INVESTIGATION REPORT
Capsule Shell Brittleness Observed During Capsule Manufacturing
Investigation Details
Company Name: XXYYZZ
Company Location: AABBCC
Product Name: Amoxicillin 500 mg
Batch Number: PGH/C/26-002
Date of Incident: DD/MM/YYYY
Stage of Detection: Capsule manufacturing / filling
Nature of Deviation: Brittle capsule shells
Observation: During the manufacturing of Amoxycilline 500 mg capsules, Batch No. PGH/C/26-002, capsule shell brittleness was observed. The capsule shells appeared fragile and may crack, split, or break during handling or filling.
Capsule shell brittleness can be associated with low shell moisture, unsuitable temperature or relative humidity, improper storage, or defects in the supplied capsule shells. The investigation must determine the actual cause using shell quality results, storage records, environmental data, and supplier documentation.
Proposed primary root cause: Low moisture content in the capsule shells due to unsuitable storage or environmental conditions is a potential cause of brittleness. This must be confirmed through investigation; it should not be recorded as a proven root cause unless supported by evidence.
1. Objective
The objective of this investigation is to identify the root cause of capsule shell brittleness observed during the manufacturing of Amoxicillin 500 mg, Batch No. PGH/C/26-002.
The investigation aims to:
- Determine why the capsule shells became brittle and prone to cracking or breakage.
- Evaluate the quality of the supplied capsule shells and their storage conditions.
- Review temperature, relative humidity, handling, and manufacturing practices.
- Assess the impact on capsule filling, product quality, batch yield, and patient safety.
- Identify corrective and preventive actions to prevent recurrence.
- Ensure that the affected batch is evaluated and handled according to approved pharmaceutical quality procedures.
2. Scope
This investigation covers the capsule shell storage, dispensing, handling, and capsule filling activities associated with Amoxicillin 500 mg, Batch No. PGH/C/26-002, manufactured at XXYYZZ, location AABBCC.
The scope includes:
- Inspection of the brittle capsule shells and affected capsules.
- Review of the capsule shell supplier’s certificate of analysis and incoming material inspection records.
- Review of capsule shell storage conditions and environmental monitoring records.
- Verification of the storage duration and status of the capsule shells before use.
Key Parameter of the Below Page:
INVESTIGATION REPORT FOR CAPSULE SHELL BRITTLENESS OBSERVED DURING CAPSULE MANUFACTURING
Find below pages for the complete report
Key Parameter of the Below Page:
INVESTIGATION REPORT FOR CAPSULE SHELL BRITTLENESS OBSERVED DURING CAPSULE MANUFACTURING
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-capsule-shell-brittleness-observed-during-capsule-manufacturing/
Key Parameter of the Below Page:
INVESTIGATION REPORT FOR CAPSULE SHELL BRITTLENESS OBSERVED DURING CAPSULE MANUFACTURING
Find below pages for the complete report
Key Parameter of the Below Page:
INVESTIGATION REPORT FOR CAPSULE SHELL BRITTLENESS OBSERVED DURING CAPSULE MANUFACTURING
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-capsule-shell-brittleness-observed-during-capsule-manufacturing/
Key Parameter of the Below Page:
INVESTIGATION REPORT FOR CAPSULE SHELL BRITTLENESS OBSERVED DURING CAPSULE MANUFACTURING
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-capsule-shell-brittleness-observed-during-capsule-manufacturing/
Key Parameter of the Below Page:
INVESTIGATION REPORT FOR CAPSULE SHELL BRITTLENESS OBSERVED DURING CAPSULE MANUFACTURING
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-capsule-shell-brittleness-observed-during-capsule-manufacturing/
Key Parameter of the Below Page:
INVESTIGATION REPORT FOR CAPSULE SHELL BRITTLENESS OBSERVED DURING CAPSULE MANUFACTURING
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-capsule-shell-brittleness-observed-during-capsule-manufacturing/
Key Parameter of the Below Page:
INVESTIGATION REPORT FOR CAPSULE SHELL BRITTLENESS OBSERVED DURING CAPSULE MANUFACTURING
Find below pages for the complete report
Key Parameter of the Below Page:
INVESTIGATION REPORT FOR CAPSULE SHELL BRITTLENESS OBSERVED DURING CAPSULE MANUFACTURING
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-capsule-shell-brittleness-observed-during-capsule-manufacturing/
Key Parameter of the Below Page:
INVESTIGATION REPORT FOR CAPSULE SHELL BRITTLENESS OBSERVED DURING CAPSULE MANUFACTURING
Find below pages for the complete report
Key Parameter of the Below Page:
INVESTIGATION REPORT FOR CAPSULE SHELL BRITTLENESS OBSERVED DURING CAPSULE MANUFACTURING
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-capsule-shell-brittleness-observed-during-capsule-manufacturing/
Click the link to download the word file copy of this document: https://pharmaguidehub.com/product/investigation-report-for-capsule-shell-brittleness-observed-during-capsule-manufacturing/
