SOP on Standard Operating Procedures

General

A Standard Operating Procedure is an authorized written procedure, giving instruction for performing operation not necessary to a given product or material but of more general nature. This procedure is applicable for all GMP relevant areas within Company.

Regulatory basis, reference documents

• 21 CFR Part 211.100(a) 211.100(b)
• EudraLex Volume 4, Chapter 4 - Documentation

Table of Content (just Headers):

1          Purpose

2          Objective

3          Regulatory basis, reference documents

3.1       Quality Management Representative / Quality Assurance

3.2       Functional Units

4          Related documents

5          Definitions

6          Procedure

6.1       SOP layout and format

6.1.1 Numbering system

6.1.2    SOP page header (footer)

6.1.3    SOPs first page

6.1.4    Table of content

6.1.5    SOP content

6.2       Creating a SOP

6.3       Reviewing a SOP

6.4       Signing and approving a SOP

6.5       Issuing a SOP

6.6       SOP retention times

7          Attachments

7.1       Attachment 1: Flow chart SOP Process (1 page)

8          SOP distribution

9          Health, safety and environmental considerations

Size and Format:

    Microsoft Office 2003

    Word File

    9 pages procedure