Standard Operating Procedure for Handling of Deviations

1) Purpose

The purpose of this SOP is to establish procedures for identifying, documenting, investigating, and resolving deviations from standard processes to ensure product quality and compliance.

2) Scope

This SOP applies to all personnel involved in handling deviations at [Company Name] in the production of intramuscular, subcutaneous, and intravenous injection products.

3) Responsibilities

The responsibilities of this SOP include:
– Production Personnel: Identifying and reporting deviations.
– Quality Assurance (QA) Department: Investigating and documenting deviations, implementing corrective actions, and approving deviation reports.

4) Procedure

4.1 Identification of Deviations
4.1.1 Identify deviations from standard processes during production, testing, or any other phase of operations.
4.1.2 Report deviations immediately to the supervisor or QA department.
4.2 Documentation of Deviations
4.2.1 Document the deviation in a deviation report, including a description of the deviation, date, time, and personnel involved.
4.2.2 Ensure the deviation report is signed and dated by the personnel reporting the deviation.
4.3 Investigation of Deviations
4.3.1 QA to conduct an investigation to determine the cause of the deviation.
4.3.2 Document the investigation findings, including root cause analysis and impact assessment.
4.4 Corrective and Preventive Actions (CAPA)
4.4.1 Develop and implement corrective actions to address the immediate cause of the deviation.
4.4.2 Develop preventive actions to avoid recurrence of the deviation.
4.4.3 Document all CAPA activities and ensure they are completed in a timely manner.
4.5 Review and Approval
4.5.1 QA to review the deviation report, investigation findings, and CAPA activities.
4.5.2 Approve the deviation report by signing and dating the document.
4.6 Documentation
4.6.1 Maintain records of all deviations, investigations, and CAPA activities.
4.6.2 Ensure all records are signed and dated by the responsible personnel.

5) Abbreviations, if any

– QA: Quality Assurance
– CAPA: Corrective and Preventive Actions

6) Documents, if any

– Deviation Reports
– Investigation Reports
– CAPA Records

7) Reference, if any

– Good Manufacturing Practices (GMP) Guidelines
– International Organization for Standardization (ISO) Standards

8) SOP Version

Version 1.0