Organogram in Pharma Industry

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Organogram in Pharma Industry in Pharma Industry

  • Objective

To describe the procedure for preparation of Organogram in Pharma Industry.

  • Scope

This procedure is applicable for preparation of organograms of all the departments in Pharma Industry.

  • Responsibility
    • P&A Department is responsible for preparation of organogram.
    • Head – User department is responsible for review of respective Organograms.
    • Head – QA is responsible for approval of organograms.
  • Accountability

Department Head and QA Head shall be accountable for the implementation of this SOP in Pharma Industry. 

  • Abbreviations and Definitions

SOP :  Standard Operating Procedure

QA: Quality Assurance

No.: Number

E.g.: Example

P&A :Personnel and Administration

Dept.: Department

  • Procedure
    • Organization Structure in Pharma Industry
      • Organization structure is typically the hierarchical arrangement of lines of authority, communications, roles and responsibilities of an organization.
      • It determines how roles, authority and responsibilities are assigned, controlled & coordinated and also how information flows between different levels of management. 
  • Preparation of Organograms in Pharma Industry
    • The individual department head shall prepared the organograms for their own departments in consultation with QA Head.
  • system for organograms shall be as follows:-
Company Name Separator (Slash) Organogram Separator (Slash) Department Separator (Dash) Revision Number
/ O R G / X X – Z Z
  • List of codes for “XX” representing the Department Code as per SOP on SOP (SOP/QA-001).
  • The alphabets “ZZ” represent Revision No. of Organogram starting from 00,01, 02 and so on…
  • The following organograms shall be prepared :
    • Site – wide (Unit) organograms in Pharma Industry
  • This organogram shall headed by the Managing Director, Executive Director, Plant Head and the QA Head with downward reporting to the level of Department Heads, second line Staff and Supervisors / Officers and other key positions.
  • The Organogram shall be prepared by the P&A, checked by Plant Head and approved by QA Head.
  • This organogram shall have names of position holders with current designations.
    • Department – wide organograms in Pharma Industry
  • This organogram shall headed by the Department Head with downward reporting to the level of second line Managers, Executives, Officers/ Supervisors and other key operating personnel.
  • The Organograms shall be prepared by the P&A, checked by User Department Head and approved by QA Head.
  • The organogram shall have names of position holders with current designations.
  • In case of lower operating levels only positions with number shall be specified.
    • The organograms shall be reviewed quarterly or as when required accordingly. The revision shall be through change control procedure.
    • The Master Copy of all organograms shall be preserved with QA Department and Controlled Copy of relevant organograms shall be issued to respective Department for clarity of roles and responsibilities.
    • The organogram once revised, the obsolete Controlled Copies of the organograms shall be retrieved by QA from respective user departments.
    • The Master Copies of obsolete organograms shall be stamped as OBSOLETE and preserved with QA department as define in SOP on data control.
    • Record of issuance of Controlled Copies, retrieval and destruction shall be maintained by QA as per document and data control SOP.
  • The copies of organograms provided to Regulatory inspectors or external auditors or customer audit personnel shall be stamped as UNCONTROLLED COPY.
  • Training
    • Training shall be imparted to all key operating personnel about the Organization structure, Roles and Responsibilities of key personnel, authorities to QA and Department Heads. 
  • Forms and Records (Annexures)
    • NA
  • Distribution
    • Master copy      –      Quality Assurance
    • Controlled copies – Quality Assurance, Production, Quality Control, Stores, Engineering, & Human Resources.
  • History
Date Revision Number Reason for Revision
– – New SOP