Standard Operating Procedure (SOP)

Here is a Standard Operating Procedure (SOP) for Re-analysis of Raw Material to ensure that any raw material that has failed in its initial testing or has been questioned is re-analyzed under controlled and documented conditions.

1. Purpose

This SOP outlines the procedure for re-analyzing raw materials that have either failed initial quality control tests or have been questioned due to inconsistencies, discrepancies, or other factors. The goal is to confirm the integrity and conformity of the material before it is accepted for use in production.

2. Scope

This procedure applies to all raw materials received at [Company/Facility Name] that undergo re-analysis, including active pharmaceutical ingredients (APIs), excipients, and packaging materials. It applies to the Quality Control (QC) department and any personnel involved in raw material testing.

3. Responsibilities

• Quality Control (QC) Personnel:

  • Perform re-analysis of raw materials following the guidelines set in this SOP.

  • Ensure proper handling, documentation, and reporting of re-analysis results.

• Warehouse Personnel:

  • Retrieve and securely store the raw materials to be re-analyzed.

  • Provide the QC team with any necessary information about the material.

• Quality Assurance (QA):

  • Review and approve re-analysis results and any related investigation or corrective actions.

4. Definitions

• Re-analysis: The process of repeating the testing of a raw material to confirm or correct the initial results, following failure or discrepancies.

• Out-of-Specification (OOS): Test results that do not meet the predefined acceptance criteria.

• Investigational Testing: Testing performed to verify whether initial failures were due to testing errors, material issues, or environmental factors.

5. Materials and Equipment Required

• Raw material sample(s)

• Laboratory equipment (e.g., balances, pH meters, HPLC, etc.)

• Standard laboratory glassware and consumables

• Reference standards and solvents

• Documentation forms (e.g., Raw Material Re-analysis Log)

• Personal Protective Equipment (PPE) (gloves, lab coat, eyewear)

6. Procedure

6.1 Initiating Re-analysis

1. Identify the Raw Material for Re-analysis:

   • Raw materials that failed quality control tests, or those with discrepancies in batch records, shall be flagged for re-analysis.

2. Check the Investigation Status:

   • If the material failure is related to an investigation (e.g., OOS results), review the findings of the initial investigation before proceeding.

3. Prepare the Necessary Documentation:

   • Complete the Raw Material Re-analysis Request Form that includes details such as the batch/lot number, reason for re-analysis, initial test results, and any corrective actions taken.

4. Coordinate with Warehouse:

   • Retrieve the required quantity of material from the warehouse or storage location.

   • Ensure that the material is properly labeled and segregated to avoid cross-contamination with other materials.

6.2 Sampling for Re-analysis

1. Sample Selection:

   • Select a new, representative sample of the raw material from the original batch or lot, following the sampling guidelines established in the raw material sampling SOP.

2. Preparation:

   • If necessary, homogenize or mix the raw material to ensure consistency before testing.

6.3 Testing and Re-analysis

1. Perform Tests According to Specifications:

   • Conduct the re-analysis using the same methods and procedures as the original analysis, unless otherwise specified. This includes the following tests:

     • Identity Testing (e.g., spectroscopic, chromatographic methods)

     • Purity/Impurity Analysis

     • Assay (Potency or Concentration)

     • Physical Characteristics (e.g., color, odor, appearance)

     • Microbiological Testing (if applicable)

2. Record All Observations and Results:

   • Document all results in the Raw Material Re-analysis Log.

   • Ensure that all test conditions, results, and any deviations are recorded.

6.4 Review of Results

1. Compare Results with Specifications:

   • Once the testing is complete, compare the results with the established acceptance criteria for the raw material.

2. Investigate Any Discrepancies:

   • If the re-analysis results are still out of specification (OOS), initiate an OOS investigation to determine whether the issue is due to material quality, testing errors, or other factors.

3. Confirm Re-analysis Validity:

   • If the re-analysis results are within specification, confirm that the material conforms to the required standards and is suitable for use.

6.5 Documentation and Reporting

1. Record All Re-analysis Results:

   • Ensure that all results are documented, signed by the responsible analyst, and stored appropriately.

   • Include any relevant comments, deviations, or investigations in the final report.

2. Approval of Results:

   • The QA department must review and approve the re-analysis results, along with any investigation or corrective action taken.

3. Disposition of Material:

   • If the raw material passes the re-analysis, it is released for use in production.

   • If the material fails, the QA department will determine the appropriate disposition action (e.g., rejection, return to supplier, or disposal).

6.6 Investigating Root Cause of Initial Failure (If Applicable)

1. Root Cause Analysis:

   • If re-analysis fails, or if discrepancies are found, conduct a thorough investigation to determine the root cause (e.g., incorrect testing, contamination, or material issues).

2. Corrective Actions:

   • Implement corrective actions based on the investigation’s findings to prevent future occurrences. This may include adjustments in sampling procedures, testing methods, or supplier controls.

3. Documentation of Investigation and Actions:

   • Document all findings and corrective actions taken in the Investigation Report.

7. Documentation and Record Keeping

• Maintain records of all re-analysis activities in a dedicated Re-analysis Logbook or digital system.

• Include:

  • Sample details (batch/lot number, material name, quantity)

  • Testing methods and results

  • Investigation reports (if applicable)

  • Approval of final results by QA

• Store all records in accordance with the company’s document retention policy.

8. Compliance and Auditing

• Ensure compliance with Good Manufacturing Practices (GMP), Quality Assurance guidelines, and regulatory standards for raw material testing.

• Conduct regular audits of the re-analysis process to verify adherence to this SOP.

9. References

• Company Quality Manual

• GMP Guidelines for Raw Material Testing

• ISO 9001 Standards

• Raw Material Specifications Document

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