SOP of Signature Log Pharmaceutical Industry

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SOP of Signature Log | Pharmaceutical Industry

1. Purpose :

 To lay down the procedure for signature log.

2.Scope :

 This procedure is applicable to all employees working in a company including

contractual workers also.

3.Responsibilities:

i. Employee:

 Shall fill the relevant details in specimen signature record & shall ensure to sign

the same as recorded in log.

ii. Personnel & Administration Person

 Shall maintain the Specimen Signature Log

 Shall update the same while joining & relieving of employee.

4. Definitions:

 GMP Records: All records which directly or indirectly and individually or

collectively control the strength, identity, safety, purity and quality of a drug

product.
5. Procedure:

 During joining of an employee, Personnel & Administration person shall take

the signature of employee in Specimen Signature Log, which shall be maintained

department wise.

 Employee shall record their full signature & short signature in the Specimen

Signature Log before signing in any GMP related document & employee should

ensure that he /she can do either their long or short signatures in any GMP records

which have been recorded by them in log .

 This signature log shall be updated while relieving of an employee along with

their relieving date. (Refer Format) & it should be reviewed periodically.

6.Abbreviation:

 SOP : Standard Operating Procedure

 GMP : Good Manufacturing Practices

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