This document presents a summary of manufacturing bulk and sterile drugs. It discusses the benefits of bulk and sterile manufacturing in hospitals, including developing physician relationships and making unavailable drugs accessible. It also outlines various requirements for bulk compounding and sterile manufacturing like facilities, equipment, quality control, staffing, and costs. Sterile manufacturing has more stringent specifications around sterility and environmental controls. The document emphasizes maintaining high standards throughout the manufacturing process.
The document outlines good manufacturing practices (GMP) for nutraceuticals. It discusses 12 key areas that GMP for nutraceuticals covers: 1) Premises, 2) Equipment, 3) Personnel, 4) Quality Assurance, 5) Sanitation Program, 6) Operations, 7) Specifications, 8) Stability, 9) Samples, 10) Records, and 11) Recalls. Under each area, it provides details on requirements. For premises, it describes requirements for personnel and material flow, walls/ceilings, HVAC systems, utilities, and pest control. It emphasizes the need for preventative maintenance of equipment, calibration of instruments, and cleaning procedures. It also outlines personnel requirements for
This document provides an overview of Good Manufacturing Practices (GMP) for pharmaceutical manufacturing. It defines GMP and explains that GMP aims to ensure consistent production of quality products through established processes and quality control. Key aspects of GMP covered include organization and personnel qualifications, facility and equipment design, material management, production operations, quality control testing, and documentation. Maintaining high standards of hygiene, sanitation, maintenance and training are emphasized. The goals of GMP are to minimize risks like contamination, incorrect dosing, and protect patient safety.
The document provides an overview of current good manufacturing practices (cGMP) as defined by the World Health Organization (WHO). It discusses key aspects of cGMP including personnel, facilities, equipment, material management, quality management, manufacturing operations, validation, sterile products, security, documentation, and records. The goal of cGMP is to consistently produce pharmaceutical products that meet quality standards for their intended use and legal requirements.
Current good manufacturing practice .pptxOsamaTauseef2
Current good manufacturing practice according to Leon Lachman
Helpful contains for al pharmacy students like diploma, degree and also masters of pharmacy students
So use the contains and build your knowledge.
QUALITY ASSURANCE OF PHARMACEUTICAL RELATED TO PLANT DESIGNsiddy-07
The document discusses quality assurance considerations related to plant design for pharmaceutical manufacturing. It covers topics like building construction, personnel flow, material flow patterns, effluent treatment, sterilization process control, temperature/humidity control via air handling units, air flow testing and validation of manufacturing equipment, water systems, and air handling units. Proper plant design is important to ensure consistent production of safe, effective pharmaceutical products and compliance with good manufacturing practices (GMP) regulations.
Quality control measures in pharmaceutical industryChemOnTheGo
QUALITY CONTROL
ROLE OF QUALITY CONTROL IN PHARMACEUTICAL INDUSTRY
OBJECTIVES OF QUALITY CONTROL
STEPS IN QUALITY CONTROL
COST OF QUALITY CONTROL
TOTAL QUALITY MANAGEMENT
QUALITY CIRCLE
Objectives and policies of cGMP & Inventory management and controlArul Packiadhas
This document discusses objectives and policies of CGMP (current good manufacturing practices) and inventory management and control. It outlines the importance of CGMP in assuring quality standards and preventing issues. CGMP regulations provide systems to properly design, monitor, and control manufacturing processes. The document also describes objectives of inventory control such as minimizing costs and ensuring adequate stock levels. It provides details on inventory management policies, documentation requirements, and quality control standards under CGMP.
STERILE AND BULK MANUFACTURING. final.pptxPartha70
This document discusses sterile and bulk manufacturing in hospitals. It covers several key points:
1) Hospitals are increasingly manufacturing some medical items internally rather than purchasing everything externally. This includes sterile products as well as non-sterile items.
2) When manufacturing internally, hospitals must consider factors like production capacity, staffing needs, quality control testing, and operating costs.
3) For sterile manufacturing specifically, selection of components, facilities, packaging and quality control processes are important to prevent contamination and ensure sterility. Proper filtration and sterilization of air, containers, and other materials is required.
The document outlines good manufacturing practices (GMP) for nutraceuticals. It discusses 12 key areas that GMP for nutraceuticals covers: 1) Premises, 2) Equipment, 3) Personnel, 4) Quality Assurance, 5) Sanitation Program, 6) Operations, 7) Specifications, 8) Stability, 9) Samples, 10) Records, and 11) Recalls. Under each area, it provides details on requirements. For premises, it describes requirements for personnel and material flow, walls/ceilings, HVAC systems, utilities, and pest control. It emphasizes the need for preventative maintenance of equipment, calibration of instruments, and cleaning procedures. It also outlines personnel requirements for
This document provides an overview of Good Manufacturing Practices (GMP) for pharmaceutical manufacturing. It defines GMP and explains that GMP aims to ensure consistent production of quality products through established processes and quality control. Key aspects of GMP covered include organization and personnel qualifications, facility and equipment design, material management, production operations, quality control testing, and documentation. Maintaining high standards of hygiene, sanitation, maintenance and training are emphasized. The goals of GMP are to minimize risks like contamination, incorrect dosing, and protect patient safety.
The document provides an overview of current good manufacturing practices (cGMP) as defined by the World Health Organization (WHO). It discusses key aspects of cGMP including personnel, facilities, equipment, material management, quality management, manufacturing operations, validation, sterile products, security, documentation, and records. The goal of cGMP is to consistently produce pharmaceutical products that meet quality standards for their intended use and legal requirements.
Current good manufacturing practice .pptxOsamaTauseef2
Current good manufacturing practice according to Leon Lachman
Helpful contains for al pharmacy students like diploma, degree and also masters of pharmacy students
So use the contains and build your knowledge.
QUALITY ASSURANCE OF PHARMACEUTICAL RELATED TO PLANT DESIGNsiddy-07
The document discusses quality assurance considerations related to plant design for pharmaceutical manufacturing. It covers topics like building construction, personnel flow, material flow patterns, effluent treatment, sterilization process control, temperature/humidity control via air handling units, air flow testing and validation of manufacturing equipment, water systems, and air handling units. Proper plant design is important to ensure consistent production of safe, effective pharmaceutical products and compliance with good manufacturing practices (GMP) regulations.
Quality control measures in pharmaceutical industryChemOnTheGo
QUALITY CONTROL
ROLE OF QUALITY CONTROL IN PHARMACEUTICAL INDUSTRY
OBJECTIVES OF QUALITY CONTROL
STEPS IN QUALITY CONTROL
COST OF QUALITY CONTROL
TOTAL QUALITY MANAGEMENT
QUALITY CIRCLE
Objectives and policies of cGMP & Inventory management and controlArul Packiadhas
This document discusses objectives and policies of CGMP (current good manufacturing practices) and inventory management and control. It outlines the importance of CGMP in assuring quality standards and preventing issues. CGMP regulations provide systems to properly design, monitor, and control manufacturing processes. The document also describes objectives of inventory control such as minimizing costs and ensuring adequate stock levels. It provides details on inventory management policies, documentation requirements, and quality control standards under CGMP.
STERILE AND BULK MANUFACTURING. final.pptxPartha70
This document discusses sterile and bulk manufacturing in hospitals. It covers several key points:
1) Hospitals are increasingly manufacturing some medical items internally rather than purchasing everything externally. This includes sterile products as well as non-sterile items.
2) When manufacturing internally, hospitals must consider factors like production capacity, staffing needs, quality control testing, and operating costs.
3) For sterile manufacturing specifically, selection of components, facilities, packaging and quality control processes are important to prevent contamination and ensure sterility. Proper filtration and sterilization of air, containers, and other materials is required.
The document discusses the design and operation of a pilot plant for tablet and capsule production. It provides details on:
1) The purpose of a pilot plant is to transform a lab-scale formula into a viable product by developing reliable manufacturing methods. It helps evaluate scale-up and technology transfer.
2) Key considerations for pilot plant design include simulating production equipment, identifying critical parameters, and collecting data to characterize unit operations while following cGMP.
3) The document outlines various unit operations like blending, granulation, drying, milling and compression and important aspects to consider when scaling them up.
The document discusses pilot plant scale up techniques for tablet design. It defines a pilot plant as transforming a lab formula into a viable product by developing a reliable manufacturing method. The pilot plant must include GMP compliance, trained staff, equipment to support multiple dosage forms and scales similar to production. It plays a key role in technology evaluation, scale up, and regulatory submissions. Process parameters, equipment selection, and data collection are important to characterize each unit operation during scale up. Personnel require pharmaceutical knowledge and experience, and training programs must meet development priorities while ensuring GMP compliance.
The document discusses objectives and policies of CGMP (current good manufacturing practices) and inventory management control. It provides 11 sections that outline CGMP policies related to personnel, premises, equipment, sanitation, storage, production, packaging, quality control, documentation, self-inspection, and product complaints. It also discusses the objectives of inventory control to minimize costs and disruption while ensuring adequate stock. Various techniques for inventory control are analyzed including ABC, VED, XYZ and SOS analyses.
Pilot plant scale-up is a branch of the pharma companies in which a lab-scale formula is converted into a commercially viable product by creating a reliable manufacturing technique. The same techniques employed in dosage form Research and Development are adapted to multiple output volumes, frequently larger than those obtained during Research and Development. There is always a requirement for an intermediate batch scale describing techniques and imitating those in commercial manufacturing in any new or established pharmaceutical sector. This is accomplished by testing the formula’s ability to survive batch-scale and process changes.
This document discusses control procedures for manufacturing bulk drugs and sterile products in hospital pharmacies. It covers budgetary control, which regulates economic aspects, and quality control to ensure purity, strength and quality of manufactured products. Specific areas covered include manufacturing requirements, material requirements, capacity, equipment, staffing, operating costs, and quality control procedures such as checks and laboratory analysis. Good manufacturing practice regulations for hospitals are also outlined relating to organization, personnel, facilities, equipment, component and container controls, production processes, and holding and distribution of finished products.
cGMp guidelines as per WHO ayansh singh.pptxAyanshSingh11
cGMP provides guidelines for pharmaceutical manufacturing and quality control. It aims to ensure products are consistently produced and meet quality standards. Key aspects of cGMP include having qualified personnel, adequate facilities and equipment, proper material management, quality management systems, validation of manufacturing processes, and documentation and record keeping. cGMP guidelines cover all stages of production from personnel and facilities to manufacturing, quality control testing, and maintenance of production records. Adherence to cGMP helps increase product quality and safety.
GAP and GMP are practices to ensure safety and quality in agriculture and food manufacturing. GAP involves activities on farms like clean soil/water and worker hygiene. GMP involves following written procedures, documentation, facility maintenance, training and audits in manufacturing. Certification in GAP and GMP gives benefits like market access, consumer confidence and compliance with regulations.
CGMP guidelines, CFR, CDER and CBER, PIC/S, Environment control in pharma industry, plant layout, maintenance of sterile area, Clean room classification, Environmental monitoring, Types of contaminants in pharma industry & Good Warehousing Practices.
WHO Good Manufacturing Practice Requirements
Good Manufacturing Practice is the part of quality assurance that ensures that products are consistently manufactured and controlled to the quality standards appropriate to their intended use.
The document discusses current good manufacturing practices (cGMP) regulations for pharmaceutical manufacturing. It covers several topics:
cGMP regulations provide systems for proper design, monitoring, and control of manufacturing to ensure identity, strength, quality and purity of drug products. Facilities must have adequate design and construction to prevent contamination. Equipment must be properly qualified, installed and maintained. Sanitation procedures help prevent contamination and ensure compliance. Overall, cGMP helps assure safety and efficacy of drug products.
Quality-by-Design In Pharmaceutical DevelopmentPrabhjot kaur
Quality-by-Design In Pharmaceutical Development: Introduction, ICH Q8 guideline, Regulatory and industry views on QbD, Scientifically based QbD - examples of application. M. Pharmacy 2nd Semester (Computer aided drug delivery system)
CGMP (current good manufacturing practices) ensures that products are consistently produced and controlled to quality standards appropriate for their intended use through both production and quality control. All manufacturing of pharmaceuticals must comply with FDA cGMP regulations, which are constantly updated. cGMP covers all aspects of manufacturing from personnel training to facilities, equipment, production, testing, and record keeping to ensure quality pharmaceutical products.
This document discusses Good Manufacturing Practices (GMP) and current Good Manufacturing Practices (cGMP). It provides definitions of GMP and cGMP, explaining that GMP ensures quality and safety in manufacturing while cGMP refers specifically to FDA regulations. The principles and regulations of GMP, cGMP, and their comparison are outlined. Key aspects like facilities, equipment, documentation, packaging and labeling, quality control, and standard operating procedures are summarized.
This document provides an overview of requirements for Good Manufacturing Practices (GMP), Current Good Manufacturing Practices (cGMP), Good Laboratory Practices (GLP), USFDA guidelines, and ISO 9000 standards. It discusses key elements of GMP/cGMP including facilities, equipment, documentation, quality control, and compliance. It also outlines 10 key principles of GLP relating to test facility organization, quality assurance, facilities, equipment, test systems, substances, standard operating procedures, performance, reporting and record keeping. The document is intended to present information on regulatory standards for pharmaceutical manufacturing and laboratory testing.
The cleaning methodology and validation process play pivotal roles in ensuring pharmaceutical manufacturing meets stringent quality standards, safeguarding against contaminants and ensuring product purity. Rigorous adherence to cleaning methodology and validation protocols is imperative to uphold the integrity of pharmaceutical production and regulatory compliance. Checkout the complete pdf here- https://www.ipa-india.org/wp-content/uploads/2021/12/ipa-cleaning-methodology-and-valodation.pdf
This document provides information on current good manufacturing practices (CGMP) regulations enforced by the FDA to ensure quality in pharmaceutical manufacturing. It discusses the importance of CGMP for quality products, customer satisfaction, consistency and company reputation. The objectives are to understand regulatory requirements and minimize risks that can't be detected by final testing. The document outlines various CGMP guidelines related to facilities, equipment, personnel, documentation, batch records, quality control and more. It provides details on specific areas like premises, warehousing, water systems, waste disposal, production areas and equipment cleaning/validation.
The document discusses good manufacturing practices (GMP) and food safety. It defines GMP as quality assurance to ensure food meets quality and safety standards required for its intended use. GMP covers all aspects of manufacturing from processes and facilities to personnel, documentation, and product tracing. Food plants must implement pest control and maintain sanitary facilities, equipment, and employee hygiene practices. Buildings should be designed for cleanability, segregation of raw and finished goods, and protection from pests. The Codex Alimentarius Commission establishes international food safety standards including GMP and Hazard Analysis and Critical Control Point programs.
PILOT PLANT SCALE- UP TECHNIQUE
Plant, Pilot Plant, Scale-up, Objective, Significance, Steps in scale up, General considerations, Master Manufacturing Procedures, GMP consideration.
Pilot plant scaleup techniques used in pharmaceutical manufacturingSunil Boreddy Rx
The document discusses pilot plant scale-up techniques. It defines a pilot plant as transforming a lab scale formula into a viable product through developing a reliable manufacturing process. The objectives of pilot plant studies are to examine a formula's ability to withstand scale-up, identify critical process aspects, and provide manufacturing guidelines to avoid problems. Key considerations for pilot plants include personnel requirements, equipment selection, production rates, process evaluation, and product stability testing.
The document discusses the design and operation of a pilot plant for tablet and capsule production. It provides details on:
1) The purpose of a pilot plant is to transform a lab-scale formula into a viable product by developing reliable manufacturing methods. It helps evaluate scale-up and technology transfer.
2) Key considerations for pilot plant design include simulating production equipment, identifying critical parameters, and collecting data to characterize unit operations while following cGMP.
3) The document outlines various unit operations like blending, granulation, drying, milling and compression and important aspects to consider when scaling them up.
The document discusses pilot plant scale up techniques for tablet design. It defines a pilot plant as transforming a lab formula into a viable product by developing a reliable manufacturing method. The pilot plant must include GMP compliance, trained staff, equipment to support multiple dosage forms and scales similar to production. It plays a key role in technology evaluation, scale up, and regulatory submissions. Process parameters, equipment selection, and data collection are important to characterize each unit operation during scale up. Personnel require pharmaceutical knowledge and experience, and training programs must meet development priorities while ensuring GMP compliance.
The document discusses objectives and policies of CGMP (current good manufacturing practices) and inventory management control. It provides 11 sections that outline CGMP policies related to personnel, premises, equipment, sanitation, storage, production, packaging, quality control, documentation, self-inspection, and product complaints. It also discusses the objectives of inventory control to minimize costs and disruption while ensuring adequate stock. Various techniques for inventory control are analyzed including ABC, VED, XYZ and SOS analyses.
Pilot plant scale-up is a branch of the pharma companies in which a lab-scale formula is converted into a commercially viable product by creating a reliable manufacturing technique. The same techniques employed in dosage form Research and Development are adapted to multiple output volumes, frequently larger than those obtained during Research and Development. There is always a requirement for an intermediate batch scale describing techniques and imitating those in commercial manufacturing in any new or established pharmaceutical sector. This is accomplished by testing the formula’s ability to survive batch-scale and process changes.
This document discusses control procedures for manufacturing bulk drugs and sterile products in hospital pharmacies. It covers budgetary control, which regulates economic aspects, and quality control to ensure purity, strength and quality of manufactured products. Specific areas covered include manufacturing requirements, material requirements, capacity, equipment, staffing, operating costs, and quality control procedures such as checks and laboratory analysis. Good manufacturing practice regulations for hospitals are also outlined relating to organization, personnel, facilities, equipment, component and container controls, production processes, and holding and distribution of finished products.
cGMp guidelines as per WHO ayansh singh.pptxAyanshSingh11
cGMP provides guidelines for pharmaceutical manufacturing and quality control. It aims to ensure products are consistently produced and meet quality standards. Key aspects of cGMP include having qualified personnel, adequate facilities and equipment, proper material management, quality management systems, validation of manufacturing processes, and documentation and record keeping. cGMP guidelines cover all stages of production from personnel and facilities to manufacturing, quality control testing, and maintenance of production records. Adherence to cGMP helps increase product quality and safety.
GAP and GMP are practices to ensure safety and quality in agriculture and food manufacturing. GAP involves activities on farms like clean soil/water and worker hygiene. GMP involves following written procedures, documentation, facility maintenance, training and audits in manufacturing. Certification in GAP and GMP gives benefits like market access, consumer confidence and compliance with regulations.
CGMP guidelines, CFR, CDER and CBER, PIC/S, Environment control in pharma industry, plant layout, maintenance of sterile area, Clean room classification, Environmental monitoring, Types of contaminants in pharma industry & Good Warehousing Practices.
WHO Good Manufacturing Practice Requirements
Good Manufacturing Practice is the part of quality assurance that ensures that products are consistently manufactured and controlled to the quality standards appropriate to their intended use.
The document discusses current good manufacturing practices (cGMP) regulations for pharmaceutical manufacturing. It covers several topics:
cGMP regulations provide systems for proper design, monitoring, and control of manufacturing to ensure identity, strength, quality and purity of drug products. Facilities must have adequate design and construction to prevent contamination. Equipment must be properly qualified, installed and maintained. Sanitation procedures help prevent contamination and ensure compliance. Overall, cGMP helps assure safety and efficacy of drug products.
Quality-by-Design In Pharmaceutical DevelopmentPrabhjot kaur
Quality-by-Design In Pharmaceutical Development: Introduction, ICH Q8 guideline, Regulatory and industry views on QbD, Scientifically based QbD - examples of application. M. Pharmacy 2nd Semester (Computer aided drug delivery system)
CGMP (current good manufacturing practices) ensures that products are consistently produced and controlled to quality standards appropriate for their intended use through both production and quality control. All manufacturing of pharmaceuticals must comply with FDA cGMP regulations, which are constantly updated. cGMP covers all aspects of manufacturing from personnel training to facilities, equipment, production, testing, and record keeping to ensure quality pharmaceutical products.
This document discusses Good Manufacturing Practices (GMP) and current Good Manufacturing Practices (cGMP). It provides definitions of GMP and cGMP, explaining that GMP ensures quality and safety in manufacturing while cGMP refers specifically to FDA regulations. The principles and regulations of GMP, cGMP, and their comparison are outlined. Key aspects like facilities, equipment, documentation, packaging and labeling, quality control, and standard operating procedures are summarized.
This document provides an overview of requirements for Good Manufacturing Practices (GMP), Current Good Manufacturing Practices (cGMP), Good Laboratory Practices (GLP), USFDA guidelines, and ISO 9000 standards. It discusses key elements of GMP/cGMP including facilities, equipment, documentation, quality control, and compliance. It also outlines 10 key principles of GLP relating to test facility organization, quality assurance, facilities, equipment, test systems, substances, standard operating procedures, performance, reporting and record keeping. The document is intended to present information on regulatory standards for pharmaceutical manufacturing and laboratory testing.
The cleaning methodology and validation process play pivotal roles in ensuring pharmaceutical manufacturing meets stringent quality standards, safeguarding against contaminants and ensuring product purity. Rigorous adherence to cleaning methodology and validation protocols is imperative to uphold the integrity of pharmaceutical production and regulatory compliance. Checkout the complete pdf here- https://www.ipa-india.org/wp-content/uploads/2021/12/ipa-cleaning-methodology-and-valodation.pdf
This document provides information on current good manufacturing practices (CGMP) regulations enforced by the FDA to ensure quality in pharmaceutical manufacturing. It discusses the importance of CGMP for quality products, customer satisfaction, consistency and company reputation. The objectives are to understand regulatory requirements and minimize risks that can't be detected by final testing. The document outlines various CGMP guidelines related to facilities, equipment, personnel, documentation, batch records, quality control and more. It provides details on specific areas like premises, warehousing, water systems, waste disposal, production areas and equipment cleaning/validation.
The document discusses good manufacturing practices (GMP) and food safety. It defines GMP as quality assurance to ensure food meets quality and safety standards required for its intended use. GMP covers all aspects of manufacturing from processes and facilities to personnel, documentation, and product tracing. Food plants must implement pest control and maintain sanitary facilities, equipment, and employee hygiene practices. Buildings should be designed for cleanability, segregation of raw and finished goods, and protection from pests. The Codex Alimentarius Commission establishes international food safety standards including GMP and Hazard Analysis and Critical Control Point programs.
PILOT PLANT SCALE- UP TECHNIQUE
Plant, Pilot Plant, Scale-up, Objective, Significance, Steps in scale up, General considerations, Master Manufacturing Procedures, GMP consideration.
Pilot plant scaleup techniques used in pharmaceutical manufacturingSunil Boreddy Rx
The document discusses pilot plant scale-up techniques. It defines a pilot plant as transforming a lab scale formula into a viable product through developing a reliable manufacturing process. The objectives of pilot plant studies are to examine a formula's ability to withstand scale-up, identify critical process aspects, and provide manufacturing guidelines to avoid problems. Key considerations for pilot plants include personnel requirements, equipment selection, production rates, process evaluation, and product stability testing.
EWOCS-I: The catalog of X-ray sources in Westerlund 1 from the Extended Weste...Sérgio Sacani
Context. With a mass exceeding several 104 M⊙ and a rich and dense population of massive stars, supermassive young star clusters
represent the most massive star-forming environment that is dominated by the feedback from massive stars and gravitational interactions
among stars.
Aims. In this paper we present the Extended Westerlund 1 and 2 Open Clusters Survey (EWOCS) project, which aims to investigate
the influence of the starburst environment on the formation of stars and planets, and on the evolution of both low and high mass stars.
The primary targets of this project are Westerlund 1 and 2, the closest supermassive star clusters to the Sun.
Methods. The project is based primarily on recent observations conducted with the Chandra and JWST observatories. Specifically,
the Chandra survey of Westerlund 1 consists of 36 new ACIS-I observations, nearly co-pointed, for a total exposure time of 1 Msec.
Additionally, we included 8 archival Chandra/ACIS-S observations. This paper presents the resulting catalog of X-ray sources within
and around Westerlund 1. Sources were detected by combining various existing methods, and photon extraction and source validation
were carried out using the ACIS-Extract software.
Results. The EWOCS X-ray catalog comprises 5963 validated sources out of the 9420 initially provided to ACIS-Extract, reaching a
photon flux threshold of approximately 2 × 10−8 photons cm−2
s
−1
. The X-ray sources exhibit a highly concentrated spatial distribution,
with 1075 sources located within the central 1 arcmin. We have successfully detected X-ray emissions from 126 out of the 166 known
massive stars of the cluster, and we have collected over 71 000 photons from the magnetar CXO J164710.20-455217.
The binding of cosmological structures by massless topological defectsSérgio Sacani
Assuming spherical symmetry and weak field, it is shown that if one solves the Poisson equation or the Einstein field
equations sourced by a topological defect, i.e. a singularity of a very specific form, the result is a localized gravitational
field capable of driving flat rotation (i.e. Keplerian circular orbits at a constant speed for all radii) of test masses on a thin
spherical shell without any underlying mass. Moreover, a large-scale structure which exploits this solution by assembling
concentrically a number of such topological defects can establish a flat stellar or galactic rotation curve, and can also deflect
light in the same manner as an equipotential (isothermal) sphere. Thus, the need for dark matter or modified gravity theory is
mitigated, at least in part.
Comparing Evolved Extractive Text Summary Scores of Bidirectional Encoder Rep...University of Maribor
Slides from:
11th International Conference on Electrical, Electronics and Computer Engineering (IcETRAN), Niš, 3-6 June 2024
Track: Artificial Intelligence
https://www.etran.rs/2024/en/home-english/
Phenomics assisted breeding in crop improvementIshaGoswami9
As the population is increasing and will reach about 9 billion upto 2050. Also due to climate change, it is difficult to meet the food requirement of such a large population. Facing the challenges presented by resource shortages, climate
change, and increasing global population, crop yield and quality need to be improved in a sustainable way over the coming decades. Genetic improvement by breeding is the best way to increase crop productivity. With the rapid progression of functional
genomics, an increasing number of crop genomes have been sequenced and dozens of genes influencing key agronomic traits have been identified. However, current genome sequence information has not been adequately exploited for understanding
the complex characteristics of multiple gene, owing to a lack of crop phenotypic data. Efficient, automatic, and accurate technologies and platforms that can capture phenotypic data that can
be linked to genomics information for crop improvement at all growth stages have become as important as genotyping. Thus,
high-throughput phenotyping has become the major bottleneck restricting crop breeding. Plant phenomics has been defined as the high-throughput, accurate acquisition and analysis of multi-dimensional phenotypes
during crop growing stages at the organism level, including the cell, tissue, organ, individual plant, plot, and field levels. With the rapid development of novel sensors, imaging technology,
and analysis methods, numerous infrastructure platforms have been developed for phenotyping.
Travis Hills' Endeavors in Minnesota: Fostering Environmental and Economic Pr...Travis Hills MN
Travis Hills of Minnesota developed a method to convert waste into high-value dry fertilizer, significantly enriching soil quality. By providing farmers with a valuable resource derived from waste, Travis Hills helps enhance farm profitability while promoting environmental stewardship. Travis Hills' sustainable practices lead to cost savings and increased revenue for farmers by improving resource efficiency and reducing waste.
BREEDING METHODS FOR DISEASE RESISTANCE.pptxRASHMI M G
Plant breeding for disease resistance is a strategy to reduce crop losses caused by disease. Plants have an innate immune system that allows them to recognize pathogens and provide resistance. However, breeding for long-lasting resistance often involves combining multiple resistance genes
Nucleophilic Addition of carbonyl compounds.pptxSSR02
Nucleophilic addition is the most important reaction of carbonyls. Not just aldehydes and ketones, but also carboxylic acid derivatives in general.
Carbonyls undergo addition reactions with a large range of nucleophiles.
Comparing the relative basicity of the nucleophile and the product is extremely helpful in determining how reversible the addition reaction is. Reactions with Grignards and hydrides are irreversible. Reactions with weak bases like halides and carboxylates generally don’t happen.
Electronic effects (inductive effects, electron donation) have a large impact on reactivity.
Large groups adjacent to the carbonyl will slow the rate of reaction.
Neutral nucleophiles can also add to carbonyls, although their additions are generally slower and more reversible. Acid catalysis is sometimes employed to increase the rate of addition.
Current Ms word generated power point presentation covers major details about the micronuclei test. It's significance and assays to conduct it. It is used to detect the micronuclei formation inside the cells of nearly every multicellular organism. It's formation takes place during chromosomal sepration at metaphase.
ANAMOLOUS SECONDARY GROWTH IN DICOT ROOTS.pptxRASHMI M G
Abnormal or anomalous secondary growth in plants. It defines secondary growth as an increase in plant girth due to vascular cambium or cork cambium. Anomalous secondary growth does not follow the normal pattern of a single vascular cambium producing xylem internally and phloem externally.
Deep Behavioral Phenotyping in Systems Neuroscience for Functional Atlasing a...Ana Luísa Pinho
Functional Magnetic Resonance Imaging (fMRI) provides means to characterize brain activations in response to behavior. However, cognitive neuroscience has been limited to group-level effects referring to the performance of specific tasks. To obtain the functional profile of elementary cognitive mechanisms, the combination of brain responses to many tasks is required. Yet, to date, both structural atlases and parcellation-based activations do not fully account for cognitive function and still present several limitations. Further, they do not adapt overall to individual characteristics. In this talk, I will give an account of deep-behavioral phenotyping strategies, namely data-driven methods in large task-fMRI datasets, to optimize functional brain-data collection and improve inference of effects-of-interest related to mental processes. Key to this approach is the employment of fast multi-functional paradigms rich on features that can be well parametrized and, consequently, facilitate the creation of psycho-physiological constructs to be modelled with imaging data. Particular emphasis will be given to music stimuli when studying high-order cognitive mechanisms, due to their ecological nature and quality to enable complex behavior compounded by discrete entities. I will also discuss how deep-behavioral phenotyping and individualized models applied to neuroimaging data can better account for the subject-specific organization of domain-general cognitive systems in the human brain. Finally, the accumulation of functional brain signatures brings the possibility to clarify relationships among tasks and create a univocal link between brain systems and mental functions through: (1) the development of ontologies proposing an organization of cognitive processes; and (2) brain-network taxonomies describing functional specialization. To this end, tools to improve commensurability in cognitive science are necessary, such as public repositories, ontology-based platforms and automated meta-analysis tools. I will thus discuss some brain-atlasing resources currently under development, and their applicability in cognitive as well as clinical neuroscience.
3. CONTENT
Introduction
Benefits of the manufacturing bulk and sterile
Bulk compound
Control system
Manufacturing process control
Quality control
Budgetary control
Requirement for manufacturing
Material requirements
Manufacturing capacity
Manufacturing facilities
Manufacturing stuff
Manufacturing costs
Maintenance of manufacturing equipment’s
Sterile manufacturing
Facilities and requirements
Precautions and requirements of personnal in aseptic area
4. INTRODUCTION
The in-house preparation of drugs in hospital pharmacy may be categorized into
bulk compounding, preparation of nonsterile drugs and sterile
manufacturing.
The bulk compounding programs is instituted for preparation of drugs not
commercially available and modified formulations to be used for clinical or
investigation purpose.
Whereby sterile manufacturing is used for preparation of sterile topical solution,
small volume injectables, special sterile products for clinical and investigational
purposes, IV admixtures and total parenteral in the hospital pharmacy.
5. BENEFITS OF THE MANUFACTURING
BULK AND STERILE
1. Development of a close relationship between hospital pharmacist and the physicians.
2. Promotion economy within the hospital.
3. Complementing the operation of formulary system.
4. Making drugs available, which are not commercially available.
5. Enabling physician to cope with the problem of unavailability of the drugs for unusual
illnesses.
6. BULK COMPOUND
Bulk Compound means the bulk drug or active pharmaceutical ingredient of
client product, in bulk form, supplied by client.
0r,
A bulk drug also called active pharmaceutical ingredient (API) is the chemical
molecule in a pharmaceutical product (medicines we buy from the chemist) that
lends the product the claimed therapeutic effect. As is evident from this, there are
ingredients other than the API in products sold as medicines.
8. MANUFACTURING PROCESS CONTROL
It responsibility of hospital pharmacist to make a product which meet high
pharmaceutical standards.
Adequate controls over manufacturing eventuate into the products accurate in
identity, strength, purity and quality.
Sufficient packaging and labeling controls prevent product/package/label mix-
ups.
The good manufacturing practice regulations provide minimum requirements for
the preparation of drug product for administration to humans with reference to
the premises, environment, men, methods, machinery, documentation,etc.
9. QUALITY CONTROL
Quality of a product is its degree of possession of those characteristics designed
and manufactured into it which contribute to performance of an intended function
when it is used as directed.
Quality control implies procedures by which decision may be made whether a
product is meeting standards established previously.
The quality control in the pharmacy department falls into the following categories:
1. Quality control of raw materials.
2. Quality control of instruments used. .
3. Quality control of area to ensure the specified pharmaceutical environment.
4. Quality control of the finished products.
10. BUDGETARY CONTROL
• The budgetary control is employed to regulate economic aspects of hospital
pharmacy manufacturing program.
• The feasibility of a manufacturing program in hospital pharmacy depends on
the budgetary control.
• An adequate budgetary control over the manufacturing program requires careful
planning for the manufacturing requirements, raw materials requirement,
manufacturing capacity, available personnel and operating, costs.
12. MANUFACTURING REQUIREMENTS
• The manufacturing requirements can be estimated in terms
of rate or production volume, batch quantity, or
manufacturing frequency.
• The manufacturing requirements of any item depend on its
expected consumption rate.
• The best is to plan for the consumption rate for smaller
periods, i.e., consumption rate for one quarter of a year.
13. MATERIAL REQUIREMENTS
• Materials for which the planning is done include raw materials, containers, labels, ancillary
materials.
• The estimated manufacturing requirements provide the basis for the prediction of materials
requirement for a particular manufacturing program.
• For effective material planning, the required material can be divided into four quarter to allow
an ample time to utilize the basic principles of good purchasing technique and at the same
time ensures against over inventory and shortage of materials in the pharmacy.
14. MANUFACTURING CAPACITY
• The type and size of manufacturing equipment required for
manufacturing program vary from institution to institution.
• Modern technology has made possible the availability of
equipment's that meet every production needs.
• These are automatic, semi automatic or manual
equipment's and can handle amounts that are considered to
be practical volume/quantity for a particular hospital.
15. MANUFACTURING FACILITIES
Manufacturing facilities include maximum degree of cleanliness in aseptic filling rooms, while
as surrounding areas provide a buffer area in which standards of cleanliness are slightly lower
than those maintained in aseptic rooms. For construction, it requires best material and design.
The ceiling, walls and floors should be constructed of materials which are easy to clean and non-
porous so as to prevent accumulation of dust and moisture.
16. MANUFACTURING STAFF
• Number of manufacturing staff constitutes pharmacist as
a supervisor and the ancillary personnel.
• The number of manufacturing staff is also a very critical
factor for economics of a bulk compounding program.
• Reduction in labor cost is the aim of an administrator but
under no circumstances should a bulk compounding
program be undertaken without services of a pharmacist.
17. OPERATING COSTS
• The operating costs include both direct and indirect (overhead) costs.
• The direct cost is price spent on materials and labor involved in
manufacturing.
• On the other hand, the costs of supervisory personnel, space,
equipment depreciation, maintenance, housekeeping, are the indirect or
overhead costs.
• The increase in batch size will, to a point, reduce the unit cost, though
this reduction is not geometrically with the increase in batch size.
18. MAINTENANCE OF MANUFACTURING
EQUIPMENT'S
• Maintenance of manufacturing equipment's is actually a control over equipment
operation.
• A high investment on pharmaceutical manufacturing equipment and expense
associated with frequent repairs necessitate an equipment maintenance program to
ensure maximum performance with the lowest possible repair cost.
• The development of an equipment maintenance program would be the
responsibility of a pharmacist.
20. STERILE MANUFACTURING
• The sterile manufacturing involves the same basic principles as required for the
bulk compounding only difference of more stringent specifications, sterility and a
pyrogenicity of the products.
• Besides various controls discussed earlier, additional environmental controls are
needed for sterile manufacturing.
• Components of sterile manufacturing program are intravenous additive program
and the intravenous additive services.
21. FACILITIES AND REQUIREMENTS
For sterile manufacture following equipment's are necessary to meet the requirements of Drugs and
Cosmetics Act.
• Storage equipment for ampoules and vials
• Ampoule washing and drying machine
• Filling and sealing unit
• Sintered glass funnel
• Hot air oven
• Autoclave
• laminar air flow
• Labeling and packing units
22. SOME PRECAUTIONS AND REQUIREMENTS OF
PERSONNEL IN ASEPTIC AREA
• They should be of good health and free from any dermatological conditions that might increase
microbial contamination.
• They must have some knowledge about the basic principles of aseptic process.
• Movements within the room should be minimum and in and out movements are restricted
during filling operations.
• Every individual shall use fresh sterile uniform after every break period.
• Uniform consist of overalls for both men and women, hoods to completely cover the hair, face
mask, plastic shoes, sterile rubber gloves, goggles.
• An air shower is also used for personnel to remove any loose shreds.