Equipment used in pharmaceuticals dosage form manufacturing need to observe continuous qualification to monitor its performance and Concept of URS ,DQ, IQ,OQ,PQ,MQ...
role of quality system and audit in pharmaceutical manufacturing environment....MridulBindra2
M. pharma quality assurance
role of quality system and audit in pharmaceutical manufacturing environment.
topics covered are as follows
cGMP regulation
quality assurance functions
quality system approach
management responsibility
resources
Equipment used in pharmaceuticals dosage form manufacturing need to observe continuous qualification to monitor its performance and Concept of URS ,DQ, IQ,OQ,PQ,MQ...
role of quality system and audit in pharmaceutical manufacturing environment....MridulBindra2
M. pharma quality assurance
role of quality system and audit in pharmaceutical manufacturing environment.
topics covered are as follows
cGMP regulation
quality assurance functions
quality system approach
management responsibility
resources
Fluidized Bed Dryer
Principle of FBD
Construction of FBD
Working of FBD
Steps of Fluidization
Qualification of FBD
Design Qualification
Installation Qualification
Operational Qualification
Performance Qualification
References
QUALIFICATION & VALIDATION.Validation is an essential part of GMP, and an element of QA.Critical steps in the process need to be validated.Need for confidence that the product will consistently meet predetermined specifications and attributes.
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.
Qualification and Validation have big Weightage in the Regulatory Compliance and GMP. Qualification and Validation only can guarantee about the Product Safety, Integrity, Strength, Purity and Quality assurance.
WHO Good Manufacturing Practice Requirements
Good Manufacturing Practice is the part of quality assurance that ensures that products are consistently manufactured and controlled to the quality standards appropriate to their intended use.
Fluidized Bed Dryer
Principle of FBD
Construction of FBD
Working of FBD
Steps of Fluidization
Qualification of FBD
Design Qualification
Installation Qualification
Operational Qualification
Performance Qualification
References
QUALIFICATION & VALIDATION.Validation is an essential part of GMP, and an element of QA.Critical steps in the process need to be validated.Need for confidence that the product will consistently meet predetermined specifications and attributes.
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.
Qualification and Validation have big Weightage in the Regulatory Compliance and GMP. Qualification and Validation only can guarantee about the Product Safety, Integrity, Strength, Purity and Quality assurance.
WHO Good Manufacturing Practice Requirements
Good Manufacturing Practice is the part of quality assurance that ensures that products are consistently manufactured and controlled to the quality standards appropriate to their intended use.
On FDA’s Guidance on Pharmaceutical Process Validation (2011)lAjaz Hussain
Connectors between Culture – Metrics – Continued Process Verification in Process Validation?
Confidence is a critical quality attribute. CGMP violations erode confidence and increase nocebo effects. Currently – “breaches in assurance of data integrity” is a global concern. Have exposed the prevailing ‘regulator heterogeneity’. Re-building ‘epistemic trust” is difficult generally; more so with US FDA. Some thoughts on how to ....
the various categories of qualifications necessary for Validating an equipment or instrument before & after installation. Those are
DQ(Design Qualification)
IQ(Installation Qualification)
OQ(Operation Qualification)
PQ(Performance Qualification)
validation is a technique of validating the final product either starting from the raw material or within the process, its all types cover the methods of validation and sequence in the product development.
Title: Sense of Taste
Presenter: Dr. Faiza, Assistant Professor of Physiology
Qualifications:
MBBS (Best Graduate, AIMC Lahore)
FCPS Physiology
ICMT, CHPE, DHPE (STMU)
MPH (GC University, Faisalabad)
MBA (Virtual University of Pakistan)
Learning Objectives:
Describe the structure and function of taste buds.
Describe the relationship between the taste threshold and taste index of common substances.
Explain the chemical basis and signal transduction of taste perception for each type of primary taste sensation.
Recognize different abnormalities of taste perception and their causes.
Key Topics:
Significance of Taste Sensation:
Differentiation between pleasant and harmful food
Influence on behavior
Selection of food based on metabolic needs
Receptors of Taste:
Taste buds on the tongue
Influence of sense of smell, texture of food, and pain stimulation (e.g., by pepper)
Primary and Secondary Taste Sensations:
Primary taste sensations: Sweet, Sour, Salty, Bitter, Umami
Chemical basis and signal transduction mechanisms for each taste
Taste Threshold and Index:
Taste threshold values for Sweet (sucrose), Salty (NaCl), Sour (HCl), and Bitter (Quinine)
Taste index relationship: Inversely proportional to taste threshold
Taste Blindness:
Inability to taste certain substances, particularly thiourea compounds
Example: Phenylthiocarbamide
Structure and Function of Taste Buds:
Composition: Epithelial cells, Sustentacular/Supporting cells, Taste cells, Basal cells
Features: Taste pores, Taste hairs/microvilli, and Taste nerve fibers
Location of Taste Buds:
Found in papillae of the tongue (Fungiform, Circumvallate, Foliate)
Also present on the palate, tonsillar pillars, epiglottis, and proximal esophagus
Mechanism of Taste Stimulation:
Interaction of taste substances with receptors on microvilli
Signal transduction pathways for Umami, Sweet, Bitter, Sour, and Salty tastes
Taste Sensitivity and Adaptation:
Decrease in sensitivity with age
Rapid adaptation of taste sensation
Role of Saliva in Taste:
Dissolution of tastants to reach receptors
Washing away the stimulus
Taste Preferences and Aversions:
Mechanisms behind taste preference and aversion
Influence of receptors and neural pathways
Impact of Sensory Nerve Damage:
Degeneration of taste buds if the sensory nerve fiber is cut
Abnormalities of Taste Detection:
Conditions: Ageusia, Hypogeusia, Dysgeusia (parageusia)
Causes: Nerve damage, neurological disorders, infections, poor oral hygiene, adverse drug effects, deficiencies, aging, tobacco use, altered neurotransmitter levels
Neurotransmitters and Taste Threshold:
Effects of serotonin (5-HT) and norepinephrine (NE) on taste sensitivity
Supertasters:
25% of the population with heightened sensitivity to taste, especially bitterness
Increased number of fungiform papillae
Flu Vaccine Alert in Bangalore Karnatakaaddon Scans
As flu season approaches, health officials in Bangalore, Karnataka, are urging residents to get their flu vaccinations. The seasonal flu, while common, can lead to severe health complications, particularly for vulnerable populations such as young children, the elderly, and those with underlying health conditions.
Dr. Vidisha Kumari, a leading epidemiologist in Bangalore, emphasizes the importance of getting vaccinated. "The flu vaccine is our best defense against the influenza virus. It not only protects individuals but also helps prevent the spread of the virus in our communities," he says.
This year, the flu season is expected to coincide with a potential increase in other respiratory illnesses. The Karnataka Health Department has launched an awareness campaign highlighting the significance of flu vaccinations. They have set up multiple vaccination centers across Bangalore, making it convenient for residents to receive their shots.
To encourage widespread vaccination, the government is also collaborating with local schools, workplaces, and community centers to facilitate vaccination drives. Special attention is being given to ensuring that the vaccine is accessible to all, including marginalized communities who may have limited access to healthcare.
Residents are reminded that the flu vaccine is safe and effective. Common side effects are mild and may include soreness at the injection site, mild fever, or muscle aches. These side effects are generally short-lived and far less severe than the flu itself.
Healthcare providers are also stressing the importance of continuing COVID-19 precautions. Wearing masks, practicing good hand hygiene, and maintaining social distancing are still crucial, especially in crowded places.
Protect yourself and your loved ones by getting vaccinated. Together, we can help keep Bangalore healthy and safe this flu season. For more information on vaccination centers and schedules, residents can visit the Karnataka Health Department’s official website or follow their social media pages.
Stay informed, stay safe, and get your flu shot today!
Anti ulcer drugs and their Advance pharmacology ||
Anti-ulcer drugs are medications used to prevent and treat ulcers in the stomach and upper part of the small intestine (duodenal ulcers). These ulcers are often caused by an imbalance between stomach acid and the mucosal lining, which protects the stomach lining.
||Scope: Overview of various classes of anti-ulcer drugs, their mechanisms of action, indications, side effects, and clinical considerations.
- Video recording of this lecture in English language: https://youtu.be/lK81BzxMqdo
- Video recording of this lecture in Arabic language: https://youtu.be/Ve4P0COk9OI
- Link to download the book free: https://nephrotube.blogspot.com/p/nephrotube-nephrology-books.html
- Link to NephroTube website: www.NephroTube.com
- Link to NephroTube social media accounts: https://nephrotube.blogspot.com/p/join-nephrotube-on-social-media.html
MANAGEMENT OF ATRIOVENTRICULAR CONDUCTION BLOCK.pdfJim Jacob Roy
Cardiac conduction defects can occur due to various causes.
Atrioventricular conduction blocks ( AV blocks ) are classified into 3 types.
This document describes the acute management of AV block.
micro teaching on communication m.sc nursing.pdfAnurag Sharma
Microteaching is a unique model of practice teaching. It is a viable instrument for the. desired change in the teaching behavior or the behavior potential which, in specified types of real. classroom situations, tends to facilitate the achievement of specified types of objectives.
Couples presenting to the infertility clinic- Do they really have infertility...Sujoy Dasgupta
Dr Sujoy Dasgupta presented the study on "Couples presenting to the infertility clinic- Do they really have infertility? – The unexplored stories of non-consummation" in the 13th Congress of the Asia Pacific Initiative on Reproduction (ASPIRE 2024) at Manila on 24 May, 2024.
Ozempic: Preoperative Management of Patients on GLP-1 Receptor Agonists Saeid Safari
Preoperative Management of Patients on GLP-1 Receptor Agonists like Ozempic and Semiglutide
ASA GUIDELINE
NYSORA Guideline
2 Case Reports of Gastric Ultrasound
These lecture slides, by Dr Sidra Arshad, offer a quick overview of physiological basis of a normal electrocardiogram.
Learning objectives:
1. Define an electrocardiogram (ECG) and electrocardiography
2. Describe how dipoles generated by the heart produce the waveforms of the ECG
3. Describe the components of a normal electrocardiogram of a typical bipolar leads (limb II)
4. Differentiate between intervals and segments
5. Enlist some common indications for obtaining an ECG
Study Resources:
1. Chapter 11, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 9, Human Physiology - From Cells to Systems, Lauralee Sherwood, 9th edition
3. Chapter 29, Ganong’s Review of Medical Physiology, 26th edition
4. Electrocardiogram, StatPearls - https://www.ncbi.nlm.nih.gov/books/NBK549803/
5. ECG in Medical Practice by ABM Abdullah, 4th edition
6. ECG Basics, http://www.nataliescasebook.com/tag/e-c-g-basics
Report Back from SGO 2024: What’s the Latest in Cervical Cancer?bkling
Are you curious about what’s new in cervical cancer research or unsure what the findings mean? Join Dr. Emily Ko, a gynecologic oncologist at Penn Medicine, to learn about the latest updates from the Society of Gynecologic Oncology (SGO) 2024 Annual Meeting on Women’s Cancer. Dr. Ko will discuss what the research presented at the conference means for you and answer your questions about the new developments.
2. 02/11/15 2
Qualification & ValidationQualification & Validation
EquipmentEquipment
11
EquipmentEquipment
11
SystemSystem
AA
SystemSystem
AA
EquipmentEquipment
22
EquipmentEquipment
22
SystemSystem
BB
SystemSystem
BB
EquipmentEquipment
33
EquipmentEquipment
33
EquipmentEquipment
44
EquipmentEquipment
44
ProcessProcessProcessProcess
QualificationQualification
ValidationValidation
ValidationValidation&&
Qualification is a part of validation
3. 02/11/15 3
Definition:
Action of proving and documenting that the premises,
system & equipment are properly installed, and or work
correctly and lead to expected result.
QualificationQualification
5. 02/11/15 5
Validation Project
System Build /
Implementation
System Build /
Implementation
PlanningPlanning
VMP
SpecificationSpecificationURS
FS
VerificationVerification PV/PQ
IQ
OQ
DS/DQ
FAT SAT
ReportingReporting
Summary &
Recommendation
Final Report
6. 02/11/15 6
Validation Master PlanValidation Master Plan
Definition
A Validation Master Plan is a
document that summarizes the firm's
overall philosophy, intention and
approach to be used for establishing
performance adequacy
performance adequacy
QualificationQualification ValidationValidation
Validation Master PlanValidation Master Plan
ProcessProcess
ValidationValidation
CleaningCleaning Validation
Method Validation
EquipmentEquipmentPremisesPremisesSystems/
Utilities
7. 02/11/15 7Change ControlChange Control
Planning & SchedulingPlanning & Scheduling
Required SOP'sRequired SOP's
Documentation FormatDocumentation Format
Key Acceptance CriteriaKey Acceptance Criteria
List of Products/Processes/ Systems/Equipment to be ValidatedList of Products/Processes/ Systems/Equipment to be Validated
Validation Approach (Prospective, concurrent, Retrospective, Revalidation)Validation Approach (Prospective, concurrent, Retrospective, Revalidation)
Plant / Process / Product DescriptionPlant / Process / Product Description
Organizational Structure of All Validation ActivitiesOrganizational Structure of All Validation Activities
Introduction & Firm's validation policy,Introduction & Firm's validation policy,
Specific Process Considerations (Critical Point of process)Specific Process Considerations (Critical Point of process)
VMPFormat & contents
8. 02/11/15 8
USER required specificationUSER required specification
Definition
A document stating the specified
user requirement for a select piece
of equipment, System or Facility.
The contents of a URS typically include, but are not limited to
the following:
The contents of a URS typically include, but are not limited to
the following:
Functional &
Operational
requirement
Regulatory
requirement
Migration of any
electronic data
Cost
Maintenance
requirement
EH&S
requirement
9. 02/11/15 9
functional Specificationfunctional Specification
Definition:
The Functional Specification
describes the detailed operation
of the equipment, from which an
OQ test plan can be constructed.
10. 02/11/15 10
Design SpecificationDesign Specification
Definition:
The Design Specification usually
consists of the electrical
schematics, part descriptions, and
the detail required to construct the
system. from which an IQ test plan
can be constructed.
11. 02/11/15 11
Factory AcceptanceTestFactory AcceptanceTest
Factory Acceptance Test (FAT):
is a test conducted at the
Vender’s premises, usually by a
third party, to verify that the
System, Equipment operates
according to the specifications.
12. 02/11/15 12
SAT: Site Acceptance TestEquipment testing done at
the Final operational site.orExecuted with thecustomer on site.
SITE AcceptanceTestSITE AcceptanceTest
13. 02/11/15 13
Design QualificationDesign Qualification
Definition:The documented evidence that
premises, supporting system,
utilities, equipment & process
have been designed inaccordance with therequirement of GMP.
14. 02/11/15 14
Installation Qualification
I.Q
Documentation
&Identification
Peripheral
equipments
Utilities Maintenance
&Lubrications
CalibrationTraining
Safety
feature
Evaluation of
Machine
motor
Definition
The performance of test to ensure that the installation
(such as machine, measuring device, utilities,
manufacturing area) used in manufacturing process are
appropriately selected and correctly installed &
operate in accordance with establish specification.
Design SpecificationDesign Specification
Verify
Installation QualificationInstallation Qualification
15. 02/11/15 15
Operational QualificationOperational Qualification
Definition:
The documented verification that the system or
subsystem performs as intended over all anticipated
operating ranges.
Control function Test Operational test
O.QO.Q
Functional SpecificationFunctional Specification
Verify
Operational QualificationOperational Qualification
16. 02/11/15 16
Process/PerformanceQualificationProcess/PerformanceQualification
Definition
The documented verification that the facilities,
systems and equipment operate consistently and
gives reproducibility within define specification
and parameter for prolong period.
Or
Confirming that the manufacturing process as
designed is capable of reproducible commercial
manufacturing. (FDA)
URSURS
Verify
PQPQ
Excellent
Good
Too Much
Variation
Specification
USL LSL
Specification
USL LSL
Specification
USL LSL
17. 02/11/15 17
A condition or set of conditions encompassing upper and
lower processing limits and circumstances, within SOP,
which pose the greatest chance of product or process
failure when compared to ideal conditions. Such
conditions do not necessarily induce product or process
failure.
(e.g. start-up after shutdown, temperature recovery
time, Autoclave largest load, or largest mass)
Worst CaseScenariosWorst CaseScenarios
18. 02/11/15 18
ProtocolProtocol
Protocol:
A document that spells out
what tests are to be
performed, how the tests
are to be performed, what
data are to be collected,
and what the accep
tance criteria are.
19. 02/11/15 19
reportreport
Report:
A document in which the records,
results & evaluation of a completed
validation / Qualification programme
are assemble & summarized. it may also
contain proposal for improvement of
process, System and/or Equipment.
20. 02/11/15 20
ProspectiveProspective
New Product/process/system/
Equipment
New Product/process/system/
Equipment
Routine Product/Process/system/equipment
Concurrent
Review and analysis of historical DataRetrospective
Repetition of theQualification/validation processor a specific portion of it.
Re-Validation /Qualification
Typeof ValidationTypeof Validation
21. 02/11/15 21
A formal system by which qualified
representatives of appropriate
disciplines review proposed or
actual changes that might affect
the validated status of facilities,
systems, equipment or processes.
Changecontrol
22. 02/11/15 22
STAGE 01
Process Design
Based on
product
Quality &
patient safety
Know the
process
Know the
Variable
Have the
confidence Vigilance
1. Process
Understanding
1. Process
Understanding
2. Process
Design
2. Process
Design
3. Process
Qualification
3. Process
Qualification
4. Commercial
Manufacturing
4. Commercial
Manufacturing
5. Monitoring &
Improvement
5. Monitoring &
Improvement
Change ControlChange Control
ProcessValidation
STAGE 02
Process
Qualification
STAGE 03
Continue process
verification