Good Laboratory Practices: General Provisions, Organization and Personnel, Facilities,
Equipment, Testing Facilities Operation, Test and Control Articles, Protocol for Conduct
of a Nonclinical Laboratory Study, Records and Reports, Disqualification of Testing
Facilities
GOOD LABORATORY PRACTICES - A DETAILED STUDYTeny Thomas
A detailed study of the rules, regulations and guidelines of Good Laboratory Practices that should be practiced while conducting a Non Clinical Laboratory Study in Animals.
A detailed study of the organisation and personnel involved in the pharmaceutical industry. These are involved in the guidelines of Good Manufacturing Practices.
GOOD LABORATORY PRACTICES - A DETAILED STUDYTeny Thomas
A detailed study of the rules, regulations and guidelines of Good Laboratory Practices that should be practiced while conducting a Non Clinical Laboratory Study in Animals.
A detailed study of the organisation and personnel involved in the pharmaceutical industry. These are involved in the guidelines of Good Manufacturing Practices.
Document Maintenance in Pharmaceutical IndustryNAKUL DHORE
Document Maintenance in Pharmaceutical Industry.
By_ NAKUL DHORE
❖ Introduction
❖ Batch Formula Record
❖ Master Formula Record
❖ SOPs
❖ Quality Audit
❖ Quality Review & Quality Documentation
❖ Reports & Documents
❖ Distribution Records
❖ MCQs
Quality Assurance
As per B.PHARM 3rd Year Semester-6
(PCI Syllabus New)
PHARMACEUTICAL QUALITY ASSURANCE SIXTH SEMSTER B PHARM
Introduction, definition and general principles of calibration, qualification
and validation, importance and scope of validation, types of validation, validation master plan. Calibration of pH meter, Qualification of UV-Visible spectrophotometer, General principles of Analytical
method Validation.
Unit 2 organization and personnel and permisies himanshuhimanshu kamboj
pharmaceutical quality assurance
b pharma 6th sem
Personnel objectives
Personnel qualifications
Personnel responsibilities
Key personnel
Responsibilities of the head of the production department
Responsibilities of the head of quality control department
Training
Personnel hygiene
Premises
Layout of pharmaceutical industry
Areas of premises
Environmental control in sterile areas
Equipment and raw materials
Stages of equipment
Cleaning and maintenance
Raw materials
Steps involved in purchase procedure
Maintenance of stores
Storage conditions
General Principles of Analytical Method of Validation.pdfTamannaKumari8
Validation is the process of establishing documentary evidence demonstrating that a procedure, process, activity carried out in
testing and then production maintain the desirable level of compliance all stages.
The process of providing the analytical procedure is acceptable or its intended us.(ICH Q
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.
Good Laboratory Practices (GLP)
History
Reason behind GLP created
Advantages and disadvantages of GLP
Objectives of GLP
Practice of GLP
b pharma 6th sem
pharmaceutical quality assurance
Document Maintenance in Pharmaceutical IndustryNAKUL DHORE
Document Maintenance in Pharmaceutical Industry.
By_ NAKUL DHORE
❖ Introduction
❖ Batch Formula Record
❖ Master Formula Record
❖ SOPs
❖ Quality Audit
❖ Quality Review & Quality Documentation
❖ Reports & Documents
❖ Distribution Records
❖ MCQs
Quality Assurance
As per B.PHARM 3rd Year Semester-6
(PCI Syllabus New)
PHARMACEUTICAL QUALITY ASSURANCE SIXTH SEMSTER B PHARM
Introduction, definition and general principles of calibration, qualification
and validation, importance and scope of validation, types of validation, validation master plan. Calibration of pH meter, Qualification of UV-Visible spectrophotometer, General principles of Analytical
method Validation.
Unit 2 organization and personnel and permisies himanshuhimanshu kamboj
pharmaceutical quality assurance
b pharma 6th sem
Personnel objectives
Personnel qualifications
Personnel responsibilities
Key personnel
Responsibilities of the head of the production department
Responsibilities of the head of quality control department
Training
Personnel hygiene
Premises
Layout of pharmaceutical industry
Areas of premises
Environmental control in sterile areas
Equipment and raw materials
Stages of equipment
Cleaning and maintenance
Raw materials
Steps involved in purchase procedure
Maintenance of stores
Storage conditions
General Principles of Analytical Method of Validation.pdfTamannaKumari8
Validation is the process of establishing documentary evidence demonstrating that a procedure, process, activity carried out in
testing and then production maintain the desirable level of compliance all stages.
The process of providing the analytical procedure is acceptable or its intended us.(ICH Q
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.
Good Laboratory Practices (GLP)
History
Reason behind GLP created
Advantages and disadvantages of GLP
Objectives of GLP
Practice of GLP
b pharma 6th sem
pharmaceutical quality assurance
GLP is an FDA regulation.
It is defined in OECD principles as ―a quality system concerned with organizational process and the conditions under which non-clinical health and environmental safety studies are planned, performed, monitored, recorded, archived and reported.
GLP extends to include food and color additives, animal food additives, human and animal drugs, medical devices for human use, biological products, and electronic products.
GLP is a formal regulation that was created by the USFDA in 1978 having worldwide impact.
Non-US companies that wanted to do business with the United states or register their pharmacies in the United States had to comply with the United States GLP regulations.
In 1981 an organization named OECD (organization for economic co-operation and development ) produced GLP principles that are international standard.
Quality and Integrity of the Safety Data
In the early 70’s FDA became aware of cases of ( PLP ) poor laboratory practice all over the United States.
FDA decided to do an in-depth investigation in 40 toxicology labs. They discovered a lot fraudulent activities and a lot of poor lab practices.
Examples of some of these ( PLP )poor lab practices found were: Equipment not been calibrated to standard form , therefore giving wrong measurements. Incorrect/inaccurate accounts of the actual lab study.
Good Laboratory Practices, Protocol, Contents of protocol, Conduct of a non-clinical laboratory study, Reporting of non-clinical laboratory study results,
Quality management systems: Good Laboratory Practice (QMS GLP)Dr Ajay Kumar Tiwari
Fundamental knowledge on pharmaceutical
product development and translation from laboratory to market.
Quality management systems: Quality management & Certifications.
1. Introduction to GLP
2. Definition of GLP
3. Fundamentals of GLP
4. GLP Principles
5. Aim of GLP
Quality management systems: Good Laboratory Practice (QMS GLP)Dr Ajay Kumar Tiwari
Fundamental knowledge on pharmaceutical
product development and translation from laboratory to market.
Quality management systems: Quality management & Certifications.
1. Introduction to GLP
2. Definition of GLP
3. Fundamentals of GLP
4. GLP Principles
5. Aim of GLP
Preformulation Studies: Introduction to preformulation, goals and objectives, study of
physicochemical characteristics of drug substances.
a. Physical properties: Physical form (crystal & amorphous), particle size, shape, flow
properties, solubility profile (pKa, pH, partition coefficient), polymorphism.
b. Chemical Properties: Hydrolysis, oxidation, reduction, racemisation, polymerization
BCS classification of drugs & its significant
Application of preformulation considerations in the development of solid, liquid oral and
parenteral dosage forms and its impact on stability of dosage forms.
Extraction, isolation and structure elucidation of lignans(podophyllotoxin)Mohammad Khalid
Extraction, isolation and structure elucidation of- Lignans(Podophyllotoxin)
Introduction
Extraction and Isolation
Identification test
Sructure elucidation of Podophyllotoxin
Adverse Effects
Extraction, isolation and structure elucidation of flavonoids: QuercetinMohammad Khalid
Extraction, isolation and structure elucidation of- Flavonoids Quercetin
Introduction
FLAVONOIDS & THEIR EXAMPLES
Quercetin
general isolation method
Extraction and isolation
Extraction from neem leaves
Isolation of Quercetin Methanolic Extract of Azadirachta indica leaves
Structure elucidation of Quercetin
Health benefits
Side Effects of Quercetin
Brief introduction to Agmark, BIS and FSSAI
Introduction (AGMARK)
Objectives of Agmark Scheme
Requirement of Agmark Application Proceedings
Advantages of agmark
Bureau of Indian Standards (B.I.S)
Structure of BIS/ Members of BIS
OBJECTIVES and FUNCTIOS OF BIS
Food Safety and Standards Authority of India (FSSAI)
NEED OF FSSAI
Functions of fssai
FSSAI Structure
Landmark cases with FSSAI
Differences between agmark and fssai
Extraction , Isolation and Structure Elucidation of DigoxinMohammad Khalid
Introduction
Mechanism of Action
Pharmacokinetics
Indication
Administration
Contraindication and Precaution
Use cautiously in
Adverse Effects
Extraction and Isolation of Digoxin
CHEMICAL TESTS
Structure Elucidation
Testing of neutraceuticals and food products
Introduction
Testing of microbial load
Bioburden Test
Total Aerobic Microbial Count
Total combined yeast and molds count
Testing of nutritional value
Laboratory based nutraceutical Analysis
Testing of heavy metals
Calorific Value
Nutraceutical label claim testing
Packaging, Label claims. Regulatory aspects of nutraceutical products in India.Mohammad Khalid
Packaging,
label claims.
regulatory aspects of nutraceutical products in India.
INTRODUCTION (Packaging)
TYPES OF PACKAGING
Objective of Packaging
Consideration for packaging
FUNCTIONS OF PACKAGING
Factors for package design in international market
Introduction (Labelling)
Function of labels
Objective of labeling
Which Information Is Mandatory
Contents in a Nutraceutical label
Definition of Nutrition Claim/s
Definition of Health Claim/s
New FDA Labeling Requirements
Regulation of Nutraceuticals in India
Food Safety and Standards Authority of India (fssai)
Regulatory Requirements in India
Registration Process in India
Functional food & Phytonutrients
Definition
Examples of some functional food worldwide
Functional Food Components
Concept of functional foods
Cereals as functional food
Legumes as functional foods
Vegetables as functional food
Fruits as functional foods
Probiotics as functional food
Functional food and fortification
Phytonutrients
General functions of phytonutrients
Various Phytochemicals
Mechanisms of action of Phytonutrients
Fortified Food
Introduction
enriched food
Who will benefit from fortified foods
Purpose of food fortification
Iodine deficiency disorders
Fortification of flour
Main methods of food fortification
Fortification prevents and treats iron deficiency and nutritional anaemia
Criticism (Side Effect)
Future Challenges of Food Fortification
Reserpine(Structure Elucidation, Extraction and Isolation)Mohammad Khalid
Reserpine(Structure Elucidation, Extraction and Isolation)
Introduction
Constitution of reserpine
Structure of Reserpic acid
Structure of Yobyrine
Synthesis of Yobyrine
Structure of Reserpine
Synthesis of Reserpine
Classification
Extraction
Isolation:
Identification test
Mode of Action
dietary supplements
Overview on supplements
Definition
Facts about Supplements
Should you be taking supplements?
What about protein powders?
Regulation of dietary Supplements
Dietary Supplement and Health Education Act
ICH STABILITY TESTING GUIDELINES, Drug Stability, Stability studies are preformed on Drug Stability (DS)
Drug product (DP), TYPE SIZE, NUMBER OF BATCHES (ICH/WHO GUIDELINES), LONG TERM STABILITY STUDIES, ACCELERATED STABILITY STUDIES, PROTECTION AGAINST HYDROLYSIS, PROTECTION AGAINST OXIDATION, Testing scope for solid dosages, Testing scope for liquid form, Testing scope for oral liquid form
Schedule T – Good Manufacturing Practice of Indian systems of medicine
Components of GMP (Schedule – T) and its objectives
Infrastructural requirements, working space, storage area, machinery and equipments,
standard operating procedures, health and hygiene, documentation and records.
INTRODUCTION
Components of GMP
GMP Provisions: Under Schedule-T are grouped
Location and surroundings
Factory Premises
Buildings
Water supply
Containers cleaning
Disposal of Waste
Requirements for the sterile products
store
Working space:
Space requirement for manufacturing of Unani medicine
Health & Hygiene
Machinery and Equipments
Machinery and equipments for maufacturing of ayurveda and siddha medicine
Documentation and Records
Herbs, Herbal Drugs
Present Scope of Herbal Drug Industry
Scope of Herbal Drug Medicine and Industry
Indian Herbal Industry
International Scope of Herbal Medicines
World Wide Herbal Trade
Overview on plant based industries and research institutions in India
List of few herbal drug industries in India
List of few herbal research institution/ centres in India
General Introduction to Herbal Industry
Herbal drugs industry: Present scope and future prospects.
A brief account of plant based industries and institutions involved in work on medicinal and
aromatic plants in India.
Regulations in India (ASU DTAB, ASU DCC), Regulation of
manufacture of ASU drugs - Schedule Z of Drugs & Cosmetics Act for ASU drugs.
Introduction
Regulatory Requirements
Key function of regulatory agencies
Regulation in India
DRUG TECHNICAL ADVISORY BOARD
Drugs Consultative committee-DCC
Schedule Z of Drugs & Cosmetics Act for ASU drugs.
Patenting aspects of traditional knowledge and natural products(curcuma & neem)Mohammad Khalid
Patenting aspects of Traditional Knowledge and Natural Products. Case study of Curcuma
& Neem.
Introduction
Meaning Of Traditional Knowledge
Patents And Traditional Knowledge In India
Traditional Knowledge In Danger
Turmeric Patent
Neem Patent
WHAT INDIA NEEDS TO DO?
Introduction
Concept of Bioprospecting
Why is it needed
Process of Bioprospecting
Who does bioprospecting
Added potential environmental impacts of Bioprospecting
Key issues & challenges
Lack of legal clarity
Greater sector involvement:
A comprehensive bioprospecting policy
Definition of biopiracy
History of biopiracy
Types of Biopiracy
How does it happens?
Famous Cases of biopiracy
Why is There a Need to Stop Biopiracy ?
Actions Taken Against Biopiracy
Conclusion
Good Laboratory Practices: General Provisions, Organization and Personnel, Facilities,
Equipment, Testing Facilities Operation, Test and Control Articles, Protocol for Conduct
of a Nonclinical Laboratory Study, Records and Reports, Disqualification of Testing
Facilities
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
Recomendações da OMS sobre cuidados maternos e neonatais para uma experiência pós-natal positiva.
Em consonância com os ODS – Objetivos do Desenvolvimento Sustentável e a Estratégia Global para a Saúde das Mulheres, Crianças e Adolescentes, e aplicando uma abordagem baseada nos direitos humanos, os esforços de cuidados pós-natais devem expandir-se para além da cobertura e da simples sobrevivência, de modo a incluir cuidados de qualidade.
Estas diretrizes visam melhorar a qualidade dos cuidados pós-natais essenciais e de rotina prestados às mulheres e aos recém-nascidos, com o objetivo final de melhorar a saúde e o bem-estar materno e neonatal.
Uma “experiência pós-natal positiva” é um resultado importante para todas as mulheres que dão à luz e para os seus recém-nascidos, estabelecendo as bases para a melhoria da saúde e do bem-estar a curto e longo prazo. Uma experiência pós-natal positiva é definida como aquela em que as mulheres, pessoas que gestam, os recém-nascidos, os casais, os pais, os cuidadores e as famílias recebem informação consistente, garantia e apoio de profissionais de saúde motivados; e onde um sistema de saúde flexível e com recursos reconheça as necessidades das mulheres e dos bebês e respeite o seu contexto cultural.
Estas diretrizes consolidadas apresentam algumas recomendações novas e já bem fundamentadas sobre cuidados pós-natais de rotina para mulheres e neonatos que recebem cuidados no pós-parto em unidades de saúde ou na comunidade, independentemente dos recursos disponíveis.
É fornecido um conjunto abrangente de recomendações para cuidados durante o período puerperal, com ênfase nos cuidados essenciais que todas as mulheres e recém-nascidos devem receber, e com a devida atenção à qualidade dos cuidados; isto é, a entrega e a experiência do cuidado recebido. Estas diretrizes atualizam e ampliam as recomendações da OMS de 2014 sobre cuidados pós-natais da mãe e do recém-nascido e complementam as atuais diretrizes da OMS sobre a gestão de complicações pós-natais.
O estabelecimento da amamentação e o manejo das principais intercorrências é contemplada.
Recomendamos muito.
Vamos discutir essas recomendações no nosso curso de pós-graduação em Aleitamento no Instituto Ciclos.
Esta publicação só está disponível em inglês até o momento.
Prof. Marcus Renato de Carvalho
www.agostodourado.com
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.
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
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
- 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
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.
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
New Drug Discovery and Development .....NEHA GUPTA
The "New Drug Discovery and Development" process involves the identification, design, testing, and manufacturing of novel pharmaceutical compounds with the aim of introducing new and improved treatments for various medical conditions. This comprehensive endeavor encompasses various stages, including target identification, preclinical studies, clinical trials, regulatory approval, and post-market surveillance. It involves multidisciplinary collaboration among scientists, researchers, clinicians, regulatory experts, and pharmaceutical companies to bring innovative therapies to market and address unmet medical needs.
263778731218 Abortion Clinic /Pills In Harare ,sisternakatoto
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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.
Acute scrotum is a general term referring to an emergency condition affecting the contents or the wall of the scrotum.
There are a number of conditions that present acutely, predominantly with pain and/or swelling
A careful and detailed history and examination, and in some cases, investigations allow differentiation between these diagnoses. A prompt diagnosis is essential as the patient may require urgent surgical intervention
Testicular torsion refers to twisting of the spermatic cord, causing ischaemia of the testicle.
Testicular torsion results from inadequate fixation of the testis to the tunica vaginalis producing ischemia from reduced arterial inflow and venous outflow obstruction.
The prevalence of testicular torsion in adult patients hospitalized with acute scrotal pain is approximately 25 to 50 percent
The prostate is an exocrine gland of the male mammalian reproductive system
It is a walnut-sized gland that forms part of the male reproductive system and is located in front of the rectum and just below the urinary bladder
Function is to store and secrete a clear, slightly alkaline fluid that constitutes 10-30% of the volume of the seminal fluid that along with the spermatozoa, constitutes semen
A healthy human prostate measures (4cm-vertical, by 3cm-horizontal, 2cm ant-post ).
It surrounds the urethra just below the urinary bladder. It has anterior, median, posterior and two lateral lobes
It’s work is regulated by androgens which are responsible for male sex characteristics
Generalised disease of the prostate due to hormonal derangement which leads to non malignant enlargement of the gland (increase in the number of epithelial cells and stromal tissue)to cause compression of the urethra leading to symptoms (LUTS
2. General Provisions,
Organization and Personnel,
Facilities, Equipment,
Testing Facilities Operation,
Test and Control Articles,
Protocol for Conduct of a Nonclinical Laboratory Study,
Records and Reports,
Disqualification of Testing Facilities
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3. GLP: GOOD LABORATORY PRACTICE
GLP is a FDA regulation.
Definition: GLP is a quality system concerned
with the organizational process and the conditions
under which non-clinical health and
environmental safety studies are planned,
performed, monitored, recorded, archived and
reported.
GLP is sometimes confused with the standards of
laboratory safety like wearing safety goggles.
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4. HISTORY
The formal regulatory concept of “Good Laboratory
Practice” (GLP) originated in the USA in the 1970’s.
GLP is a formal regulation that was created by the FDA
(United states food and drug administration) in 1978.
GLP helps assure regulatory authorities that the data
submitted are a true.
The FDA’s publication of Proposed Regulations on GLP
in 1976, with establishment of the Final Rule in June
1979 (21 CFR 58).
In 1981 an organization named OECD produced GLP
principles that are international standard.
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5. HISTORY continue…
Although GLP originated in the United States, it
had a world wide impact.
Non-US companies that wanted to do business
with the United states or register their pharmacies
in the United States had to comply with the United
States GLP regulations.
They eventually started making GLP regulations
in their home countries.
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6. 6
In the early 70’s FDA became aware of cases of poor
laboratory practice all over the United States.
FDA decided to do an in-depth investigation on 40 toxicology labs.
They discovered a lot fraudulent activities and a lot of poor lab practices.
Examples of some of these poor lab practices found were:
1. Equipment not been calibrated to standard form, therefore giving wrong
measurements.
2. Incorrect/inaccurate accounts of the actual lab study
3. Inadequate test systems
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7. 7
One of the labs that went under such an investigation made
headline news.
The name of the Lab was Industrial Bio Test. This was a big lab
that ran tests for big companies such as Procter and Gamble.
It was discovered that mice that they had used to test cosmetics
such as lotion and deodorants had developed cancer and died.
CONTI…
Industrial Bio Test lab threw the
dead mice and covered results
deeming the products good for
human consumption.
Those involved in production,
distribution and sales for the lab
eventually served jail time.
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8. 8
FDA decided a standard approach was required…To ensure
quality, integrity & reproducibility of data.
The Organisation for Economic Cooperation and
Development (OECD) formulated the first worldwide OECD
Principles of GLP 1981 ( revised in 1997)
•To avoid non-tariff barriers to trade
•To promote mutual acceptance to non-clinical safety test
•To eliminate unnecessary duplication of experiments
ISO (International Organization of Standardization) is a
worldwide federation of national standards from 130
countries.
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9. 30 March 2020 Krishna Pharmacy College, Bijnor
9
GLP should be applied to the non-clinical
safety testing of test items contained in:
Pharmaceutical product
Pesticides product
Cosmetic product
Food additives
Feed additives
Industrial chemical
10. 10
OBJECTIVES OF GLP
To promote the development of quality and validity of test data used
for determining the safety of chemicals and chemicals product.
Makes sure that the data submitted are a true reflection of the results
that are obtained during the study.
Promotes international acceptance of tests.
Also makes sure that data is traceable.
Help scientists to obtain results which are:
Reliable
Repeatable
Audible
Recognized by scientists worldwide
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11. 11
Test systems
Archiving of records and materials
Apparatus, material and reagent
facilities
Quality assurance programs
Performance of the study
Reporting of study results
Standard operating procedures (SOPs)
Personnel and test facility organization
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12. 30 March 2020 Krishna Pharmacy College, Bijnor 12
Concerned with how we organize our laboratories and
how we organize our studies.
Addresses responsibilities for managing people,
facilities and equipment for good science
Concerned with how we plan, perform and report
our experiments and studies
Importantly it does not interfere with the ability of
scientists to make scientific decision
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Benefits of Good Laboratory Practices
It will give better image of company as a Quality
producer in Global market.
Provide hot tips on analysis of data as well as
measure uncertainty and perfect record keeping.
Provide guideline for doing testing and
measurement in detail.
Provide guidelines and better control for
maintenance of instruments, environment control,
preservation of test records etc.
14. Subpart A: General Provisions
Subpart B: Organization and Personnel
Subpart C: Facilities
Subpart D: Equipment
Subpart E: Testing Facilities Operation
Subpart F: Test and Control Articles
Subpart G: Protocol for and Conduct of a Non-Clinical Laboratory Study
Subpart J: Records and Reports
Subpart K: Disqualification of Testing Facilities
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15. GLP Regulations: Rules and Tools
Chemical and sample inventory,
expiration dates
TEST, CONTROL, AND
REFERENCE SUBSTANCES
Timely reporting, storage of raw
data and reports
RECORDS AND REPORTS
Standard operating proceduresFACILITY OPERATION
Calibration, logbooks of use, repair,
and maintenance
EQUIPMENT
Maintain adequate space/separation
of chemicals from office areas
FACILITIES
Training records, CVs, GLP trainingORGANIZATION AND
PERSONNEL
Documentation (Tools)GLP Regulations (Rules)
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16. 58.29 Personnel :
(a)“Each individual engaged in the conduct of or responsible
for the supervision of a nonclinical laboratory study shall
have education, training, and experience, or combination
thereof, to enable that individual to perform the assigned
functions.”
(b)“Each testing facility shall maintain a current summary of
training and experience and job description for each
individual engaged in or supervising the conduct of a
nonclinical laboratory study.”
16
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17. Organization and Personnel
58.33Study Director
“For each nonclinical laboratory study, a scientist or other professional of
appropriate education, training, and experience, or combination thereof, shall
be identified as the study director. The study director has overall
responsibility for the technical conduct of the study, as well as for the
interpretation, analysis, documentation, and reporting of results, and
represents the single point of study control.”
“A testing facility shall have a quality assurance unit which shall be
responsible for monitoring each study to assure management that the
facilities, equipment, personnel, methods, practices, records, and
controls are in conformance with the regulations in this part. For any
given study, the quality assurance unit shall be entirely separate from
and independent of the personnel engaged in the direction and conduct
of that study.”
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58.35 QualityAssurance Unit
18. 58.41 General
“Each testing facility shall be of suitable size and
construction to facilitate the proper conduct of
nonclinical laboratory studies. It shall be designed so
that there is a degree of separation that will prevent any
function or activity from having an adverse effect on the
study.”
Animal care facilities
Animal supply facilities
Facilities for handling test and control articles
Laboratory operation areas
Specimen and data storage facilities
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19. 58.61 EquipmentDesign
“Equipment used in ... shall be of appropriate design and adequate capacity
...”
58.63 MaintenanceandCalibration
(a) “The written standard operating procedures ...”
(b) “Written records shall be maintained ...”
Log book
Fit for use
Not for GLP use.
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20. • Verification(Testing):
External check of equipment
accuracy (e.g. check balance
accuracy against weights at
laboratory- no adjustment)
• Calibration:
Equipment is adjusted based on
comparison to certified or known
reference materials (e.g. balance
adjusted after comparison to certified
weights by trained professional)
• Standardization:
Comparison with similar equipment
(e.g. use two thermometers of similar
design to compare readings)
Verification?
Calibration ?
Standardization?
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21. Test and control articles
Control articles or reference substances as they re-called in
the OECD principles are of utmost importance as they are
commonly used to calibrate the instrument.
Main requirements for control articles are: the identity,
strength, purity, composition and other characteristics
should be determined for each batch and documented.
The stability of each test and articles should also be
determined.
Certified reference standards can be purchased from
appropriate suppliers. If standards are not available , the
recommendation is to take a lot of your own material and
analyze, certify and use it as the standard.
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22. Analyst Certification
Some acceptable proof of satisfactory training
and/or competence with specific laboratory
procedures must be established for each analyst.
Qualification can come from education,
experience or additional trainings, but it should
be documented
Sufficient people
Requirements of certification vary
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23. Laboratory Certification
Normally done by an external agency
Evaluation is concerned with issues such as
Adequate space
Ventilation
Storage
Hygiene
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24. Documentation and Maintenance of
Records
Maintenance of all records provide documentation
which may be required in the event of legal
challenges due to repercussions of decisions based
on the original analytical results.
General guidelines followed in regulated
laboratories is to maintain records for at least five
years
Length of time over which laboratory records
should be maintained will vary with the situation
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25. 58.120 Protocol
“Each study shall have an approved written protocol that clearly indicates the
objectives and all methods for the conduct of the study.”
58.130 Conduct of a Non-clinicalLaboratoryStudy
“The nonclinical laboratory study shall be conducted in accordance with the
protocol”
58.185 Reporting of Non-clinical LaboratoryStudyResults
“A final report shall be prepared for each nonclinical laboratory study ...”
58.190 Storageand Retrieval of Records and Data
“All raw data, documentation, protocols, final reports, and specimens ... shall
be retained.”
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26. 30 March 2020 Krishna Pharmacy College, Bijnor 26
Data should be recorded :
Directly
Promptly
Accurately
Legibly
Should be signed and dated
27. CONTENTS
Name & address of test facility
Dates of study (start and finish)
Name of Study Director
Study objectives
Test article & system details
Methods
Results/statistics
Summary of findings
Discussion
References
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28. What is left when study is over?
Study plan
Raw data
Specimens (not forever?)
Final report
QA documents
Personnel records
Facilities/equipment qualification records
Historical SOP file
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29. MANAGEMENT REVIEW
At least once in 12 months to cover
Internal & external audit report
Complaints & customer feedback received
from laboratory customers
Training records of the staff.
Other laboratory requirements
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30. Definitions. “’Raw data’ means any
laboratory worksheets, records, memoranda,
notes, or exact copies thereof, that are the
result of original observations and activities of
a study and are necessary for the
reconstruction and evaluation of the report of
that study.”
If anyone scribble some notes on a scrap of paper,
are those notes considered raw data?
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31. RAW DATA
examples of raw data:-
• Logbooks (to record
temperatures or equipment
use, repair, and
maintenance)
• Field or laboratory
notebooks
• Forms (for field or
laboratory observations,
chain-of-custody, sample
or chemical receipt)
• Training reports
• Computer printouts
• Recorded data from
automated instruments
Question:
What happens if you
make a mistake?
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32. 32
40 CFR Part 160 (EPA GLP regulations)
“Section 160.81 Standard operating procedures. (a) A testing
facility shall have standard operating procedures in writing setting
forth study methods that management is satisfied are adequate to
insure the quality and integrity of the data generated in the course
of a study.”
Written procedures for a laboratories program.
They define how to carry out protocol-specified activities.
Most often written in a chronological listing of action steps.
They are written to explain how the procedures are suppose to work
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33. 33
Standard Operating Procedures
(SOP)
SOPs should
accurately reflect how
routine tasks are
performed
Routine inspection,
cleaning, maintenance,
testing and calibration.
Actions to be taken in
response to equipment
failure.
Reviewed on regular
basis.
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34. 34
What happens if a workplace
does not comply with federal
Good Laboratory Practice
standards?
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Disqualification of a Facility
35. 35
Falsifying information for permit, registration
or any required records
Falsifying information related to testing~
protocols, ingredients, observations, data
equipment, ect.
Failure to prepare, retain, or submit written
records required by law.
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36. 36
Consequences of Noncompliance
The FDA states the following consequences of noncompliance:
The commissioner will send a written proposal of
disqualification to the testing facility
A regulatory hearing on the disqualification will be scheduled
If the commissioner finds that after the hearing, the facility has
complied, then a written statement with an explanation of
termination of disqualification will be sent to the facility
Thus, if it can be shown that such disqualifications did not affect
the integrity and outcome of the study itself, or did not occur at
all, then the study may be reinstated at the will of the
commissioner
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37. 37
Upon Disqualification…
If the commissioner finds that the facility showed a
noncompliance, any of the grounds after the hearing, then a
final order of noncompliance will be sent to the facility
with explanations
If a testing facility has been disqualified, any studies done
before of after the disqualification will need to be determined
as essential to a decision (acceptable or not)
If the study is determined unacceptable, then the facility itself
may need to show that the study was not affected by the
noncompliance that led to the disqualification
Once finally disqualified, the facility may not receive or be
considered for a research or marketing permit and the study is
rejected.
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38. 38
Upon Disqualification…
The commissioner may notify the public and all interested
persons, including other federal agencies the facility may have
contacted
The FDA may ask the other agencies to consider whether to
support the facility or not under the disqualification
Civil or criminal proceedings may occur at the discretion of
the commissioner
Fines of up to $50,000 if one knowingly commits crime
and/or 1 year imprisonment~ for registration applicants and
producers
Fines up to $5,000 all others~ civil penalty after failing to
improve after a minor violation warning was issued~ only
those involved in testing will be given civil penalties
Those involved in the distribution or sales will be assessed
more heavy penalties, such as criminal penalties
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39. 39
Upon Disqualification…
The FDA may turn it over to the federal, state or local
law enforcement
The facility’s sponsor may terminate or suspend the
facility from doing any non- clinical study for a
permit
The sponsor is required to notify the FDA in writing
within 15 working days that the facility is to be
suspended or terminated and why
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40. 40
Reinstatement of a Disqualified
Facility
The commissioner will inspect the facility and
determine if it shall be reinstated
If it is reinstated, the commissioner is required
to notify all persons that were notified of the
disqualification including the facility itself
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41. Non-clinical health and environmental safety studies
Physical and chemical test systems
biological test systems
OECD
Adequate facility, trained personnel, approved procedures.
Validated test methods
Records- Reports, specifications, calibration SOPs
Analysis of RM, In-process & FP for release
Product complaints & recall
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43. OECD Principles of Good Laboratory Practice (as revised in 1997)".
OECD Environmental Health and Safety Publications (OECD) 1.
1998.
http://www.oecd.org/document/63/0,2340,en_2649_34381_2346175_
1_1_1_37465,00.html.
Schneider, K (1983(Spring)). "Faking it: The case against Industrial
Bio-Test Laboratories". Amicus Journal (Natural Resources Defence
Council): 14-26.
http://planetwaves.net/contents/faking_it.html.
Handbook: good laboratory practice (GLP): quality practices for
regulated non-clinical research and development -2nd ed., WHO
Library Cataloguing-in-Publication Data, 2nd ed., 7,15-20.
.
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44. Tweedale, AC (2011). "Uses of ‘Good Laboratory
Practices’ by regulated industry and agencies, and the
safety of bisphenol A". J Epidemiol Community Health
(BMJ Group) Online First: 15 February 2011.
doi:10.1136/jech.2010.127761.
Webster, Gregory K. et al. (2005). "JALA Tutorial:
Considerations When Implementing Automated Methods
into GcP". Journal of the Association for Laboratory
Automation (Elsevier) 10 (3): 182–191.
doi:10.1016/j.jala.2005.03.003
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