INVESTIGATION REPORT
Batch Mixing Error Observed During Inspection After Compression
Investigation Details
Company Name: XXYYZZ
Location: AABBCC
Product Name: Paracetamol 500 mg
Batch Number: PGH/T/25-002
Incident Date: DD/MM/YYYY
Stage of Detection: Inspection after compression
Nature of Deviation: Suspected batch mixing / product mix-up
Observation: During inspection after the compression stage, peach-coloured tablets were observed in the batch of Paracetamol 500 mg, whereas the expected colour of the product is off-white. The observation indicates a possible product or batch mix-up and requires investigation before further processing or release.
Important: The report below provides a proposed investigation and root-cause hypothesis based on the observation. The final root cause must be confirmed against actual batch records, equipment and area clearance records, material reconciliation, and identification of the peach-coloured tablets before QA approval.
1. Objective
The objective of this investigation is to determine the root cause of the observation of peach-coloured tablets in Paracetamol 500 mg, Batch No. PGH/T/25-002, during inspection after compression.
The investigation aims to:
- Identify how tablets of a different colour may have entered the inspected batch.
- Evaluate the possibility of product mix-up, batch mixing, or contamination from a previous product or batch.
- Review personnel practices, manufacturing procedures, equipment condition, material handling, and inspection controls.
- Assess the potential impact on product quality, patient safety, and batch integrity.
- Define corrective and preventive actions (CAPA) to prevent recurrence.
2. Scope
This investigation covers the activities performed before and during the compression stage and the inspection conducted after compression for Paracetamol 500 mg, Batch No. PGH/T/25-002.
The scope includes:
- Review of the compression area and line-clearance records.
- Verification of the identity and colour of the approved product.
- Review of previous product or batch manufacturing activities in the area.
- Inspection of the compression machine, tablet collection containers, and transfer equipment.
- Review of dispensing, granulation, compression, and material transfer records, as applicable.
- Assessment of personnel practices, identification labels, and segregation controls.
- Evaluation of the affected batch and determination of appropriate disposition by the Quality Assurance department.
INVESTIGATION REPORT
Batch Mixing Error Observed During Inspection After Compression
Investigation Details
Company Name: XXYYZZ
Location: AABBCC
Product Name: Paracetamol 500 mg
Batch Number: PGH/T/25-002
Incident Date: DD/MM/YYYY
Stage of Detection: Inspection after compression
Nature of Deviation: Suspected batch mixing / product mix-up
Observation: During inspection after the compression stage, peach-coloured tablets were observed in the batch of Paracetamol 500 mg, whereas the expected colour of the product is off-white. The observation indicates a possible product or batch mix-up and requires investigation before further processing or release.
Important: The report below provides a proposed investigation and root-cause hypothesis based on the observation. The final root cause must be confirmed against actual batch records, equipment and area clearance records, material reconciliation, and identification of the peach-coloured tablets before QA approval.
1. Objective
The objective of this investigation is to determine the root cause of the observation of peach-coloured tablets in Paracetamol 500 mg, Batch No. PGH/T/25-002, during inspection after compression.
The investigation aims to:
- Identify how tablets of a different colour may have entered the inspected batch.
- Evaluate the possibility of product mix-up, batch mixing, or contamination from a previous product or batch.
- Review personnel practices, manufacturing procedures, equipment condition, material handling, and inspection controls.
- Assess the potential impact on product quality, patient safety, and batch integrity.
- Define corrective and preventive actions (CAPA) to prevent recurrence.
2. Scope
This investigation covers the activities performed before and during the compression stage and the inspection conducted after compression for Paracetamol 500 mg, Batch No. PGH/T/25-002.
The scope includes:
- Review of the compression area and line-clearance records.
- Verification of the identity and colour of the approved product.
- Review of previous product or batch manufacturing activities in the area.
- Inspection of the compression machine, tablet collection containers, and transfer equipment.
- Review of dispensing, granulation, compression, and material transfer records, as applicable.
- Assessment of personnel practices, identification labels, and segregation controls.
- Evaluation of the affected batch and determination of appropriate disposition by the Quality Assurance department.
Key Parameter of the Below Page:
INVESTIGATION REPORT BATCH MIXING ERROR OBSERVED DURING INSPECTION AFTER COMPRESSION
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Click the link to download the word file copy of this document: https://pharmaguidehub.com/product/investigation-report-batch-mixing-error-observed-during-inspection-after-compression/
Key Parameter of the Below Page:
INVESTIGATION REPORT BATCH MIXING ERROR OBSERVED DURING INSPECTION AFTER COMPRESSION
Find below pages for the complete report
Key Parameter of the Below Page:
INVESTIGATION REPORT BATCH MIXING ERROR OBSERVED DURING INSPECTION AFTER COMPRESSION
Find below pages for the complete report
Click the link to download the word file copy of this document: https://pharmaguidehub.com/product/investigation-report-batch-mixing-error-observed-during-inspection-after-compression/
Key Parameter of the Below Page:
INVESTIGATION REPORT BATCH MIXING ERROR OBSERVED DURING INSPECTION AFTER COMPRESSION
Find below pages for the complete report
Key Parameter of the Below Page:
INVESTIGATION REPORT BATCH MIXING ERROR OBSERVED DURING INSPECTION AFTER COMPRESSION
Find below pages for the complete report
Click the link to download the word file copy of this document: https://pharmaguidehub.com/product/investigation-report-batch-mixing-error-observed-during-inspection-after-compression/
Key Parameter of the Below Page:
INVESTIGATION REPORT BATCH MIXING ERROR OBSERVED DURING INSPECTION AFTER COMPRESSION
Find below pages for the complete report
Click the link to download the word file copy of this document: https://pharmaguidehub.com/product/investigation-report-batch-mixing-error-observed-during-inspection-after-compression/
Key Parameter of the Below Page:
INVESTIGATION REPORT BATCH MIXING ERROR OBSERVED DURING INSPECTION AFTER COMPRESSION
Find below pages for the complete report
Key Parameter of the Below Page:
INVESTIGATION REPORT BATCH MIXING ERROR OBSERVED DURING INSPECTION AFTER COMPRESSION
Find below pages for the complete report
Key Parameter of the Below Page:
INVESTIGATION REPORT BATCH MIXING ERROR OBSERVED DURING INSPECTION AFTER COMPRESSION
Find below pages for the complete report
Click the link to download the word file copy of this document: https://pharmaguidehub.com/product/investigation-report-batch-mixing-error-observed-during-inspection-after-compression/
Key Parameter of the Below Page:
INVESTIGATION REPORT BATCH MIXING ERROR OBSERVED DURING INSPECTION AFTER COMPRESSION
Find below pages for the complete report
Key Parameter of the Below Page:
INVESTIGATION REPORT BATCH MIXING ERROR OBSERVED DURING INSPECTION AFTER COMPRESSION
Find below pages for the complete report
Click the link to download the word file copy of this document: https://pharmaguidehub.com/product/investigation-report-batch-mixing-error-observed-during-inspection-after-compression/
