Preparation Review Approval Distribution And Revision Of Standard Operating Procedure

1.0    PURPOSE

To lay down the procedure for preparation, review, approval, distribution and revision of Standard Operating Procedures 

2.0    SCOPE

2.1    This procedure is applicable for preparation, review, approval, distribution and revision of standard operating procedures in all the departments.

3.0    RESPONSIBILITY

3.1    Head of user department

3.1.1  Identify activities that are being performed routinely by different personnel, which require the procedures.

3.1.2  Identify personnel to prepare draft procedure for routine activities.

3.1.3   Review the draft procedure with the users for its accuracy of content, sequence of activity, etc and finalize the draft procedure and submit this to QA for review for cGMP compliance.

3.1.4    Review the finalized procedure and sign for checked by.

3.1.5    Destroy all the drafts prepared during the process of finalizing the procedure immediately after the procedure is approved.

3.1.6    Quarantine soft copy(ies) of the procedure from the systems after the procedure is approved.

3.1.7    Identify personnel to receive the approved procedure and introduce into the operating activities.

3.1.8    Provide for all the physical, training and other needs for the implementation of the procedure.

3.1.9    Identify personnel to review the activities with reference to the procedure on a periodic basis and ensure compliance.

3.2      Identified personnel in user departments

3.2.1   Prepare the SOP as per the sequence of operations and using the format defined in this SOP.

3.2.2   Maintain the index of SOPs to assign SOP numbers as per this SOP.

3.2.3   Review the finalized procedure and sign at ‘prepared by’ column.

3.2.4   Receive the controlled copy(ies) of the approved procedure and position them at identified locations.

3.2.5   Ensure that previous documents are withdrawn from different locations of the department.

3.2.6   Ensure that the current documents are complied with while implementing the activity.

3.3     Head of QA department

3.3.1   Identify activities routinely performed, which do not have an approved procedure.

3.3.2   Identify personnel of the QA department to review the draft procedures for compliance to cGMP requirements and format as per this procedure.

3.3.3   Review the draft procedure with reference to overall quality system requirements of the organization and incorporate changes, if any.

3.3.4   Review the finalized procedure for identified changes and sign for Approved by.

3.3.5   Identify personnel to prepare controlled copies and follow distribution and retrieval procedures as per this SOP.

3.4     Identified personnel in QA department

3.4.1   Review the draft procedure with reference to requirements of cGMP and format as per this procedure and incorporate changes.

3.4.2   Review the finalized procedure for identified changes and sign for Checked by.

3.4.3   Issue controlled copies and uncontrolled copies of approved procedures as per this SOP.

3.4.4   Retrieve the previous versions of controlled copies of the procedures from different departments and account for the issued distribution list.

3.4.5   To destruct the controlled copies and Obsolete the MASTER COPY and the distribution list.

4.0     ACCOUNTABILITY

4.1     Manager- QA & RA 

4.1.1  Accountable for implementation and compliance of all the procedures in the plant to this SOP.
    
5.0     PROCEDURE

5.1     Preparation of standard operating procedure:

5.1.1    The personnel identified for preparation of the procedure shall write the SOP in English as per Format xxxxx. Where required the SOP in English is translated to Telugu (local language).

5.1.2    All the characters in SOP Header, Footer and text matter shall be taken in “Times New Roman” with font size of “12” and format number font size is “8”.

5.2    SOP Header

5.2.1    The SOP Header consists of the following Information in the respective cells of the specimen format given in xxxxx

5.3    Footer:

5.3.1    The names of the personnel prepared by, checked by and Approved by shall be printed while printing the final copy in Preparation, Review, Approval, Distribution And Revision Of Standard Operating Procedure. These shall be signed by the respective personnel with date.

5.4    Sub Heading Format:

5.4.1    All subheadings of the SOP shall be in bold upper case letters. Following are the subheading:

5.4.2    REVISION SUMMARY: It details the history of SOP i.e. the changes undergone from introduction of the SOP in ascending order.

5.4.3    PURPOSE: It defines the purpose of the procedure. It starts with sentence “To lay down the procedure for …………..”. If the purpose consists of different objectives, then they are listed serially.

5.4.4    SCOPE: It defines the area of application. 

5.4.5    RESPONSIBILITY: Personnel directly associated with the implementation of the procedure.

5.4.6    ACCOUNTABILITY: Person directly associated with the implementation of the system under which the procedure falls.

5.4.7    PROCEDURE: Details the actual way of carrying out stepwise operations/activities.

5.4.8    END OF DOCUMENT: Indicates end of SOP.
        
5.5    SOP Numbering

5.5.1    SOPs shall have a unique number consisting of five characters of alphanumeric system as described below.

5.5.2    Department Code

5.5.2.1    The department code shall be as per the list of department codes maintained in format Preparation, Review, Approval, Distribution And Revision Of Standard Operating Procedurein Quality Assurance department.

Example: The first SOP number of Quality Assurance is Defining, Preparation, Approval and Revision of Master Documents. - See more at: http://ichapps.com/article-detail.php?type=qms&id=782#sthash.b4eKWgw3.dpuf

5.5.3    Version Number

5.5.4    Identified personnel in the department shall maintain an index of SOP numbers as per format Preparation, Review, Approval, Distribution And Revision Of Standard Operating Procedureand assign the latest number when a new procedure is identified. The draft is prepared with this new number and finalized as per this SOP.

5.6    SOP Preparation and Approval:

5.6.1    The person identified shall prepare a draft procedure in the format Preparation, Review, Approval, Distribution And Revision Of Standard Operating Procedureas per this SOP. Emphasis is laid on the sequence and content of activities performed by each individual. Any formats equired for recording data during operation of the procedure shall also be prepared at this stage.

5.6.2    The person identified shall discuss the procedure along with formats with all users, Quality assurance, safety & environment and other related departments, as applicable. Emphasis during this stage shall be on compliance of the procedure to the following :

5.6.2.1    Actual operating activities in user departments

5.6.2.2    cGMP requirements as envisaged in different quality system policies / procedures.

5.6.2.3    Safety & Environment requirements. 

5.6.2.4    Legal / regulatory requirements of different governmental agencies.

5.6.2.5   Other requirements such as manufacturer’s recommendations with respect to equipment, etc.

5.6.3      The identified person, Heads of user department, QA shall finalise the draft.

5.6.4      The identified person shall update the procedure and attached formats as per the discussions and reviews at draft stage and prints one copy of the SOP. 

5.6.5    The person preparing the SOP shall review the final printout and sign at  “PREPARED BY” column along with date in all pages. Signature at this column indicates the preparation of the attached formats.

5.6.6    The concerned department Head or his deputy shall review the procedure for identified changes on draft and sign in the first part of “CHECKED BY” with date in all pages. Signature at this column indicates the checking of the attached formats.

5.6.7    Identified personnel in QA who have reviewed the draft procedure shall review for identified changes and sign in the second part of  “CHECKED BY” column with date in all pages. In case of System SOPs, they shall be reviewed by the Operational-Head and signed in second part of  “CHECKED BY” column with date in all pages. Signature at this column indicates the checking of the attached formats.

5.6.8    Manager-QA or his designee who have reviewed the draft shall review the identified changes on draft procedures and approve the procedure in the “APPROVED BY” column with date in all pages. Signature at this column indicates the approval of the attached formats.

5.6.9  After the approval of the procedure, the Head of user department shall ensure destruction of the draft copies. 

5.7    Distribution of SOPs.

5.7.1  The Approved SOP shall be stamped as “MASTER COPY” on the top left hand side in red colour and stored in documentation cell. 
 
5.7.2   Quality Assurance shall prepare a document cell copy by photocopying the “MASTER COPY” and stamping “CONTROLLED COPY “ in blue ink on bottom corner towards right hand side on all pages.

5.7.3   Quality Assurance representative shall issue the SOP to the all applicable departments defined in the area column in the header. 
 
5.7.4    QA representative shall photocopy the document cell copy and shall initial along with the copy number and date in the space provided in the “CONTROLLED COPY” stamp. 

5.7.5    Copies shall be issued as per the requirement against a written request from user department.

5.7.6    QA representative shall record the distribution details in SOP Distribution/Retrieval record for each SOP given in Preparation, Review, Approval, Distribution And Revision Of Standard Operating Procedure. This record shall be attached with the document cell copy.

5.7.7    When SOP is required to distribute out of the company’s control such as for customers, vendors, etc. by photocopying the MASTER COPY and stamping as “UNCONTROLLED COPY NOT FOR OPERATIONAL USE” in red ink on bottom corner towards right hand side on all pages.

5.7.8    When SOP is required to distribute out of the company’s control at Regulatory agencies, the same is prepared by photocopying the MASTER COPY and without stamping. List of such submissions shall be maintained by Regulatory affairs department as per format Preparation, Review, Approval, Distribution And Revision Of Standard Operating Procedure
5.7.9    Individual departments, as per the format Preparation, Review, Approval, Distribution And Revision Of Standard Operating Procedure, shall maintain an index with a current version of all SOPs in the user department. For any change or introduction of new procedure the index shall be updated.

5.8    Review and Revision of SOPs

5.8.1  SOP shall be reviewed every 2 years or as and when it needs revision.
    
5.8.2   User department shall revise the SOP as per change control procedure. 

5.8.3   QA representative shall issue the revised SOP as early as the document is approved and retrieve the old version at the earliest opportunity. During the period, the respective Heads of department shall ensure that current version of SOP is followed.

5.8.4    In case of discontinuation of SOP, the particular SOP number shall not be assigned to any other SOP. Change control procedure is followed to make any document obsolete.

5.8.5    In case SOP is no change is required in SOP, the MASTER COPY of the SOP shall be stamped with “REVIEWED” along with signature & date. The next revision shall be considered the next 2 years from the “REVIEWED” stamping date or whenever is needed.  

5.8.6    The issue of “REVIEWED” copy shall be same as point 5.7.2. All controlled copies and document cell copy of old copy shall be destroyed with suitable procedure. 

5.8.7    QA should ensure retrieval of all copies and destroy except “MASTER COPY”. 

5.8.8    “MASTER COPY” of previous version shall be stamped as “OBSOLETE FOR REFERENCE ONLY” in red colour diagonally on the document and archived in Quality Assurance department.

END OF DOCUMENT

Standard operating procedure, quality assurance, distribution, approval distribution