Q04-0104 DOCUMENT SIGNATURE REGISTER

$30.00

As Good Documentation Practice – This SOP and register/form record each employee’s identification. This allows traceability to any GMP process that has a signature.

Description

Purpose of this procedure and form:

The purpose of this Standard Operating Procedure (SOP) is to define the requirements of the signature and initial register so as to ensure possible identification and traceability to personnel, who have acknowledged or authorized a particular task or process which could affect the safety, efficacy, identity, strength, purity or quality of the product manufactured. This SOP is part of the GMP Documentation Practice and Document Control.

Core Concepts applied to Quality Management System

Q04-0000 Core Concepts applied to Quality Management System

Related Regulatory references:

  • FDA Q7A Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients, Section VI. Documentation and Records
  • ICH Good Manufacturing Practice Guide for API Q7, Section 6 Documentation and Records
  • PIC/S PE 009-8 (Part I) Guide to GMP for Medicinal Products Part 1, Chapter 4 Documentation: Good documentation constitutes an essential part of the quality assurance system.

Who needs this procedure?

  • Quality assurance and Document Control for the management and control of documentation
  • All departments that generate GMP documentation

Keywords:

Documentation Document Control

Related Documents:

Q00-0001   Policy Statement – Quality Management System

Q04-0102   Document Control Procedure

Q04-0103   Good Documentation Practice

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