affairs and Compliance an electronic copy of the final version of the SOP and any supporting documents.

   
   
8. 
   

   Regulatory Affairs and Compliance circulates the SOP for approval signatures.

   
   
9. 
   

   After obtaining all approval signatures, Regulatory Affairs and Compliance adds an effective date to the SOP, as detailed in Section IV.B.2(b)(2). A period for training is often allotted prior to the effective date, and the need for training may be part of the SOP itself, particularly as it applies to new employees.

D. Periodic review of SOPs and document maintenance

1. 
   

   Regulatory Affairs and Compliance maintains the master SOP manual with the original, signed paper copy of each SOP and its attachments.

   
   
2. 
   

   All previous versions of revised/inactivated SOPs are maintained in the Regulatory Affairs historical files.

   
   
3. 
   

   The review of each SOP is initiated and documented by Regulatory Affairs and Compliance on a biennial basis to determine whether it should remain in use and/or whether revisions are needed.

   
   
4. 
   

   If it is determined that an SOP is no longer necessary, a “Request for SOP Inactivation” (see Attachment B) is signed by both the person who approved the SOP and the Vice President of Regulatory Affairs to approve inactivation of the SOP. Inactivating the SOP also inactivates any supporting documents and closes any planned deviations in effect. The inactivated SOP and all of its supporting documents are removed from each SOP manual and the company SOP directory. Regulatory Affairs and Compliance maintains a list of all inactive SOPs.

   
   
5. 
   

   If no changes to the SOP are necessary after the biennial review, the SOP is still revised to the next appropriate revision number with the History of Change stating the revision as “Biennial review, no changes”.

   
   
6. 
   

   SOPs are confidential internal documents of the company. SOPs are not given to personnel who are not employed by the company without prior authorization from Regulatory Affairs and Compliance. Regulatory authorities may request to examine SOPs when auditing the company’s files.

E. Distribution of SOPs

1. 
   

   When an SOP is approved, Regulatory Affairs and Compliance is responsible for placing the original signed paper copy in the master SOP manual and updating the table of contents.

   
   
2. 
   

   Regulatory Affairs and Compliance also updates the SOP directory on the company m: drive for use by company personnel.

F. Planned deviations

1. 
   

   Under certain circumstances, a deviation from an existing SOP is necessary and appropriate. Planned deviations are requested and implemented in accordance with SOP AD-002 and must be documented prior to implementation.

V. Review and revision

1. 
   

   This SOP is reviewed on a biennial basis or if personnel report that the SOP does not reflect current operations or is no longer consistent with published policies and regulations governing the conduct of clinical trials or other functions.

VI. Contingencies

1. 
   

   Any circumstances indicating that this SOP cannot be followed must be reported to the Vice President of Regulatory Affairs. Inability to conform to this SOP must result in either prompt revision of the SOP or an immediate corrective action if a planned deviation is not in place.

VII. References

AD-002

Planned Deviations

VIII. Definitions

Standard Operating Procedures: Detailed, written instructions to achieve uniformity of the performance of a specific function. Planned Deviations: Deviations from an existing SOP which are planned and approved in advance.

IX. Attachments (forms)

1. 
   

   Initial Request for SOP Review

   
   
2. 
   

   Request for SOP Inactivation

X. History of change

Note: All SOPs produced prior to issuance of this version of this SOP (AD-001.00) do not contain a history of change. The history of change for previous versions of SOPs will not be added retrospectively to the SOPs.

CL-001

Rev 0 (previous SOP)

N/A

N/A

9/29/02

AD-001.00

SOP Number

SOP numbers are revised to reflect new numbering system and a new procedure for all SOPs.

1/21/05

All

Complete SOP rewrite to reflect new practice.

AD-001.01

Section 2. b.

Date on which SOP is implemented into practice. This occurs no more than 30 days after the SOP receives final authorization and any required training is completed.

6/01/05

Attachment A

Initial request for SOP review

Initiated by:

Date initiated:

SOP number:

SOP title:

Change requested:

Reason/Justification for change:

1.

VP, Clinical

2.

VP, Manufacturing

Others (add titles)

3.

VP, Regulatory Affairs

4.

Attachment B

Request for SOP inactivation

Initiated by:

Date initiated:

SOP number:

SOP title:

Justification for SOP inactivation:

1. Name of Person who originally approved the SOP

Others as in Form A

Same as in Form A