Description

Failure to identify and correct the root cause of deviations continues to be a major concern for regulatory agencies. Regulatory bodies expect companies to quickly identify, fully investigate and properly analyse and document deviations and unplanned quality incidents. 

This 12-page Standard Operating Procedure (SOP) will guide you step by step through this process, helping ensure that deviations are investigated within 30 working days, that all investigations are fully documented and analysed by the responsible line units and quality assurance, that corrective measures are implemented if applicable, that implementation is tracked and that the entire process is managed, monitored and controlled. 

This Standard Operating Procedure (SOP) is applicable for industries dealing with drug products, drug substances, medical devices and biotech products. The SOP needs only a small amount of site-specific modification before it can be adopted for your own operations.

Table of Content

1. Regulatory Basis, Reference Documents
2. Purpose
3. Scope
4. Responsibilities and Accountabilities
4.1 Manufacturing Department
4.2 Quality Control Department
4.3 Engineering Department
4.4 Information Technology Department
4.5 Quality Assurance Department
4.6 Other Departments
5. Definitions
5.1. Deviation
5.2 Incident (minor deviation)
5.3 Investigation
5.4. Immediate Action
5.5. Corrective Actions
5.6. Preventative Action
5.7 Trending
6. Procedure
7. Distribution
8. Attachments: Deviation form (4 pages)
Section I: Details of Deviation
Section II: QA confirmation
Section III: Investigation
Section IV: Corrective actions
Section V: Preventive actions
Section VI: Quality Assurance Review
Section VI: Deviation close out