Organogram in Pharma Industry

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:-

• 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