INVESTIGATION REPORT
Observation: Moisture Content After Drying Outside Specified Limit
Company Name: XXYYZZ
Manufacturing Location: AABBCC
Product Name: Calcium Carbonate 500 mg and Vitamin D3 125 IU Tablet
Batch Number: PGH/T/26-002
Date of Incident: DD/MM/YYYY
Department: Production / Quality Assurance
Investigation Methodology: 6M – Ishikawa (Fishbone) Analysis
1. OBJECTIVE
The objective of this investigation is to determine the cause of the observation that the moisture content of the granules after completion of the drying operation was found to be 2.8% against the specified acceptance limit of 3.0% to 5.0% for Calcium Carbonate 500 mg and Vitamin D3 125 IU Tablet, Batch No. PGH/T/26-002.
The investigation is intended to:
- Establish the factual sequence of events associated with the out-of-limit moisture result.
- Determine whether the drying operation was performed according to the approved Batch Manufacturing Record (BMR), Master Formula Record (MFR), and applicable SOP.
- Review the drying equipment, process parameters, operating conditions, and equipment status.
- Review the raw materials, granulation process and material characteristics that may have influenced moisture removal.
- Assess the sampling and moisture-testing process to determine whether the reported result was representative and analytically reliable.
- Identify possible causes and contributing factors using the 6M Ishikawa methodology:
- Man
- Machine
- Material
- Method
- Measurement
- Milieu
- Assess the potential impact of the low moisture content on granule quality, subsequent processing and finished-product quality.
- Establish the most probable root cause based on documented evidence.
- Define appropriate corrective and preventive actions (CAPA) to prevent recurrence.
2. SCOPE
The scope of this investigation covers the manufacturing activities associated with:
Product: Calcium Carbonate 500 mg and Vitamin D3 125 IU Tablet
Batch: PGH/T/26-002
The investigation specifically covers the process beginning with preparation of the wet granules through completion of drying and determination of moisture content.
The investigation includes a review of:
- Approved Batch Manufacturing Record.
- Master Formula Record.
- Applicable granulation SOP.
- Applicable drying SOP.
- Equipment operating procedure.
- Drying parameters.
- Drying time.
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INVESTIGATION REPORT FOR MOISTURE CONTENT AFTER DRYING OUTSIDE SPECIFIED LIMIT
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INVESTIGATION REPORT FOR MOISTURE CONTENT AFTER DRYING OUTSIDE SPECIFIED LIMIT
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INVESTIGATION REPORT FOR MOISTURE CONTENT AFTER DRYING OUTSIDE SPECIFIED LIMIT
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INVESTIGATION REPORT FOR MOISTURE CONTENT AFTER DRYING OUTSIDE SPECIFIED LIMIT
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Key Parameter of the Below Page:
INVESTIGATION REPORT FOR MOISTURE CONTENT AFTER DRYING OUTSIDE SPECIFIED LIMIT
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Key Parameter of the Below Page:
INVESTIGATION REPORT FOR MOISTURE CONTENT AFTER DRYING OUTSIDE SPECIFIED LIMIT
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Key Parameter of the Below Page:
INVESTIGATION REPORT FOR MOISTURE CONTENT AFTER DRYING OUTSIDE SPECIFIED LIMIT
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Key Parameter of the Below Page:
INVESTIGATION REPORT FOR MOISTURE CONTENT AFTER DRYING OUTSIDE SPECIFIED LIMIT
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Key Parameter of the Below Page:
INVESTIGATION REPORT FOR MOISTURE CONTENT AFTER DRYING OUTSIDE SPECIFIED LIMIT
Find below pages for the complete report
Key Parameter of the Below Page:
INVESTIGATION REPORT FOR MOISTURE CONTENT AFTER DRYING OUTSIDE SPECIFIED LIMIT
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Click the link to download the word file copy of this document: https://pharmaguidehub.com/product/investigation-report-for-moisture-content-after-drying-outside-specified-limit/
Key Parameter of the Below Page:
INVESTIGATION REPORT FOR MOISTURE CONTENT AFTER DRYING OUTSIDE SPECIFIED LIMIT
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Key Parameter of the Below Page:
INVESTIGATION REPORT FOR MOISTURE CONTENT AFTER DRYING OUTSIDE SPECIFIED LIMIT
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Click the link to download the word file copy of this document: https://pharmaguidehub.com/product/investigation-report-for-moisture-content-after-drying-outside-specified-limit/
Key Parameter of the Below Page:
INVESTIGATION REPORT FOR MOISTURE CONTENT AFTER DRYING OUTSIDE SPECIFIED LIMIT
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Key Parameter of the Below Page:
INVESTIGATION REPORT FOR MOISTURE CONTENT AFTER DRYING OUTSIDE SPECIFIED LIMIT
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Click the link to download the word file copy of this document: https://pharmaguidehub.com/product/investigation-report-for-moisture-content-after-drying-outside-specified-limit/
Key Parameter of the Below Page:
INVESTIGATION REPORT FOR MOISTURE CONTENT AFTER DRYING OUTSIDE SPECIFIED LIMIT
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Key Parameter of the Below Page:
INVESTIGATION REPORT FOR MOISTURE CONTENT AFTER DRYING OUTSIDE SPECIFIED LIMIT
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Click the link to download the word file copy of this document: https://pharmaguidehub.com/product/investigation-report-for-moisture-content-after-drying-outside-specified-limit/
Key Parameter of the Below Page:
INVESTIGATION REPORT FOR MOISTURE CONTENT AFTER DRYING OUTSIDE SPECIFIED LIMIT
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Key Parameter of the Below Page:
INVESTIGATION REPORT FOR MOISTURE CONTENT AFTER DRYING OUTSIDE SPECIFIED LIMIT
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Click the link to download the word file copy of this document: https://pharmaguidehub.com/product/investigation-report-for-moisture-content-after-drying-outside-specified-limit/
Key Parameter of the Below Page:
INVESTIGATION REPORT FOR MOISTURE CONTENT AFTER DRYING OUTSIDE SPECIFIED LIMIT
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Key Parameter of the Below Page:
INVESTIGATION REPORT FOR MOISTURE CONTENT AFTER DRYING OUTSIDE SPECIFIED LIMIT
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Key Parameter of the Below Page:
INVESTIGATION REPORT FOR MOISTURE CONTENT AFTER DRYING OUTSIDE SPECIFIED LIMIT
Find below pages for the complete report
Key Parameter of the Below Page:
INVESTIGATION REPORT FOR MOISTURE CONTENT AFTER DRYING OUTSIDE SPECIFIED LIMIT
Find below pages for the complete report
Key Parameter of the Below Page:
INVESTIGATION REPORT FOR MOISTURE CONTENT AFTER DRYING OUTSIDE SPECIFIED LIMIT
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-moisture-content-after-drying-outside-specified-limit/
Key Parameter of the Below Page:
INVESTIGATION REPORT FOR MOISTURE CONTENT AFTER DRYING OUTSIDE SPECIFIED LIMIT
Find below pages for the complete report
Key Parameter of the Below Page:
INVESTIGATION REPORT FOR MOISTURE CONTENT AFTER DRYING OUTSIDE SPECIFIED LIMIT
Find below pages for the complete report
Key Parameter of the Below Page:
INVESTIGATION REPORT FOR MOISTURE CONTENT AFTER DRYING OUTSIDE SPECIFIED LIMIT
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-moisture-content-after-drying-outside-specified-limit/
Click the link to download the word file copy of this document: https://pharmaguidehub.com/product/investigation-report-for-moisture-content-after-drying-outside-specified-limit/
