Deviations and Non-Conformances SOP

General

This SOP is applicable to all GxP manufacturing and quality operations including development processes manufacturing clinical trail materials, toxicity testing and stability studies as well as to the personnel who are responsible for conducting Deviations according to this SOP.
All deviation investigations must be conducted and documented on the attached deviation form.

 

Regulatory basis, reference documents

• 21 CFR 211.100(b)
• 21 CFR 211.111
• EU GMP Guide Part 1, 1.3 (xii)s

 

Table of Content:

1 Purpose

2 Objective

3 Regulatory basis, reference documents

4 Responsibility and accountability

4.1 Company Management

4.2 Manufacturing Department

4.3 Quality Assurance

4.4 Quality Control Department

4.5 Engineering Department

4.6 Information Technology Department

4.7 Other Departments

5 Related documents

6 Definitions

7 Procedure

7.1 Deviation (general)

7.2 Incident (minor deviation)

7.3 Investigation (general)

7.4 Immediate Action

7.5 Corrective Actions

7.6 Preventative Action

7.7 Trending of Deviations

8 Procedure

8.1 Deviation occurred

8.2 Details of Deviation Section I (attached form)

8.3 QA Confirmation Section II (attached form)

8.4 Investigation Section III (attached form)

8.5 Corrective Actions Section IV (attached form)

8.6 Preventive Actions Deviation Section V (attached form)

8.7 Quality Assurance Review Section VI (attached form)

8.8 Deviation close out Section VII (attached form)

9 Attachments

10 SOP distribution

11 Health, safety and environmental considerations

 

Size and Format:

• Microsoft Office
• Word File
• 17 pages procedure