SOP for Authorization of Designee in pharma

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SOP for Authorization of Designee:

1.Objective:

To lay down the procedure for Authorization of designee.

2.Scope:

The procedure is applicable to all unit operation of company.

3. Responsibilities:

Role ResponsibilityDepartment
Analyst/Section HeadTo prepare the list of designeeUser
Head QCTo authorized the list of designeeUser
Head QA or Head QualityTo Approve the lost of designee and to ensure the compliance of procedureQA
SOP for Authorization of Designee: Responsibilities

4. Procedure:

  1. In absence of HOD or where the presence of HOD is not feasible, an employee of the department is nominated by the Head of user department to perform the those activities or decisions making pertaining to the Manufacturing, Packing, QC, QA, Engineering, Warehouse, Regulatory Affaires, HR, IT, R&D and Safety dept.
  2. The nominated designee shall be listed by the Analyst or Section head and list shall be authorized by Head of user department in addition to the current role.
  3. Head of user department shall sign in the “HOD sign and Date” column along with date.
  4. The nominated personal shall sign in the “Designee sign and Date” column along with date.
  5. The designee shall be aware that they are the designee to the HOD in their absence.
  6. The prepared list of designee shall be approved by Head QA or Head Quality.
  7. QA shall stamp the effective date on the document and shall issue controlled copy to the user department based on the request.
  8. This list shall be updated when there are any changes in HOD or Designee due to new role or resigned or any other changes.
  9. The first list of designee shall be start with version 01 and shall be increased by one number on every update and previous version shall be obsoleted.
  10. The obsolete list of designee shall be maintained at documentation cell.
  11. The master copy of list of authorized designee shall be archived with QA department.
  12. Issuance and retention of list of authorized designee shall be handled as per document life cycle management procedure.

5. Abbreviation:

HOD – Head of the Department

QC – Quality Control

QA – Quality Assurance

6. References:

Document Life Cycle Management

7. Annexure:

List of Authorized Designee

Annexure-1

List of Authorized Designee
S. No.Document TitleAuthorized Designee
Name SignatureInitial
01    
02   
03   
04   
05   
Prepared By: Approved By:

SOP for Authorization of Designee

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refer YT Channel: Pharmabeejpro