Pharmaceutical Guidelines

Quality Assurance (QA) in the Pharmaceutical industry, is very essential for ensuring that Pharmaceutical Products are manufactured to a safe and consistent standard, and references with the guidelines, WHO, GMP are the main principles for pharmaceutical products.

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Thursday 26 November 2020

SOP For Specimen Signature

 

1.0              OBJECTIVE:

To lay down the procedure for maintaining Specimen Signatures of employees working in


2.0              SCOPE:

The SOP is applicable to all employees of who are involved in signing during preparation, review, approval & authorization of documents.

3.0              RESPONSIBILITY:

3.1              Quality Assurance Officer /Executive to take the signature of the new employees as per SOP

3.2              Concerned department HOD to inform about the new employee to QA department

3.3              Employees to provide his/her specimen signature in Specimen Signature record as per Format No.: F/QA-005-01 in QA department.

4.0              ACCOUNTABILITY:                       

Quality Assurance Head to implement this SOP in Plant Name, Address.

                                          

5.0              PROCEDURE:

5.1              Specimen Signature is a Signature of an employee to proof authenticity of a person who is signing the documents. Specimen Signatures shall provide documentary evidence for signing the particular documents and performing particular jobs.

5.2              Specimen Signature shall provide a traceability of the documents signed by that particular employee.

5.3              Specimen Signature of each & every employee, who is responsible for signing the documents, shall be maintained in Format number F/QA-005-01 named Specimen Signature Record.

5.4              The format contains Department, employee’s name, Designation, Date of joining, initial signature, and full signature and Remark column for Quality assurance personnel for Quality assurance personnel for maintaining the status of the employee.

5.5              When any employee resigns or transfers to other location, Specimen Signatures record shall be updated in the remark column by writing Resigned or transferred.

5.6              Employee shall not change the specimen signature during the signing the documents, if any employee wants to change his/her specimen signature he/she shall change it through change control with proper justification.

5.7              For any new employee the employee has to maintain the specimen record in the same format as per Format No. F/QA-005-01 in Quality assurance department.

5.8              Acceptance criteria

5.12.1  Specimen Signature of all employees should be documented as authenticity proof.

5.12.2  Frequency: Whenever required or according to the above mentioned criteria.

 

6.0              LIST OF ANNEXURE AND FORMATS:    

Sr. No.

Title of Format

Format No.

  1.  

Specimen Signature Record

F/QA-005-01

7.0              REFERENCE:

7.1              SOP-QA- 001

7.2              F/QA-001-01

7.3              SOP-QA- 014

 

 

 

 

 

 

 

8.0              REVISION HISTORY:

 

Sr. No.

Date

Reason for Revision

Revision No

1.          

31/10/2018

New SOP

R0

2.          

31/10/2020

Schedule Revision

R1

 

9.0              ABBREVIATIONS:

Sr. No

Abbreviations

Details

01

QA

Quality Assurance

02

SOP

Standard operating procedure

             

 

 

 

 

 

END OF DOCUMENT

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