Modern Company For Drugs Industries Standard Operating Procedure PDF

# Modern Company For Drugs Industries ## Standard Operating Procedure **SOP # QC-008E** **Effective Date: 30/08/2022** **Page 1 of 9** **Title:** Specifications and Chemical, Physical Analysis Methods for Raw and Purified Water in Normal Production Department | **Prepared By: Quality Control An...

# Modern Company For Drugs Industries ## Standard Operating Procedure **SOP # QC-008E** **Effective Date: 30/08/2022** **Page 1 of 9** **Title:** Specifications and Chemical, Physical Analysis Methods for Raw and Purified Water in Normal Production Department | **Prepared By: Quality Control Analyst** | **Reviewed By: Quality Control Manager** | **Reviewed by: Engineering Manager** | **Approved By: Quality Assurance Manager** | |---|---|---|---| | Name: Mustafa Majeed | Name: Eng. Shafaa dhyaa | Name: Eng. Khalid Mahdi | Name: Dr. Mushtaq Hafiz | | Signature: | Signature: | Signature: | Signature: | | Date: 30-8-2022 | Date: 30-8-2022 | Date: 30-8-2022 | Date: 30-8-2022 | **Revision Date:** 3 years after effective date or when needed. ## Table of Contents: 1. **History** 2. **Purpose** 3. **Scope** 4. **References** 5. **Abbreviations and definitions** 6. **Procedure** 7. **Responsibility** 8. **Documents Revision** **Page 2 of 9** ### 1. History This is the sixth version SOP. Add logbook form. ### 2. Purpose To analyses the Raw and purified water used in the company according to the methods of analysis and specifications set for this purpose. ### 3. Scope This SOP applies for raw and purified water testing in normal production building. ### 4. References MDI own generated SOP. ### 5. Abbreviations and Definitions * **(SOP)** Standard Operating Procedures. * **(MDI)** Modern Company for Drugs Industries. * **(QA)** Quality Assurance. * **(QC)** Quality Control. * **(SIP)** Sampling in Progress. * **(µs)** Micro Siemens. * **(NTU)** Nephelometric Turbidity Unit. * **(mg/l)** milligram/litter. * **(Max)** Maximum. * **(Ref)** Reference. * **(Cond./ °C)** Conductivity/ Degree Centigrade. * **(LCD)** Light Crystal Display. * **(cm)** Centimeter. * **(EDTA)** Ethylene Di Amine Tetra Acetic Acid. * **(EGTA)** Ethylene Glycol Tetra Acetic Acid. * **(TDS)** Total Dissolved Solid. * **(TOC)** Total Organic Carbon. * **(ppb)** part per billion. ### 6. Procedure **6.1: Preparation of sample (purified and Raw water for Chemical and physical analysis):** * Before collection of sample .open the valve and allow the water to drain for at least 2 minute. * For purified water collect samples from each section of production and water treatment unit. For raw water collect samples from the source of raw water taps. * All water taps are numbered and shown in SOP (Factory Layouts, Structure, Maps And Equipment Technical Data) * Rinse the Conical flask with water sample three times before fill it. * Do not fill the bottle up the neck and put the stopper. * Dry from outside and label them with information tap no. & department name. **For tabs of purified water which are used for preparation of products purpose the test performed:** * daily for the tests (appearance, odor, color, PH, conductivity, TDS, turbidity, total chlorine). * weekly for the tests (ammonia, iron, calcium hardness, magnesium hardness, sulfate, TOC). * All results documented in log book and by Using (Appendix-1). **For tabs of purified water which are used for washing purpose the test performed:** * weekly for the tests (appearance, odor, color, PH, conductivity, TDS, turbidity, total chlorine). * All results documented in log book. **For Raw water the tests perform monthly and documented by using (Appendix-2).** **Page 3 of 9** **6.2: Chemical & physical Analysis Methods for Raw and Purified Water:** All the Instruments must be calibrated before start the analysis **1. PH Test:** * Turn on the meter by pressing ON/OFF key. * Calibrate by using standard buffer solutions of PH (4, 7and 10). * After calibration, the PH meter is ready to measure the value of PH. * Fill the beaker with 100 ml of sample and immerse the probe into the sample and wait till the instrument will show the stable result. * Note the result in the logbook. **2. Turbidity Test:** * Turn on the meter by pressing ON/OFF key. * Rinse inside the cuvette three times with a sample, and fill it with sample. * Replace light shield cap and ensure all outside surface are clean and dry. * Insert the cuvette into the optical well and index to the lowest reading. * Note the result in the logbook. **3. Sulfate Test:** * Turn on the meter by pressing ON/OFF key. * When the LCD displays "---" the instrument is ready. * Fill the cuvette with 10 ml of sample and replace the cap. * Place the cuvette into the holder and ensure that the notch on the cap is positioned securely into the groove. * Press Zero and SIP will appear on the display. * Wait for a few seconds and the display will show -00-. * Now the meter is Zeroed and ready for measurement. * Remove the cuvette and add the content of one packet of HI 93751-0 reagent. * Shake very gently for 1 minute. * Reinsert the cuvette into the instrument. * Press READ TIMD and the display will show the countdown prior to the measurement or, alternatively wait for 5 minutes and press READ DIRECT. in both cases SIP will appear during measurement. * The instrument directly displays concentration in mg/l of sulfate on the liquid. * Note the result in the logbook. **Page 4 of 9** **4. Ammonia Test:** * Turn on the meter by pressing ON/OFF key. * Select the program number from the instrument by pressing or * Fill the cuvette with 10 ml of sample.up to the mark and replace the cap. * Place the cuvette into the holder and ensure that the notch on the cup is positioned securely into the groove. * Press ZERO and SIP will blink on the display. * Wait for a few seconds and the display will show -00-, now the meter is Zeroed and ready for measurement. * Remove the cuvette and add 4 drops from first reagent.replace the cap and mix the solution. Remove the cup and add 4 drops. From second reagent. Place the cup and mix for seconds. * Reinsert the cuvette into the instrument.press TIMER. And the display will show the countdown prior to the measurement or alternatively wait for 3 minutes and 30 seconds and press READ DIRECT. * The instrument directly displays concentration in mg/l * Note the result in the logbook. **5. Total Chlorine Test:** * Turn on the meter by pressing ON/OFF key. * Select the program number from the instrument by pressing or * Fill the cuvette with 10 ml of sample up to the mark and replace the cap. * Place the cuvette into the holder and ensure that the notch on the cup is positioned securely into the groove. * Press ZERO and SIP will blink on the display. * Wait for a few seconds and the display will show -00-, now the meter is Zeroed and ready for measurement. * Remove the cuvette and add content of one packet HI 93711 Reagent. Replace the cap and shake gently for 20 second. * Reinsert the cuvette into the instruments, Press TIMER and the display will show the countdown prior to the measurement or, wait for 2 minutes and 30 seconds and press READ DIRECT. In both cases "SIP" will blink during_measurement. * The instrument will display concentration in mg/l of Total Chlorine. * Note the result in the logbook. **Page 5 of 9** **6. Calcium Hardness Test:** * Turn on the meter on by pressing ON/OFF key. * Select the program number by pressing or * Rinse graduate beaker several times with the sample before filling it into 50 ml, to the mark. Fill both cuvette up to 10 ml mark. * Add 0.5 ml of HI 93720A Calcium solution and swirl to mix. * Add 0.5 ml of HI 93720B Alkali solution and swirl to mix. * Use the solution to rinse 2 cuvette before filling them up to the 10 ml to the mark. * Add 1 drop of 93720C EGTA solution to cuvette (#1) replace the cup and invert the cuvette several times to mix.this is the blank. * Place the blank (#1) into the holder, ensure that the notch on the cup is positioned securely into the groove. * Press zero and "SIP" will blink on the display. * Wait for a few seconds and the display will show "-00-". Now the meter is ready for measurement. * Remove the blank and insert the cuvette (#2) into the instrument. * Press READ DIRCT.and "SIP" will blink during measurement. * The instrument directly displays concentration in mg/l of calcium hardness. * Note the result in the logbook. **Page 6 of 9** **7. Iron Test:** * Turn on the meter by pressing ON/OFF key. * Select the program number by pressing Vor * Fill the cuvette with the sample. * Insert the cuvette into the holder and ensure that the notch on the cap is positioned securely into the groove. * Press ZERO, and the SIP will blink on the display.wait for a few seconds and the display will show-00-, now the meter is ready for measurement. * Remove the cuvette and add content of one packet HI93721 Reagent. Replace the cap and shake until dissolution complete. * Reinsert the cuvette into the instrument. * Press TIMER and wait for three minutes and the display show the countdown prior to the measurement. * Note the result in the logbook. **Page 7 of 9** **8. Magnesium Hardness Test:** * Turn on the meter by pressing ON/OF key. * Select the program number by pressing Vor * Rinse graduate beaker several times with the sample before filling it into 50 ml mark. * Add 0.5 ml of HI 93719A Magnesium indicator solution and swirl to mix. * Add 0.5 ml of HI 93719B Alkali solution and swirl to mix. * Use the solution to rinse 2 cuvette before filling them up to 10 ml. mark. * Fill both cuvette up to 10 ml. mark. * Add 1 drop from HI93719C EDTA solution to cuvette (#1).replace the cap and invert the cuvette several times to mix.this is the BLANK. * Add 1 drop from HI93719D EGTA solution to cuvette (#1).replace the cap and invert the cuvette several times to mix.this is this is the SAMPLE. * Place the blank (#1) into the holder and ensure that the notch now the meter is ready for measurement. * Press zero and SIP will blink on the display. * Wait for a few seconds and the display will show -00-. Now the meter is ready for measurement. * Remove the blank (#1) and insert the sample (#2) into the instrument making sure that the notch now the meter is ready for measurement. * Press READ DIRECT.SIP will blink during measurement. * The instrument directly displays concentration in mg/l of Magnesium hardness. **Page 8 of 9** ### 9. Total Dissolved Solid Test Total dissolved solid are define as the materials residue left in the vessel after evaporation of the water. **Glassware:** * 50 ml beaker * reference thermometer **Procedure** * Make sure that the probe is connecting to the meter and AC power supply is properly connected to an electrical outlet. * Wash the electrode and the beaker 3 times by distilled water. * Fill the beaker with 50 ml from the water sample. * Turned the meter (on) from button( * Put the probe and reference thermometer in container of water at approximately 25°C and allow the temperature to stabilize * Compare the temperature read by the meter with that of the reference thermometer. The difference is the adjustment value for the meter. Example: reference thermometer: 24.5°C; meter: 24.3°C adjustment value:0.2 °C * Enter the adjustment value for 25 reading : * From the main menu use the or select system. Confirm. * Use the or * Use the or * Use the arrow keys to enter the adjustment value for 25°C. Confirm. * Choose the TDS MEASURE button from button ( * Press button (√) again to start measurement. * The screen will display the value of TDS. * Record the value of TDS in the logbook. * If the measurement not complete make sure that the temperature degree of sample is stable and equivalent to 25°C. * Note the results above in the logbook. ### 10. Total Organic Carbon Test Operation will be done as per SOP REF # QC-CAL-021. **Page 9 of 9** ### 7 - Responsibility: * It is the responsibility of QC analysts to perform the analysis of raw water and purified water as per required frequency. * It is the responsibility of QC Manager to check the reports according to the specifications before release for production and fill the follow up program. * It is the responsibility of production not to start any production before analysis of purified water. * It is the responsibility of QA for follow up. ### 8- Documents Revision: | No. | Section | Pages | Initials/Date | |---|---|---|---| | 1 | History | 2 | 01/09/2013 | | | Procedure | 8 | | | 2 | History | 2 | 23/10/2014 | | | Procedure | 8 | | | | Responsibility | 9 | | | | Attachments | | | | 3 | History | 2 | 23/10/2017 | | | Scope | 2 | | | | Procedure | 3 | | | | Responsibility | 9 | | | | Attachments | | | | 4 | History | 2 | 22/08/2020 | | | Procedure | 8 | | | | Attachments-2 | 1 | | | | Appendix-2 | 1 | | | 5 | History | 2 | 30/08/2022 | | | Attachment -3 | 1 | | ### Attachments: * Raw water specifications (Attachment-1). * Purified water specifications (Attachment-2). * Chemical test logbook of Purified water (Attachment-3). * Certificate of analysis for raw water (Appendix- 1). * Certificate of analysis for purified water (Appendix- 2). * Follow Up Program For Purified Water & Raw Water (Appendix-3). **Page 10 of 1** **Attachment-2** ## Purified Water Specifications | Test | Specifications | |---|---| | Color | Colorless | | Odor | Odorless | | Appearance | Clean Clear Liquid | | PH | 5.0 - 7.0 | | Conductivity | Max 4.3 με | | Turbidity | Max. 5 NTU | | Sulfate | Max. 1.00 mg/l | | Ammonium | Max. 1.00 mg/l | | Total chlorine | Max. 1.00 mg/l | | Calcium Hardness | Max. 1.00 mg/l | | Magnesium Hardness | Max. 1.00 mg/l | | Iron | Max. 0.5 mg/l | | Total Dissolve Solids | Max. 10.00 mg/l | | Total Organic Carbon | Max. 500 ppb | **Page 11 of 1** **Attachment-1** ## Raw Water Specifications | Test | specifications | |---|---| | Description | Clear Colorless Liquid | | Odor | Odorless | | Taste | tasteless | | Turbidity | Max. 5 NTU | | pH | 6.5 - 8.5 | | Conductivity | 1500 – 2000 με | | Sulfate | Max. 400 mg/l | | Total chlorine | Max. 350 mg/l | | Calcium Hardness | Max. 150 mg/l | | Magnesium Hardness | Max. 100 mg/l | | Iron | Max. 0.3 mg/l | | Total Dissolve Solids | Max. 1000 mg/l | **Page 12 of 1** **SOP # QC-008E** **Attachment-3** ## Chemical test of Purified water | Tap No. | Tap no. | Tap no. | Tap no. | Tap no. | Tap no. | Tap no. | Tap no. | |---|---|---|---|---|---|---|---| | Test | | | | | | | | **Page 13 of 1** **Appendix-1** **SOP # QC-008E** ## Certificate of analysis for raw water | Test | Description | Result | Specifications. | |---|---|---|---| | pH | | | 6.5-8.5 | | Conductivity | | | 1500 - 2000 με | | Turbidity | | | Max. 5 NTU | | Sulfate | | | Max. 400 mg/l | | Ammonia | | | Max.1.0 mg/l | | Total chlorine | | | Max.350 mg/l | | Calcium (Hardness) | | | Max. 150 mg/l | | Magnesium (Hardness) | | | Max.100 mg/l | | Iron | | | Max.0.3 mg/l | | Total Dissolved Solids | | | Max. 1000 mg/l | | Other test | | | | | Comments | | | | **Page 14 of 1** **Appendix-2** **SOP # QC-008E** ## Certificate of analysis for purified water | Test | Description | Result | Specifications | |---|---|---|---| | pH | | | 5-7 | | Conductivity | | | Max.4.3 με | | Turbidity | | | Max. 5 NTU | | Sulfate | | | Max. 1.0 mg/l | | Ammonia | | | Max.1.0 mg/l | | Total chlorine | | | Max.1.0 mg/l | | Calcium (Hardness) | | | Max.1.0 mg/l | | Magnesium (Hardness) | | | Max.1.0 mg/l | | Iron | | | Max.0.5mg/1 | | Total Dissolved Solids | | | Max.10.00 mg/l | | Total Organic Carbon | | | Max. 500 ppb | | Other test | | | | | Comments | | | | **Page 15 of 1** **Appendix-3** **SOP # QC-008E** ## Follow Up Program For Purified Water Station *(Month/Year):* | Date | 1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 | 10 | 11 | 12 | 13 | 14 | 15 | 16 | 17 | 18 | 19 | 20 | 21 | 22 | 23 | 24 | 25 | 26 | 27 | 28 | 29 | 30 | 31 | |---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---| | Tab no. | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | Tab no.(1) <br> Before raw water storage | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | Tab no.(2) <br> After raw water storage | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | Tab no.(3) <br> after RO unit | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | Tab no.(4) <br> After biological filter | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | Tab no.(5) <br> Before RC storage | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | Tab no.(6) <br> Preparation room suspension | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | Tab no.(7) <br> biological lab (washing room) | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | Tab no.(8) <br> Biological lab | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | Tab no.(9) <br> Chemical lab | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | Tab no.(10) <br> Preparation room syrup | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | Tab no.(11) <br> Washing room tablet | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | Tab no.(12) <br> Preparation room tablet | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | Tab no.(13) <br> Preparation room ointment | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | Tab no.(14) <br> Washing room ointment | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | Done | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | Not Done | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | Prepared by: <br> QC Manager | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |