Standard Operating Procedure for Out-of-Specification (OOS) Results

1) Purpose

This SOP outlines the procedures for handling and investigating Out-of-Specification (OOS) results encountered during testing of pharmaceutical products to ensure accurate and reliable data, compliance with regulatory requirements, and appropriate corrective actions.

2) Scope

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

3) Responsibilities

The Quality Control (QC) department is responsible for initiating, investigating, and documenting OOS results. The Quality Assurance (QA) department oversees the OOS investigation process and ensures compliance with regulatory requirements.

4) Procedure

4.1 Detection of OOS Results

1. Immediately notify the QC department upon detection of any OOS result during routine testing.
2. Isolate the sample and prevent further testing until the investigation is complete, if necessary.
3. Document the initial OOS observation and notify QA of the OOS occurrence.

4.2 Preliminary Investigation

1. QC conducts a preliminary investigation to verify the accuracy of the OOS result and rule out any procedural errors or instrument malfunctions.
2. Review relevant documentation, such as raw data, chromatograms, and sample preparation records.
3. Document the findings of the preliminary investigation in the OOS Preliminary Investigation Report Form.

4.3 Full OOS Investigation

1. Initiate a full investigation for confirmed OOS results, involving a cross-functional investigation team if necessary.
2. Perform a detailed root cause analysis using appropriate investigative tools and techniques (e.g., fishbone diagram, 5 Whys).
3. Document all investigation findings, including identified root causes, in the OOS Investigation Report Form.

4.4 CAPA Implementation

1. Develop a Corrective and Preventive Action (CAPA) plan based on the investigation findings to address the root cause(s) of the OOS result.
2. Implement the CAPA plan, ensuring all corrective actions are effective in preventing recurrence.
3. Document the implementation of CAPA actions and monitor their effectiveness.

4.5 Retesting and Decision

1. Upon completion of CAPA implementation, retest the sample if necessary and confirm the resolution of the OOS.
2. Review all documentation related to the investigation and CAPA implementation to make a decision on the disposition of affected materials or batches.
3. Obtain approval from QA or designated approver before releasing or rejecting materials or batches.

4.6 Documentation and Records

1. Maintain complete and accurate records of all OOS investigations, including OOS Preliminary Investigation Report Form, OOS Investigation Report Form, CAPA Plan, and CAPA Effectiveness Verification.
2. Ensure that all documentation is readily accessible for audits and regulatory inspections.

5) Abbreviations, if any

QC: Quality Control
QA: Quality Assurance
OOS: Out-of-Specification
SOP: Standard Operating Procedure
CAPA: Corrective and Preventive Action

6) Documents, if any

OOS Preliminary Investigation Report Form, OOS Investigation Report Form, CAPA Plan, CAPA Effectiveness Verification

7) Reference, if any

Regulatory guidelines such as FDA, EMA, ICH Q7 (Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients), and ICH Q9 (Quality Risk Management)

8) SOP Version

Version 1.0