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Deviations (failure investigations, non-conformance)
Standard Operating Procedure

Updated Version

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.

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	Price:	79.– EUR * (appr. 102.- USD)

* additional 19% tax for customers from germany / no shipping costs will be charged



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		Open Word Document* You will be able to enter your data into the Word document. Please note: We do not deliver hard copies.



	Further details of this Standard Operation Procedure: Table of Content of this Standard Operating Procedure: 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

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Deviations (failure investigations, non-conformance) Standard Operating Procedure

Deviations (failure investigations, non-conformance)
Standard Operating Procedure