OBJECTIVE:

• To establish a procedure for preparation, control, issuance, and maintenance of Specimen Signature Records of all authorized personnel involved in GMP activities.

 SCOPE:

• This SOP shall be applicable to all personnel authorized to sign GMP documents and any other documents related to the Company

RESPONSIBILITIES:

• Concerned Department Head: Shall ensure submission of authorized personnel list to Human Resources (HR) department.
• Human Resources: Shall prepare, review, control, and maintain the Specimen Signature Register.
• Authorized Personnel: Shall provide signature and initials in prescribed format.

 DEFINATIONS:

Specimen Signature Record: A controlled document containing specimen signatures and initials of authorized personnel, maintained for verification of entries in GMP documents.

 PROCEDURE:

Preparation of Specimen Signature Record:

• QA shall prepare the Specimen Signature Record in a controlled format.
• Each page shall be uniquely numbered and controlled.

Authorization:

• Only personnel authorized by Department Head shall be allowed to sign GMP documents.
• Authorization shall be based on:
  • Training completion
  • Role and responsibility
  • Job description
• HR shall verify training status before including the name in the specimen register.

Control and Issuance:

• The Specimen Signature Register shall be maintained as a controlled document under HR custody.
• The master copy shall be maintained in hard copy form.
• Soft copy (if maintained) shall be access controlled.
• The register shall not be issued outside HR without proper authorization.

Changes and Updates:

• In case of:
• • • Role change
    • Signature change
    • New joining
• HR shall update the register accordingly.

REFERENCES:

• WHO TRS 1019 / EU GMP Chapter 4

RECORDS:

REVISION HISTORY.