INVESTIGATION REPORT
Punch Breakage During Compression
Pharmaceutical Manufacturing Unit — AABBCC
Product Name: Nifedipine 5 mg
Batch Number: PGH/T/25-002
Incident Date: DD/MM/YYYY
Department: Production / Compression
Document Type: Deviation Investigation Report
Incident Description: Punch breakage was observed during the tablet compression operation for Nifedipine 5 mg, Batch No. PGH/T/25-002. The incident required investigation to identify the probable cause, assess the impact on product quality, and define corrective and preventive actions to avoid recurrence.
Important: This report is a detailed investigation template. The actual broken punch position, equipment details, batch quantities, inspection findings, and confirmed root cause must be completed using verified shop-floor records. The cause must not be considered confirmed until supported by investigation evidence.
1. Objective
The objective of this investigation is to identify the cause of punch breakage observed during the compression of Nifedipine 5 mg tablets, Batch No. PGH/T/25-002.
The investigation aims to:
- Determine the probable reason for punch breakage during compression.
- Investigate possible causes related to Man, Machine, Material, Method, Measurement, and Mother Nature (Environment) using the 6M Ishikawa approach.
- Assess the impact of the incident on product quality, batch integrity, equipment, and patient safety.
- Determine whether any tablets may have been affected by metal contamination or other defects.
- Establish appropriate corrective and preventive actions (CAPA).
- Prevent recurrence of similar incidents in future manufacturing batches.
2. Scope
This investigation covers the compression stage of Nifedipine 5 mg tablets, Batch No. PGH/T/25-002, manufactured at XXYYZZ, AABBCC.
The scope includes:
- Review of the compression operation and the circumstances surrounding punch breakage.
- Examination of the broken punch and the remaining punches and tooling.
- Review of the compression machine, machine settings, and maintenance records.
- Verification of the granules and their suitability for compression.
- Review of the applicable SOPs, batch manufacturing record (BMR), and equipment logbook.
- Assessment of tablets manufactured before and after detection of the incident.
- Evaluation of the possibility of foreign-particle contamination.
- Identification and implementation of suitable CAPA.
Key Parameter of the Below Page:
| INVESTIGATION REPORT FOR PUNCH BREAKAGE DURING COMPRESSION |
Find below pages for the complete report
Key Parameter of the Below Page:
| INVESTIGATION REPORT FOR PUNCH BREAKAGE DURING 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-for-punch-breakage-during-compression/
Key Parameter of the Below Page:
| INVESTIGATION REPORT FOR PUNCH BREAKAGE DURING COMPRESSION |
Find below pages for the complete report
Key Parameter of the Below Page:
| INVESTIGATION REPORT FOR PUNCH BREAKAGE DURING 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-for-punch-breakage-during-compression/
Key Parameter of the Below Page:
| INVESTIGATION REPORT FOR PUNCH BREAKAGE DURING COMPRESSION |
Find below pages for the complete report
Key Parameter of the Below Page:
| INVESTIGATION REPORT FOR PUNCH BREAKAGE DURING 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-for-punch-breakage-during-compression/
Key Parameter of the Below Page:
| INVESTIGATION REPORT FOR PUNCH BREAKAGE DURING COMPRESSION |
Find below pages for the complete report
Key Parameter of the Below Page:
| INVESTIGATION REPORT FOR PUNCH BREAKAGE DURING 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-for-punch-breakage-during-compression/
Key Parameter of the Below Page:
| INVESTIGATION REPORT FOR PUNCH BREAKAGE DURING COMPRESSION |
Find below pages for the complete report
Key Parameter of the Below Page:
| INVESTIGATION REPORT FOR PUNCH BREAKAGE DURING 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-for-punch-breakage-during-compression/
Key Parameter of the Below Page:
| INVESTIGATION REPORT FOR PUNCH BREAKAGE DURING COMPRESSION |
Find below pages for the complete report
Key Parameter of the Below Page:
| INVESTIGATION REPORT FOR PUNCH BREAKAGE DURING 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-for-punch-breakage-during-compression/
Key Parameter of the Below Page:
| INVESTIGATION REPORT FOR PUNCH BREAKAGE DURING COMPRESSION |
Find below pages for the complete report
Key Parameter of the Below Page:
| INVESTIGATION REPORT FOR PUNCH BREAKAGE DURING 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-for-punch-breakage-during-compression/
Click the link to download the word file copy of this document: https://pharmaguidehub.com/product/investigation-report-for-punch-breakage-during-compression/
