sop template version 01 final

Quality Management Documents & Templates

Title Subtitle

Dear customer,

Thank you for purchasing this SOP template from QMdocs.

To assure a proper implementation of this SOP within your company’s Quality System please follow the below described steps:

1. Save a copy of this template according to your file naming standards.

2. Exchange the existing QMdocs logo in the right header section with the logo of your

company.

3. Exchange left header section with your company name and department.

4. If you have legally purchased this SOP delete the copyright information in the footer

section, or replace it with your company’s copyright information.

5. Perform a careful review of the SOP and related content to assure you understand all

requirements.

6. Check whether all requirements are in compliance with your company’s general

standards and whether there are any conflicts to existing policies, standards or SOPs.

7. Complete the chapter 3 REGULATORY BASIS, REFERENCE DOCUMENTS with

internal references where applicable.

8. Exchange or fill green colored text with your company’s data.

9. Indicate the name and the department of the persons who will receive a controlled copy

of the finalized and approved SOP.

10. Assure SOP training before implementation.

11. Conduct an internal audit within an appropriate time after approval of the SOP to verify

whether the SOP requirements have been followed and if the deliverables are effective

and in compliance to your company’s expectations.

12. Delete this instruction note (first page).

Document Type Document ID Version Status Page

SOP XX_WWW_ZZZ_YYYY 1.0 Approved 1/6

Copyright © by QMdocs 2010Reproduction, photocopying, storage or transmission by magnetic or electronic means strictly prohibited by law. Neither the document

nor the information contained therein may be reproduced or disclosed without written consent of QMdocs.


Title Subtitle

AUTHORED BY: TITLE: DATE: SIGNATURE:

REVIEWED BY: TITLE: DATE: SIGNATURE:

Signs to confirm the content and structure of this document

Signs to confirm the content and structure of this document

APPROVED BY: TITLE: DATE: SIGNATURE:

Signs to confirm that this document is in compliance with the Quality Management System

DOCUMENT HISTORY

Effective Date Date Revision Required Supersedes

DD/MM/YYYY DD/MM/YYYY DD/MM/YYYY

Version Approval Date Description of the Change Author / Changed by

1.0 DD/MM/YYYY All Initial Document Name






Title Subtitle

TABLE OF CONTENT

1 Purpose.................................................................................................................................................. 4

2 Objective................................................................................................................................................ 4

3 Regulatory basis, reference documents.................................................................................................4

4 Responsibility and accountability............................................................................................................4

5 Related documents................................................................................................................................. 5

6 Definitions............................................................................................................................................... 5

7 Procedure............................................................................................................................................... 6

7.1 Description of the Procedures and Processes................................................................6

8 Attachments........................................................................................................................................... 6

# 1 Title of attachment 1........................................................................................................6

# 2 Title of attachment 2........................................................................................................6

9 SOP distribution...................................................................................................................................... 6

10 Health, safety and environmental considerations.............................................................................6






Title Subtitle

1 PURPOSE

This section describes the purpose of the Standard Operating Procedure.

2 OBJECTIVE

This paragraph should contain a description about the scope or objective of this Standard Operating Procedure.

3 REGULATORY BASIS, REFERENCE DOCUMENTS

This section should include the regulatory references that were used to produce this SOP.

E.g.:

21 CFR 211.xx

21 CFR 211.113: Control of Microbiological Contamination

21 CFR 820.70 (c): Production and Process Controls, Environmental Control

EU GMP Guide § xyz

International Standard, ISO 14644-1, First edition, 1999-05-01Clean room and Associated Controlled Environments, Part 1: Classification of Air Cleanliness,

2005 USP 28, U.S. Pharmacopoeia, <1116> Microbiological Evaluation of Clean Rooms and Other Controlled Environments

4 RESPONSIBILITY AND ACCOUNTABILITY

This section should list all relevant participating parties within a company, their duties and responsibilities related to this SOP and the described procedures and processes.

Quality Assurance (QA):

Review environmental monitoring data reports.

Ensure environmental monitoring investigations are appropriate and adequate, root causes are identified and corrective actions are implemented.

Assess and close environmental monitoring investigations.






Title Subtitle

5 RELATED DOCUMENTS

Table 1 : References to documents needed to proceed according to this procedure

Document ID Document Title

6 DEFINITIONS

Table 2: Glossary of Terminology used in the SOP

Term Description

21 CFR 210 &211

EU GMP Guide

ISO 13485

SOP






Title Subtitle

7 PROCEDURE

7.1 Description of the Procedures and Processes

This Paragraph has a detailed description of the individual steps of the related process and the instructions on how to execute the process.

8 ATTACHMENTS

# 1 Title of attachment 1

# 2 Title of attachment 2

9 SOP DISTRIBUTION

In this paragraph the customer should indicate the persons and department with authorized copies of this SOP

SOP Authorized Copy Number

Department Name

01 Production Mr. Sample

02

03

04

10 HEALTH, SAFETY AND ENVIRONMENTAL CONSIDERATIONS

This Paragraph should give relevant instructions in regard to related health, safety and environmental conditions.



