Preparation, Approval and Control of Guidelines (Quality Assurance)

Preparation, Approval and Control of Guidelines (Quality Assurance)

  • To lay down the procedure for the preparation, approval and control of Guidelines.
  • All the personnel shall to be familiar with this SOP.
  • The approver to ensure that all proposed Guidelines conform to this SOP before approving any Guidelines.
  • Definition of Guidelines :
  • Guidelines are only ” Indicative in Nature “. Person responsible for carrying out the activity given in Guidelines shall refer to appropriate portion of the guidelines and or follow the Guidelines as applicable.
  • All  the Guidelines are  to  be generated by computer on the format known as “Guidelines”.
  • Various columns in the format shall be filled as described below.
  • Guidelines No. :
  • This is a unique number given to each Guideline. This number consists of Nine characters as described below:
  • The first character is alphabet “G” indicating “Guidelines”.
  • The next two characters are letters denoting the department code.
  • The next  three  characters  are  serial  number  starting  from  001  in the sequential order within the department.
  • The seventh character is  “-” Dash.
  • The  last  two  characters  denote  revision  number. The  first time any Guideline is written, it shall be numbered as “00”. The first revision of the Guideline shall be “01” and so on.
  • Example : The first Guideline prepared for Research & Development Department shall be numbered as “GRD001-00” and the same when revised for first time shall be numbered as “GRD001-01”.
  • Page No. :
  • Give  the  specific  page  number  as  well  as  the  total pages comprising the Guideline.
  • Example : 1 of  5.
  • Department :
  • Give the name of the Department to which the Guidelines pertains.
  • Example : Quality Assurance.
  • Title :
  • Give the detailed heading of the Guideline.
  • Effective Date :
  • The effective date is the date when the contents of  Guideline becomes operative.
  • Initiated by :
  • The person who prepares the Guideline, shall sign with date in this column.
  • Approved by :
  • Guidelines shall be approved by two functional heads :
  • Head of the Operating Department.
  • Head of Quality Assurance / related user Department.
  • Authorised by :
  • Guidelines shall be authorised  by the Divisional Head or his designee with signature and date.
  • A typical Guideline may have the following headings :
  1. Objective 2.  Responsibility        3.  Procedure       4.  Documentation
  • 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
  • Objective :
  • An overview of the intent of the Guideline shall be briefly mentioned here.
  • Responsibility :
  • Specify the personnel to whom the Guideline is applicable.
  • Procedure :
  • Describe the detailed procedure to be followed as required, in simple and clear sentences. It may  include  the details  of   all   operations,  operational  conditions and precautions to be taken, if any etc.,
  • Documentation :
  • Include  appropriate  formats,  specimen labels etc., needed  to record the compliance of the Guidelines, wherever applicable.
  • Submission of New Guidelines :
  • The initiator of the Guidelines shall prepare a draft copy of the proposed 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 / related user department and the Divisional Head.
  • The  Original copy of  the Guideline shall be initiated, approved  and authorised with signature and date.
  • Revision Procedure for Guidelines :
  • Whenever Guideline is revised, the changes made shall be entered in the “Change history” and attached at the end of the Guideline.
  • Distribution and Control of Guidelines :
  • The original copy  of the Guidelines shall have the original signatures and shall be maintained at Documentation cell.
  • Issue of the Guidelines shall be controlled by Documentation Cell. The details of issuance shall be entered in “Issue Record” (Annexure -1).
  • Officer-Documentation shall provide photocopy of the Guidelines from the original copy to the concerned departments.
  • Officer – Documentation shall stamp
  • “Issued by : ____________”
  • ”Issued to  : ____________”
  • “User Copy No.: ____________”
  • on the top of the Guidelines, sign with date and issue the copy to the concerned Department/Section/Area.
  • If  need  arises  for  an  additional copy of Guidelines, the concerned Head of the Department or his designee shall make request to Officer – Documentation.
  • Officer – Documentation shall arrange for  the issue of  a copy of the requested Guidelines.
  • Any guideline 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.
  • The details of issuance shall be recorded in ‘Issue record’ (Annexure-1)
  • User copies of old and superseded Guidelines shall be returned to QA department.
  • QA- Head shall  ensure  reconciliation  and  destruction. The  destruction details shall be entered in “Issue Record” (annexure-1). The  Original copy  shall  be stamped as “Obsolete – For reference only” and stored.
  • Forms and Records (Annexures)
  • Specimen format of “Issue Record” – Annexure  1.
  • Distribution
  • Master copy –  Quality Assurance
  • Controlled copies- Quality Assurance, Production, Quality Control
  • History
    Date Revision Number
    Reason for Revision
    00 New SOP

Annexure -1

Specimen format of “Issue Record”

User Copy No. Location Issued by Received by Returned by Destroyed by Destroyed on


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