This document discusses validation of pharmaceutical manufacturing processes and equipment. It covers the phases of validation including design qualification, installation qualification, operational qualification, performance qualification, and maintenance qualification. User requirement specification is identified as a critical document for validation. Guidelines are provided for developing the user requirements specification to include requirements that are testable and unambiguous. The roles of qualification and validation in ensuring validated equipment and processes are also summarized.
The document discusses various concepts related to validation of pharmaceutical processes including user requirement specification (URS), design qualification (DQ), installation qualification (IQ), operational qualification (OQ), performance qualification (PQ), and maintenance qualification (MQ). It explains that URS is a critical document that defines the requirements for the system. Validation involves qualification of the design, installation, operation, and performance of the system to ensure it meets predetermined specifications.
This document discusses validation concepts including user requirement specification, phases of validation such as design qualification, installation qualification, operational qualification, performance qualification, and maintenance qualification. It provides definitions and guidelines for each phase. The key phases involve design qualification to define functional specifications, installation qualification to ensure proper installation, operational qualification to test functions, performance qualification to ensure consistent performance over time, and maintenance qualification to document maintenance. The overall goal of validation is to provide high assurance that a process will consistently produce quality products meeting specifications.
Equipment used in pharmaceuticals dosage form manufacturing need to observe continuous qualification to monitor its performance and Concept of URS ,DQ, IQ,OQ,PQ,MQ...
the various categories of qualifications necessary for Validating an equipment or instrument before & after installation. Those are
DQ(Design Qualification)
IQ(Installation Qualification)
OQ(Operation Qualification)
PQ(Performance Qualification)
The document discusses developing a validation master plan (VMP) for a new pharmaceutical facility. Key points:
- A VMP comprehensively describes validation requirements and plans for meeting them. It covers production, storage, utilities, and staff areas.
- The VMP sets goals and limits for validation projects. It defines the scope and systems included.
- Developing the VMP involves determining standards, qualifications for design, installation, operation, and performance, documentation requirements, and change control procedures.
- User requirement specifications (URS) are critical documents that validation is dependent on. Developing clear, testable URS in multiple levels is important, especially for software.
The document discusses pharmaceutical validation requirements according to various regulatory bodies like USFDA, EU, WHO and cGMP. It explains the manufacturing process model involving three stages - process design, process qualification and continued process verification. It also describes the user requirement specification document and the different phases of qualification - design qualification, installation qualification, operational qualification and performance qualification. The qualifications are methods to demonstrate that equipment and processes will consistently produce products meeting quality standards.
Facility Qualification & Consideration of Validation Aspects Apoorva Bauskar
This document discusses various aspects of facility qualification including validation master plans, user requirement specifications, design qualifications, installation qualifications, operational qualifications, performance qualifications, and requalification. It emphasizes that qualification proves systems work correctly and as expected. Validation plans encompass all validation aspects for facilities and equipment. User requirements specify functional and operational needs. Design reviews verify design suitability. Installation and operational qualifications check that systems are installed and perform as intended. Performance qualifications demonstrate effective performance under routine conditions. Requalification occurs on a defined schedule. Change control reviews changes that could affect validation status. Comprehensive documentation is also needed.
The document discusses various concepts related to validation of pharmaceutical processes including user requirement specification (URS), design qualification (DQ), installation qualification (IQ), operational qualification (OQ), performance qualification (PQ), and maintenance qualification (MQ). It explains that URS is a critical document that defines the requirements for the system. Validation involves qualification of the design, installation, operation, and performance of the system to ensure it meets predetermined specifications.
This document discusses validation concepts including user requirement specification, phases of validation such as design qualification, installation qualification, operational qualification, performance qualification, and maintenance qualification. It provides definitions and guidelines for each phase. The key phases involve design qualification to define functional specifications, installation qualification to ensure proper installation, operational qualification to test functions, performance qualification to ensure consistent performance over time, and maintenance qualification to document maintenance. The overall goal of validation is to provide high assurance that a process will consistently produce quality products meeting specifications.
Equipment used in pharmaceuticals dosage form manufacturing need to observe continuous qualification to monitor its performance and Concept of URS ,DQ, IQ,OQ,PQ,MQ...
the various categories of qualifications necessary for Validating an equipment or instrument before & after installation. Those are
DQ(Design Qualification)
IQ(Installation Qualification)
OQ(Operation Qualification)
PQ(Performance Qualification)
The document discusses developing a validation master plan (VMP) for a new pharmaceutical facility. Key points:
- A VMP comprehensively describes validation requirements and plans for meeting them. It covers production, storage, utilities, and staff areas.
- The VMP sets goals and limits for validation projects. It defines the scope and systems included.
- Developing the VMP involves determining standards, qualifications for design, installation, operation, and performance, documentation requirements, and change control procedures.
- User requirement specifications (URS) are critical documents that validation is dependent on. Developing clear, testable URS in multiple levels is important, especially for software.
The document discusses pharmaceutical validation requirements according to various regulatory bodies like USFDA, EU, WHO and cGMP. It explains the manufacturing process model involving three stages - process design, process qualification and continued process verification. It also describes the user requirement specification document and the different phases of qualification - design qualification, installation qualification, operational qualification and performance qualification. The qualifications are methods to demonstrate that equipment and processes will consistently produce products meeting quality standards.
Facility Qualification & Consideration of Validation Aspects Apoorva Bauskar
This document discusses various aspects of facility qualification including validation master plans, user requirement specifications, design qualifications, installation qualifications, operational qualifications, performance qualifications, and requalification. It emphasizes that qualification proves systems work correctly and as expected. Validation plans encompass all validation aspects for facilities and equipment. User requirements specify functional and operational needs. Design reviews verify design suitability. Installation and operational qualifications check that systems are installed and perform as intended. Performance qualifications demonstrate effective performance under routine conditions. Requalification occurs on a defined schedule. Change control reviews changes that could affect validation status. Comprehensive documentation is also needed.
This document discusses equipment qualification, which involves verifying through inspections and tests that critical equipment can satisfy product quality requirements and is properly operated and maintained. It is a regulatory requirement and includes design qualification, installation qualification, operational qualification, and performance qualification. Design qualification verifies a design is suitable, installation qualification verifies proper installation, operational qualification verifies performance within operating ranges, and performance qualification verifies effective and reproducible performance of connected equipment and systems based on approved processes. The document provides details on the stages, requirements, and documentation for each type of qualification.
This document provides information on various qualification documents used in pharmaceutical industries, including:
- User Requirement Specification (URS) which documents the end user requirements and functionality.
- Design Qualification (DQ) which verifies that the design will meet the requirements in the URS.
- Installation Qualification (IQ) which verifies proper installation.
- Operational Qualification (OQ) which tests the operation of the equipment.
- Performance Qualification (PQ) which verifies the equipment can perform as intended based on approved processes and specifications.
Guidance and requirements for each qualification type are defined. Supporting documents required for each are also listed.
Qualification of Laboratory Equipments.pptxHemlataMore3
This document discusses equipment qualification and provides details on the key aspects: design qualification (DQ), installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ). It defines these qualification types and describes their objectives. For example, DQ defines functional specifications, IQ verifies correct installation, OQ demonstrates functions work as specified, and PQ ensures consistent performance under normal operating conditions. The document also discusses applying these qualifications to dissolution test apparatus to ensure quality and regulatory compliance. It stresses the importance of documentation systems for locating documents quickly.
The document discusses validation and project management. It defines validation as proving that a process will consistently produce expected results. Validation involves qualification and testing stages like installation qualification and operational qualification. A requirement traceability matrix links requirements throughout the validation process to ensure all are tested. Deviations from expected test results are tracked, and a validation summary report provides an overview of the completed validation project. Change control manages how changes are introduced to validated systems.
computer system is a latest validation system in pharmaceutical industries.
To compliance with the good laboratory practice and good manufacturing practice.
it`s part of 211CFR part 11.
The document discusses quality standards, practices, and conventions for software testing and quality assurance. It covers topics such as software testing types, quality assurance, quality concepts, software standards organizations, basic practices like reviews and inspections, and coding conventions. Software configuration management is also introduced which involves tracking and controlling changes in software.
The document discusses analytical instrument qualification (AIQ) in the pharmaceutical industry. It states that AIQ involves collecting evidence that an instrument is suitable for its intended purpose. The key phases of AIQ are design qualification, installation qualification, operational qualification, and performance qualification. It also discusses the roles and responsibilities of various parties in ensuring instruments are properly qualified.
The Validation Master Plan (VMP) outlines the company's approach to validation. It defines responsibilities, schedules, and documentation requirements for qualification of facilities, equipment, and processes. The VMP ensures management understands validation needs and the validation team understands their tasks. Key elements include qualification protocols for equipment operational performance and process validation protocols to demonstrate processes consistently meet requirements. The VMP is a living document that is updated with changes to facilities, equipment, or processes.
The Validation Master Plan (VMP) outlines the company's approach to validation. It defines responsibilities, schedules, and documentation requirements for qualification of facilities, equipment, and processes. The VMP ensures management understands validation needs and the validation team understands their tasks. Key elements include qualification of equipment and facilities, process validation, cleaning validation, change control procedures, and periodic revalidation. Qualification includes design, installation, operational, and performance qualification to confirm equipment and facilities operate as intended. Process validation demonstrates manufacturing processes consistently produce products meeting specifications. The VMP helps regulatory inspectors evaluate the company's validation program.
The document provides an overview of validation requirements in the pharmaceutical industry. It defines validation and traces its origins back to the 1970s where it began with sterilization processes and has now expanded to all product, process, and facility matters. Validation is important as it assures quality, is a regulatory requirement, reduces costs, and is legally required. The document outlines the various stages of validation from user requirement specification to process validation and continuous process verification. It provides details on what each stage involves and its goals.
This document discusses validation and qualification processes for pharmaceutical equipment and systems. It defines validation as providing objective evidence that a process meets its intended use consistently, while qualification ensures equipment is ready for its intended use. The document outlines the key steps in validation including developing a validation master plan, user requirement specification, design qualification, installation qualification, operational qualification and performance qualification. It provides details on each stage and emphasizes that validation and qualification are critical to ensuring product quality and compliance with cGMP regulations.
Validation is required by the FDA to demonstrate that pharmaceutical manufacturing processes and equipment consistently produce quality products meeting specifications. It involves establishing documented evidence through qualification protocols that address installation, operation, and performance of processes and systems. The goals of validation are to prove quality, functionality, and reproducibility and provide high assurance that specific processes and equipment reliably produce the intended results. Pharmaceutical companies must conduct validation according to FDA guidelines tailored to their unique systems and operations.
The document discusses the process of equipment qualification which includes design qualification (DQ), installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ). DQ establishes that the equipment design meets predefined user requirements. IQ demonstrates that equipment has been properly installed. OQ shows that equipment can consistently operate within defined parameters. PQ shows that equipment can consistently meet performance standards under real-world conditions. The document provides details on the documentation and tests required for each qualification step.
The document discusses the process of equipment qualification which includes design qualification (DQ), installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ). DQ establishes that the equipment design meets predefined user requirements. IQ demonstrates that equipment has been properly installed. OQ shows that equipment can consistently operate within defined parameters. PQ shows that equipment can consistently meet performance standards under real-world conditions. The document provides details on the documentation and tests required for each qualification step.
This tutorial provides an overview of validation for biotechnological and pharmaceutical processes. It defines validation and describes the three phases: installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ). It explains that the FDA regulates validation through guidelines like 21 CFR Parts 210, 211, 600 and 610. Both equipment and overall manufacturing processes must be validated to consistently produce quality products. Facility design should also consider validation requirements.
This document discusses validation in the pharmaceutical industry. It defines validation and explains why it is important. Validation ensures a process will consistently produce products meeting requirements. The document outlines the scope of validation, including analytical methods, equipment, and facilities. It also describes a validation master plan, which provides documentation for qualification and process validation. Validation has advantages like reduced costs, assured quality, and process optimization.
validation of blister packaging machineNilesh Utpure
The document discusses validation of packaging machines. It outlines the objectives, importance, and responsibilities of process validation. Validation establishes that a machine meets installation, operational, and performance qualification requirements. The document describes user requirement specifications that cover mandatory parts to guarantee final product quality and compliance. It details the scope, steps in the machine's lifecycle, types of packaging machines, their detailed assembly, key parameters, and the validation SOP.
This document provides an overview of GAMP (Good Automated Manufacturing Practice) guidelines for validation of computer systems used in regulated industries. It discusses the history of GAMP, key terms and concepts in validation like validation life cycle, risk management, categories of software. It also summarizes the validation requirements for different categories of software and records as per GAMP-4 guidelines. The document emphasizes that validation is important to ensure computer systems consistently produce intended results and meet safety standards.
The document provides an overview of validation requirements in the pharmaceutical industry. It defines key terms like process validation, cleaning validation, and maximum allowable carryover. It describes the importance of validation in assuring quality and reducing costs. The document outlines the various stages of validation including process design, qualification, and continuous verification. It emphasizes that validation is an ongoing process to demonstrate consistency. Key aspects that must be addressed in a validation program are also summarized such as personnel training, change control procedures, and documentation.
This document outlines validation and calibration master plans. It discusses the objectives of validation including reducing risks and costs. It describes the contents and members involved in a validation master plan, which provides the framework for validation activities. It also discusses the calibration process, including defining calibrated equipment, classification, and verification. The calibration master plan establishes requirements for an effective calibration control program.
The use of Nauplii and metanauplii artemia in aquaculture (brine shrimp).pptxMAGOTI ERNEST
Although Artemia has been known to man for centuries, its use as a food for the culture of larval organisms apparently began only in the 1930s, when several investigators found that it made an excellent food for newly hatched fish larvae (Litvinenko et al., 2023). As aquaculture developed in the 1960s and ‘70s, the use of Artemia also became more widespread, due both to its convenience and to its nutritional value for larval organisms (Arenas-Pardo et al., 2024). The fact that Artemia dormant cysts can be stored for long periods in cans, and then used as an off-the-shelf food requiring only 24 h of incubation makes them the most convenient, least labor-intensive, live food available for aquaculture (Sorgeloos & Roubach, 2021). The nutritional value of Artemia, especially for marine organisms, is not constant, but varies both geographically and temporally. During the last decade, however, both the causes of Artemia nutritional variability and methods to improve poorquality Artemia have been identified (Loufi et al., 2024).
Brine shrimp (Artemia spp.) are used in marine aquaculture worldwide. Annually, more than 2,000 metric tons of dry cysts are used for cultivation of fish, crustacean, and shellfish larva. Brine shrimp are important to aquaculture because newly hatched brine shrimp nauplii (larvae) provide a food source for many fish fry (Mozanzadeh et al., 2021). Culture and harvesting of brine shrimp eggs represents another aspect of the aquaculture industry. Nauplii and metanauplii of Artemia, commonly known as brine shrimp, play a crucial role in aquaculture due to their nutritional value and suitability as live feed for many aquatic species, particularly in larval stages (Sorgeloos & Roubach, 2021).
This document discusses equipment qualification, which involves verifying through inspections and tests that critical equipment can satisfy product quality requirements and is properly operated and maintained. It is a regulatory requirement and includes design qualification, installation qualification, operational qualification, and performance qualification. Design qualification verifies a design is suitable, installation qualification verifies proper installation, operational qualification verifies performance within operating ranges, and performance qualification verifies effective and reproducible performance of connected equipment and systems based on approved processes. The document provides details on the stages, requirements, and documentation for each type of qualification.
This document provides information on various qualification documents used in pharmaceutical industries, including:
- User Requirement Specification (URS) which documents the end user requirements and functionality.
- Design Qualification (DQ) which verifies that the design will meet the requirements in the URS.
- Installation Qualification (IQ) which verifies proper installation.
- Operational Qualification (OQ) which tests the operation of the equipment.
- Performance Qualification (PQ) which verifies the equipment can perform as intended based on approved processes and specifications.
Guidance and requirements for each qualification type are defined. Supporting documents required for each are also listed.
Qualification of Laboratory Equipments.pptxHemlataMore3
This document discusses equipment qualification and provides details on the key aspects: design qualification (DQ), installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ). It defines these qualification types and describes their objectives. For example, DQ defines functional specifications, IQ verifies correct installation, OQ demonstrates functions work as specified, and PQ ensures consistent performance under normal operating conditions. The document also discusses applying these qualifications to dissolution test apparatus to ensure quality and regulatory compliance. It stresses the importance of documentation systems for locating documents quickly.
The document discusses validation and project management. It defines validation as proving that a process will consistently produce expected results. Validation involves qualification and testing stages like installation qualification and operational qualification. A requirement traceability matrix links requirements throughout the validation process to ensure all are tested. Deviations from expected test results are tracked, and a validation summary report provides an overview of the completed validation project. Change control manages how changes are introduced to validated systems.
computer system is a latest validation system in pharmaceutical industries.
To compliance with the good laboratory practice and good manufacturing practice.
it`s part of 211CFR part 11.
The document discusses quality standards, practices, and conventions for software testing and quality assurance. It covers topics such as software testing types, quality assurance, quality concepts, software standards organizations, basic practices like reviews and inspections, and coding conventions. Software configuration management is also introduced which involves tracking and controlling changes in software.
The document discusses analytical instrument qualification (AIQ) in the pharmaceutical industry. It states that AIQ involves collecting evidence that an instrument is suitable for its intended purpose. The key phases of AIQ are design qualification, installation qualification, operational qualification, and performance qualification. It also discusses the roles and responsibilities of various parties in ensuring instruments are properly qualified.
The Validation Master Plan (VMP) outlines the company's approach to validation. It defines responsibilities, schedules, and documentation requirements for qualification of facilities, equipment, and processes. The VMP ensures management understands validation needs and the validation team understands their tasks. Key elements include qualification protocols for equipment operational performance and process validation protocols to demonstrate processes consistently meet requirements. The VMP is a living document that is updated with changes to facilities, equipment, or processes.
The Validation Master Plan (VMP) outlines the company's approach to validation. It defines responsibilities, schedules, and documentation requirements for qualification of facilities, equipment, and processes. The VMP ensures management understands validation needs and the validation team understands their tasks. Key elements include qualification of equipment and facilities, process validation, cleaning validation, change control procedures, and periodic revalidation. Qualification includes design, installation, operational, and performance qualification to confirm equipment and facilities operate as intended. Process validation demonstrates manufacturing processes consistently produce products meeting specifications. The VMP helps regulatory inspectors evaluate the company's validation program.
The document provides an overview of validation requirements in the pharmaceutical industry. It defines validation and traces its origins back to the 1970s where it began with sterilization processes and has now expanded to all product, process, and facility matters. Validation is important as it assures quality, is a regulatory requirement, reduces costs, and is legally required. The document outlines the various stages of validation from user requirement specification to process validation and continuous process verification. It provides details on what each stage involves and its goals.
This document discusses validation and qualification processes for pharmaceutical equipment and systems. It defines validation as providing objective evidence that a process meets its intended use consistently, while qualification ensures equipment is ready for its intended use. The document outlines the key steps in validation including developing a validation master plan, user requirement specification, design qualification, installation qualification, operational qualification and performance qualification. It provides details on each stage and emphasizes that validation and qualification are critical to ensuring product quality and compliance with cGMP regulations.
Validation is required by the FDA to demonstrate that pharmaceutical manufacturing processes and equipment consistently produce quality products meeting specifications. It involves establishing documented evidence through qualification protocols that address installation, operation, and performance of processes and systems. The goals of validation are to prove quality, functionality, and reproducibility and provide high assurance that specific processes and equipment reliably produce the intended results. Pharmaceutical companies must conduct validation according to FDA guidelines tailored to their unique systems and operations.
The document discusses the process of equipment qualification which includes design qualification (DQ), installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ). DQ establishes that the equipment design meets predefined user requirements. IQ demonstrates that equipment has been properly installed. OQ shows that equipment can consistently operate within defined parameters. PQ shows that equipment can consistently meet performance standards under real-world conditions. The document provides details on the documentation and tests required for each qualification step.
The document discusses the process of equipment qualification which includes design qualification (DQ), installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ). DQ establishes that the equipment design meets predefined user requirements. IQ demonstrates that equipment has been properly installed. OQ shows that equipment can consistently operate within defined parameters. PQ shows that equipment can consistently meet performance standards under real-world conditions. The document provides details on the documentation and tests required for each qualification step.
This tutorial provides an overview of validation for biotechnological and pharmaceutical processes. It defines validation and describes the three phases: installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ). It explains that the FDA regulates validation through guidelines like 21 CFR Parts 210, 211, 600 and 610. Both equipment and overall manufacturing processes must be validated to consistently produce quality products. Facility design should also consider validation requirements.
This document discusses validation in the pharmaceutical industry. It defines validation and explains why it is important. Validation ensures a process will consistently produce products meeting requirements. The document outlines the scope of validation, including analytical methods, equipment, and facilities. It also describes a validation master plan, which provides documentation for qualification and process validation. Validation has advantages like reduced costs, assured quality, and process optimization.
validation of blister packaging machineNilesh Utpure
The document discusses validation of packaging machines. It outlines the objectives, importance, and responsibilities of process validation. Validation establishes that a machine meets installation, operational, and performance qualification requirements. The document describes user requirement specifications that cover mandatory parts to guarantee final product quality and compliance. It details the scope, steps in the machine's lifecycle, types of packaging machines, their detailed assembly, key parameters, and the validation SOP.
This document provides an overview of GAMP (Good Automated Manufacturing Practice) guidelines for validation of computer systems used in regulated industries. It discusses the history of GAMP, key terms and concepts in validation like validation life cycle, risk management, categories of software. It also summarizes the validation requirements for different categories of software and records as per GAMP-4 guidelines. The document emphasizes that validation is important to ensure computer systems consistently produce intended results and meet safety standards.
The document provides an overview of validation requirements in the pharmaceutical industry. It defines key terms like process validation, cleaning validation, and maximum allowable carryover. It describes the importance of validation in assuring quality and reducing costs. The document outlines the various stages of validation including process design, qualification, and continuous verification. It emphasizes that validation is an ongoing process to demonstrate consistency. Key aspects that must be addressed in a validation program are also summarized such as personnel training, change control procedures, and documentation.
This document outlines validation and calibration master plans. It discusses the objectives of validation including reducing risks and costs. It describes the contents and members involved in a validation master plan, which provides the framework for validation activities. It also discusses the calibration process, including defining calibrated equipment, classification, and verification. The calibration master plan establishes requirements for an effective calibration control program.
The use of Nauplii and metanauplii artemia in aquaculture (brine shrimp).pptxMAGOTI ERNEST
Although Artemia has been known to man for centuries, its use as a food for the culture of larval organisms apparently began only in the 1930s, when several investigators found that it made an excellent food for newly hatched fish larvae (Litvinenko et al., 2023). As aquaculture developed in the 1960s and ‘70s, the use of Artemia also became more widespread, due both to its convenience and to its nutritional value for larval organisms (Arenas-Pardo et al., 2024). The fact that Artemia dormant cysts can be stored for long periods in cans, and then used as an off-the-shelf food requiring only 24 h of incubation makes them the most convenient, least labor-intensive, live food available for aquaculture (Sorgeloos & Roubach, 2021). The nutritional value of Artemia, especially for marine organisms, is not constant, but varies both geographically and temporally. During the last decade, however, both the causes of Artemia nutritional variability and methods to improve poorquality Artemia have been identified (Loufi et al., 2024).
Brine shrimp (Artemia spp.) are used in marine aquaculture worldwide. Annually, more than 2,000 metric tons of dry cysts are used for cultivation of fish, crustacean, and shellfish larva. Brine shrimp are important to aquaculture because newly hatched brine shrimp nauplii (larvae) provide a food source for many fish fry (Mozanzadeh et al., 2021). Culture and harvesting of brine shrimp eggs represents another aspect of the aquaculture industry. Nauplii and metanauplii of Artemia, commonly known as brine shrimp, play a crucial role in aquaculture due to their nutritional value and suitability as live feed for many aquatic species, particularly in larval stages (Sorgeloos & Roubach, 2021).
ESPP presentation to EU Waste Water Network, 4th June 2024 “EU policies driving nutrient removal and recycling
and the revised UWWTD (Urban Waste Water Treatment Directive)”
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.
The technology uses reclaimed CO₂ as the dyeing medium in a closed loop process. When pressurized, CO₂ becomes supercritical (SC-CO₂). In this state CO₂ has a very high solvent power, allowing the dye to dissolve easily.
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.
Immersive Learning That Works: Research Grounding and Paths ForwardLeonel Morgado
We will metaverse into the essence of immersive learning, into its three dimensions and conceptual models. This approach encompasses elements from teaching methodologies to social involvement, through organizational concerns and technologies. Challenging the perception of learning as knowledge transfer, we introduce a 'Uses, Practices & Strategies' model operationalized by the 'Immersive Learning Brain' and ‘Immersion Cube’ frameworks. This approach offers a comprehensive guide through the intricacies of immersive educational experiences and spotlighting research frontiers, along the immersion dimensions of system, narrative, and agency. Our discourse extends to stakeholders beyond the academic sphere, addressing the interests of technologists, instructional designers, and policymakers. We span various contexts, from formal education to organizational transformation to the new horizon of an AI-pervasive society. This keynote aims to unite the iLRN community in a collaborative journey towards a future where immersive learning research and practice coalesce, paving the way for innovative educational research and practice landscapes.
ESR spectroscopy in liquid food and beverages.pptxPRIYANKA PATEL
With increasing population, people need to rely on packaged food stuffs. Packaging of food materials requires the preservation of food. There are various methods for the treatment of food to preserve them and irradiation treatment of food is one of them. It is the most common and the most harmless method for the food preservation as it does not alter the necessary micronutrients of food materials. Although irradiated food doesn’t cause any harm to the human health but still the quality assessment of food is required to provide consumers with necessary information about the food. ESR spectroscopy is the most sophisticated way to investigate the quality of the food and the free radicals induced during the processing of the food. ESR spin trapping technique is useful for the detection of highly unstable radicals in the food. The antioxidant capability of liquid food and beverages in mainly performed by spin trapping technique.
3. According to the Food and Drug Administration (FDA), the
goal of validation is to:
“Establish documented evidence which provides a high
degree of assurance that a specific process will consistently
produce a product meeting its predetermined specifications
and quality attributes.”
It is a requirement for Good Manufacturing Practices and
other regulatory requirements.
4. What does this mean?
An quantitative approach is needed to prove quality,
functionality, and performance of a
pharmaceutical/biotechnological manufacturing process.
This approach will be applied to individual pieces of
equipment as well as the manufacturing process as a whole.
Guidelines for validation are set by the FDA, but the
specifications of validation are determined by the
pharmaceutical/biotech company.
5. User Requirements Specification (URS), is the most critical of
documents and yet, the most often bungled. Whether the
system is purely mechanical, or a mix of electro-mechanical,
or solely a software program, the successful compilation and
execution of the Installation Qualification (IQ) (for
installation), Operational Qualification (OQ) (for functionality)
and the Performance / Product Qualification (PQ) (for
operability), is dependent on an User Requirements
Specification (URS) containing clear, concise and testable
requirements.
6. Once the end user requirements specification is documented,
agreed and approved they form the basic URS Level-1 document.
The engineers (or vendor) can then commence the preliminary
design to establish exactly what functions are required for each of
the items specified in the user requirements specification, the
end user has listed. Once this functionality is documented and
approved it forms URS Level-2 document. This is the final level of
the URS unless software is used.
If software is to be used, the URS Level-2 document, is passed to
the code writers. As the code is written, lines, or groups of lines,
of code must be attributed to the individual functions that
necessitate their presence. The completion of this task results in
the completion of the URS Level-3 document
7. Developing the URS to this level is unique in most industries, but
is, standard practice in strictly regulated industries, as it is a
major building block in the creation of quality software. The URS
Level-3 document, contains all the traceability which is deemed
mandatory for software assessed to be critical to product quality,
in the pharmaceutical regulated industries.
8. The URS can contain a large number of requirements and
should therefore be structured in a way that will permit easy
access to information.
The requirement specification must be formally reviewed and
approved by the pharmaceutical manufacturer.
The following guidelines should be followed during the
production of the URS :
1. Each requirement statement to be uniquely referenced,and
no longer than 250 words.
2. Requirement statements should not be duplicated nor
contradicted.
9. 3. The URS should express requirements and not design solutions.
4. Each requirement should be testable.
5. The URS must be understood by both user and supplier;
ambiguity and jargon should be avoided.
6. The use of diagrams is often useful.
7. The scope for readers to make assumptions or misinterpret
should be minimized.
8. Wherever possible, the URS should distinguish between
mandatory/regulatory requirements and desirable features.
10. The URS for a GMP computer control system application will typically
address the following:
Scope of system supply
Project objectives
Regulatory requirements
Process overview
System boundaries
Operational considerations
Manufacturing design data
Instrument application data
Data records
System functions
System software
System hardware and peripherals
11. System interfaces
Environmental conditions
Access security
Diagnostics
System availability
Safety
Test and calibration
Quality procedures
Software development life cycle
Documentation requirements
Training
Engineering/installation standards
Ongoing support
Warranty
Delivery/commercial requirements
12. Newly sanctioned systems will require compliance with
regulations for GMP electronic records and electronic signatures,
and definition of the functionality required will need to be
included.
The structure of the URS be used as the basis for the
presentation format of the FDS and hardware and software
design specifications; this helps ensure design decisions are
auditable back to the source requirement.
Once reviewed and approved internally, the URS is issued to
prospective suppliers as part of the tender document set so that
detailed quotations for the system application can be obtained.
13. URS provides the following key benefits for the validation
program:
1. Clarifies technical, quality, and documentation
requirements to the vendor( s).
2. Enables the pharmaceutical manufacturer to assess the
technical, regulatory, and commercial compliance (or
otherwise) of submitted bids against a formal specification.
3. Ensures the basis of a structured approach to the
presentation of information.
4. Provides a basis for testing and test acceptance criteria.
5. Provide a baseline for validation and verification..
14. They must be comprehensive. Each and every requirement
relating to product safety, identity, strength, purity, and
quality must be identified. Hence, Quality Assurance (QA)
must have a significant role in reviewing and approving the
final set of requirements, and must be an approver of
changes to any requirement that can affect the above
product or process attributes (e.g., cGMP’s).
15. Given a comprehensive User Requirements Specification that
has been approved by QA and is under project change
management, the Design Qualification(DQ) process then can be
reduced to two key objectives:
Documented verification that the overall design appears to
address, by some means, each and every requirement affecting
the product and performance of the manufacturing process (or, in
the case of unknown product or multi-product manufacturing
facility, the required equipment/ system performance
capabilities).
Identification (and documentation) of the critical individual
physical components, attributes, and operational features that
directly support meeting each requirement.
16. Validation is broken down into 5 main phases,
Design qualification (DQ).
Installation qualification (IQ).
Operational qualification (OQ).
Performance qualification (PQ).
Maintenance Qualification (MQ)
Component qualification (CQ).
17.
18. Vendor’s Site Owner’s site
Before Purchase Before Use After Use
Structurally
Validated
Products
DQ
Functional Validation
Installation Operational Performance
Qualification Qualification Qualification
Maintenance
OQ
PQ
IQ OQ PQ
System Suitability During Use
19. Validation:
Refers to the total life cycle of a product from development
through use and maintenance.
Owners are responsible for Validating Their Processes (personnel,
equipment, methods, SOPs) to ensure compliance to cGMP/GLP
regulations.
Qualification: (Inspection, functional testing and documentation review)
Is a part of the validation process which verifies module and
system functional performance prior to being placed on-line
and thereafter according to a standard operating procedure.
20.
21. It is a basic requirement of good analytical chemistry that
balances and other analytical instruments must be suitable
for the purpose for which they are used and that they must
be appropriately calibrated. As a consequence, Equipment
Qualification is gaining more and more importance in
ensuring the validity of results. Regulatory bodies also seem
to be turning their attention increasingly to this area, and
manufacturers of analytical equipment are forced to play a
significant role in the various steps of Equipment
Qualification.
22. Step 1: Design Qualification (DQ) defines the functional and operational
specifications of a balance or instrument.
Step 2 :Installation Qualification (IQ) ensures that a balance or instrument
is received as designed and specified. It documents the installation in the
selected user environment.
Step 3: Operational Qualification (OQ) demonstrates that a balance or
instrument will function according to its operational specification in the
selected environment.
Step 4: Performance Qualification (PQ) demonstrates that a balance or
instrument consistently performs according to a specification appropriate
to its routine use.
Step 5: Maintenance Qualification (MQ) describes and documents any
maintenance required on the equipment.
23.
24. Design qualification (DQ) is the process of completing and
documenting design reviews to illustrate that all quality aspects
have been fully considered at the design stage. The purpose is to
ensure that all the requirements for the final systems have been
clearly defined at the start.
Design Qualification (DQ) defines the functional and operational
specifications of the instrument and details the conscious decisions
made in the selection of the supplier. DQ should ensure that
instruments have all the necessary functions and performance
criteria that will enable them to be successfully implemented for
the intended application and to meet user requirements.
25. The list below shows the recommended steps that should be
considered for inclusion in a Design Qualification.
- Description of the analysis problem
- Description of the intended use for the equipment
- Description of the intended environment
- Preliminary selection of the functional and performance
specifications (technical, environmental, safety)
- Preliminary selection of the supplier
- Final selection of the supplier and equipment
- Development and documentation of final functional and
operational specifications
26. As part of the design qualification process, the vendor should
be qualified; the question is how should this be done? Is an
established and documented quality system enough (e.g. ISO
9001), or should there be a direct audit?
The answer is that there may be situations where a vendor
audit is recommended: for example, when complex computer
systems are being developed for a specific user. However, this
is rarely the case for balances and analytical instruments.
If equipment does not include a computer system, a good
reputation, one's own experience or good references from
other users - together with ISO 9001 certification - can be
sufficient.
27.
28. Installation qualification (IQ) is the process of checking the
installation, to ensure that the components meet the approved
specification and are installed correctly, and to see how that
information is recorded. The purpose is to ensure that all
aspects (static attributes) of the facility or equipment are
installed correctly and comply with the original design.
all of the instrumentation components are identified and
checked against the manufacturer’s component listing.
The working environment conditions are documented and
checked to ensure that they are suitable for the operation of the
instrument.
29. Installation Qualification establishes that the instrument is
received as designed and specified, that it is properly installed in
the selected environment, and that this environment is suitable
for the operation and use of the instrument.
Before installation:
- Obtain manufacturer's recommendations for installation site
requirements.
- Check the site for the fulfillment of the manufacturer's
recommendations (utilities such as electricity, water and gases
plus environmental conditions such as humidity, temperature,
vibration level and dust).
- Allow sufficient shelf space for the equipment itself, related
SOPs, operating manuals, logbooks and software.
30.
31. Operational qualification (OQ) is the process of testing to ensure
that the individual and combined systems function to meet
agreed performance criteria and to check how the result of
testing is recorded. The purpose is to ensure that all the dynamic
attributes comply with the original design. Each of the
instrument’s function are checked to ensure that they conform to
the manufacturer’s specifications.
This includes the use of certified, traceable electrical simulators
and standards to verify that the equipment is processing input
signals correctly.
32.
33. Performance qualification (PQ), also called process qualification,
is the process of testing to ensure that the individual and
combined systems function to meet agreed performance criteria
on a consistent basis and to check how the result of testing is
recorded. The purpose is to ensure that the criteria specified can
be achieved on a reliable basis over a period of time.
The performance of the equipment for its routine analytical use
is checked to ensure that this complies with its specification.
The temperature sensor readings are compared with a certified
reference thermometer. After calibration, the conductivity sensor
readings are compared using certified, traceable control
standards.
34. Control Standards of similar values to the intended test samples
must be used for PQ.
Performance Qualification (PQ) is the process of demonstrating
that an instrument consistently performs according to a
specification appropriate to its routine use.
Important here is the word consistently. The test frequency is
much higher than for OQ. Another difference is that PQ should
always be performed under conditions that are similar to
routine sample analysis.
35. PQ should be performed on a daily (or at least a weekly) basis,
or whenever the instrument is used. The test frequency
depends not only on the stability of the equipment but also on
everything in the system that may contribute to the analysis
results.
1. Define the performance criteria and test procedures.
2. Select critical parameters.
3. Define the test intervals.
36.
37. The MQ describes and documents any maintenance required
on the equipment. This includes routine servicing and any
repairs necessary. Details of any maintenance contracts are
also documented in this section, together with a list of
authorized service engineers. In addition, the MQ includes
the routine cleaning of the equipment and also its ultimate
disposal.
38. Component qualification (CQ) – is a relatively new term
developed in 2005. This term refers to the manufacturing of
auxiliary components to ensure that they are manufactured
to the correct design criteria. This could include packaging
components such as folding cartons, shipping cases, labels or
even phase change material. All of these components must
have some type of random inspection to ensure that the third
party manufacturer's process is consistently producing
components that are used in the world of GMP at drug or
biologic manufacturer.
39. Instrument Validation should not be viewed as a one-off
event – confidence in analytical results is required for the
whole of the instrument’s working life.
To ensure that this confidence is retained, the instrument
validation process should be repeated at regular intervals
during the instruments operational life.
The difference between Installation Validation and Re-
Qualification is that IQ is omitted for the Re-Qualification
Re-Qualification should be performed at least annually and
should be performed more frequently for applications whose
test results have critical implications
40. Nash. A.Robert and Wachter H. Alfred “Pharmaceutical Process Validation”
an international 3rd edition volume 129 revised and expended
WORLD HEALTH ORGANIZATION ORGANISATION MONDIALE DE LA SANTE
SUPPLEMENTARY GUIDELINES ON GOOD MANUFACTURING PRACTICES
(GMP):VALIDATION
ICH Topic Q 7 Good Manufacturing Practice for Active Pharmaceutical
Ingredients.
Validation in pharmaceutical industries by P.P. Sharma
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