This document discusses auditing of quality assurance and engineering departments. It defines quality audit and discusses the importance of quality maintenance through pillars such as focused improvement and autonomous maintenance. Critical systems like HVAC, WFI, and ETP are explained. HVAC is described as maintaining temperature and air flow. Validation of HVAC, WFI, and ETP systems is outlined. The document provides references for further information.
Role of quality system and audits in pharmamaceuticalganpat420
Introduction
cGMP Regulations
Quality Assurance Function
Quality Systems Approach
Management Responsibilities
Resources
Manufacturing Operations
Evaluation Activities
Transitioning to Quality Systems Approach
Audit Checklist for Drug Industry
As the audit proceeds, there might arise some situations where the facts indicate there is a failure, either partially or wholly, of the quality management system, such a situation is called nonconformity/ deficiencies”.
Role of quality system and audits in pharmamaceuticalganpat420
Introduction
cGMP Regulations
Quality Assurance Function
Quality Systems Approach
Management Responsibilities
Resources
Manufacturing Operations
Evaluation Activities
Transitioning to Quality Systems Approach
Audit Checklist for Drug Industry
As the audit proceeds, there might arise some situations where the facts indicate there is a failure, either partially or wholly, of the quality management system, such a situation is called nonconformity/ deficiencies”.
QUALIFICATION OF MANUFACTURING EQUIPMENTSANKUSH JADHAV
it gives the information about qualification of various manufacturing equipment which is used into the pharmaceutical labs. (only for information purpose)
Qualification of tablet compression machinePritam Kolge
Qualification of Tablet Compression Machine ...
This topic comes under Quality Control and Quality Assurance....
This is useful for M.Pharm (Pharaceutical Quality Assurance) Students who studying in First year sem II....
This Presentation Contain following...
#Introduction
#Design Qualification
#Installation Qualification
#Operational Qualification
#Performance Qualification
#Case Study
#Conclusion
#References
Thanks For Help and Guidance of Dr. Mrs. N. M. Bhatia Mam
Role of quality systems and audits in pharmaceutical manufacturing environmentMalay Pandya
By regulation, appropriate practice, and common sense, quality assurance (QA) is a critical function in the pharmaceutical manufacturing environment. The need for an independent unit to audit and comment on the appropriate application of standard operating procedures, master batch records, procedures approved in product applications, and the proper functioning of the quality control (QC) unit is paramount.
This helps assure that products are manufactured reliably, with adherence to approved specifications, and that current good manufacturing practices (cGMP) are maintained in conformance to regulation, both in the facility in general and the microenvironment of each product ’s manufacturing sequence.
It is process of “Establishing documentary evidence that provide a high degree of assurance that a specific process will consistently produce a product meeting its predetermined specifications and quality attributes”.
In the pharmaceutical industry, it is very important that in addition to final testing and compliance of products, it is also assured that the process will consistently produce the expected results.
Validation is action of proving in accordance with the principles of good manufacturing practices, that any procedure, process, equipment, material, activity or system actually leads to expected results.
Cleaning validation is documented evidence with a high degree assurance that one can consistently clean a system or a piece of equipment to predetermined and acceptable limits.
The primary regulatory concern driving the need for cleaning validation is cross contamination of the desired drug substance either by other API from previous batch runs or by residues from the cleaning agents used.
The prime purpose of validating a cleaning process is to ensure compliance with federal and other standard regulations
1. Cross contamination with active ingredients
Contamination of one batch of product with significant levels of residual active ingredients from previous batch cannot be tolerated.
In addition to the obvious problems posed by subjecting consumers or patients to unintended contaminants, potential clinically significant synergistic interactions between pharmacologically active chemicals are a real concern.
2. Contamination with unintended materials or compounds
While inert ingredients used in drug products are generally recognized as safe for human consumption, the routine use, maintenance and cleaning of equipment's provide the potential contamination with such items as equipment parts, lubricants and chemical cleaning agents3. Microbiological contamination
Maintenance , cleaning and storage conditions may provide adventitious microorganisms with the opportunity to proliferate within the processing equipment.
Auditing of Granulation Operation in Dry Production AreaPritam Kolge
Auditing of Granulation Operation in Dry Production Area.....
This topic comes under Audits and Regulatory Compliance....
This is useful for M.Pharm (Pharaceutical Quality Assurance) Students who studying in First year sem II....
This Presentation Contain following...
#Objectives
#Fundamentals of Granulation
#Reasons for Granulation
#Methods of Granulation
#Agglomeration
#Fundamentals and Audit of Dry Granulation
#Steps in Dry Granulation
#Fundamentals and Audit of Fluid Bed Granulation
#Scale-Up of Fluid bed Granulation
#High share granulation-Fundamentals, Audit and Scale-Up
#Overview and Comparison of Different Granulating Techniques
#Audit of Mixing and Blending, Wet granulation, Wet milling, Drying, Milling
#Conclusion
#References
Thanks For Help and Guidance of Mr. D.P.Mali Sir
Autoclave
Principle of Autoclave
Construction of Autoclave
Working of Autoclave
Qualification of Autoclave
Installation Qualification
Operational Qualification
Performance Qualification
References
Qualification of Tablet Compression Machine.pptxDhruvi50
Tablet Compression Machine
Principle of Tablet Compression Machine
Construction of Tablet Compression Machine
Working of Tablet Compression Machine
Qualification of Tablet Compression Machine
Installation Qualification
Operational Qualification
Performance Qualification
References
Qualification of Dissolution Test Apparatus and Validation of Utility System this presentation will help to enhance your knowledge in validation and qualification area.
AUDITING OF QUALITY ASSURANCE AND ENGINEERING DEPARTMENT.pptxShankar Maind Patil
This Slideshare Contain a Brief information about the How Auditing Of QA Department is considered and followed in the Industry to get . Desired Quality product throughout the all production step and in the batch .
Objective importance and Advantages of QA Auditing are explained here. In this slide for giving out and detailed study About it .
QUALIFICATION OF MANUFACTURING EQUIPMENTSANKUSH JADHAV
it gives the information about qualification of various manufacturing equipment which is used into the pharmaceutical labs. (only for information purpose)
Qualification of tablet compression machinePritam Kolge
Qualification of Tablet Compression Machine ...
This topic comes under Quality Control and Quality Assurance....
This is useful for M.Pharm (Pharaceutical Quality Assurance) Students who studying in First year sem II....
This Presentation Contain following...
#Introduction
#Design Qualification
#Installation Qualification
#Operational Qualification
#Performance Qualification
#Case Study
#Conclusion
#References
Thanks For Help and Guidance of Dr. Mrs. N. M. Bhatia Mam
Role of quality systems and audits in pharmaceutical manufacturing environmentMalay Pandya
By regulation, appropriate practice, and common sense, quality assurance (QA) is a critical function in the pharmaceutical manufacturing environment. The need for an independent unit to audit and comment on the appropriate application of standard operating procedures, master batch records, procedures approved in product applications, and the proper functioning of the quality control (QC) unit is paramount.
This helps assure that products are manufactured reliably, with adherence to approved specifications, and that current good manufacturing practices (cGMP) are maintained in conformance to regulation, both in the facility in general and the microenvironment of each product ’s manufacturing sequence.
It is process of “Establishing documentary evidence that provide a high degree of assurance that a specific process will consistently produce a product meeting its predetermined specifications and quality attributes”.
In the pharmaceutical industry, it is very important that in addition to final testing and compliance of products, it is also assured that the process will consistently produce the expected results.
Validation is action of proving in accordance with the principles of good manufacturing practices, that any procedure, process, equipment, material, activity or system actually leads to expected results.
Cleaning validation is documented evidence with a high degree assurance that one can consistently clean a system or a piece of equipment to predetermined and acceptable limits.
The primary regulatory concern driving the need for cleaning validation is cross contamination of the desired drug substance either by other API from previous batch runs or by residues from the cleaning agents used.
The prime purpose of validating a cleaning process is to ensure compliance with federal and other standard regulations
1. Cross contamination with active ingredients
Contamination of one batch of product with significant levels of residual active ingredients from previous batch cannot be tolerated.
In addition to the obvious problems posed by subjecting consumers or patients to unintended contaminants, potential clinically significant synergistic interactions between pharmacologically active chemicals are a real concern.
2. Contamination with unintended materials or compounds
While inert ingredients used in drug products are generally recognized as safe for human consumption, the routine use, maintenance and cleaning of equipment's provide the potential contamination with such items as equipment parts, lubricants and chemical cleaning agents3. Microbiological contamination
Maintenance , cleaning and storage conditions may provide adventitious microorganisms with the opportunity to proliferate within the processing equipment.
Auditing of Granulation Operation in Dry Production AreaPritam Kolge
Auditing of Granulation Operation in Dry Production Area.....
This topic comes under Audits and Regulatory Compliance....
This is useful for M.Pharm (Pharaceutical Quality Assurance) Students who studying in First year sem II....
This Presentation Contain following...
#Objectives
#Fundamentals of Granulation
#Reasons for Granulation
#Methods of Granulation
#Agglomeration
#Fundamentals and Audit of Dry Granulation
#Steps in Dry Granulation
#Fundamentals and Audit of Fluid Bed Granulation
#Scale-Up of Fluid bed Granulation
#High share granulation-Fundamentals, Audit and Scale-Up
#Overview and Comparison of Different Granulating Techniques
#Audit of Mixing and Blending, Wet granulation, Wet milling, Drying, Milling
#Conclusion
#References
Thanks For Help and Guidance of Mr. D.P.Mali Sir
Autoclave
Principle of Autoclave
Construction of Autoclave
Working of Autoclave
Qualification of Autoclave
Installation Qualification
Operational Qualification
Performance Qualification
References
Qualification of Tablet Compression Machine.pptxDhruvi50
Tablet Compression Machine
Principle of Tablet Compression Machine
Construction of Tablet Compression Machine
Working of Tablet Compression Machine
Qualification of Tablet Compression Machine
Installation Qualification
Operational Qualification
Performance Qualification
References
Qualification of Dissolution Test Apparatus and Validation of Utility System this presentation will help to enhance your knowledge in validation and qualification area.
AUDITING OF QUALITY ASSURANCE AND ENGINEERING DEPARTMENT.pptxShankar Maind Patil
This Slideshare Contain a Brief information about the How Auditing Of QA Department is considered and followed in the Industry to get . Desired Quality product throughout the all production step and in the batch .
Objective importance and Advantages of QA Auditing are explained here. In this slide for giving out and detailed study About it .
Validation of HVAC pharma geeta TUBE (Utility Systems)Saikat Bagchi
Validation Of HVAC, Heating, Ventilation, Air Conditioning; Utility Systems, Validation Parameters, Air Handling Unit, Work Flow Animation Diagram, Validation Process Tests & Parameters.
The Roman Empire A Historical Colossus.pdfkaushalkr1407
The Roman Empire, a vast and enduring power, stands as one of history's most remarkable civilizations, leaving an indelible imprint on the world. It emerged from the Roman Republic, transitioning into an imperial powerhouse under the leadership of Augustus Caesar in 27 BCE. This transformation marked the beginning of an era defined by unprecedented territorial expansion, architectural marvels, and profound cultural influence.
The empire's roots lie in the city of Rome, founded, according to legend, by Romulus in 753 BCE. Over centuries, Rome evolved from a small settlement to a formidable republic, characterized by a complex political system with elected officials and checks on power. However, internal strife, class conflicts, and military ambitions paved the way for the end of the Republic. Julius Caesar’s dictatorship and subsequent assassination in 44 BCE created a power vacuum, leading to a civil war. Octavian, later Augustus, emerged victorious, heralding the Roman Empire’s birth.
Under Augustus, the empire experienced the Pax Romana, a 200-year period of relative peace and stability. Augustus reformed the military, established efficient administrative systems, and initiated grand construction projects. The empire's borders expanded, encompassing territories from Britain to Egypt and from Spain to the Euphrates. Roman legions, renowned for their discipline and engineering prowess, secured and maintained these vast territories, building roads, fortifications, and cities that facilitated control and integration.
The Roman Empire’s society was hierarchical, with a rigid class system. At the top were the patricians, wealthy elites who held significant political power. Below them were the plebeians, free citizens with limited political influence, and the vast numbers of slaves who formed the backbone of the economy. The family unit was central, governed by the paterfamilias, the male head who held absolute authority.
Culturally, the Romans were eclectic, absorbing and adapting elements from the civilizations they encountered, particularly the Greeks. Roman art, literature, and philosophy reflected this synthesis, creating a rich cultural tapestry. Latin, the Roman language, became the lingua franca of the Western world, influencing numerous modern languages.
Roman architecture and engineering achievements were monumental. They perfected the arch, vault, and dome, constructing enduring structures like the Colosseum, Pantheon, and aqueducts. These engineering marvels not only showcased Roman ingenuity but also served practical purposes, from public entertainment to water supply.
Read| The latest issue of The Challenger is here! We are thrilled to announce that our school paper has qualified for the NATIONAL SCHOOLS PRESS CONFERENCE (NSPC) 2024. Thank you for your unwavering support and trust. Dive into the stories that made us stand out!
Embracing GenAI - A Strategic ImperativePeter Windle
Artificial Intelligence (AI) technologies such as Generative AI, Image Generators and Large Language Models have had a dramatic impact on teaching, learning and assessment over the past 18 months. The most immediate threat AI posed was to Academic Integrity with Higher Education Institutes (HEIs) focusing their efforts on combating the use of GenAI in assessment. Guidelines were developed for staff and students, policies put in place too. Innovative educators have forged paths in the use of Generative AI for teaching, learning and assessments leading to pockets of transformation springing up across HEIs, often with little or no top-down guidance, support or direction.
This Gasta posits a strategic approach to integrating AI into HEIs to prepare staff, students and the curriculum for an evolving world and workplace. We will highlight the advantages of working with these technologies beyond the realm of teaching, learning and assessment by considering prompt engineering skills, industry impact, curriculum changes, and the need for staff upskilling. In contrast, not engaging strategically with Generative AI poses risks, including falling behind peers, missed opportunities and failing to ensure our graduates remain employable. The rapid evolution of AI technologies necessitates a proactive and strategic approach if we are to remain relevant.
Acetabularia Information For Class 9 .docxvaibhavrinwa19
Acetabularia acetabulum is a single-celled green alga that in its vegetative state is morphologically differentiated into a basal rhizoid and an axially elongated stalk, which bears whorls of branching hairs. The single diploid nucleus resides in the rhizoid.
Model Attribute Check Company Auto PropertyCeline George
In Odoo, the multi-company feature allows you to manage multiple companies within a single Odoo database instance. Each company can have its own configurations while still sharing common resources such as products, customers, and suppliers.
The French Revolution, which began in 1789, was a period of radical social and political upheaval in France. It marked the decline of absolute monarchies, the rise of secular and democratic republics, and the eventual rise of Napoleon Bonaparte. This revolutionary period is crucial in understanding the transition from feudalism to modernity in Europe.
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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
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
11.
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 ±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.
17.
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 )
19.
20.
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