m.pharm (pharmaceutics) modern pharmaceutics- unit 2 validation- part 2 Validation of specific dosage form,
Types of validation. Government regulation, Manufacturing Process Model,
URS, DQ, IQ, OQ & P.Q. of facilities.
M.pharm (Pharmaceutics) Modern Pharmaceutics unit- Validation Part-1 introduction, scope and merits of validation, Validation and calibration of Master plan, ICH & WHO guidelines for calibration and validation of equipment.
M.pharm (Pharmaceutics) Modern Pharmaceutics unit- Validation Part-1 introduction, scope and merits of validation, Validation and calibration of Master plan, ICH & WHO guidelines for calibration and validation of equipment.
Types of validation & validation of specific dosage.pptxankitanakashe21
Validation is a proven assurance of the process efficiency and sturdiness, and it is the full-fledged quality control tool for the pharmaceutical industries. It eliminates the chances of batch failures as the products are manufactured as per pre optimization of each manufacturing steps. The conventional process of testing at last stage created much problems in maintaining the uniformity of each batch but with the introduction of concept of validation, it has been easy to maintain the batch uniformity of the product along with imparting quality in them.
Types of validation & validation of specific dosage.pptxankitanakashe21
Validation is a proven assurance of the process efficiency and sturdiness, and it is the full-fledged quality control tool for the pharmaceutical industries. It eliminates the chances of batch failures as the products are manufactured as per pre optimization of each manufacturing steps. The conventional process of testing at last stage created much problems in maintaining the uniformity of each batch but with the introduction of concept of validation, it has been easy to maintain the batch uniformity of the product along with imparting quality in them.
Pharmaceutical Instrument and Analytical Validation and Qualification (SHOPNI...ShopnilAkash5
Validation is the process of establishing documentary evidence demonstrating that a procedure, process, or activity carried out in testing and then production maintains the desired level of compliance at all stages
It is essential to ensure the quality Of a product and Good Manufacturing Practices including all other regulatory requirements
Raw material validation- process validationRavish Yadav
The all the content in this profile is completed by the teachers, students as well as other health care peoples.
thank you, all the respected peoples, for giving the information to complete this presentation.
this information is free to use by anyone.
DRUG ABSORPTION FROM GASTROINTESTINAL TRACTMehak AggarwAl
MPHARMACY PHARMACEUTICS 2 SEMESTER
ADVANCED BIOPHARMACEUTICS AND PHARMACOKINETICS
UNIT 1 DRUG ABSORPTION FROM GASTROINTESTINAL TRACT
MECHANISM OF DRUG ABSOPTION
M.pharm (Pharmaceutics) Molecular Pharmaceutics (NTDS) unit 1 part 1 Targeted Drug Delivery Systems: Concepts, Events and biological process involved in drug targeting.
regulatory affairs m.pharm pharmaceutics - Non clinical drug development: Global submission of IND, NDA, ANDA.
Investigation of medicinal products dossier, dossier (IMPD) and investigator brochure (IB)
M.pharm (Pharmaceutics) modern pharmacy unit-5 Study of consolidation parameters; Diffusion parameters, Dissolution
parameters and Pharmacokinetic parameters, Heckel plots, Similarity factors – f2
and f1, Higuchi and Peppas plot, Linearity Concept of significance, Standard
deviation , Chi square test, students T-test , ANOVA test
Tom Selleck Health: A Comprehensive Look at the Iconic Actor’s Wellness Journeygreendigital
Tom Selleck, an enduring figure in Hollywood. has captivated audiences for decades with his rugged charm, iconic moustache. and memorable roles in television and film. From his breakout role as Thomas Magnum in Magnum P.I. to his current portrayal of Frank Reagan in Blue Bloods. Selleck's career has spanned over 50 years. But beyond his professional achievements. fans have often been curious about Tom Selleck Health. especially as he has aged in the public eye.
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Introduction
Many have been interested in Tom Selleck health. not only because of his enduring presence on screen but also because of the challenges. and lifestyle choices he has faced and made over the years. This article delves into the various aspects of Tom Selleck health. exploring his fitness regimen, diet, mental health. and the challenges he has encountered as he ages. We'll look at how he maintains his well-being. the health issues he has faced, and his approach to ageing .
Early Life and Career
Childhood and Athletic Beginnings
Tom Selleck was born on January 29, 1945, in Detroit, Michigan, and grew up in Sherman Oaks, California. From an early age, he was involved in sports, particularly basketball. which played a significant role in his physical development. His athletic pursuits continued into college. where he attended the University of Southern California (USC) on a basketball scholarship. This early involvement in sports laid a strong foundation for his physical health and disciplined lifestyle.
Transition to Acting
Selleck's transition from an athlete to an actor came with its physical demands. His first significant role in "Magnum P.I." required him to perform various stunts and maintain a fit appearance. This role, which he played from 1980 to 1988. necessitated a rigorous fitness routine to meet the show's demands. setting the stage for his long-term commitment to health and wellness.
Fitness Regimen
Workout Routine
Tom Selleck health and fitness regimen has evolved. adapting to his changing roles and age. During his "Magnum, P.I." days. Selleck's workouts were intense and focused on building and maintaining muscle mass. His routine included weightlifting, cardiovascular exercises. and specific training for the stunts he performed on the show.
Selleck adjusted his fitness routine as he aged to suit his body's needs. Today, his workouts focus on maintaining flexibility, strength, and cardiovascular health. He incorporates low-impact exercises such as swimming, walking, and light weightlifting. This balanced approach helps him stay fit without putting undue strain on his joints and muscles.
Importance of Flexibility and Mobility
In recent years, Selleck has emphasized the importance of flexibility and mobility in his fitness regimen. Understanding the natural decline in muscle mass and joint flexibility with age. he includes stretching and yoga in his routine. These practices help prevent injuries, improve posture, and maintain mobilit
Prix Galien International 2024 Forum ProgramLevi Shapiro
June 20, 2024, Prix Galien International and Jerusalem Ethics Forum in ROME. Detailed agenda including panels:
- ADVANCES IN CARDIOLOGY: A NEW PARADIGM IS COMING
- WOMEN’S HEALTH: FERTILITY PRESERVATION
- WHAT’S NEW IN THE TREATMENT OF INFECTIOUS,
ONCOLOGICAL AND INFLAMMATORY SKIN DISEASES?
- ARTIFICIAL INTELLIGENCE AND ETHICS
- GENE THERAPY
- BEYOND BORDERS: GLOBAL INITIATIVES FOR DEMOCRATIZING LIFE SCIENCE TECHNOLOGIES AND PROMOTING ACCESS TO HEALTHCARE
- ETHICAL CHALLENGES IN LIFE SCIENCES
- Prix Galien International Awards Ceremony
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.
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
Lung Cancer: Artificial Intelligence, Synergetics, Complex System Analysis, S...Oleg Kshivets
RESULTS: Overall life span (LS) was 2252.1±1742.5 days and cumulative 5-year survival (5YS) reached 73.2%, 10 years – 64.8%, 20 years – 42.5%. 513 LCP lived more than 5 years (LS=3124.6±1525.6 days), 148 LCP – more than 10 years (LS=5054.4±1504.1 days).199 LCP died because of LC (LS=562.7±374.5 days). 5YS of LCP after bi/lobectomies was significantly superior in comparison with LCP after pneumonectomies (78.1% vs.63.7%, P=0.00001 by log-rank test). AT significantly improved 5YS (66.3% vs. 34.8%) (P=0.00000 by log-rank test) only for LCP with N1-2. Cox modeling displayed that 5YS of LCP significantly depended on: phase transition (PT) early-invasive LC in terms of synergetics, PT N0—N12, cell ratio factors (ratio between cancer cells- CC and blood cells subpopulations), G1-3, histology, glucose, AT, blood cell circuit, prothrombin index, heparin tolerance, recalcification time (P=0.000-0.038). Neural networks, genetic algorithm selection and bootstrap simulation revealed relationships between 5YS and PT early-invasive LC (rank=1), PT N0—N12 (rank=2), thrombocytes/CC (3), erythrocytes/CC (4), eosinophils/CC (5), healthy cells/CC (6), lymphocytes/CC (7), segmented neutrophils/CC (8), stick neutrophils/CC (9), monocytes/CC (10); leucocytes/CC (11). Correct prediction of 5YS was 100% by neural networks computing (area under ROC curve=1.0; error=0.0).
CONCLUSIONS: 5YS of LCP after radical procedures significantly depended on: 1) PT early-invasive cancer; 2) PT N0--N12; 3) cell ratio factors; 4) blood cell circuit; 5) biochemical factors; 6) hemostasis system; 7) AT; 8) LC characteristics; 9) LC cell dynamics; 10) surgery type: lobectomy/pneumonectomy; 11) anthropometric data. Optimal diagnosis and treatment strategies for LC are: 1) screening and early detection of LC; 2) availability of experienced thoracic surgeons because of complexity of radical procedures; 3) aggressive en block surgery and adequate lymph node dissection for completeness; 4) precise prediction; 5) adjuvant chemoimmunoradiotherapy for LCP with unfavorable prognosis.
ARTIFICIAL INTELLIGENCE IN HEALTHCARE.pdfAnujkumaranit
Artificial intelligence (AI) refers to the simulation of human intelligence processes by machines, especially computer systems. It encompasses tasks such as learning, reasoning, problem-solving, perception, and language understanding. AI technologies are revolutionizing various fields, from healthcare to finance, by enabling machines to perform tasks that typically require human intelligence.
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
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These simplified slides by Dr. Sidra Arshad present an overview of the non-respiratory functions of the respiratory tract.
Learning objectives:
1. Enlist the non-respiratory functions of the respiratory tract
2. Briefly explain how these functions are carried out
3. Discuss the significance of dead space
4. Differentiate between minute ventilation and alveolar ventilation
5. Describe the cough and sneeze reflexes
Study Resources:
1. Chapter 39, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 34, Ganong’s Review of Medical Physiology, 26th edition
3. Chapter 17, Human Physiology by Lauralee Sherwood, 9th edition
4. Non-respiratory functions of the lungs https://academic.oup.com/bjaed/article/13/3/98/278874
NVBDCP.pptx Nation vector borne disease control programSapna Thakur
NVBDCP was launched in 2003-2004 . Vector-Borne Disease: Disease that results from an infection transmitted to humans and other animals by blood-feeding arthropods, such as mosquitoes, ticks, and fleas. Examples of vector-borne diseases include Dengue fever, West Nile Virus, Lyme disease, and malaria.
Title: Sense of Smell
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 primary categories of smells and the concept of odor blindness.
Explain the structure and location of the olfactory membrane and mucosa, including the types and roles of cells involved in olfaction.
Describe the pathway and mechanisms of olfactory signal transmission from the olfactory receptors to the brain.
Illustrate the biochemical cascade triggered by odorant binding to olfactory receptors, including the role of G-proteins and second messengers in generating an action potential.
Identify different types of olfactory disorders such as anosmia, hyposmia, hyperosmia, and dysosmia, including their potential causes.
Key Topics:
Olfactory Genes:
3% of the human genome accounts for olfactory genes.
400 genes for odorant receptors.
Olfactory Membrane:
Located in the superior part of the nasal cavity.
Medially: Folds downward along the superior septum.
Laterally: Folds over the superior turbinate and upper surface of the middle turbinate.
Total surface area: 5-10 square centimeters.
Olfactory Mucosa:
Olfactory Cells: Bipolar nerve cells derived from the CNS (100 million), with 4-25 olfactory cilia per cell.
Sustentacular Cells: Produce mucus and maintain ionic and molecular environment.
Basal Cells: Replace worn-out olfactory cells with an average lifespan of 1-2 months.
Bowman’s Gland: Secretes mucus.
Stimulation of Olfactory Cells:
Odorant dissolves in mucus and attaches to receptors on olfactory cilia.
Involves a cascade effect through G-proteins and second messengers, leading to depolarization and action potential generation in the olfactory nerve.
Quality of a Good Odorant:
Small (3-20 Carbon atoms), volatile, water-soluble, and lipid-soluble.
Facilitated by odorant-binding proteins in mucus.
Membrane Potential and Action Potential:
Resting membrane potential: -55mV.
Action potential frequency in the olfactory nerve increases with odorant strength.
Adaptation Towards the Sense of Smell:
Rapid adaptation within the first second, with further slow adaptation.
Psychological adaptation greater than receptor adaptation, involving feedback inhibition from the central nervous system.
Primary Sensations of Smell:
Camphoraceous, Musky, Floral, Pepperminty, Ethereal, Pungent, Putrid.
Odor Detection Threshold:
Examples: Hydrogen sulfide (0.0005 ppm), Methyl-mercaptan (0.002 ppm).
Some toxic substances are odorless at lethal concentrations.
Characteristics of Smell:
Odor blindness for single substances due to lack of appropriate receptor protein.
Behavioral and emotional influences of smell.
Transmission of Olfactory Signals:
From olfactory cells to glomeruli in the olfactory bulb, involving lateral inhibition.
Primitive, less old, and new olfactory systems with different path
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
Explore natural remedies for syphilis treatment in Singapore. Discover alternative therapies, herbal remedies, and lifestyle changes that may complement conventional treatments. Learn about holistic approaches to managing syphilis symptoms and supporting overall health.
2. CONTENT
Validation of specific dosage form
Types of validation
URS
DQ
IQ
OQ
PQ
Government Regulation
References
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3. VALIDATION OF SPECIFIC DOSAGE FORM
PROCESS VALIDATION OF TABLETS
PROCESS STEP CONTROL VARIABLE (MONITOR) MEASURED RESPONSE (TEST)
Pre-Blending Blending time, RPM, Load size, order of addition Blending uniformity
Granulation Mixing speed, amount of granulation fluid, feed rate,
granulation time, load
Drug distribution, water solvent content, appearance,
particle size distribution, densities, loss on drying
Drying Initial temp., outlet temp., drying temp. Particle size distribution, densities, loss on drying
Milling Screen size, milling speed, feed rate Particle size, distribution shape
Lubrication Blending time, blender speed, load size Particle size distribution, loose/tapped densities, flow
properties
Compression Compression rate, granule feed rate,
Precompression force
Appearance, wt. variation, hardness, friability, thickness,
moisture content, disintegration, dissolution, dose
uniformity
Coating Pan load, pan speed, inlet/exhaust temp. and humidity % wt. gain, thickness, dissolution, assay, degradation level
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4. PROCESS VALIDATION OF CAPSULE
PROCESS STEP CONTROL VARIABLE (MONITOR) MEASURED RESPONSE (TEST)
Mixing Load size, RPM, mixing time Mixing uniformity
Blending Load size, RPM, blending time Blend uniformity, flow characteristics
Capsulating Capsulation speed, powder feed
rate
Weight variation, disintegration time,
locking
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5. TYPES OF VALIDATION
Major types of validation are:
1. Process Validation
2. Cleaning Validation
3. Equipment Validation
4. Validation of analytical methods
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6. PROCESS VALIDATION
As per FDA, ‘The collection of data from the process design stage throughout production, which
establishes scientific evidence that a process is capable of consistently delivering quality products’.
PROCESS VALIDATION LIFE CYCLE
Stage 1: Process Design
Stage 2: Process Qualification
Stage 3: Continued process verification
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7. PROCESS VALIDATION FLOW CHART
Planning
Installation
qualification
Operational
qualification
Process
qualification
Process
qualification
Revalidate
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8. TYPES OF PROCESS VALIDATION
1. Prospective Validation
2. Retrospective Validation
3. Concurrent Validation
4. Revalidation
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9. 1. PROSPECTIVE VALIDATION
• It is establishing documented evidence prior to process implementation that a system does what it
proposed to do based on pre-planned protocols.
•An experimental plan called the validation protocol is executed before the process is put into
commercial use.
•It is normally undertaken for a new drug product or new facilities are introduced into a routine
pharmaceutical production.
OBJECTIVES
•To prove that the process will work in accordance with a validation protocol.
•During Product development stage, Production process broken down into individual steps
•Each steps evaluated on the basis of experience or theoretical considerations
•Critical factors that may affect the quality of the finished product are determined.
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10. 2. RETROSPECTIVE VALIDATION
•It is an establishing documented evidence that a process does what it is supposed to do based on
review and analysis of historic data.
•Validation of these processes - historical data to provide the necessary documentary evidence that the
the process is doing what it is supposed to do. Steps require for validation are:
Protocol preparation
Validation reports
Data analysis
Conclusion
Recommendations
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MEHAK AGGARWAL 10
11. 3. CONCURRENT VALIDATION
•Concurrent Validation means establishing documented evidence a process does what it is supposed to
to do based on data generated during actual implementation of the process.
•It is done during routine production Validation involves –
In-process monitoring
End product testing
•Personnel required are the authorized staff.
•Documentation is done as per Prospective Validation.
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12. 4. REVALIDATION
• Re-validation provides the evidence that changes in a process and/or the process environment,
introduced either intentionally or unintentionally, do not adversely affect process characteristics and
product quality.
•There are two basic categories of Re-validation:
Re-validation in cases of known change (including transfer of processes from one company to another
another or from one site to another).
Periodic Re-validation carried out at scheduled intervals.
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13. •Revalidation is done when there is:
Changes of raw materials
Change of starting material
Changes of packaging material
Changes in the process (e.g. mixing times, drying temperatures)
Changes in the equipment (e.g. addition of automatic detection systems)
Changes of equipment
Production area and support system changes (e.g. rearrangement of areas, new water treatment
method)
Transfer of processes to another site
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14. CLEANING VALIDATION
•A process of attaining and document in sufficient evidence to give reasonable assurance, given the
current state of Science and Technology, that the cleaning process under consideration does, and / or
will do, what it purpose to do.
•Objectives are:
To minimize cross contamination.
To determine efficiency of cleaning process.
To do troubleshooting in case problem identified in the cleaning process and give suggestions to
improve the process.
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16. EQUIPMENT VALIDATION
•Action of proving that any equipment works correctly and leads to the expected result is equipment
qualification.
•It is not a single step activity but instead result from many discrete activities.
•Steps involved are:
User requirement specification
Design qualification
Installation qualifications
Operational qualifications
Performance qualification
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17. PROCESS FLOW CHART
DQ
•Before purchasing a new instrument
IQ
•At documented installation of new or existing instruments
OQ
•After installation
•After major changes e.g., repair, updates
•At regular intervals (risk based)
PQ
•Whenever the instrument is used e.g., daily
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18. VALIDATION OF ANALYTICAL
METHODS
•“The process by, which it is established, by laboratory studies, that the performance characteristics of
the method meet the requirements for the intended analytical application”.
•Accuracy : “The closeness of test results obtained by that method to the true value. This accuracy
should be established across its range.”
•Precision: “The degree of agreement among individual test results when the method is applied
repeatedly to multiple sampling of a homogenous sample.”
•Specificity : “The ability to assess unequivocally the analyte in the presence of components that may
expected to be present, such as impurities degradation products and matrix components.”
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MEHAK AGGARWAL 18
19. •Limit of Quantitation : “A characteristic of quantitative assays for low levels of compounds in sample
matrices such as impurities in bulk substances and degradation products in finished pharmaceuticals. It
It is the lowest amount of analyte in a sample that can be determined with acceptable precision and
accuracy under the stated experimental conditions.”
•Range : “Interval between the upper and lower of analyte (including these levels) that have been
demonstrated to be determined with a suitable level of precision , accuracy and linearity using the
method as written. The range is normally expressed in the same units as test results. ( e.g. Percentage ,
, parts per million, etc.) obtained by the analytical method.”
•Ruggedness: The degree of reproducibility of test results obtained by the analysis of the same sample
under a variety of conditions such as different laboratories, different analysts, different instruments ,
different lots of reagents, different elapsed assay times, different assay temperatures, different days,
etc.”
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MEHAK AGGARWAL 19
20. •Robustness: "A measure of its capacity to remain unaffected by small but deliberate variations in
method parameters and provides an indication of its reliability during normal usage.”
•Linearity : “Its ability to elicit tests that are directly or by a well defined mathematical transformations
proportional to the concentration of analyte in samples within a given range.”
•Limit of Detection : The lowest amount of analyte in a sample that can be detected but not necessarily
quantitated, under the stated experimental conditions.”
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21. USER REQUIREMENTS SPECIFICATION
(URS)
• User Requirements Specification (URS), is the most critical of documents and yet, the most often
bungled. Whether the system is purely mechanical, or a mix of electro-mechanical, or solely a
software program, the successful compilation and execution of the Installation Qualification (IQ) (for
installation), Operational Qualification (OQ) (for functionality) and the Performance / Product
Qualification (PQ) (for operability), is dependent on an User Requirements Specification (URS)
containing clear, concise and testable requirements.
•The URS can contain a large number of requirements and should therefore be structured in a way that
will permit easy access to information.
•The requirement specification must be formally reviewed and approved by the pharmaceutical
manufacturer.
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MEHAK AGGARWAL 21
22. •The following guidelines should be followed during the production of the URS :
1. Each requirement statement to be uniquely referenced, and no longer than 250 words.
2. Requirement statements should not be duplicated nor contradicted.
3. The URS should express requirements and not design solutions.
4. Each requirement should be testable.
5. The URS must be understood by both user and supplier; ambiguity and jargon should be avoided.
6. The use of diagrams is often useful.
7. The scope for readers to make assumptions or misinterpret should be minimized.
8. Wherever possible, the URS should distinguish between mandatory/regulatory requirements and
desirable features.
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23. BENEFITS TO VALIDATION
1. Clarifies technical, quality, and documentation requirements to the vendor.
2. Enables the pharmaceutical manufacturer to assess the technical, regulatory, and commercial
compliance (or otherwise) of submitted bids against a formal specification.
3. Ensures the basis of a structured approach to the presentation of information.
4. Provides a basis for testing and test acceptance criteria.
5. Provide a baseline for validation and verification.
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24. DESIGN QUALIFICATION
(DQ)
•Design qualification (DQ) is the process of completing and documenting design reviews to illustrate
that all quality aspects have been fully considered at the design stage.
•The purpose is to ensure that all the requirements for the final systems have been clearly defined at
the start.
•Design Qualification (DQ) defines the functional and operational specifications of the instrument and
details the conscious decisions made in the selection of the supplier.
•DQ should ensure that instruments have all the necessary functions and performance criteria that will
enable them to be successfully implemented for the intended application and to meet user
requirements.
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MEHAK AGGARWAL 24
25. The list below shows the recommended steps that should be considered for inclusion in a Design
Qualification.
Description of the analysis problem
Description of the intended use for the equipment
Description of the intended environment
Preliminary selection of the functional and performance specifications (technical, environmental,
safety)
Preliminary selection of the supplier
Final selection of the supplier and equipment
Development and documentation of final functional and operational specifications
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26. INSTALLATION QUALIFICATION
(IQ)
•Installation qualification (IQ) is the process of checking the installation, to ensure that the
components meet the approved specification and are installed correctly, and to see how that
information is recorded.
•The purpose is to ensure that all aspects (static attributes) of the facility or equipment are installed
correctly and comply with the original design.
•All of the instrumentation components are identified and checked against the manufacturer’s
component listing.
•The working environment conditions are documented and checked to ensure that they are suitable
for the operation of the instrument.
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27. OPERATIONAL QUALIFICATION
(OQ)
•Operational qualification (OQ) is the process of testing to ensure that the individual and combined
systems function to meet agreed performance criteria and to check how the result of testing is
recorded.
•The purpose is to ensure that all the dynamic attributes comply with the original design.
•Each of the instrument’s function are checked to ensure that they conform to the manufacturer’s
specifications.
•This includes the use of certified, traceable electrical simulators and standards to verify that the
equipment is processing input signals correctly.
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28. PERFORMANCE QUALIFICATION
(PQ)
•Performance qualification (PQ), also called process qualification, is the process of testing to ensure
that the individual and combined systems function to meet agreed performance criteria on a
consistent basis and to check how the result of testing is recorded.
•The purpose is to ensure that the criteria specified can be achieved on a reliable basis over a period
of time.
•The performance of the equipment for its routine analytical use is checked to ensure that this
complies with its specification.
•The temperature sensor readings are compared with a certified reference thermometer.
•After calibration, the conductivity sensor readings are compared using certified, traceable control
standards.
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29. GOVERNMENT REGULATION
•Validation is considered to be an integral part of GMPs.
•Worldwide compliance with validation requirements is necessary for obtaining approval to
manufacture and to introduce new products.
•The accuracy, sensitivity, specificity and reproducibility of test methods employed by the firm shall be
established and documented.
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30. REFERENCES
•P. P. Sharma, “Validation in Pharmaceutical Industry- concepts, approaches & guidelines”, 1st edition, 2007
Vandana Publication House.
•B. T. Loftus & R. A. Nash, "Pharmaceutical Process Validation", Drugs and Pharm Sci. Series, Vol. 129, 3rd
Ed., Marcel Dekker Inc., N.Y.
•R. Sawant & S. Hapse, “Fundamental of quality assurance techniques”, First edition Dec 2011, Career
publications.
•M. Potdar, “Pharmaceutical Quality Assurance”, Second edition Dec 2007,Nirali Prakashan.
•N. Kumar, et.al., IJRPC 2011 ‘An overview of pharmaceutical validation: quality assurance.
•E. Jatto, A.O. Okhamafe, TJPR Review Article ‘An Overview of Pharmaceutical Validation and Process
Controls in Drug Development’.
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