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Standard Operating Procedure (SOP) for the recording of Specimen Signatures of Employees and contract personnel. Specimen Signature is a copy of your name written by yourself that an organization keeps so that they can be sure that your name on a document was also written by you.

SOP for Recording of Specimen Signature

1.0   PURPOSE:

• • The purpose of this SOP is to provide a procedure for recording of specimen signatures of employees and Contract personnel.

2.0   SCOPE:

• • This procedure is applicable for a specimen signature of all the employees and Contract personnel working at pharmaceutical drug manufacturing plants.

3.0   REFERENCES:

• • SOP for Good Documentation Practices

4.0   RESPONSIBILITY:

• • QA shall get the specimen signature of employees of the all Department recorded in Annexure 1.

• • P&A shall be responsible for getting the specimen signature of Contract and temporary personnel in Annexure 2.

• • QA Head or Designee to impart training and ensure proper implementation of the SOP.

5.0   ABBREVIATIONS – SOP SPECIMEN SIGNATURE:

• • CCR: Change Control Record (Related: SOP for Change Control Management)

• • NA: Not Applicable

• • P & A: Personnel and Administration

• • PMS: Packing Material Store

• • QA: Quality Assurance

• • RMS: Raw Material Store

• • SOP: Standard Operating Procedure

• • DEFINITION:

• • Specimen Signature: A copy of your name written by yourself that an organization keeps so that they can be sure that your name on a document was also written by you.

• • Contract Personnel: A contract Personnel does not become a regular addition to the staff, hired for a specific job, perform under the close monitoring/supervision company staff.

7.0   PROCEDURE FOR RECORDING OF SPECIMEN SIGNATURE:

• • Procedure for Company Pay Role Employees:

• • Specimen signatures of the individual new joinee shall be entered during the induction training or prior to the start of his/her activity in the QA department.

• • QA shall get the specimen signatures of employees in Annexure 1(Record of Specimen Signatures of Employee’s) as per department.

• • Head QA or Designee shall review the record of specimen signatures of employees

• • QA shall maintain the master specimen signatures of all Company Pay Role Employees.

• • If any person changes the signature, its prior information shall be given to QA, and a specimen of changed signature shall be maintained by QA.

• • Procedure for Contract and Temporary Personnel:

• • Specimen signatures of the individual contract and temporary personnel shall be entered after joining or prior to start of his/her activity in the P&A department.

• • P&A shall get the specimen signatures of temporary personnel in Annexure 2 (Record of Specimen Signatures of Contract and Temporary Personnel) as per department.

• • QA Head or designee shall review the record of specimen signatures of contract and temporary personnel.

• • P&A shall be maintained the master specimen signatures of all Contract and Temporary Personnel.

• • If any person changes the signature, its prior information shall be given to QA, and a specimen of changed signature shall be maintained by P&A.

8.0   ANNEXURES:

Annexure 1: Record of Specimen Signatures of Employees.

Annexure 2: Record of Specimen Signatures of Contract and Temporary Personnel.