Audit and regulatory affairs

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

14. Component
Piping
Valves
Pumps
Sensors
Pressure
Gauze
Heat
Exchange
Filter
Distillati
on unit
Deionizer
Component Of Water System

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 ±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

23. THANK YOU !