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Preparation, Approval, Review and Control of Standard Operating Procedures

  • OBJECTIVE:    
  • To lay down the procedure for the preparation, approval, review and control of Standard Operating Procedures.
  • RESPONSIBILITY:   
  • All the personnel of  all department to be familiar with this Standard Operating Procedure (SOP).
  • The approving authorities to ensure compliance to the preparation, approval and
  • Review procedure.
  • Head – QA or his designee to ensure controlled distribution of SOPs.
  • PROCEDURE:  
  • All the official SOPs are to be generated by computer on the format known as “Standard Operating Procedure” (Refer annexure -1). Guidelines for filling the format are described below:
  • SOP No.:  
  • This is a unique number given to each SOP. This number consists of eight characters as described below:
  • The first two characters are letters denoting the department code.
  • The next three characters  are  serial  number  starting  from  001  in thesequential order within the department.
  • The sixth character is  “-” Dash.
  • The  last  two  characters  denote  revision  number. The  first time any SOP is written, it shall be numbered as “00”. The first revision SOP shall be “01” and so on.
  • Example : The first SOP prepared for Quality Assurance Department shall be numbered as “QA001-00” and the same when revised  for first time shall be numbered as “QA001-01”.
  • Page No. : 
  • Give  the  specific  page  number  as  well  as  the  total pages comprising the Standard Operating Procedure. Example : 1 of  5.
  • Department :     
  • Give the name of the Department to which the SOP pertains.
  • Example : Quality Assurance.
  • Title :        
  • Give the detailed heading of the SOP.
  • Effective Date :  
  • The effective date is the date when the contents of SOP become operative, after training of the concerned personnel on the SOP.
  • Initiated by :      
  • The person who prepares the SOP, shall sign with date in this column. The operating personnel of the respective department shall prepare the SOP.
  • Approved by :   
  • Each SOP shall be approved by two functional heads :
  1. a)  Head of the Operating Department.
  2. b)  Head of Quality Assurance.
  • The approving authority shall ensure that the SOP is validated/operational suitability of the SOP is verified.
  • Authorised by :  
  • Every SOP shall be authorised  by the Plant Head or his designee.
  • The SOP shall have the following headings :
  1.   Objective       2.  Responsibility        3.  Procedure     4.  Documentation
  • Objective :
  •  An overview of the intent of the SOP shall be briefly mentioned here.
  • Responsibility :  
  • Shall specify the personnel responsible to ensure implementation and compliance.
  • Procedure :        
  • Shall describe the detailed operating procedure in simple and clear sentences. It   shall   include  the   details  of   all   operations,  operational  conditions  and precautions to be taken, if any.
  • Documentation :
  • Shall  include  appropriate  formats,  specimen labels etc., needed  to record the compliance of the SOP.
  • Each format shall be given a number. The number consists of 12 characters.
  • The first two letters denote department code
  • The next three characters denote serial number of the SOP.
  • The sixth character is “-” dash.
  • The seventh character is ‘F’ denotes “Format”.
  • The eighth and ninth characters denote the serial number of the Format of that particular SOP.   The tenth character is “-” dash.
  • The last two characters denote revision number of the respective format.
  • Format No. shall appear on left bottom of the format.
  • A specimen of each format shall be enclosed with respective SOP and stamped as “Specimen” and signed with date by the Head of Quality Assurance or his designee.
  • Submission of New SOP :    
  • The initiator of the SOP shall prepare a draft copy of the proposed SOP based on the above guidelines and forward it to the Department Head for approval.
  • Once approved by the Department Head, the same shall be routed for approval to the Head of Quality Assurance and the Divisional Head.
  • A disagreement on any aspect of the SOP from any one of the approvers shall  stop  any  ‘New SOP  submission’ until  all  approvers  come  to an agreement on the proposed new SOP.
  • The  Original copy of  the SOP  shall be initiated, approved  and authorised  with signature and date. The effective date shall be entered after training the concerned personnel on the new SOP.
  • Review procedure of SOP :  
  • Every SOP shall be reviewed once in every two years by the concerned personnel and the Head of the Department.
  • During review or otherwise any changes desired and deemed necessary shall be initiated through a ‘Change Request Notice’ as per SOP on ‘Change Control Programme’.
  • Whenever  SOP  is  reviewed, the  changes  made  shall  be  entered  on  the  ‘Change History’  and attached at the end of the SOP.
  • The reviewed and approved SOP shall be effective after training of concerned personnel.
  • In case there are no changes required in the existing SOP during review, the same  shall  be  mentioned  in  the   Change   History   as ‘No  changes required, Reviewed  due  to  mandatory  requirements’ and  the  same  SOP shall  be  valid  for  the next two years with no change in the revision number or effective date.
  • Distribution and Control of SOP :
  • The original copy  of the SOP shall have the original signatures and shall be maintained at Documentation cell. Issue of the SOP shall be controlled by QA department. The details of issuance shall be entered in “Issue Record”.
  • Officer – Documentation shall provide the photocopy of the SOPs from the original copy to the concerned department(s).
  • Officer – Documentation shall stamp “Issued by : ____________”
  • ”Issued to : ____________”
  • “User Copy No.: ____________”  on the top of the SOP, sign with date and issue the copy to the concerned
  • Department/Section/Area.
  • If  need  arises  for  an  additional copy of SOP, the concerned Head of the Department shall make request to Head of Quality Assurance Department.
  • Head – QA shall arrange for  the issue of  a copy of the requested SOP.
  • The details of issuance shall be recorded in  Issue record
  • Photocopying of any SOP is prohibited, unless written permission is obtained from the Head of Quality Assurance Department.
  • Any SOP issued for non-operational use shall be stamped as ‘Uncontrolled Copy, Not  for  Operational Use’ on  every page, with signature of Head of Quality Assurance  Department or his designee.
  • User copies of old and superseded SOPs shall be returned to QA department.
  • QA- Head shall  ensure  reconciliation  and  destruction. The  destruction details shall be entered in “Issue Record” . The  Original copy  shall  be stamped as “Obsolete – For reference only” and stored.

 

List of Department Codes
Quality Assurance – QA
Quality  Control – QC
Research & Development – RD
Analytical Development – AD
Regulatory Affairs – RA
Production – PD
Pilot Production – PP
Production Planning – PL
Training – TR
Engineering – EN
Warehouse – WH
Materials – MT
Administration – AM
Information Technology – IT
Accounts – AC
Safety – SA
Novel Drug Delivery Research -NR
Validation -VD
Audit & Compliance -CA
  • Forms and Records (Annexures)
  • Not Applicable
  • Distribution
  • Master copy –  Quality Assurance
  • Controlled copies- Quality Assurance, Production, Quality Control
  • History
    Date Revision Number Reason for Revision

     

    00 New SOP

     

 

 

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