Podcast
Questions and Answers
What is the purpose of this SOP?
What is the purpose of this SOP?
To analyze the raw and purified water used in the company according to the methods of analysis and specifications set for this purpose.
What does the abbreviation "MDI" stand for?
What does the abbreviation "MDI" stand for?
Modern Company for Drugs Industries
Which of the following tests are performed daily for purified water?
Which of the following tests are performed daily for purified water?
- Turbidity (correct)
- Odor (correct)
- Conductivity (correct)
- TOC
- Iron
- Color (correct)
- Total chlorine (correct)
- Appearance (correct)
- PH (correct)
- Calcium hardness
- Ammonia
- Sulfate
- TDS (correct)
- Magnesium hardness
Which of the following tests are performed weekly for purified water used for washing purposes?
Which of the following tests are performed weekly for purified water used for washing purposes?
What is the minimum pH requirement for purified water?
What is the minimum pH requirement for purified water?
What is the maximum turbidity level allowed for purified water?
What is the maximum turbidity level allowed for purified water?
What is the maximum sulfate level allowed for purified water?
What is the maximum sulfate level allowed for purified water?
What is the maximum calcium hardness level allowed for purified water?
What is the maximum calcium hardness level allowed for purified water?
What is the maximum iron level allowed for purified water?
What is the maximum iron level allowed for purified water?
What are the total dissolved solids (TDS) limits for purified water?
What are the total dissolved solids (TDS) limits for purified water?
What is the maximum total organic carbon (TOC) allowed for purified water?
What is the maximum total organic carbon (TOC) allowed for purified water?
What is the pH range for raw water?
What is the pH range for raw water?
What is the maximum turbidity level allowed for raw water?
What is the maximum turbidity level allowed for raw water?
What is the maximum sulfate level allowed for raw water?
What is the maximum sulfate level allowed for raw water?
What is the maximum calcium hardness level allowed for raw water?
What is the maximum calcium hardness level allowed for raw water?
What is the maximum iron level allowed for raw water?
What is the maximum iron level allowed for raw water?
What is the maximum total dissolved solids (TDS) allowed for raw water?
What is the maximum total dissolved solids (TDS) allowed for raw water?
This SOP applies for raw and purified water testing in the ______ production building.
This SOP applies for raw and purified water testing in the ______ production building.
The sixth version of this SOP includes a logbook format.
The sixth version of this SOP includes a logbook format.
Which of the following is NOT a test performed on purified water?
Which of the following is NOT a test performed on purified water?
The instrument directly displays concentration in mg/l of ______ on the liquid.
The instrument directly displays concentration in mg/l of ______ on the liquid.
Flashcards
SOP # QC-008E
SOP # QC-008E
Standard Operating Procedure for water quality analysis in production.
Raw water
Raw water
Untreated water from the water source.
Purified water
Purified water
Treated water, suitable for production.
PH test
PH test
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Turbidity test
Turbidity test
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Conductivity
Conductivity
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TDS
TDS
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TOC
TOC
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Calibration
Calibration
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Sample collection
Sample collection
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Conical flask
Conical flask
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Micro Siemens
Micro Siemens
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Nephelometric Turbidity Unit
Nephelometric Turbidity Unit
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Log book
Log book
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Quality Control
Quality Control
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Quality Assurance
Quality Assurance
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Sampling in Progress
Sampling in Progress
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Standard Operating Procedure (SOP)
Standard Operating Procedure (SOP)
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Monthly
Monthly
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Weekly
Weekly
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Daily
Daily
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Calibration
Calibration
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Study Notes
Standard Operating Procedure (SOP) for Water Analysis
- Title: Specifications and Chemical, Physical Analysis Methods for Raw and Purified Water in Normal Production
- SOP Number: QC-008E
- Effective Date: 30/08/2022
- Document Revision: Every 3 years or as needed
- Company: Modern Company For Drugs Industries (MDI)
Table of Contents
- History: Page 2
- Purpose: To analyze raw and purified water according to analysis methods and specifications
- Scope: Applies to raw and purified water testing in normal production
- References: MDI's internal SOPs
- Abbreviations and Definitions: Lists various abbreviations used in the SOP (e.g., SOP, MDI, QA, QC, µs, NTU, mg/l, Max, Ref)
- Procedure: Page 3, detailed steps for chemical and physical analysis of raw and purified water
- Responsibility: Outlines responsibilities of different personnel (Quality Control Analyst, Quality Control Manager, Engineering Manager, and Quality Assurance Manager) involved in water testing and quality control
- Documents Revision: Page 9, lists the different revisions of the document and the dates
Procedure Details (Partial)
- Sample Preparation: Collect samples from various sections; allow water to drain for 2 minutes for purified water; Collect samples from raw water sources.; Rinse bottles with sample water three times before filling
- Testing Methods (Examples): Daily tests for purified water include appearance, odor, color, pH, conductivity, TDS, turbidity, and total chlorine. Weekly tests include ammonia, iron, calcium hardness, magnesium hardness, sulfate, and TOC
- Instrument Calibration: Calibration is required for pH, turbidity, and sulfate tests using standard solutions.
- Results: Results are documented in logbooks (Appendix-1 and Appendix-2)
- Frequency: Raw water testing is monthly; Purified water testing differs according to usage and purpose (daily, weekly).
Water Specifications (Examples)
- Purified Water: Colorless, odorless, clean liquid
- Raw Water: Specifies parameters like color, odor, taste, turbidity, pH, conductivity, sulfate, ammonia, total chlorine, calcium hardness, magnesium hardness, iron, total dissolved solids, and total organic carbon
- Values Provided: Maximum permissible values for each respective parameter are given for both raw and purified water
Appendices
- Appendix-1: Detailed logbook for purified water tests
- Appendix-2: Detailed logbook for raw water tests
- Appendix-3: Follow-up program for the purified water station for different tests involved
Responsibility
- Quality Control Analyst (QC Analyst): Performs analysis
- Quality Control Manager (QC Manager): Reviews reports before release to production
- Production: Does not start production without analysis of purified water
- Quality Assurance Manager (QA Manager): Provides oversight and follow-up
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