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1581995753943audit-221215085248-ec81c6e4 (1) (1).pdf

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This document discusses auditing of quality assurance and engineering departments. It defines quality audit as an examination to determine compliance with plans and effectiveness in achieving objectives. It discusses the importance of quality maintenance in maintaining perfect equipment and products. The key pillars of quality maintenance are focused improvement, autonomous maintenance, planned maintenance, maintenance prevention, and training. Critical systems like HVAC, WFI, and ETP are also discussed. HVAC maintenance is important for temperature control, airflow, and preventing cross-contamination. Validation of these critical systems ensures the sterile area and systems operate as intended.

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AUDITING OF QUALITY ASSURANCE AND ENGINEERING DEPARTMENT BY: HEMLATA R. MORE ASSISTANT PROFESSOR QUALITY ASSURANCE
Definition Introduction Critical system Pillars Of Quality Maintenance Advantages Critical systems:- HVAC WFI ETP Contents
Quality audit is defined as a systematic and independent examination to determine whether activities and related results comply with planned arrangements and whether are implemented effectively and are suitable to achieve objectives. Definition
There is an important correlation between quality and maintenance. Maintenance management has become the essential part of quality system. It is an investment rather than the cost. Improving the quality of maintenance will lead to improve efficiency and effectiveness. Maintaining perfect equipment means maintaining the perfect quality of products. Introduction
It is executed by inspecting and monitoring conditions to eliminate variation. The key is to prevent defect from being produced in the first place, rather than installing rigorous inspection systems to detect the defect after it has been produced. It is aimed towards higher customer satisfaction or customer delight through highest quality achieved from defect free manufacturing. What is Quality Maintenance ?
Focused Improvement. Autonomous Maintenance. Planned Maintenance. Maintenance Prevention. Training and Education. Pillars of Quality Maintenance
Some of the advantages of Quality maintenance are: Reduces cost of quality. Reduces waste and rework. In-line detection and segregation of defects. Achieve and sustain customer complaints at zero. Higher customer satisfaction. Advantages
Critical systems:- It includes , HVAC( Heating, Ventilation and Air conditioning) WFI(Water for injection) ETP(Effluent treatment plant) HVAC What is HVAC ? Heating, ventilation and air conditioning (HVAC) system It is integral component of pharmaceutical facility functionality. The system is needed for maintenance of a suitable temperature, for continuous flow of air, which ultimately prevent cross contamination and accumulation of air and to ensure the cooling of air in the premises. Critical systems
1. Air conditioner 2. AHUs (Air Handling Units) 3. Dehumidifier /Heater 4. Filters(Pre & HEPA) 5. Dust extractors 6. Ducting (For delivery of controlled air) 7. Supply Fans 8. Dampers 9. Humidity/temperature/pressure sensors 10. Mixer 11. Heating /cooling coils HVAC consist of
HVAC is important to architectural design efforts for four reasons: These system often require substantial floor space and building volume for equipment and distribution element that must accommodated during design process. HVAC system constitute a major budget items for common building. Success or failure of thermal comfort efforts usually directly related to the success of failure of buildings. Maintenance appropriate thermal condition through HVAC system. Importance of HVAC system
1581995753943audit-221215085248-ec81c6e4 (1) (1).pdf
Validation of HVAC System HVAC system validation is required for pharmaceutical cleanroom validation. The sterile area is validated through the following tests. 1. Air Flow Pattern 2. Air Flow Velocity And Change Per Hour 3. Filter Leak Test 4. Particles Count 5. Viable Monitoring 6. Filter Integrity Test 7. Pressure Difference 8. Temperature and Humidity Uniformity Test 9. Fresh Air Determination
Water and Water for Injection System Types of Water Potable Water Purified Water WFI Sterile Water For Injection Sterile Water For Bacteriostatic Injection
Component Piping Valves Pumps Sensors Pressure Gauze Heat Exchange Filter Distillati on unit Deionizer Component Of Water System
Validation of WFI System 1. Perform Installation Qualification. Verify piping, fittings, proper dimensions drawings, wiring, PC software, calibration, and quality of materials. 2. Check flow rates, low volume of water supply, excessive pressure drop, resistivity drops below-set point, and temperature drop or increase beyond the set level. 3. Perform general operational controls verification testing. 4. Operate system throughout the range of operating design specifications or range of intended use. 5. System regulators must operate within 賊2 psi of design level.
Validation of WFI System continue 6. Operate the system per SOP for operation and maintenance of purified water system. Perform sampling over a 1 month period per the sampling procedure and schedule. Test samples for conformance to current USP Water for Injection monograph, microbial content and endotoxin content. Identify all morphological distinct colony forming units (CFUs) to at least the genus level. 7. Measure the flow rate and calculate the velocity of the water, or measure the velocity directly at a point between the last use point and the storage tank. 8. Record the range of all process or equipment parameters (set points, flow rates, timing sequences, concentrations, etc.) verified during Operational and Performance Qualification testing.
1581995753943audit-221215085248-ec81c6e4 (1) (1).pdf
ETP audit determine if contractor complied with ETP contract ,regulations and policies . Information shown here summarize routine ETP audit processes . Auditors will provide detailed information and guidance through an actual audit. IMPORTANCE OF ETP To remove as much of the solid and organic matter as possible Reused for various hospitals purpose , To provide some degree of treatment of to waste water before it can be used for other purpose . EFFLUENT: Liquid waste flowing out of a factory ,farm, commercial establishment or household into a water body such as river ,lake or lagoon. ETP (Effluent Treatment Plant )
1581995753943audit-221215085248-ec81c6e4 (1) (1).pdf
1581995753943audit-221215085248-ec81c6e4 (1) (1).pdf
Validation of ETP System Treated water is then analyzed for the required quality. Following is the specification for the treated wastewater that can be used for irrigation. SR. NO. PARAMETERS LIMIT 1. pH 6.5-8.0 2. Suspended solid 100 mg/lit. 3. COD 250 mg/lit. 4. BOD 100 mg/lit 5. Oil & Grease 10 mg/lit
1. Pharmaceutical dosage forms: Parenteral medication, Revised and Expanded, Edited by Kenneth E. Avis, Herbert A. libermann and Leon Lachmann, Volume 3, Second Edition, page no:- 363-420 2. Quality Manual, D. H. Shah, First edition, page no:- 184-216 3. https://www.pharmaguideline.com/2013/01/water-for-injection-wfi- system.html?m=1 References
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1581995753943audit-221215085248-ec81c6e4 (1) (1).pdf

  • 1. AUDITING OF QUALITY ASSURANCE AND ENGINEERING DEPARTMENT BY: HEMLATA R. MORE ASSISTANT PROFESSOR QUALITY ASSURANCE
  • 2. Definition Introduction Critical system Pillars Of Quality Maintenance Advantages Critical systems:- HVAC WFI ETP Contents
  • 3. Quality audit is defined as a systematic and independent examination to determine whether activities and related results comply with planned arrangements and whether are implemented effectively and are suitable to achieve objectives. Definition
  • 4. There is an important correlation between quality and maintenance. Maintenance management has become the essential part of quality system. It is an investment rather than the cost. Improving the quality of maintenance will lead to improve efficiency and effectiveness. Maintaining perfect equipment means maintaining the perfect quality of products. Introduction
  • 5. It is executed by inspecting and monitoring conditions to eliminate variation. The key is to prevent defect from being produced in the first place, rather than installing rigorous inspection systems to detect the defect after it has been produced. It is aimed towards higher customer satisfaction or customer delight through highest quality achieved from defect free manufacturing. What is Quality Maintenance ?
  • 6. Focused Improvement. Autonomous Maintenance. Planned Maintenance. Maintenance Prevention. Training and Education. Pillars of Quality Maintenance
  • 7. Some of the advantages of Quality maintenance are: Reduces cost of quality. Reduces waste and rework. In-line detection and segregation of defects. Achieve and sustain customer complaints at zero. Higher customer satisfaction. Advantages
  • 8. Critical systems:- It includes , HVAC( Heating, Ventilation and Air conditioning) WFI(Water for injection) ETP(Effluent treatment plant) HVAC What is HVAC ? Heating, ventilation and air conditioning (HVAC) system It is integral component of pharmaceutical facility functionality. The system is needed for maintenance of a suitable temperature, for continuous flow of air, which ultimately prevent cross contamination and accumulation of air and to ensure the cooling of air in the premises. Critical systems
  • 9. 1. Air conditioner 2. AHUs (Air Handling Units) 3. Dehumidifier /Heater 4. Filters(Pre & HEPA) 5. Dust extractors 6. Ducting (For delivery of controlled air) 7. Supply Fans 8. Dampers 9. Humidity/temperature/pressure sensors 10. Mixer 11. Heating /cooling coils HVAC consist of
  • 10. HVAC is important to architectural design efforts for four reasons: These system often require substantial floor space and building volume for equipment and distribution element that must accommodated during design process. HVAC system constitute a major budget items for common building. Success or failure of thermal comfort efforts usually directly related to the success of failure of buildings. Maintenance appropriate thermal condition through HVAC system. Importance of HVAC system
  • 12. Validation of HVAC System HVAC system validation is required for pharmaceutical cleanroom validation. The sterile area is validated through the following tests. 1. Air Flow Pattern 2. Air Flow Velocity And Change Per Hour 3. Filter Leak Test 4. Particles Count 5. Viable Monitoring 6. Filter Integrity Test 7. Pressure Difference 8. Temperature and Humidity Uniformity Test 9. Fresh Air Determination
  • 13. Water and Water for Injection System Types of Water Potable Water Purified Water WFI Sterile Water For Injection Sterile Water For Bacteriostatic Injection
  • 15. Validation of WFI System 1. Perform Installation Qualification. Verify piping, fittings, proper dimensions drawings, wiring, PC software, calibration, and quality of materials. 2. Check flow rates, low volume of water supply, excessive pressure drop, resistivity drops below-set point, and temperature drop or increase beyond the set level. 3. Perform general operational controls verification testing. 4. Operate system throughout the range of operating design specifications or range of intended use. 5. System regulators must operate within 賊2 psi of design level.
  • 16. Validation of WFI System continue 6. Operate the system per SOP for operation and maintenance of purified water system. Perform sampling over a 1 month period per the sampling procedure and schedule. Test samples for conformance to current USP Water for Injection monograph, microbial content and endotoxin content. Identify all morphological distinct colony forming units (CFUs) to at least the genus level. 7. Measure the flow rate and calculate the velocity of the water, or measure the velocity directly at a point between the last use point and the storage tank. 8. Record the range of all process or equipment parameters (set points, flow rates, timing sequences, concentrations, etc.) verified during Operational and Performance Qualification testing.
  • 18. ETP audit determine if contractor complied with ETP contract ,regulations and policies . Information shown here summarize routine ETP audit processes . Auditors will provide detailed information and guidance through an actual audit. IMPORTANCE OF ETP To remove as much of the solid and organic matter as possible Reused for various hospitals purpose , To provide some degree of treatment of to waste water before it can be used for other purpose . EFFLUENT: Liquid waste flowing out of a factory ,farm, commercial establishment or household into a water body such as river ,lake or lagoon. ETP (Effluent Treatment Plant )
  • 21. Validation of ETP System Treated water is then analyzed for the required quality. Following is the specification for the treated wastewater that can be used for irrigation. SR. NO. PARAMETERS LIMIT 1. pH 6.5-8.0 2. Suspended solid 100 mg/lit. 3. COD 250 mg/lit. 4. BOD 100 mg/lit 5. Oil & Grease 10 mg/lit
  • 22. 1. Pharmaceutical dosage forms: Parenteral medication, Revised and Expanded, Edited by Kenneth E. Avis, Herbert A. libermann and Leon Lachmann, Volume 3, Second Edition, page no:- 363-420 2. Quality Manual, D. H. Shah, First edition, page no:- 184-216 3. https://www.pharmaguideline.com/2013/01/water-for-injection-wfi- system.html?m=1 References