Standard Operating Procedure for Handling Deviations

1) Purpose

This SOP outlines the procedures for identifying, documenting, investigating, and resolving deviations from established procedures or specifications to ensure product quality and compliance with regulatory requirements.

2) Scope

This SOP applies to all departments and personnel involved in the manufacturing, testing, and quality assurance of pharmaceutical products within the company.

3) Responsibilities

The Quality Assurance (QA) department is responsible for overseeing the deviation management process. All personnel are responsible for reporting deviations and supporting investigations and corrective actions.

4) Procedure

4.1 Identification and Documentation of Deviations

1. Identify any deviations from established procedures, specifications, or regulatory requirements during routine operations.
2. Immediately document the deviation using the Deviation Report Form, including a detailed description of the event, date, time, and personnel involved.
3. Notify the QA department of the deviation as soon as possible.

4.2 Initial Assessment

1. The QA department conducts an initial assessment of the deviation to determine its potential impact on product quality and regulatory compliance.
2. Classify the deviation as minor, major, or critical based on its severity and potential impact.
3. Decide whether to proceed with an immediate investigation or to implement immediate corrective actions to mitigate any risks.

4.3 Investigation

1. Assign a cross-functional investigation team to conduct a thorough investigation of the deviation.
2. Collect and review all relevant data, documents, and evidence related to the deviation.
3. Interview personnel involved and identify the root cause(s) of the deviation.
4. Document the investigation findings in the Deviation Report Form.

4.4 Corrective and Preventive Actions (CAPA)

1. Develop a Corrective and Preventive Action (CAPA) plan to address the root cause(s) of the deviation and prevent recurrence.
2. Review and approve the CAPA plan, ensuring it is adequate and effective.
3. Implement the CAPA plan and monitor its effectiveness over time.
4. Document the implementation and effectiveness of CAPA actions in the Deviation Report Form.

4.5 Deviation Closure

1. Verify that all corrective and preventive actions have been completed and are effective in preventing recurrence of the deviation.
2. Review and approve the final Deviation Report Form, ensuring all required documentation is complete and accurate.
3. Close the deviation in the deviation management system and update any relevant documents or procedures as needed.

4.6 Documentation and Records

1. Maintain complete and accurate records of all deviations, including Deviation Report Forms, investigation reports, CAPA plans, and closure documentation.
2. Ensure that all documentation is readily accessible for audits and regulatory inspections.

5) Abbreviations, if any

QA: Quality Assurance
SOP: Standard Operating Procedure
CAPA: Corrective and Preventive Actions

6) Documents, if any

Deviation Report Forms, Investigation Reports, CAPA Plans, Deviation Management System Records

7) Reference, if any

Regulatory guidelines such as FDA, EMA, ICH Q9 (Quality Risk Management), and ICH Q10 (Pharmaceutical Quality System)

8) SOP Version

Version 1.0