manufacturing and control of dosage forms
•Download as PPT, PDF•
2 likes•649 views
This document discusses manufacturing and dosage control in the pharmaceutical industry. It appears to be lecture notes or course material for an M.Pharm student in the first semester studying quality assurance. The document focuses on producing pharmaceutical dosage forms while maintaining proper dosage levels and consistency in manufacturing.
Report
Share
Report
Share
Recommended
Out of specification shravan
An out of specification (OOS) occurs when analytical results fall outside established specification ranges. There are guidelines from organizations like MHRA, CDER, and PIC/S for handling OOS events. OOS can occur during stability studies, finished products, or raw materials due to laboratory errors, process issues, or sample homogeneity problems. Investigations follow a phased approach starting with the quality control laboratory and then involving manufacturing operations if needed. The fate of an OOS batch may include reprocessing, reworking, or destruction depending on the investigation conclusions.
IMPURITIES OF NEW DRUG PRODUCTS
This document provides guidance on reporting and controlling degradation products in new drug products. It defines key terms like degradation products and qualification thresholds. The guidance recommends identifying degradation products observed during manufacturing and stability studies above the identification threshold. It also provides recommendations for validating analytical procedures to detect and quantify degradation products and reporting degradation product content from batches used in clinical and stability testing.
Concept & evolution of qa & qc
QA and QC are related but distinct concepts in quality management. QA refers to the overall system that aims to prevent defects through processes, while QC tests products to identify defects. QA is a preventative system involving all employees to ensure quality standards are met throughout development. In contrast, QC is reactive and conducted by a specialized team to detect defects in finished products before release. Both work together to continually meet customer requirements, with QA focusing on building quality in from the start and QC checking for quality along the way.
Quality audit plan
This document discusses quality auditing in the pharmaceutical industry. It defines quality auditing and explains that it involves systematically examining quality systems to determine compliance. The document outlines different types of audits including internal, external, regulatory, product, process, and system audits. It discusses planning, conducting, and reporting on audits. The key objectives of audits are to ensure quality, assess effectiveness of quality assurance systems, and permit timely correction of any issues. Audits help build confidence in quality management practices and identify areas for improvement.
Analytical method validation as per ich and usp
Analytical method validation is a process of documenting/ proving that an analytical method provides analytical data acceptable for the intended use.After the development of an analytical procedure, it is must important to assure that the procedure will consistently produce the intended a precise result with high degree of accuracy. The method should give a specific result that may not be affected by external matters. This creates a requirement to validate the analytical procedures. The validation procedures consists of some characteristics parameters that makes the method acceptable with addition of statistical tools.
Residual solvents as impurities
This presentation discusses impurities in residual solvents and provides guidelines for their classification and acceptable limits. It summarizes the ICH Q3C guideline, which classifies residual solvents into four categories based on toxicity. Class 1 solvents are to be avoided, while Class 2 solvents should be limited and Class 3 solvents have low toxic potential but levels should not exceed recommendations. Analytical methods for determining residual solvent levels are also covered. The guideline aims to recommend safe amounts of residual solvents in pharmaceuticals to protect patient safety.
Impurities in drug substance (ich q3 a)
This document discusses guidelines for classifying, reporting, controlling, and qualifying impurities in new drug substances. It defines types of impurities and provides thresholds for reporting, identifying, and qualifying impurities. The key points are:
- Impurities are classified as organic, inorganic, or residual solvents. Organic impurities can arise from starting materials, byproducts, or degradation.
- Identification thresholds determine which impurities must be identified and qualified. Impurities above reporting thresholds must be reported.
- Specifications list individual specified impurities and general limits for unspecified impurities.
- Qualification involves evaluating safety data for impurities at specified levels. Impurities may need further study if usual qualification thresholds
Basics of Impurity Profiling
describes what are impurities, sources of impurity, applications of impurity profiling and how to do impurity profiling.
Recommended
Out of specification shravan
An out of specification (OOS) occurs when analytical results fall outside established specification ranges. There are guidelines from organizations like MHRA, CDER, and PIC/S for handling OOS events. OOS can occur during stability studies, finished products, or raw materials due to laboratory errors, process issues, or sample homogeneity problems. Investigations follow a phased approach starting with the quality control laboratory and then involving manufacturing operations if needed. The fate of an OOS batch may include reprocessing, reworking, or destruction depending on the investigation conclusions.
IMPURITIES OF NEW DRUG PRODUCTS
This document provides guidance on reporting and controlling degradation products in new drug products. It defines key terms like degradation products and qualification thresholds. The guidance recommends identifying degradation products observed during manufacturing and stability studies above the identification threshold. It also provides recommendations for validating analytical procedures to detect and quantify degradation products and reporting degradation product content from batches used in clinical and stability testing.
Concept & evolution of qa & qc
QA and QC are related but distinct concepts in quality management. QA refers to the overall system that aims to prevent defects through processes, while QC tests products to identify defects. QA is a preventative system involving all employees to ensure quality standards are met throughout development. In contrast, QC is reactive and conducted by a specialized team to detect defects in finished products before release. Both work together to continually meet customer requirements, with QA focusing on building quality in from the start and QC checking for quality along the way.
Quality audit plan
This document discusses quality auditing in the pharmaceutical industry. It defines quality auditing and explains that it involves systematically examining quality systems to determine compliance. The document outlines different types of audits including internal, external, regulatory, product, process, and system audits. It discusses planning, conducting, and reporting on audits. The key objectives of audits are to ensure quality, assess effectiveness of quality assurance systems, and permit timely correction of any issues. Audits help build confidence in quality management practices and identify areas for improvement.
Analytical method validation as per ich and usp
Analytical method validation is a process of documenting/ proving that an analytical method provides analytical data acceptable for the intended use.After the development of an analytical procedure, it is must important to assure that the procedure will consistently produce the intended a precise result with high degree of accuracy. The method should give a specific result that may not be affected by external matters. This creates a requirement to validate the analytical procedures. The validation procedures consists of some characteristics parameters that makes the method acceptable with addition of statistical tools.
Residual solvents as impurities
This presentation discusses impurities in residual solvents and provides guidelines for their classification and acceptable limits. It summarizes the ICH Q3C guideline, which classifies residual solvents into four categories based on toxicity. Class 1 solvents are to be avoided, while Class 2 solvents should be limited and Class 3 solvents have low toxic potential but levels should not exceed recommendations. Analytical methods for determining residual solvent levels are also covered. The guideline aims to recommend safe amounts of residual solvents in pharmaceuticals to protect patient safety.
Impurities in drug substance (ich q3 a)
This document discusses guidelines for classifying, reporting, controlling, and qualifying impurities in new drug substances. It defines types of impurities and provides thresholds for reporting, identifying, and qualifying impurities. The key points are:
- Impurities are classified as organic, inorganic, or residual solvents. Organic impurities can arise from starting materials, byproducts, or degradation.
- Identification thresholds determine which impurities must be identified and qualified. Impurities above reporting thresholds must be reported.
- Specifications list individual specified impurities and general limits for unspecified impurities.
- Qualification involves evaluating safety data for impurities at specified levels. Impurities may need further study if usual qualification thresholds
Basics of Impurity Profiling
describes what are impurities, sources of impurity, applications of impurity profiling and how to do impurity profiling.
QUALITY MANAGEMNT SYSTEMS: Change Control (CC)
This document discusses change control in the pharmaceutical industry. It begins by defining change control as a formal system to review proposed or actual changes that could affect facilities, systems, equipment, or processes. The functions of change control are then outlined as identifying, reviewing, approving, validating, analyzing, and monitoring changes. The areas of change that would require control are described, including manufacturing, quality control, research and development, engineering, and marketing. Finally, the document states that written procedures and documentation like standard operating procedures and change control forms are necessary parts of the change control system.
Documentation in pharmaceutical industry
This document discusses various quality control and documentation procedures in the pharmaceutical industry. It includes 3 key points:
1. It discusses the importance of documentation in defining specifications, methods, providing an audit trail and ensuring authorized personnel have necessary information. This includes documents like specifications, batch production records, SOPs etc.
2. It describes procedures for developing key documents like master formulas, batch manufacturing records, audit plans and reports. This ensures uniform processes and allows tracing of batch history.
3. It discusses quality audits which systematically examine if quality activities comply with arrangements and objectives. This includes internal audits as well as those imposed by regulators or customers.
cGMP Guidelines According to Schedule M
This document provides an overview of cGMP guidelines according to Schedule M. It defines cGMP and outlines key areas that must be addressed including personnel, premises, equipment, standard operating procedures, raw materials, self inspections, master formula records, batch manufacturing records, warehousing, and validation. The guidelines ensure quality products are consistently produced and that quality is built into every step of the manufacturing process.
ICH- Q3 Impurity
This document discusses ICH guidelines related to impurities in new drug substances and products. It defines key terms like impurity, identified impurity, and potential impurity. It categorizes impurities as organic, inorganic, or residual solvents. The guidelines provide thresholds for identification, qualification, and reporting of impurities. They also classify residual solvents and elemental impurities based on their toxicity, providing permissible daily exposure limits. The guidelines aim to establish qualification of impurities at levels present in early clinical trials and provide a risk-based approach to control impurities.
bio analytical method validation usfda guidlines
This document provides guidance from the US FDA on bioanalytical method validation. It discusses key principles such as method development, validation parameters for chromatographic and ligand binding assays, calibration curves, quality controls, selectivity, sensitivity, accuracy, precision, recovery, and stability. The guidance is intended to help sponsors validate analytical methods used in human and animal studies to quantify drug, metabolite, protein, and biomarker levels in biological matrices like blood, serum and tissue.
In process & finished products quality control test for pharmaceuticals
This document discusses in-process quality control (IPQC) and finished product quality control (FPQC) for pharmaceutical products. It defines IPQC and outlines its objectives to optimize processes, monitor operations, and inspect raw materials, equipment, environment and more. Key IPQC tests are described including physical/chemical tests (identity, quality, purity, potency), biological/microbiological tests. Specific IPQC parameters and checks are provided for tablets, including tests for size/shape, color, thickness, assay, dissolution and more. Acceptance criteria are defined according to pharmacopeial standards. The importance of IPQC for ensuring quality products is emphasized.
IMPURITY PROFILING (SOURCES OF IMPURITIES)
The description, characterization and quantitation of identified and unidentified impurities present in the drug substances is known as impurity profile.
IMPURITIES in pharmaceuticals are unwanted chemicals, that even in small amounts may influence the efficacy and safety of the pharmaceutical products.
Qualification of laboratory equipments by Mayuri Soni
The document provides standard operating procedures (SOPs) for qualifying common laboratory equipment used for quality control testing of pharmaceuticals. It describes calibration procedures for hardness testers, friability test apparatus, tap density apparatus, disintegration testers, and dissolution test apparatus. The SOPs outline how to test that the equipment meets specifications for factors like force measurements, rotation speeds, temperature control, and oscillations. Regular calibration is necessary to confirm equipment is functioning properly and producing accurate results.
extraction of drug from biological matrix.pptx
This document discusses extraction of drugs and metabolites from biological matrices. It covers topics like sample preparation techniques, types of samples, physicochemical properties of drugs, and methods of extraction. The key goals of sample preparation are to isolate analytes from interfering compounds, dissolve them in a suitable solvent, and pre-concentrate them at a level suitable for detection. Common extraction methods mentioned are liquid-liquid extraction, solid phase extraction, protein precipitation, solid phase microextraction, matrix solid phase dispersion, and supercritical fluid extraction.
CLEANING METHOD DEVELOPMENT
In this slide contains Introduction, levels of cleaning, mechanism, sampling method of cleaning validation.
Presented by: P. VENKATESH (Department of pharmaceutical analysis).RIPER, anantapur
Developing specifications q3 q6
This document provides guidelines for developing specifications for new drug substances and products according to ICH Q6A. It discusses universal and specific tests/criteria that should be included for drug substances and products, such as identification, description, assay, impurities, dissolution, disintegration, content uniformity, and microbial limits. The document gives acceptance criteria and justification for key tests like dissolution, discussing how to set Q values and limits based on biobatch results and BCS classification. It also provides guidance on other tests for oral liquids, parenterals and solid dosage forms.
Impurity Profile
Introduction,
Definition,
Source of impurities,
Inorganic impurities,
Isolation of impurities,
Identification of impurities,
Calibration of analytical instruments
This document discusses the calibration of various analytical instruments used in pharmaceutical analysis. It begins with an introduction to calibration and the need for calibrating instruments. It then provides details on calibrating UV-Vis spectrophotometers, IR spectrophotometers, spectrofluorimeters, HPTLC, and gas chromatography. For each instrument, it describes the parameters checked during calibration such as wavelength accuracy, resolution, photometric accuracy, linearity, and acceptance criteria. The document aims to explain the calibration process for key analytical tools to ensure accurate measurements.
Pharmaceutical inspection convention
PIC/S is a combine term used for the execution of activities of Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme
harmonize, educate, and update aspects relating to Good Manufacturing Practice among member countries
harmonized relation among regulatory authorities and governments
members
history
role
objective and function
guidlines
Validation parameters
This document discusses the key aspects of analytical method validation including specificity, linearity, range, accuracy, precision, detection limit, quantitation limit, robustness, and system suitability testing. It provides detailed descriptions and recommendations for establishing each validation characteristic to demonstrate that an analytical procedure is suitable for its intended use.
Impurities ICH Q3 Guidelines Au Vivek Jain
This document provides an overview of ICH Q3 guidelines for impurities in pharmaceutical products. It defines impurities and discusses the objectives of controlling impurities. It describes different types of impurities including organic, inorganic, and residual solvents. It outlines ICH Q3A-Q3D guidelines and definitions related to impurities and degradation products. It also discusses thresholds for identifying, reporting, and qualifying degradation products in new drug products.
Computerized system validation
The document discusses validation of computerized systems used in the pharmaceutical industry. It outlines the importance of validation to ensure accuracy, reliability and consistent performance. The key aspects covered include validation protocols, qualification of hardware and software, user requirements, change control, and compliance with regulations like 21 CFR Part 11 and guidance like GAMP 5. The overall goal of validation is to confirm that computer systems meet intended uses and fulfill requirements.
Analytical method validation
This document provides an overview of analytical method validation. It discusses key validation characteristics such as specificity, linearity, range, accuracy, precision, LOD and LOQ. Guidelines for validation from organizations like ICH, USP, ANVISA and AOAC are also mentioned. The document describes procedures for establishing various validation parameters and evaluating the results. It emphasizes that validation is necessary to ensure analytical methods consistently provide reliable results.
Validation master plan
In this slide contains details about Validation master plan.
Presented by: HIMA BINDHU (Department of pharmaceutical analysis).RIPER, anantapur
Vendor qualification
This document discusses vendor certification and categorization. It defines vendor certification as ensuring a vendor will meet regulatory expectations. Vendors are categorized from 1 to 4 based on risk, with category 1 being experts with minimal monitoring and category 4 being sole-source API manufacturers requiring intense monitoring. The document also outlines the vendor qualification process, including selection criteria, evaluation of production processes, and standard procedures for quality audits.
Endocrine
The endocrine system is comprised of glands that secrete hormones to regulate various bodily functions such as metabolism, growth, reproduction, sleep, and mood. The major endocrine glands include the hypothalamus, pituitary gland, thyroid gland, parathyroid glands, adrenal glands, pancreas, and ovaries/testes. These glands secrete hormones directly into the bloodstream to regulate distant target organs, unlike exocrine glands which secrete substances through ducts.
Nervous system
The nervous system consists of neurons that connect the central nervous system (the brain and spinal cord) to the peripheral nervous system. The central nervous system controls voluntary and involuntary functions and processes sensory information. It is composed of the brain, spinal cord, and nerves that connect them. The peripheral nervous system includes cranial and spinal nerves that connect to sensory receptors and muscles throughout the body.
More Related Content
What's hot
QUALITY MANAGEMNT SYSTEMS: Change Control (CC)
This document discusses change control in the pharmaceutical industry. It begins by defining change control as a formal system to review proposed or actual changes that could affect facilities, systems, equipment, or processes. The functions of change control are then outlined as identifying, reviewing, approving, validating, analyzing, and monitoring changes. The areas of change that would require control are described, including manufacturing, quality control, research and development, engineering, and marketing. Finally, the document states that written procedures and documentation like standard operating procedures and change control forms are necessary parts of the change control system.
Documentation in pharmaceutical industry
This document discusses various quality control and documentation procedures in the pharmaceutical industry. It includes 3 key points:
1. It discusses the importance of documentation in defining specifications, methods, providing an audit trail and ensuring authorized personnel have necessary information. This includes documents like specifications, batch production records, SOPs etc.
2. It describes procedures for developing key documents like master formulas, batch manufacturing records, audit plans and reports. This ensures uniform processes and allows tracing of batch history.
3. It discusses quality audits which systematically examine if quality activities comply with arrangements and objectives. This includes internal audits as well as those imposed by regulators or customers.
cGMP Guidelines According to Schedule M
This document provides an overview of cGMP guidelines according to Schedule M. It defines cGMP and outlines key areas that must be addressed including personnel, premises, equipment, standard operating procedures, raw materials, self inspections, master formula records, batch manufacturing records, warehousing, and validation. The guidelines ensure quality products are consistently produced and that quality is built into every step of the manufacturing process.
ICH- Q3 Impurity
This document discusses ICH guidelines related to impurities in new drug substances and products. It defines key terms like impurity, identified impurity, and potential impurity. It categorizes impurities as organic, inorganic, or residual solvents. The guidelines provide thresholds for identification, qualification, and reporting of impurities. They also classify residual solvents and elemental impurities based on their toxicity, providing permissible daily exposure limits. The guidelines aim to establish qualification of impurities at levels present in early clinical trials and provide a risk-based approach to control impurities.
bio analytical method validation usfda guidlines
This document provides guidance from the US FDA on bioanalytical method validation. It discusses key principles such as method development, validation parameters for chromatographic and ligand binding assays, calibration curves, quality controls, selectivity, sensitivity, accuracy, precision, recovery, and stability. The guidance is intended to help sponsors validate analytical methods used in human and animal studies to quantify drug, metabolite, protein, and biomarker levels in biological matrices like blood, serum and tissue.
In process & finished products quality control test for pharmaceuticals
This document discusses in-process quality control (IPQC) and finished product quality control (FPQC) for pharmaceutical products. It defines IPQC and outlines its objectives to optimize processes, monitor operations, and inspect raw materials, equipment, environment and more. Key IPQC tests are described including physical/chemical tests (identity, quality, purity, potency), biological/microbiological tests. Specific IPQC parameters and checks are provided for tablets, including tests for size/shape, color, thickness, assay, dissolution and more. Acceptance criteria are defined according to pharmacopeial standards. The importance of IPQC for ensuring quality products is emphasized.
IMPURITY PROFILING (SOURCES OF IMPURITIES)
The description, characterization and quantitation of identified and unidentified impurities present in the drug substances is known as impurity profile.
IMPURITIES in pharmaceuticals are unwanted chemicals, that even in small amounts may influence the efficacy and safety of the pharmaceutical products.
Qualification of laboratory equipments by Mayuri Soni
The document provides standard operating procedures (SOPs) for qualifying common laboratory equipment used for quality control testing of pharmaceuticals. It describes calibration procedures for hardness testers, friability test apparatus, tap density apparatus, disintegration testers, and dissolution test apparatus. The SOPs outline how to test that the equipment meets specifications for factors like force measurements, rotation speeds, temperature control, and oscillations. Regular calibration is necessary to confirm equipment is functioning properly and producing accurate results.
extraction of drug from biological matrix.pptx
This document discusses extraction of drugs and metabolites from biological matrices. It covers topics like sample preparation techniques, types of samples, physicochemical properties of drugs, and methods of extraction. The key goals of sample preparation are to isolate analytes from interfering compounds, dissolve them in a suitable solvent, and pre-concentrate them at a level suitable for detection. Common extraction methods mentioned are liquid-liquid extraction, solid phase extraction, protein precipitation, solid phase microextraction, matrix solid phase dispersion, and supercritical fluid extraction.
CLEANING METHOD DEVELOPMENT
In this slide contains Introduction, levels of cleaning, mechanism, sampling method of cleaning validation.
Presented by: P. VENKATESH (Department of pharmaceutical analysis).RIPER, anantapur
Developing specifications q3 q6
This document provides guidelines for developing specifications for new drug substances and products according to ICH Q6A. It discusses universal and specific tests/criteria that should be included for drug substances and products, such as identification, description, assay, impurities, dissolution, disintegration, content uniformity, and microbial limits. The document gives acceptance criteria and justification for key tests like dissolution, discussing how to set Q values and limits based on biobatch results and BCS classification. It also provides guidance on other tests for oral liquids, parenterals and solid dosage forms.
Impurity Profile
Introduction,
Definition,
Source of impurities,
Inorganic impurities,
Isolation of impurities,
Identification of impurities,
Calibration of analytical instruments
This document discusses the calibration of various analytical instruments used in pharmaceutical analysis. It begins with an introduction to calibration and the need for calibrating instruments. It then provides details on calibrating UV-Vis spectrophotometers, IR spectrophotometers, spectrofluorimeters, HPTLC, and gas chromatography. For each instrument, it describes the parameters checked during calibration such as wavelength accuracy, resolution, photometric accuracy, linearity, and acceptance criteria. The document aims to explain the calibration process for key analytical tools to ensure accurate measurements.
Pharmaceutical inspection convention
PIC/S is a combine term used for the execution of activities of Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme
harmonize, educate, and update aspects relating to Good Manufacturing Practice among member countries
harmonized relation among regulatory authorities and governments
members
history
role
objective and function
guidlines
Validation parameters
This document discusses the key aspects of analytical method validation including specificity, linearity, range, accuracy, precision, detection limit, quantitation limit, robustness, and system suitability testing. It provides detailed descriptions and recommendations for establishing each validation characteristic to demonstrate that an analytical procedure is suitable for its intended use.
Impurities ICH Q3 Guidelines Au Vivek Jain
This document provides an overview of ICH Q3 guidelines for impurities in pharmaceutical products. It defines impurities and discusses the objectives of controlling impurities. It describes different types of impurities including organic, inorganic, and residual solvents. It outlines ICH Q3A-Q3D guidelines and definitions related to impurities and degradation products. It also discusses thresholds for identifying, reporting, and qualifying degradation products in new drug products.
Computerized system validation
The document discusses validation of computerized systems used in the pharmaceutical industry. It outlines the importance of validation to ensure accuracy, reliability and consistent performance. The key aspects covered include validation protocols, qualification of hardware and software, user requirements, change control, and compliance with regulations like 21 CFR Part 11 and guidance like GAMP 5. The overall goal of validation is to confirm that computer systems meet intended uses and fulfill requirements.
Analytical method validation
This document provides an overview of analytical method validation. It discusses key validation characteristics such as specificity, linearity, range, accuracy, precision, LOD and LOQ. Guidelines for validation from organizations like ICH, USP, ANVISA and AOAC are also mentioned. The document describes procedures for establishing various validation parameters and evaluating the results. It emphasizes that validation is necessary to ensure analytical methods consistently provide reliable results.
Validation master plan
In this slide contains details about Validation master plan.
Presented by: HIMA BINDHU (Department of pharmaceutical analysis).RIPER, anantapur
Vendor qualification
This document discusses vendor certification and categorization. It defines vendor certification as ensuring a vendor will meet regulatory expectations. Vendors are categorized from 1 to 4 based on risk, with category 1 being experts with minimal monitoring and category 4 being sole-source API manufacturers requiring intense monitoring. The document also outlines the vendor qualification process, including selection criteria, evaluation of production processes, and standard procedures for quality audits.
What's hot (20)
In process & finished products quality control test for pharmaceuticals
In process & finished products quality control test for pharmaceuticals
Qualification of laboratory equipments by Mayuri Soni
Qualification of laboratory equipments by Mayuri Soni
More from Nandhini Podamekala
Endocrine
The endocrine system is comprised of glands that secrete hormones to regulate various bodily functions such as metabolism, growth, reproduction, sleep, and mood. The major endocrine glands include the hypothalamus, pituitary gland, thyroid gland, parathyroid glands, adrenal glands, pancreas, and ovaries/testes. These glands secrete hormones directly into the bloodstream to regulate distant target organs, unlike exocrine glands which secrete substances through ducts.
Nervous system
The nervous system consists of neurons that connect the central nervous system (the brain and spinal cord) to the peripheral nervous system. The central nervous system controls voluntary and involuntary functions and processes sensory information. It is composed of the brain, spinal cord, and nerves that connect them. The peripheral nervous system includes cranial and spinal nerves that connect to sensory receptors and muscles throughout the body.
Muskuloskltone
The skeletal system includes 206 bones that provide structure, protection, movement and support for the body. The bones are made of cells, proteins and minerals. There are two types of skeleton - axial (skull, vertebrae, ribs) and appendicular (shoulder, pelvis, arms, legs). The skeletal system works with muscles to enable movement, with muscles connecting to bones via tendons. Key functions include protection of organs, blood cell production, calcium storage and enabling movement.
Respiratory
The respiratory system is made up of organs responsible for oxygen intake and carbon dioxide removal through inhalation and exhalation. It is divided into the upper respiratory tract consisting of the nose, sinuses and larynx, and the lower respiratory tract containing the trachea, bronchi and lungs. In the lungs, oxygen passes into the bloodstream and carbon dioxide moves out through tiny air sacs called alveoli. The diaphragm and intercostal muscles control inhalation and exhalation, expanding and contracting the lungs and chest cavity.
Digestive system
The digestive system converts food into energy and nutrients that the body can use and eliminates waste. It begins at the mouth and includes the esophagus, stomach, small intestine, large intestine, and ends at the anus. Accessory organs like the liver, gallbladder and pancreas produce digestive juices to break down food in the gastrointestinal tract.
Circulatory SYSTEM
The circulatory system consists of the heart and blood vessels that circulate blood throughout the body. The heart has four chambers and pumps oxygenated blood received from the lungs to the body and deoxygenated blood back to the lungs. The circulatory system is divided into the pulmonary circulation between the heart and lungs and the systemic circulation between the heart and body. Blood is composed of plasma, red blood cells, white blood cells, and platelets that transport oxygen, nutrients, waste, and signals between tissues and organs. Common diseases of the circulatory system include coronary artery disease, atherosclerosis, and hypertension.
Mixer
This document summarizes different types of mixers used in pharmaceutical manufacturing including planetary mixers, colloidal mills, triple roller mills, and double cone blenders. Planetary mixers use blades and vessel walls to provide kneading and shear action for mixing semi-solids like ointments. Colloidal mills reduce particle size using shear forces between a rotating conical rotor and stationary conical stator. Triple roller mills crush materials between three rotating rollers to mix powders into ointment bases. Double cone blenders thoroughly mix powders using tumbling and shearing action provided by an agitate blade.
Fbd(Fluidized Bed Dryer)
Fluidized bed dryers use hot air to fluidize granular materials for drying. Validation of fluidized bed dryers involves installation qualification to confirm proper installation, operational qualification to verify functionality across operating ranges, and performance qualification to demonstrate consistent production of safe, high-quality product. Key steps in validation include testing air temperature distribution, inlet air quality and flow rate, uniformity of mixing and drying, and analyzing trial batches. Validation establishes that a process will reliably meet specifications.
Membrane fillter (working,validation)
Membrane filters are composed of thousands of micropores that filter particles larger than the aperture. They are used to filter various solutions and remove bacteria and impurities. Membrane filters come in flat or curly styles and are made from materials like MCE, Nylon, PTFE, PES, CA, PVDF. They are classified based on pore size and can be MF, UF, NF or RO. Membrane filters are thin, brittle membranes usually made of cellulose derivatives and are available in sizes up to 60 cm2. They have uniform pores that occupy 80% of the filter volume and are used to sterilize aqueous and oily liquids through their ability to filter out
Plate &fram press
The plate and frame filter press uses alternating plates and frames to filter slurries. As the slurry passes through the filter cloth on the plates, the solids form a filter cake in the frames. Multiple plates and frames operate in parallel to provide a large surface area for filtration. The filter cake can be washed by including additional washing plates that allow wash water to pass through the cake. While effective for high value products, the plate and frame filter press has high costs and requires significant labor to operate.
laminar air flow working & validation
This document discusses laminar air flow hoods, including their purpose of providing sterile work environments, types (horizontal and vertical flow), working principles involving HEPA filtration of air, proper use and maintenance, and validation processes to ensure sterility through design, installation, operational, and performance qualifications. Laminar flow hoods use HEPA-filtered air flowing in a laminar pattern to maintain aseptic conditions for activities like cell culture work by removing airborne contaminants.
Physiological factors effecting bioavailability{ndds.2(1)}
Physiological factors such as the route of administration, gastrointestinal pH, motility and emptying time, presence of food, and disease states can impact drug absorption from the gastrointestinal tract. The route determines the absorption site and potential for first-pass metabolism. Gastrointestinal pH and surface area affect drug solubility and ionization state. Motility and emptying time influence drug contact with the mucosa. Food and disease can modify gastrointestinal conditions and blood flow, altering drug dissolution and permeability. These physiological factors must be considered for optimal drug bioavailability.
More from Nandhini Podamekala (12)
Physiological factors effecting bioavailability{ndds.2(1)}
Physiological factors effecting bioavailability{ndds.2(1)}
Recently uploaded
How to Predict Vendor Bill Product in Odoo 17
This slide will guide us through the process of predicting vendor bill products based on previous purchases from the vendor in Odoo 17.
Geography as a Discipline Chapter 1 __ Class 11 Geography NCERT _ Class Notes...
Geography as discipline
RHEOLOGY Physical pharmaceutics-II notes for B.pharm 4th sem students
Physical pharmaceutics notes for B.pharm students
Level 3 NCEA - NZ: A Nation In the Making 1872 - 1900 SML.ppt
The History of NZ 1870-1900.
Making of a Nation.
From the NZ Wars to Liberals,
Richard Seddon, George Grey,
Social Laboratory, New Zealand,
Confiscations, Kotahitanga, Kingitanga, Parliament, Suffrage, Repudiation, Economic Change, Agriculture, Gold Mining, Timber, Flax, Sheep, Dairying,
skeleton System.pdf (skeleton system wow)
🔥🔥🔥🔥🔥🔥🔥🔥🔥
إضغ بين إيديكم من أقوى الملازم التي صممتها
ملزمة تشريح الجهاز الهيكلي (نظري 3)
💀💀💀💀💀💀💀💀💀💀
تتميز هذهِ الملزمة بعِدة مُميزات :
1- مُترجمة ترجمة تُناسب جميع المستويات
2- تحتوي على 78 رسم توضيحي لكل كلمة موجودة بالملزمة (لكل كلمة !!!!)
#فهم_ماكو_درخ
3- دقة الكتابة والصور عالية جداً جداً جداً
4- هُنالك بعض المعلومات تم توضيحها بشكل تفصيلي جداً (تُعتبر لدى الطالب أو الطالبة بإنها معلومات مُبهمة ومع ذلك تم توضيح هذهِ المعلومات المُبهمة بشكل تفصيلي جداً
5- الملزمة تشرح نفسها ب نفسها بس تكلك تعال اقراني
6- تحتوي الملزمة في اول سلايد على خارطة تتضمن جميع تفرُعات معلومات الجهاز الهيكلي المذكورة في هذهِ الملزمة
واخيراً هذهِ الملزمة حلالٌ عليكم وإتمنى منكم إن تدعولي بالخير والصحة والعافية فقط
كل التوفيق زملائي وزميلاتي ، زميلكم محمد الذهبي 💊💊
🔥🔥🔥🔥🔥🔥🔥🔥🔥
BÀI TẬP BỔ TRỢ TIẾNG ANH LỚP 9 CẢ NĂM - GLOBAL SUCCESS - NĂM HỌC 2024-2025 - ...
BÀI TẬP BỔ TRỢ TIẾNG ANH LỚP 9 CẢ NĂM - GLOBAL SUCCESS - NĂM HỌC 2024-2025 - ...Nguyen Thanh Tu Collection
https://app.box.com/s/tacvl9ekroe9hqupdnjruiypvm9rdaneChapter wise All Notes of First year Basic Civil Engineering.pptx
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
Educational Technology in the Health Sciences
Plenary presentation at the NTTC Inter-university Workshop, 18 June 2024, Manila Prince Hotel.
Temple of Asclepius in Thrace. Excavation results
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).
BIOLOGY NATIONAL EXAMINATION COUNCIL (NECO) 2024 PRACTICAL MANUAL.pptx
Practical manual for National Examination Council, Nigeria.
Contains guides on answering questions on the specimens provided
How Barcodes Can Be Leveraged Within Odoo 17
In this presentation, we will explore how barcodes can be leveraged within Odoo 17 to streamline our manufacturing processes. We will cover the configuration steps, how to utilize barcodes in different manufacturing scenarios, and the overall benefits of implementing this technology.
Beyond Degrees - Empowering the Workforce in the Context of Skills-First.pptx
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
Recently uploaded (20)
SWOT analysis in the project Keeping the Memory @live.pptx
SWOT analysis in the project Keeping the Memory @live.pptx
Geography as a Discipline Chapter 1 __ Class 11 Geography NCERT _ Class Notes...
Geography as a Discipline Chapter 1 __ Class 11 Geography NCERT _ Class Notes...
RHEOLOGY Physical pharmaceutics-II notes for B.pharm 4th sem students
RHEOLOGY Physical pharmaceutics-II notes for B.pharm 4th sem students
Level 3 NCEA - NZ: A Nation In the Making 1872 - 1900 SML.ppt
Level 3 NCEA - NZ: A Nation In the Making 1872 - 1900 SML.ppt
BÀI TẬP BỔ TRỢ TIẾNG ANH LỚP 9 CẢ NĂM - GLOBAL SUCCESS - NĂM HỌC 2024-2025 - ...
BÀI TẬP BỔ TRỢ TIẾNG ANH LỚP 9 CẢ NĂM - GLOBAL SUCCESS - NĂM HỌC 2024-2025 - ...
Chapter wise All Notes of First year Basic Civil Engineering.pptx
Chapter wise All Notes of First year Basic Civil Engineering.pptx
BIOLOGY NATIONAL EXAMINATION COUNCIL (NECO) 2024 PRACTICAL MANUAL.pptx
BIOLOGY NATIONAL EXAMINATION COUNCIL (NECO) 2024 PRACTICAL MANUAL.pptx
REASIGNACION 2024 UGEL CHUPACA 2024 UGEL CHUPACA.pdf
REASIGNACION 2024 UGEL CHUPACA 2024 UGEL CHUPACA.pdf
Beyond Degrees - Empowering the Workforce in the Context of Skills-First.pptx
Beyond Degrees - Empowering the Workforce in the Context of Skills-First.pptx
manufacturing and control of dosage forms
- 1. MANUFATURING OF AND CONTROL OF DOSAGE FORMS M.pharm(1sem)QA Dept of pharmaceutics