Internal Audit

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Internal Audit Program SOP

This Standard Operating Procedure (SOP) describes the program necessary to assure compliance with all relevant GMP and Regulatory Requirement. Therefore this SOP defines the procedure and responsibility for the Internal Audit (Self-inspection) planning, implementation and follow-up to assure Site’s compliance with regulatory, cGMP and Site quality procedures.



The scope of the Internal Audit Program encompasses all current Good Pharmaceutical Manufacturing Practice (cGMP) and Good Distribution Practices (GDP) topics including Information Systems and/or Computerized Systems and related Quality Management System Controls (e.g. compliance with SOPs, the applicable QA system used, change control, etc.). The Internal Audit program also takes into account the need to review any recurrent quality/quality system issues identified through non-conformance reporting.


Regulatory basis, reference documents

  • 21 CFR 211 Section 211.84
  • EU GMP Chapter 7
  • Guide to Good Pharmaceutical Manufacturing Practice 1983.
  • Code of Federal Regulations, Food and Drug, 21.211.
  • EEC Guide to Good Manufacturing Practice for Medicininal Products, 1989.
  • Article 14 of the EU directives on GMP (91/356/EEC and 91/412/EEC).


Table of Content (just Headers):

1          Purpose

2          Objective

3          Regulatory basis, reference documents

3.1       Company Management

3.2       Quality Management Representative / Quality Assurance / (Recall coordinator)

3.3       Lead Auditor

3.4       Audit Team

3.5       Auditee / Area Leader

4          Related documents

5          Definitions

6          Procedure

6.1       General

6.2       Internal Audit Preparation

6.3       Perform Internal Audit

6.4       Internal Audit Report           

6.5       Internal Audit Follow up

6.6       Issue Categorization

6          Attachments

6.1       Attachment 1: Annual Internal Audit Program

6.2       Attachment 2: Internal Audit Report           

6.3       Attachment 2: Internal Audit Report Observations

7          SOP distribution

8          Health, safety and environmental considerations



Size and Format:

    Microsoft Office 2003

    Word File

    15 pages procedure

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