UNIT 1 QUALITY ASSURANCE B. PHARMACY PART 2Sayali Powar
Quality Assurance and Quality Management concepts: Definition and concept of Quality control, Quality assurance and GMP
Total Quality Management (TQM): Definition, elements, philosophies
ICH Guidelines: purpose, participants, process of harmonization, Brief overview of QSEM, with special emphasis on Q-series guidelines, ICH stability testing guidelines
Quality by design (QbD): Definition, overview, elements of QbD program, tools
ISO 9000 & ISO14000: Overview, Benefits, Elements, steps for registration
NABL accreditation : Principles and procedures
Types of Packaging Materials used in Pharmaceuticals.pptxSayali Powar
The document discusses various packaging materials used in pharmaceuticals including glass, plastics, rubbers, paper/cardboards, and metals. Each material type is described in 1-2 paragraphs outlining their advantages and disadvantages for pharmaceutical packaging. Glass provides protection and labeling but is fragile. Plastics are versatile, inert, and lightweight but can absorb moisture. Metals are impermeable and rigid but expensive. Rubbers are used for closures and have varying properties. Paper provides physical protection and labeling area in cartons.
The document lists common materials including glass, plastics, rubbers, paper/cardboards, and metals repeatedly over multiple lines without any further details or descriptions provided.
This document provides information on antihyperlipidemic agents (medications that lower lipid levels in the blood). It defines hyperlipidemia and atherosclerosis. It discusses the classification of lipoproteins and their normal ranges. The main classes of antihyperlipidemic agents are described - HMG CoA reductase inhibitors (statins), fibric acid derivatives, bile acid sequestrants, inhibitors of LDL oxidation, and nicotinic acid derivatives. Lovastatin, niacin, and clofibrate are discussed in more detail including their chemical structures, brand names, and uses. The biosynthetic pathway of cholesterol is shown and the mechanism of action of statins is explained.
This document outlines a course on pharmaceutical quality assurance that deals with quality control and assurance aspects of the pharmaceutical industry. The course objectives are to understand cGMP requirements, the importance of documentation, quality certifications for pharmaceuticals, and the roles of quality assurance and quality control departments. It also includes puzzles to solve.
This document discusses anti-malarial drugs, focusing on cinchona alkaloids like quinine. It describes the chemical classification of anti-malarials and the medicinal chemistry of cinchona alkaloids. Specifically, it details the extraction of quinine from cinchona bark, its chemical structure, structure-activity relationships, mechanisms of action including inhibition of hemozoin biocrystallization, and therapeutic uses while noting its replacement due to undesirable side effects.
This document summarizes regulations and guidelines for conducting pharmaceutical clinical trials in India. It outlines the major regulatory bodies like DCGI, DGFT, and GEAC. It describes the statutory functions of central and state governments regarding drug licensing, approvals, and quality monitoring. Responsibilities of sponsors, investigators, and ethics committees are provided. Key aspects like clinical trial categories, amendments, safety reporting, and biologics/device regulations are summarized.
This document provides an overview and syllabus for the textbook "A Text Book of Pharmaceutical Jurisprudence" which covers key pharmaceutical laws and regulations for pharmacy students. The textbook is divided into 5 units covering topics such as the Drugs and Cosmetics Act, Pharmacy Act, Medicinal and Toilet Preparations Act, Narcotic Drugs and Psychotropic Substances Act, Drugs and Magic Remedies Act, Prevention of Cruelty to Animals Act, and National Pharmaceutical Pricing Authority. The preface expresses the authors' goal to compile all relevant topics from the Pharmacy Council of India syllabus in a simple, lucid manner. A brief description of the content included in each
UNIT 1 QUALITY ASSURANCE B. PHARMACY PART 2Sayali Powar
Quality Assurance and Quality Management concepts: Definition and concept of Quality control, Quality assurance and GMP
Total Quality Management (TQM): Definition, elements, philosophies
ICH Guidelines: purpose, participants, process of harmonization, Brief overview of QSEM, with special emphasis on Q-series guidelines, ICH stability testing guidelines
Quality by design (QbD): Definition, overview, elements of QbD program, tools
ISO 9000 & ISO14000: Overview, Benefits, Elements, steps for registration
NABL accreditation : Principles and procedures
Types of Packaging Materials used in Pharmaceuticals.pptxSayali Powar
The document discusses various packaging materials used in pharmaceuticals including glass, plastics, rubbers, paper/cardboards, and metals. Each material type is described in 1-2 paragraphs outlining their advantages and disadvantages for pharmaceutical packaging. Glass provides protection and labeling but is fragile. Plastics are versatile, inert, and lightweight but can absorb moisture. Metals are impermeable and rigid but expensive. Rubbers are used for closures and have varying properties. Paper provides physical protection and labeling area in cartons.
The document lists common materials including glass, plastics, rubbers, paper/cardboards, and metals repeatedly over multiple lines without any further details or descriptions provided.
This document provides information on antihyperlipidemic agents (medications that lower lipid levels in the blood). It defines hyperlipidemia and atherosclerosis. It discusses the classification of lipoproteins and their normal ranges. The main classes of antihyperlipidemic agents are described - HMG CoA reductase inhibitors (statins), fibric acid derivatives, bile acid sequestrants, inhibitors of LDL oxidation, and nicotinic acid derivatives. Lovastatin, niacin, and clofibrate are discussed in more detail including their chemical structures, brand names, and uses. The biosynthetic pathway of cholesterol is shown and the mechanism of action of statins is explained.
This document outlines a course on pharmaceutical quality assurance that deals with quality control and assurance aspects of the pharmaceutical industry. The course objectives are to understand cGMP requirements, the importance of documentation, quality certifications for pharmaceuticals, and the roles of quality assurance and quality control departments. It also includes puzzles to solve.
This document discusses anti-malarial drugs, focusing on cinchona alkaloids like quinine. It describes the chemical classification of anti-malarials and the medicinal chemistry of cinchona alkaloids. Specifically, it details the extraction of quinine from cinchona bark, its chemical structure, structure-activity relationships, mechanisms of action including inhibition of hemozoin biocrystallization, and therapeutic uses while noting its replacement due to undesirable side effects.
This document summarizes regulations and guidelines for conducting pharmaceutical clinical trials in India. It outlines the major regulatory bodies like DCGI, DGFT, and GEAC. It describes the statutory functions of central and state governments regarding drug licensing, approvals, and quality monitoring. Responsibilities of sponsors, investigators, and ethics committees are provided. Key aspects like clinical trial categories, amendments, safety reporting, and biologics/device regulations are summarized.
This document provides an overview and syllabus for the textbook "A Text Book of Pharmaceutical Jurisprudence" which covers key pharmaceutical laws and regulations for pharmacy students. The textbook is divided into 5 units covering topics such as the Drugs and Cosmetics Act, Pharmacy Act, Medicinal and Toilet Preparations Act, Narcotic Drugs and Psychotropic Substances Act, Drugs and Magic Remedies Act, Prevention of Cruelty to Animals Act, and National Pharmaceutical Pricing Authority. The preface expresses the authors' goal to compile all relevant topics from the Pharmacy Council of India syllabus in a simple, lucid manner. A brief description of the content included in each
This document discusses good regulatory practices across different pharmacy settings. It defines good regulatory practices as internationally recognized processes, systems, tools and methods for improving the quality of regulation. It then discusses good regulatory practices for community pharmacies, wholesale pharmacies, hospital pharmacies, and manufacturing and import/export of drugs and medical devices. Key aspects of good regulatory practices include online licensing and renewal systems, electronic record-keeping for traceability, documentation standards, and the use of electronic medical record systems.
Pathological urine refers to urine that contains abnormal constituents that are not normally present or are present in abnormal amounts. The presence of these abnormal constituents can provide important clues to underlying diseases or conditions affecting the kidneys or other organs.
(i) Not below the rank of Deputy Drugs Controller
(ii) Qualification as prescribed for licensing authority
Functions:
(i) Grant/renewal/suspension/cancellation of licences
(ii) Inspection of premises
(iii) Collection of samples
(iv) Prosecution of offenders
SJTPC 25
Controlling authority
Qualification:
(i) Graduate in Pharmacy or Pharmaceutical
Chemistry or Medicine with specialization in
clinical pharmacology or microbiology
Functions:
(i) Co-ordination and unification of the activities of all
licensing authorities under it.
(ii) Appellate authority against the orders
Pharmaceutical packaging serves several important functions:
1) It identifies and protects pharmaceutical products, facilitating their safe use by consumers.
2) Common packaging materials include glass, plastics, rubber, metals, and paper which are chosen based on their ability to protect contents and compatibility with dosage forms.
3) Packaging is tested to ensure it can withstand impacts and stresses of distribution while maintaining product integrity.
Most important questions of Medicinal Chemistry 2Payaamvohra1
This ppt gives you an idea about frequently and most commonly asked questions in pharmacy exams Do follow our slideshare instagram and youtube channel for more info
The document provides a monograph for Paracetamol as per the Indian Pharmacopoeia. It details the chemical and physical properties of Paracetamol including its definition, characteristics, identification tests, purity tests, assay, storage requirements, impurities, uses, and formulations. Paracetamol has the chemical name N-(4-Hydroxyphenyl)acetamide and is a white, crystalline powder that is sparingly soluble in water and soluble in alcohol. It is used as an analgesic and antipyretic drug in various preparations like tablets and oral solutions.
This document outlines the role of pharmacy technicians in community pharmacies. It defines a community pharmacy as an independently owned pharmacy run by pharmacists. The scope of community pharmacies includes processing prescriptions, providing clinical services, patient care, drug monitoring, and assisting with minor ailments. The document also discusses primary health care and its attributes such as being essential, universally accessible, and community-based. Finally, it describes the role of pharmacy technicians as aiding the pharmacist in filling prescriptions, operating the cash register, maintaining inventory and patient records, and preparing insurance forms.
Drugs and Cosmetics Act, 1940 and its rules 1945:
Objectives, Definitions, Legal definitions of schedules to the Act and
Rules
Import of drugs – Classes of drugs and cosmetics prohibited from import, Import under
license or permit. Offences and penalties.
Manufacture of drugs – Prohibition of manufacture and sale of certain drugs,
Conditions for grant of license and conditions of license for manufacture of drugs,
Manufacture of drugs for test, examination and analysis, manufacture of new drug, loan
license and repacking license.
Volatile oils, also known as essential oils, are oils extracted from plants that are volatile and evaporate easily. They are produced in secretory cells, ducts, or glandular hairs of plants and are often associated with other substances like gums and resins. The main extraction methods for volatile oils are distillation in water or steam, expression via scarification, solvent extraction, enzymatic hydrolysis of glycosidic oils, and enfleurage. Volatile oils have various therapeutic uses like inhalation, oral ingestion, mouthwashes, and transdermal application in aromatherapy. Oils with high phenol content have antiseptic properties.
Resins and Resin combinations by Dr .U.Srinivasa, Professor and Head, Sriniv...ummanabadsrinivas
This document summarizes various resins and their properties. It discusses the definition and sources of resins, how they are classified, and their key chemical constituents. Five specific resins are described in detail: cannabis, podophyllum, ginger, capsicum, and benzoin. For each, the biological source, diagnostic characteristics, chemical constituents, uses, and important chemical tests are outlined.
Drugs and Cosmetics Act 1940 and Rules 1945 - Detailed reviewMd Altamash Ahmad
OBJECTIVES
• To prevent substandard in drugs, presumably for treatment, maintaining high standards of medical
• To regulate the import, manufacture, distribution and sale of drugs & cosmetics through licensing.
• Manufacture, distribution and sale of drugs and cosmetics by qualified persons only.
• Act has nothing to do with the Excise duty
• To regulate the manufacture and sale of Ayurvedic, Siddha and Unani drugs.
• To establish Drugs Technical Advisory Board (DTAB) and Drugs Consultative Committees (DCC) for Allopathic and allied drugs and cosmetics.
Pharmaceutical Regulations in GCC countriesIman Ajami
The Gulf Cooperation Council (GCC) regulatory authorities approved a centralized drug registration system located in Riyadh, Saudi Arabia in 1999. The system aims to improve patient access to safe and effective medicines across GCC countries. The GCC Central Drug Registration Committee is composed of two members from each GCC state. Applications are reviewed by two selected states alphabetically, but all states are responsible for evaluating quality, safety and efficacy. States meet regularly to discuss applications and make approval decisions by agreement. Registration requirements and procedures are generally harmonized across GCC states but some variation remains. Further harmonization efforts are still needed.
The document summarizes the key aspects of the Pharmacy Act of 1948 in India. It outlines the history and objectives of establishing the Act, which was aimed at regulating the profession of pharmacy and ensuring uniform education and training standards. Some key points covered include the constitution of the Pharmacy Council of India and State Pharmacy Councils to oversee education regulations and registration of pharmacists. The roles and functions of these councils are also briefly discussed along with details around the registration process for pharmacists in India.
Description & functions of drug regulatory affairsCepal & Co.
This document provides an introduction to regulatory affairs and good regulatory practices. It defines regulatory affairs as the interface between the pharmaceutical industry and drug regulatory authorities, and notes that regulatory affairs is involved in all stages of medicine development and post-marketing activities. The document then discusses the roles and responsibilities of regulatory professionals in liaising with health authorities, ensuring regulatory compliance, and managing product life cycles. It also outlines principles of good regulatory practices such as legality, impartiality, consistency, and transparency.
This document discusses standards for particle size separation and powders. It describes how powders are separated into different grades based on the size of sieve they pass through, with finer powders passing through higher numbered sieves. The five grades specified by the Indian Pharmacopoeia are defined by the sieve size they pass through, with additional specifications for some grades. Materials, construction, and methods used for sieves are also outlined.
The Drug and Cosmetic Act of 1940 and Rules of 1945 regulate the import, manufacture, distribution and sale of drugs and cosmetics in India. The objectives are to prevent the import or manufacture of substandard drugs and cosmetics, and ensure they are only distributed by trained professionals. The Act defines key terms like "drug", "cosmetic", and categories of drugs like Ayurvedic and Homeopathic. It establishes standards for quality, prohibits misbranding and adulteration, and defines spurious drugs. Schedules list authoritative texts for Ayurvedic/Siddha/Unani medicines, quality standards, and classify drugs as prescription-only or over-the-counter. The Act aims to
This document discusses herbal drugs and technology related to their use. It defines herbs and herbal medicines, and describes herbal medicinal products and preparations. It discusses sources of herbs, including wild and cultivated sources. It covers selection, identification and authentication of herbal materials. Finally, it summarizes processing of herbal raw materials, including primary and secondary processing, as well as guidelines for good agricultural practices in cultivating medicinal plants.
chemistry and synthesis of methotrexate.pptxRAJ K. MAURYA
Methotrexate is a chemotherapy drug used to treat cancer and autoimmune diseases. It works by inhibiting dihydrofolate reductase, an enzyme involved in cell division. The document discusses the chemistry and synthesis process for producing methotrexate, which involves multiple chemical reaction steps to build up the molecule from simpler starting materials.
UNIT 1_QUALITY ASSURANCE_QC,QA,GMP,TQM and NABLSayali Powar
UNIT – I
Quality Assurance and Quality Management concepts: Definition and concept of Qualitycontrol, Quality assurance and GMP
Total Quality Management (TQM), NABL
This document discusses good regulatory practices across different pharmacy settings. It defines good regulatory practices as internationally recognized processes, systems, tools and methods for improving the quality of regulation. It then discusses good regulatory practices for community pharmacies, wholesale pharmacies, hospital pharmacies, and manufacturing and import/export of drugs and medical devices. Key aspects of good regulatory practices include online licensing and renewal systems, electronic record-keeping for traceability, documentation standards, and the use of electronic medical record systems.
Pathological urine refers to urine that contains abnormal constituents that are not normally present or are present in abnormal amounts. The presence of these abnormal constituents can provide important clues to underlying diseases or conditions affecting the kidneys or other organs.
(i) Not below the rank of Deputy Drugs Controller
(ii) Qualification as prescribed for licensing authority
Functions:
(i) Grant/renewal/suspension/cancellation of licences
(ii) Inspection of premises
(iii) Collection of samples
(iv) Prosecution of offenders
SJTPC 25
Controlling authority
Qualification:
(i) Graduate in Pharmacy or Pharmaceutical
Chemistry or Medicine with specialization in
clinical pharmacology or microbiology
Functions:
(i) Co-ordination and unification of the activities of all
licensing authorities under it.
(ii) Appellate authority against the orders
Pharmaceutical packaging serves several important functions:
1) It identifies and protects pharmaceutical products, facilitating their safe use by consumers.
2) Common packaging materials include glass, plastics, rubber, metals, and paper which are chosen based on their ability to protect contents and compatibility with dosage forms.
3) Packaging is tested to ensure it can withstand impacts and stresses of distribution while maintaining product integrity.
Most important questions of Medicinal Chemistry 2Payaamvohra1
This ppt gives you an idea about frequently and most commonly asked questions in pharmacy exams Do follow our slideshare instagram and youtube channel for more info
The document provides a monograph for Paracetamol as per the Indian Pharmacopoeia. It details the chemical and physical properties of Paracetamol including its definition, characteristics, identification tests, purity tests, assay, storage requirements, impurities, uses, and formulations. Paracetamol has the chemical name N-(4-Hydroxyphenyl)acetamide and is a white, crystalline powder that is sparingly soluble in water and soluble in alcohol. It is used as an analgesic and antipyretic drug in various preparations like tablets and oral solutions.
This document outlines the role of pharmacy technicians in community pharmacies. It defines a community pharmacy as an independently owned pharmacy run by pharmacists. The scope of community pharmacies includes processing prescriptions, providing clinical services, patient care, drug monitoring, and assisting with minor ailments. The document also discusses primary health care and its attributes such as being essential, universally accessible, and community-based. Finally, it describes the role of pharmacy technicians as aiding the pharmacist in filling prescriptions, operating the cash register, maintaining inventory and patient records, and preparing insurance forms.
Drugs and Cosmetics Act, 1940 and its rules 1945:
Objectives, Definitions, Legal definitions of schedules to the Act and
Rules
Import of drugs – Classes of drugs and cosmetics prohibited from import, Import under
license or permit. Offences and penalties.
Manufacture of drugs – Prohibition of manufacture and sale of certain drugs,
Conditions for grant of license and conditions of license for manufacture of drugs,
Manufacture of drugs for test, examination and analysis, manufacture of new drug, loan
license and repacking license.
Volatile oils, also known as essential oils, are oils extracted from plants that are volatile and evaporate easily. They are produced in secretory cells, ducts, or glandular hairs of plants and are often associated with other substances like gums and resins. The main extraction methods for volatile oils are distillation in water or steam, expression via scarification, solvent extraction, enzymatic hydrolysis of glycosidic oils, and enfleurage. Volatile oils have various therapeutic uses like inhalation, oral ingestion, mouthwashes, and transdermal application in aromatherapy. Oils with high phenol content have antiseptic properties.
Resins and Resin combinations by Dr .U.Srinivasa, Professor and Head, Sriniv...ummanabadsrinivas
This document summarizes various resins and their properties. It discusses the definition and sources of resins, how they are classified, and their key chemical constituents. Five specific resins are described in detail: cannabis, podophyllum, ginger, capsicum, and benzoin. For each, the biological source, diagnostic characteristics, chemical constituents, uses, and important chemical tests are outlined.
Drugs and Cosmetics Act 1940 and Rules 1945 - Detailed reviewMd Altamash Ahmad
OBJECTIVES
• To prevent substandard in drugs, presumably for treatment, maintaining high standards of medical
• To regulate the import, manufacture, distribution and sale of drugs & cosmetics through licensing.
• Manufacture, distribution and sale of drugs and cosmetics by qualified persons only.
• Act has nothing to do with the Excise duty
• To regulate the manufacture and sale of Ayurvedic, Siddha and Unani drugs.
• To establish Drugs Technical Advisory Board (DTAB) and Drugs Consultative Committees (DCC) for Allopathic and allied drugs and cosmetics.
Pharmaceutical Regulations in GCC countriesIman Ajami
The Gulf Cooperation Council (GCC) regulatory authorities approved a centralized drug registration system located in Riyadh, Saudi Arabia in 1999. The system aims to improve patient access to safe and effective medicines across GCC countries. The GCC Central Drug Registration Committee is composed of two members from each GCC state. Applications are reviewed by two selected states alphabetically, but all states are responsible for evaluating quality, safety and efficacy. States meet regularly to discuss applications and make approval decisions by agreement. Registration requirements and procedures are generally harmonized across GCC states but some variation remains. Further harmonization efforts are still needed.
The document summarizes the key aspects of the Pharmacy Act of 1948 in India. It outlines the history and objectives of establishing the Act, which was aimed at regulating the profession of pharmacy and ensuring uniform education and training standards. Some key points covered include the constitution of the Pharmacy Council of India and State Pharmacy Councils to oversee education regulations and registration of pharmacists. The roles and functions of these councils are also briefly discussed along with details around the registration process for pharmacists in India.
Description & functions of drug regulatory affairsCepal & Co.
This document provides an introduction to regulatory affairs and good regulatory practices. It defines regulatory affairs as the interface between the pharmaceutical industry and drug regulatory authorities, and notes that regulatory affairs is involved in all stages of medicine development and post-marketing activities. The document then discusses the roles and responsibilities of regulatory professionals in liaising with health authorities, ensuring regulatory compliance, and managing product life cycles. It also outlines principles of good regulatory practices such as legality, impartiality, consistency, and transparency.
This document discusses standards for particle size separation and powders. It describes how powders are separated into different grades based on the size of sieve they pass through, with finer powders passing through higher numbered sieves. The five grades specified by the Indian Pharmacopoeia are defined by the sieve size they pass through, with additional specifications for some grades. Materials, construction, and methods used for sieves are also outlined.
The Drug and Cosmetic Act of 1940 and Rules of 1945 regulate the import, manufacture, distribution and sale of drugs and cosmetics in India. The objectives are to prevent the import or manufacture of substandard drugs and cosmetics, and ensure they are only distributed by trained professionals. The Act defines key terms like "drug", "cosmetic", and categories of drugs like Ayurvedic and Homeopathic. It establishes standards for quality, prohibits misbranding and adulteration, and defines spurious drugs. Schedules list authoritative texts for Ayurvedic/Siddha/Unani medicines, quality standards, and classify drugs as prescription-only or over-the-counter. The Act aims to
This document discusses herbal drugs and technology related to their use. It defines herbs and herbal medicines, and describes herbal medicinal products and preparations. It discusses sources of herbs, including wild and cultivated sources. It covers selection, identification and authentication of herbal materials. Finally, it summarizes processing of herbal raw materials, including primary and secondary processing, as well as guidelines for good agricultural practices in cultivating medicinal plants.
chemistry and synthesis of methotrexate.pptxRAJ K. MAURYA
Methotrexate is a chemotherapy drug used to treat cancer and autoimmune diseases. It works by inhibiting dihydrofolate reductase, an enzyme involved in cell division. The document discusses the chemistry and synthesis process for producing methotrexate, which involves multiple chemical reaction steps to build up the molecule from simpler starting materials.
UNIT 1_QUALITY ASSURANCE_QC,QA,GMP,TQM and NABLSayali Powar
UNIT – I
Quality Assurance and Quality Management concepts: Definition and concept of Qualitycontrol, Quality assurance and GMP
Total Quality Management (TQM), NABL
The document discusses carbohydrate metabolism and its major pathways. It describes glycolysis as the breakdown of glucose to pyruvate with ATP production. The citric acid cycle (Krebs cycle) is then discussed as the oxidation of acetyl CoA to CO2, providing most of the cell's ATP. Other pathways discussed include gluconeogenesis (glucose synthesis from non-carbs), glycogenesis/glycogenolysis (glycogen formation and breakdown), and the pentose phosphate pathway for producing NADPH and other essential cell products. Disorders of carbohydrate metabolism like glycogen storage diseases and glucose-6-phosphate dehydrogenase deficiency are also mentioned.
PPT ON ORGANIZATION,PERSONNEL, PREMISES.pptxSayali Powar
This document discusses organization and personnel management as well as premises requirements for quality control. It addresses personnel responsibilities, training, hygiene, and record keeping. It also covers the design, construction, maintenance, sanitation, and environmental controls needed for premises, as well as utilities, sterile areas, and contamination control.
QC test for Packaging Materials used in Pharmaceuticals.pptxSayali Powar
This document discusses quality control testing standards for packaging materials used in pharmaceuticals. It outlines the primary and secondary components that are tested and the critical parameters for setting standards, including appearance, dimensions, compatibility and usability, and chemical testing. Testing procedures are divided into those that test the packaging material in isolation versus those that test the entire package. Material tests include chemical, mechanical, and environmental tests, while package tests focus on mechanical and environmental aspects.
UNIT 1 BIOCHEMISTRY_BIOMOLECULE_MINI PROJECT.pdfSayali Powar
The document discusses the benefits of exercise for mental health. Regular physical activity can help reduce anxiety and depression and improve mood and cognitive function. Exercise causes chemical changes in the brain that may help protect against mental illness and improve symptoms.
Bioenergetics deals with the study of energy changes in biochemical reactions. Reactions are classified as exergonic, which release energy, or endergonic, which consume energy. Free energy, the energy available to do work, is an important concept. Cells use energy for functions like growth and reproduction. Energy must be transferred and different systems require energy to function. A key energy carrier in cells is ATP, which serves as the primary energy currency and is involved in complex production processes to power various cellular activities.
LIPIDS UNIT ONE BIOMOLECULE PRESENTATIONSayali Powar
Lipids are organic compounds that are insoluble in water but soluble in organic solvents. They serve as concentrated energy stores and structural components of cell membranes. Lipids are broadly classified into simple, complex, derived, and miscellaneous categories. Simple lipids include fats, oils, and waxes. Complex lipids contain additional groups like phosphate, carbohydrates, or proteins. Derived lipids result from hydrolysis of other lipids. Miscellaneous lipids include carotenoids and hydrocarbons.
UNIT 1 BIOMOLECULE_CARBOHYDRATES PRESENTATIONSayali Powar
The document discusses biomolecules and introduces carbohydrates. It states that biomolecules are the building blocks of life and are composed mainly of carbon, hydrogen, oxygen, nitrogen, sulfur and phosphorus. Carbohydrates are one of the four major types of biomolecules and include monosaccharides, oligosaccharides, and polysaccharides. Monosaccharides are the simplest carbohydrates and include sugars with three to seven carbon atoms. Oligosaccharides contain two to ten monosaccharide units while polysaccharides are high molecular weight polymers of monosaccharides. Carbohydrates serve important biological functions as an energy source, building materials, and energy storage.
UNIT 3 QUALITY ASSURANCE LECTURE 3.pptxSayali Powar
The document discusses pharmaceutical quality assurance and packaging. It states that packaging plays an important role in product quality by providing protection, presentation, identification, information, compatibility and convenience. It also lists the requirements of good packaging, including that the packaging must not react with or impart tastes/odors to the product, and must be nontoxic, FDA approved, and tamper resistant. Finally, it describes the different types of containers used for pharmaceutical products based on their purpose, such as single dose containers for injectables and light-resistant containers for photosensitive medications.
The document discusses immunochemistry and the immune system. It describes the two main types of immunity - innate (nonspecific) immunity which is present at birth, and adaptive (specific) immunity which develops after exposure to pathogens. It also discusses antibodies and immunoglobulins which are Y-shaped proteins used by the immune system to identify and neutralize foreign substances. The five major immunoglobulins - IgG, IgA, IgM, IgD, and IgE - are also summarized based on their structure, location in the body, and function. Finally, the process of ELISA (enzyme-linked immunosorbent assay) is outlined as a common method to detect antigens, antibodies, or hormones in a patient's
Inflammatory bowel disease (IBD) is characterized by chronic inflammation of the gastrointestinal tract and causes persistent diarrhea, abdominal pain, and bloody stools. Complications include malnutrition, colorectal cancer, and intestinal rupture. Hepatitis is an inflammation of the liver with symptoms like fatigue, jaundice, and abdominal pain. It can cause liver scarring, cancer, and failure. Rheumatoid arthritis is an autoimmune disorder where the immune system attacks the synovial membrane in joints, leading to pain, stiffness, and joint damage. Osteoporosis is a disease where bone mineral density decreases, risking fractures especially in the spine and hips. Gout occurs when uric acid crystals form in joints due to
The document discusses various infectious diseases including meningitis, typhoid, leprosy, tuberculosis, urinary tract infection (UTI), and sexually transmitted diseases like AIDS, syphilis, and gonorrhea. For each disease, it provides definitions, causes, types (if any), complications, and in some cases pathogenesis. Meningitis can be caused by viral, bacterial or fungal/parasitic infections and can lead to hearing loss, seizures or cognitive issues. Typhoid fever is caused by Salmonella Typhi and can cause intestinal perforations or bleeding. Leprosy is caused by Mycobacterium leprae and can result in paralysis and limb damage if untreated.
Iron deficiency anemia is a condition where the body lacks enough red blood cells due to low iron levels, which prevents red blood cells from carrying oxygen to tissues. Symptoms include fatigue, weakness, pale skin, headaches, dizziness, and shortness of breath. The normal range for hemoglobin is 13-18 g/dL for adult men and 12-16 g/dL for adult women.
This document discusses radiopharmaceuticals and radioactive isotopes. It begins by defining radiopharmaceuticals as medicinal formulations containing radioisotopes that are safe for administration in humans for diagnosis or therapy. It then covers various topics related to radiopharmaceuticals including the different types of radioactive emissions (alpha, beta, gamma), units of radioactivity, properties of radioactive isotopes, and examples of specific radiopharmaceuticals like sodium iodide I131. The document also discusses the applications of radioactive isotopes in areas like scientific research, analysis, diagnosis and therapy.
This document discusses organ function tests, focusing on tests of thyroid, liver, and kidney function. It provides details on the purpose of these tests, what substances are measured, and what normal and abnormal results may indicate. Thyroid function tests measure TSH, T3, and T4 to diagnose hyperthyroidism or hypothyroidism. Liver function tests measure enzymes, proteins, and bilirubin to assess liver health. Kidney function tests check how well the kidneys clear waste from the blood by measuring substances such as creatinine and urea.
- Enzymes are protein biocatalysts that increase the rate of chemical reactions without being consumed. They are specific in their action and composed of apoenzyme and coenzyme.
- The active site of an enzyme binds specifically to substrates and contains residues that help hold the substrate. Changes to the active site shape affect enzyme function.
- Factors like temperature, pH, substrate/product concentration, and presence of activators or inhibitors can regulate an enzyme's activity rate. Studying an enzyme's kinetics reveals its catalytic mechanism.
- Regulation allows cells to control metabolic pathways by modulating enzyme activity. Competitive inhibitors bind the active site while non-competitive inhibitors cause conformational changes. I
The document discusses immunochemistry and the immune system. It describes the two main types of immunity - innate (nonspecific) immunity which is present at birth, and adaptive (specific) immunity which develops after exposure to pathogens. It also discusses antibodies and immunoglobulins which are Y-shaped proteins used by the immune system to identify and neutralize foreign substances. The five major immunoglobulins - IgG, IgA, IgM, IgD, and IgE - are also summarized based on their structure, location in the body, and function. Finally, the process of ELISA (enzyme-linked immunosorbent assay) is outlined as a common method to detect antigens, antibodies, or hormones in a patient's
Applied biochemistry is the part of biochemistry that applies knowledge and methods of biochemistry to real-world problems like investigating the causes of diseases in medicine and studying the effects of nutritional deficiencies. The course introduces students to the metabolism of carbohydrates, lipids, proteins, and amino acids and how alterations in these metabolic pathways relate to clinical conditions. Students will also learn about acid-base balance, hemoglobin metabolism, clinical enzymology, function tests, and immunochemistry.
Temple of Asclepius in Thrace. Excavation resultsKrassimira Luka
The temple and the sanctuary around were dedicated to Asklepios Zmidrenus. This name has been known since 1875 when an inscription dedicated to him was discovered in Rome. The inscription is dated in 227 AD and was left by soldiers originating from the city of Philippopolis (modern Plovdiv).
it describes the bony anatomy including the femoral head , acetabulum, labrum . also discusses the capsule , ligaments . muscle that act on the hip joint and the range of motion are outlined. factors affecting hip joint stability and weight transmission through the joint are summarized.
Strategies for Effective Upskilling is a presentation by Chinwendu Peace in a Your Skill Boost Masterclass organisation by the Excellence Foundation for South Sudan on 08th and 09th June 2024 from 1 PM to 3 PM on each day.
বাংলাদেশের অর্থনৈতিক সমীক্ষা ২০২৪ [Bangladesh Economic Review 2024 Bangla.pdf] কম্পিউটার , ট্যাব ও স্মার্ট ফোন ভার্সন সহ সম্পূর্ণ বাংলা ই-বুক বা pdf বই " সুচিপত্র ...বুকমার্ক মেনু 🔖 ও হাইপার লিংক মেনু 📝👆 যুক্ত ..
আমাদের সবার জন্য খুব খুব গুরুত্বপূর্ণ একটি বই ..বিসিএস, ব্যাংক, ইউনিভার্সিটি ভর্তি ও যে কোন প্রতিযোগিতা মূলক পরীক্ষার জন্য এর খুব ইম্পরট্যান্ট একটি বিষয় ...তাছাড়া বাংলাদেশের সাম্প্রতিক যে কোন ডাটা বা তথ্য এই বইতে পাবেন ...
তাই একজন নাগরিক হিসাবে এই তথ্য গুলো আপনার জানা প্রয়োজন ...।
বিসিএস ও ব্যাংক এর লিখিত পরীক্ষা ...+এছাড়া মাধ্যমিক ও উচ্চমাধ্যমিকের স্টুডেন্টদের জন্য অনেক কাজে আসবে ...
Chapter wise All Notes of First year Basic Civil Engineering.pptxDenish Jangid
Chapter wise All Notes of First year Basic Civil Engineering
Syllabus
Chapter-1
Introduction to objective, scope and outcome the subject
Chapter 2
Introduction: Scope and Specialization of Civil Engineering, Role of civil Engineer in Society, Impact of infrastructural development on economy of country.
Chapter 3
Surveying: Object Principles & Types of Surveying; Site Plans, Plans & Maps; Scales & Unit of different Measurements.
Linear Measurements: Instruments used. Linear Measurement by Tape, Ranging out Survey Lines and overcoming Obstructions; Measurements on sloping ground; Tape corrections, conventional symbols. Angular Measurements: Instruments used; Introduction to Compass Surveying, Bearings and Longitude & Latitude of a Line, Introduction to total station.
Levelling: Instrument used Object of levelling, Methods of levelling in brief, and Contour maps.
Chapter 4
Buildings: Selection of site for Buildings, Layout of Building Plan, Types of buildings, Plinth area, carpet area, floor space index, Introduction to building byelaws, concept of sun light & ventilation. Components of Buildings & their functions, Basic concept of R.C.C., Introduction to types of foundation
Chapter 5
Transportation: Introduction to Transportation Engineering; Traffic and Road Safety: Types and Characteristics of Various Modes of Transportation; Various Road Traffic Signs, Causes of Accidents and Road Safety Measures.
Chapter 6
Environmental Engineering: Environmental Pollution, Environmental Acts and Regulations, Functional Concepts of Ecology, Basics of Species, Biodiversity, Ecosystem, Hydrological Cycle; Chemical Cycles: Carbon, Nitrogen & Phosphorus; Energy Flow in Ecosystems.
Water Pollution: Water Quality standards, Introduction to Treatment & Disposal of Waste Water. Reuse and Saving of Water, Rain Water Harvesting. Solid Waste Management: Classification of Solid Waste, Collection, Transportation and Disposal of Solid. Recycling of Solid Waste: Energy Recovery, Sanitary Landfill, On-Site Sanitation. Air & Noise Pollution: Primary and Secondary air pollutants, Harmful effects of Air Pollution, Control of Air Pollution. . Noise Pollution Harmful Effects of noise pollution, control of noise pollution, Global warming & Climate Change, Ozone depletion, Greenhouse effect
Text Books:
1. Palancharmy, Basic Civil Engineering, McGraw Hill publishers.
2. Satheesh Gopi, Basic Civil Engineering, Pearson Publishers.
3. Ketki Rangwala Dalal, Essentials of Civil Engineering, Charotar Publishing House.
4. BCP, Surveying volume 1
Walmart Business+ and Spark Good for Nonprofits.pdfTechSoup
"Learn about all the ways Walmart supports nonprofit organizations.
You will hear from Liz Willett, the Head of Nonprofits, and hear about what Walmart is doing to help nonprofits, including Walmart Business and Spark Good. Walmart Business+ is a new offer for nonprofits that offers discounts and also streamlines nonprofits order and expense tracking, saving time and money.
The webinar may also give some examples on how nonprofits can best leverage Walmart Business+.
The event will cover the following::
Walmart Business + (https://business.walmart.com/plus) is a new shopping experience for nonprofits, schools, and local business customers that connects an exclusive online shopping experience to stores. Benefits include free delivery and shipping, a 'Spend Analytics” feature, special discounts, deals and tax-exempt shopping.
Special TechSoup offer for a free 180 days membership, and up to $150 in discounts on eligible orders.
Spark Good (walmart.com/sparkgood) is a charitable platform that enables nonprofits to receive donations directly from customers and associates.
Answers about how you can do more with Walmart!"
Beyond Degrees - Empowering the Workforce in the Context of Skills-First.pptxEduSkills OECD
Iván Bornacelly, Policy Analyst at the OECD Centre for Skills, OECD, presents at the webinar 'Tackling job market gaps with a skills-first approach' on 12 June 2024
3. 5/25/2024 PRESENTED BY MS. SAYALI POWAR ICH 3
UNIT – IV
Complaints: Complaints and evaluation of complaints, Handling of return
good,recalling and waste disposal.
Document maintenance in pharmaceutical industry: Batch Formula
Record, Master Formula Record, SOP, Quality audit, Quality Review and
Quality documentation, Reports and documents, distribution records.
4. 5/25/2024 PRESENTED BY MS. SAYALI POWAR ICH 4
COMPLAINTS: COMPLAINTS AND EVALUATION
OF COMPLAINTS, HANDLING OF RETURN GOOD,
RECALLING AND WASTE DISPOSAL.
Complaint is defined as statement that is something wrong or not good
enough, which shows customer dissatisfaction about the company and
the product.
A statement that says something is unsatisfied or unacceptable about the
product/ packaging in terms of any defect in Pharmaceutical product
May be received from Pharmacists, Physicians, wholesalers, Retailers,
Patients.
Therefore, as per GMP, Industry has their own procedures to maintain
records, investigation and review steps of complaints & accordingly a
system to recall the product from the market.
5. 5/25/2024 PRESENTED BY MS. SAYALI POWAR ICH 5
COMPLAINTS: COMPLAINTS
AND EVALUATION OF
COMPLAINTS
15. 5/25/2024 PRESENTED BY MS. SAYALI POWAR ICH 15
COMPLAINTS: COMPLAINTS AND
EVALUATION OF COMPLAINTS, HANDLING
OF RETURN GOOD, RECALLING AND
WASTE DISPOSAL.
28. 5/25/2024 PRESENTED BY MS. SAYALI POWAR ICH 28
UNIT – IV
Complaints: Complaints and evaluation of complaints,
Handling of return good, recalling and waste disposal.
Document maintenance in pharmaceutical industry: Batch Formula
Record, Master Formula Record, SOP, Quality audit, Quality Review and
Quality documentation, Reports and documents, distribution records.