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:-
Company NameSeparator (Slash)OrganogramSeparator (Slash)DepartmentSeparator (Dash)Revision Number
/ORG/XXZZ
  • 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
DateRevision NumberReason for Revision
New SOP

 

 

 

 

About ABHA

Abha is the Author  of pharmaceutical guidance, she is a pharmaceutical professional having more than 22 years of rich experience in pharmaceutical field. During her career, she works in the quality assurance department with multinational companies i.e Zydus Cadila Ltd, Unichem Laboratories Ltd, Indoco remedies Ltd. During his experience, she faces many regulatorily audits i.e. USFDA, MHRA, ANVISA, MCC, TGA, EU –GMP, WHO –Geneva, ISO 9001-2008 and many ROW Regularities Audit i.e.Uganda, Kenya, Tanzania, Zimbabwe. She is currently leading a regulatory pharmaceutical company as a Head Quality. You can join him by Email, Facebook, Google+, Twitter, and YouTube

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