SOP on Standard Operating Procedures

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SOP on SOPs
$150.00
$150.00

Quick Overview

This Standard Operating Procedure (SOP) describes the Process on how to write SOPs. Standard Operating Procedures (SOPs) must be written, approved and followed for any routine operation, activity or task that may impact the safety, quality, purity and efficacy or distribution of active pharmaceutical ingredient, pharmaceutical product (i.e. drug product) or medical devices to ensure consistent application and meet regulatory compliance. The purpose of this Standard Operating Procedure (SOP) is to standardize and systematize the creation, revising, approving and issuing of Standard Operating Procedures.

SOP on Standard Operating Procedures

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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

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