INVESTIGATION REPORT
Observation: Blend Uniformity Testing Not Performed After Blending
Company Name: XXYYZZ
Location: AABBCC
Product Name: Nifedipine 5 mg Tablet
Batch Number: PGH/T/25-002
Date of Incident: DD/MM/YYYY
Department: Production / Quality Assurance
Investigation Type: Manufacturing Process / In-Process Control Investigation
Investigation Method: 6M – Ishikawa (Fishbone) Analysis
1. OBJECTIVE
The objective of this investigation is to thoroughly investigate the observation that blend uniformity testing was not performed after completion of the blending operation and before further processing/compression of the Nifedipine 5 mg Tablet, Batch No. PGH/T/25-002.
The investigation is intended to:
- Establish the facts and sequence of events associated with the non-performance of blend uniformity testing.
- Determine whether the required blend uniformity sampling/testing was defined in the applicable Batch Manufacturing Record (BMR), Standard Operating Procedure (SOP), specification, or other approved manufacturing documents.
- Determine why the required/expected in-process verification was not performed.
- Assess whether the omission could have an impact on the uniformity of nifedipine within the final blend and consequently on the quality of the compressed tablets.
- Examine possible contributing factors related to man, machine, material, method, Measurement, and Milieu using the 6M/Ishikawa methodology.
- Determine the most probable root cause(s) and contributing causes.
- Assess the potential impact on the affected batch and, where applicable, other batches/products manufactured under similar conditions.
- Establish appropriate corrective and preventive actions (CAPA) to prevent recurrence.
The investigation follows the general approach used in the attached reference report, in which manufacturing-floor activities, process parameters, equipment, personnel, materials, methods, and in-process controls were examined using a 6M approach.
2. SCOPE
The scope of this investigation covers the manufacturing activities associated with the Nifedipine 5 mg Tablet, Batch No. PGH/T/25-002, with particular emphasis on the period beginning from completion of the blending operation through the subsequent processing step.
The investigation includes review of:
- Approved Batch Manufacturing Record.
- Applicable Standard Operating Procedures.
- Master Formula Record.
- Blend preparation and blending operation.
- Blender/equipment identification and status.
- Blender operating parameters.
- Dispensing and weighing records.
- Raw-material status and analytical documentation.
- Blend sampling procedure.
- Blend uniformity testing requirements.
- In-process quality-control requirements.
- Production and QA documentation.
- Operator training and qualification.
- Shift handover, where applicable.
- Environmental conditions during manufacturing.
- Equipment cleaning and line-clearance records.
- Previous and subsequent batches, where relevant.
- Finished-product testing results, where available.
- Potential impact on batch quality and patient safety.
The investigation is focused specifically on the absence/non-performance of blend uniformity testing after blending and does not assume that the batch has failed quality requirements merely because the test was not performed. The potential impact is therefore assessed separately based on available evidence.
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INVESTIGATION REPORT FOR BLEND UNIFORMITY TESTING NOT PERFORMED AFTER BLENDING
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INVESTIGATION REPORT FOR BLEND UNIFORMITY TESTING NOT PERFORMED AFTER BLENDING
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INVESTIGATION REPORT FOR BLEND UNIFORMITY TESTING NOT PERFORMED AFTER BLENDING
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INVESTIGATION REPORT FOR BLEND UNIFORMITY TESTING NOT PERFORMED AFTER BLENDING
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INVESTIGATION REPORT FOR BLEND UNIFORMITY TESTING NOT PERFORMED AFTER BLENDING
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INVESTIGATION REPORT FOR BLEND UNIFORMITY TESTING NOT PERFORMED AFTER BLENDING
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INVESTIGATION REPORT FOR BLEND UNIFORMITY TESTING NOT PERFORMED AFTER BLENDING
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INVESTIGATION REPORT FOR BLEND UNIFORMITY TESTING NOT PERFORMED AFTER BLENDING
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INVESTIGATION REPORT FOR BLEND UNIFORMITY TESTING NOT PERFORMED AFTER BLENDING
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INVESTIGATION REPORT FOR BLEND UNIFORMITY TESTING NOT PERFORMED AFTER BLENDING
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INVESTIGATION REPORT FOR BLEND UNIFORMITY TESTING NOT PERFORMED AFTER BLENDING
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INVESTIGATION REPORT FOR BLEND UNIFORMITY TESTING NOT PERFORMED AFTER BLENDING
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INVESTIGATION REPORT FOR BLEND UNIFORMITY TESTING NOT PERFORMED AFTER BLENDING
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INVESTIGATION REPORT FOR BLEND UNIFORMITY TESTING NOT PERFORMED AFTER BLENDING
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INVESTIGATION REPORT FOR BLEND UNIFORMITY TESTING NOT PERFORMED AFTER BLENDING
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INVESTIGATION REPORT FOR BLEND UNIFORMITY TESTING NOT PERFORMED AFTER BLENDING
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INVESTIGATION REPORT FOR BLEND UNIFORMITY TESTING NOT PERFORMED AFTER BLENDING
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INVESTIGATION REPORT FOR BLEND UNIFORMITY TESTING NOT PERFORMED AFTER BLENDING
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INVESTIGATION REPORT FOR BLEND UNIFORMITY TESTING NOT PERFORMED AFTER BLENDING
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INVESTIGATION REPORT FOR BLEND UNIFORMITY TESTING NOT PERFORMED AFTER BLENDING
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