This document discusses different types of validation processes that are important in the pharmaceutical industry. It describes:
1) Analytical method validation, which proves that analytical methods used for testing are suitable for their intended purpose. This includes validation of accuracy, precision, repeatability, reproducibility, and other quality attributes.
2) Equipment validation to ensure equipment functions as intended, including installation qualification, operational qualification, design qualification, and performance qualification.
3) Cleaning validation to prevent cross-contamination and ensure cleaning procedures adequately remove residues between product batches.
4) Process validation including prospective, concurrent, retrospective, and re-validation to demonstrate manufacturing processes can consistently produce products meeting specifications.
QUALIFICATION OF UV-VISIBLE SPECTROPHOTOMETER, FTIR, DSC, HPLCAnupriyaNR
Analytical method qualification consists of a simplified evaluation of a subset of validation characteristics with a goal to demonstrate that an analytical method is scientifically sound and suitable for its intended use. In contrast to validation, analytical method qualification is performed without predefined acceptability criteria. Qualification may be performed as a prerequisite to method validation, or when an assay for product knowledge has not yet been established as a test for a critical product quality attribute. Qualification of equipment is pre-requisite for validation of the process in which the equipment is being used. Many types of equipment have measuring devices on them. Calibration of measuring devices is a part of qualification. Calibration of measuring devices is important, as the data is often collected through them. If the data collected is not from measuring devices that have been calibrated, the data cannot be relied upon. Thus the whole validation exercise can be questioned.
QUALIFICATION OF UV-VISIBLE SPECTROPHOTOMETER, FTIR, DSC, HPLCAnupriyaNR
Analytical method qualification consists of a simplified evaluation of a subset of validation characteristics with a goal to demonstrate that an analytical method is scientifically sound and suitable for its intended use. In contrast to validation, analytical method qualification is performed without predefined acceptability criteria. Qualification may be performed as a prerequisite to method validation, or when an assay for product knowledge has not yet been established as a test for a critical product quality attribute. Qualification of equipment is pre-requisite for validation of the process in which the equipment is being used. Many types of equipment have measuring devices on them. Calibration of measuring devices is a part of qualification. Calibration of measuring devices is important, as the data is often collected through them. If the data collected is not from measuring devices that have been calibrated, the data cannot be relied upon. Thus the whole validation exercise can be questioned.
Introduction, Regulatory requirements for validation, Role of FDA, Code of Federal regulation, Validation life cycle, Significance of validation, Types of validation, Process valiadation, Phases of process validation, Process capability design, Process Qualification, Validation maintainance phase
Types of Process validation, Examples
Process Validation is Key important factor for the Pharmaceutical Industry to maintain Consistent Quality in product which claimed by the manufacturer.
The pharmaceutical Quality by Design (QbD) is a systematic approach to development that begins with predefined objectives and emphasizes product and process understanding and process control, based sound science and quality risk management.
Definition
Scope of calibration
Scope of validation
Frequency of calibration
Importance/ purpose of calibration
Importance/ advantages of validation
Difference between calibration & validation
Introduction, Regulatory requirements for validation, Role of FDA, Code of Federal regulation, Validation life cycle, Significance of validation, Types of validation, Process valiadation, Phases of process validation, Process capability design, Process Qualification, Validation maintainance phase
Types of Process validation, Examples
Process Validation is Key important factor for the Pharmaceutical Industry to maintain Consistent Quality in product which claimed by the manufacturer.
The pharmaceutical Quality by Design (QbD) is a systematic approach to development that begins with predefined objectives and emphasizes product and process understanding and process control, based sound science and quality risk management.
Definition
Scope of calibration
Scope of validation
Frequency of calibration
Importance/ purpose of calibration
Importance/ advantages of validation
Difference between calibration & validation
A validation programme involves various components in pharmaceutical organisation related to process, equipment and product.
It is a regulatory requirement for pharmaceutical companies to perform Instrument Validation on all new instruments.
Instrument Validation requires detailed knowledge of the instrumentation system being validated and is therefore usually performed by the company supplying the instrument.
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.
Validation.
Validation is establishing documented evidence which provides a high degree of assurances that a specific process or equipment will consistently produce a product or result meeting its predetermined specifications and quality attributes”.
A system must be qualified to operate in a validated process
The results of analytical procedures should be:
— reliable
— accurate
— reproducible
The characteristics that should be considered during validation of analytical methods are:
— specificity
— linearity
— range
— accuracy
— precision
— detection limit
— quantitation limit
— robustness
Complete discussion about the Pharmaceutical validation, its types, difference between calibration and validation, validation master & calibration master plan
New Directions in Targeted Therapeutic Approaches for Older Adults With Mantl...i3 Health
i3 Health is pleased to make the speaker slides from this activity available for use as a non-accredited self-study or teaching resource.
This slide deck presented by Dr. Kami Maddocks, Professor-Clinical in the Division of Hematology and
Associate Division Director for Ambulatory Operations
The Ohio State University Comprehensive Cancer Center, will provide insight into new directions in targeted therapeutic approaches for older adults with mantle cell lymphoma.
STATEMENT OF NEED
Mantle cell lymphoma (MCL) is a rare, aggressive B-cell non-Hodgkin lymphoma (NHL) accounting for 5% to 7% of all lymphomas. Its prognosis ranges from indolent disease that does not require treatment for years to very aggressive disease, which is associated with poor survival (Silkenstedt et al, 2021). Typically, MCL is diagnosed at advanced stage and in older patients who cannot tolerate intensive therapy (NCCN, 2022). Although recent advances have slightly increased remission rates, recurrence and relapse remain very common, leading to a median overall survival between 3 and 6 years (LLS, 2021). Though there are several effective options, progress is still needed towards establishing an accepted frontline approach for MCL (Castellino et al, 2022). Treatment selection and management of MCL are complicated by the heterogeneity of prognosis, advanced age and comorbidities of patients, and lack of an established standard approach for treatment, making it vital that clinicians be familiar with the latest research and advances in this area. In this activity chaired by Michael Wang, MD, Professor in the Department of Lymphoma & Myeloma at MD Anderson Cancer Center, expert faculty will discuss prognostic factors informing treatment, the promising results of recent trials in new therapeutic approaches, and the implications of treatment resistance in therapeutic selection for MCL.
Target Audience
Hematology/oncology fellows, attending faculty, and other health care professionals involved in the treatment of patients with mantle cell lymphoma (MCL).
Learning Objectives
1.) Identify clinical and biological prognostic factors that can guide treatment decision making for older adults with MCL
2.) Evaluate emerging data on targeted therapeutic approaches for treatment-naive and relapsed/refractory MCL and their applicability to older adults
3.) Assess mechanisms of resistance to targeted therapies for MCL and their implications for treatment selection
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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.
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
Ethanol (CH3CH2OH), or beverage alcohol, is a two-carbon alcohol
that is rapidly distributed in the body and brain. Ethanol alters many
neurochemical systems and has rewarding and addictive properties. It
is the oldest recreational drug and likely contributes to more morbidity,
mortality, and public health costs than all illicit drugs combined. The
5th edition of the Diagnostic and Statistical Manual of Mental Disorders
(DSM-5) integrates alcohol abuse and alcohol dependence into a single
disorder called alcohol use disorder (AUD), with mild, moderate,
and severe subclassifications (American Psychiatric Association, 2013).
In the DSM-5, all types of substance abuse and dependence have been
combined into a single substance use disorder (SUD) on a continuum
from mild to severe. A diagnosis of AUD requires that at least two of
the 11 DSM-5 behaviors be present within a 12-month period (mild
AUD: 2–3 criteria; moderate AUD: 4–5 criteria; severe AUD: 6–11 criteria).
The four main behavioral effects of AUD are impaired control over
drinking, negative social consequences, risky use, and altered physiological
effects (tolerance, withdrawal). This chapter presents an overview
of the prevalence and harmful consequences of AUD in the U.S.,
the systemic nature of the disease, neurocircuitry and stages of AUD,
comorbidities, fetal alcohol spectrum disorders, genetic risk factors, and
pharmacotherapies for AUD.
Pulmonary Thromboembolism - etilogy, types, medical- Surgical and nursing man...VarunMahajani
Disruption of blood supply to lung alveoli due to blockage of one or more pulmonary blood vessels is called as Pulmonary thromboembolism. In this presentation we will discuss its causes, types and its management in depth.
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.
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
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
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
3. DEFINITION
Validation means rectification or confirmation.
Validation can be defined as a procedure that demonstrates that a process under
standard conditions is capable of consistently producing a product that meets the
established product specifications.
3
5. 1) ANALYTICAL METHOD VALIDATION
Method validation must prove that the analytical method used for a specific test is
suitable for which it is to be carried out.
►Methods should be validated when:-
● When they are to be established for routine use.
● When the method is to be changed due to change in conditions.
● Whenever the equivalence between new method and the standard are
demonstrated
5
6. TYPES OF PROCEDURES TO BE VALIDATED
1) ACCURACY:-
The accuracy of an analytical method refers to the closeness of agreement between the observed
value and the value which is either conventially a true one or reference one.
► 2) PRECISION:-
The precision of an analytical method refers to the closeness of values obtained from a series of tests.
► 3) REPEATABILITY:-
Repeatability is established when the same sample is estimated repeatedly by the same analyst using
same analytical method within the same laboratory using same instrument and performed within
a short period of time.
6
7. ► 4) INTERMEDIATE PRECISION:-
When the test is repeated on different days by different persons or using different instruments within
the same laboratory,the variation is expressed in terms of intermediate precision.
► 5) REPRODUCIBILITY:-
When a method is standardized,the test is carried out in different laboratories using the same
method,the precision between the laboratories is refered to as reproducibility.
► 6) SPECIFICITY:-
Specificity is the ability of a test method to measure the analyte explicity in the presence of other
components.
7
8. 7) LINEARITY:-
● Linearity of an analytical method refers to it’s ability to measure a specific component within
a range.
► 8) DETECTION LIMIT
► 9) QUANTITATION LIMIT
► 10) ROBUSTNESS
► 11) RANGE
8
9. 2) EQUIPMENT VALIDATION
Equipment validation is to provide a high level of documented evidence that the equipment and the process
confirm to a standard.
TYPES
(a) INSTALLATION QUALIFICATION (IQ)
(b) OPERATIONAL QUALIFICATION (OQ)
(c) DESIGN QUALIFICATION (DQ)
(d) PERFORMANCE QUALIFICATION (PQ)
9
10. It ensures that all major processing and packing equipment and ancillary systems
are in conformity with installation specification,equipment manuals ,schematics
►Important IQ considerations:-
● Calibration,preventive maintenance
● Safety features
● Software documentation
● Equipment design features
(a) INSTALLATION QUALIFICATION (IQ)
10
11. It is done to provide a high degree of assurance that the equipment functions as intended.
It is conducted in 2 stages- component operational qualification & system operational
qualification.
Important OQ considerations:-
● Software procedures
● Raw material specification
● Process operation procedures
● Material handling requirements
(b) OPERATIONAL QUALIFICATION (OQ)
11
12. It is a documented review of the design, at an appropriate stage in the project, for
conformance to operational and regulatory expectation.
►Important DQ considerations are:-
● GMP’s and regulatory requirements
● Reliability and efficiency
● Safety and environment impact
● Construct ability and installation of equipment
(c) DESIGN QUALIFICATION (DQ)
12
13. It is a documented verification that all aspects of a facility, utility or equipment
perform as intended in meeting pre-determined acceptance criteria.
►Important PQ considerations:-
● Actual product & process parameters
● Acceptability of the product
● Process repeatability
● Long term process stability
(d) PERFORMANCE QUALIFICATION(PQ)
13
14. 3) CLEANING VALIDATION
Cleaning validation ensures that there is no cross contamination in a multi-product manufacturing
plant and also prevents microbial contamination
► Once a product is manufactured,the equipment is cleaned using appropriate cleaning SOP’S
established during IQ of the equipment
► TYPES OF CONTAMINATION TO BE CONSIDERED IN CLEANING VALIDATION
● Cross contamination
● Microbial contamination
● Contamination by cleaning or sanitizing agent
● Contamination by other agents
14
15. 4) PROCESS VALIDATION
Process validation is the means of ensuring & providing documentary evidence that processes are capable of
repeatedly & reliably producing a finished product of the required quality.
TYPES
(a) PROSPECTIVE VALIDATION
(b) CONCURRENT VALIDATION
(c) RETROSPECTIVE VALIDATION
(d) PROCESS RE-VALIDATION
15
16. It is conducted prior to the distribution of either a new product or a product made under a modified
production process, where the modifications are significant & may affect the product characteristics.
► It includes:-
● Initial stages of formulation devolepment & process devolepment
● Setting of process sampling plans
● Designing of batch records
● Defining raw material specifications
● Transfer of technology from scale up to commercial size batches
● Environmental controls
(a) PROSPECTIVE VALIDATION
16
17. Here, the validation protocol is executed before the process is put into
commercial use.
It is generally considered acceptable that three consecutive batches within
the finally agreed parameters,giving product of the desired quality would
constitute a proper validation of the process.
17
18. It is a process where current production batches are used to monitor processing parameters.
It gives of the present batch being studied, and offers limited assurance regarding consistency of
quality from batch to batch.
Examples of these may be when:-
● A previous validated process is being transferred to a third party contract manufacturer or to
another site
(b) CONCURRENT VALIDATION
18
19. ● The number of batches produced are limited
● Process with low production volume per batch and market demand
● The product is a different strength of a previously validated product with the same
ratio of active or inactive ingredients
19
20. It is conducted for a product already being marketed and is based on extensive
data accumulated over several lots and over time.
►This validation may be used for older products which were not validated by the
fabricator at the time that they were first marketed.
►Retrospective validation is only acceptable for well established detailed processes
and will be inappropriate when there have recent changes in the formulation of the
products,operating procedures,equipment & facility.
(c) RETROSPECTIVE VALIDATION
20
21. Some of the essential elements of this validation are:-
● Batches manufactured for a definite period
● Number of lots released per year
● Master manufacturing/packaging documents
● List of process deviations,corrective actions & changes to manufacturing documents
● Data for stability testing for several batches
21
22. Process re-validation is required when there is a change in any of the critical process
parameters ,formulation,primary packaging components,major equipmenta or premises
► Examples when process re-validation is required when:-
● Changes in raw materials ( physical properties such as density,viscosity,particle size
distribution)
● Changes in source of active raw material manufacturer
(d) PROCESS RE-VALIDATION
22
23. ● Changes in packaging material ( primary container/ closure system)
● Changes in the process (Mixing time,drying temperatures & batch size)
● Changes in the equipment
● Changes in the plant/facility
23
24. REFERENCE
Industrial pharmacy , A Comprehensive approach, by D.K Tripathi,
Pg no: 671-699
►Pharmaceutical process validation : An overview , by M.d Shoaib Alam
etal;Journal of advanced pharmacy education & research ,oct-dec
2012,vol 2, issue 4, pg no: 190-196
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