ANNUAL PRODUCT REVIEW

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Raghavendra institute of pharmaceutical education and research .

In this slide contains definition, importance, benefits of annual product review. Presented by: Ravi Sanker babu .D.V (Department of pharmaceutical analysis and quality assurance). RIPER, anantapur.

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Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721
ANNUAL PRODUCT REVIEW
Presented by
Ravi Shankar babu .D.V.
(20L81S0403)
I-M pharmacy
Quality Assurance
Subject-Quality Management System
Under the guidance of
Dr. Nawaz M.Pharm, Ph.D.
Associate Professor of Pharmaceutical Quality Assurance

RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 2
Definition
Importance of APR
Basic contents of APR
Why do APR required
Benefits
Analytical and Inspection data
FDA inspections
Contents

Annual product reviews are conducted annually to assess the quality of drug products and determine if any changes need to be made to product specifications, manufacturing processes, or quality control procedures. The review evaluates analytical data, inspection results, batch failures, complaints, recalls, deviations, stability monitoring results, and corrective actions to verify process consistency and identify quality trends over time. The goal is to continually improve product quality and manufacturing processes.

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Auditing of Granulation Operation in Dry Production Area..... This topic comes under Audits and Regulatory Compliance.... This is useful for M.Pharm (Pharaceutical Quality Assurance) Students who studying in First year sem II.... This Presentation Contain following... #Objectives #Fundamentals of Granulation #Reasons for Granulation #Methods of Granulation #Agglomeration #Fundamentals and Audit of Dry Granulation #Steps in Dry Granulation #Fundamentals and Audit of Fluid Bed Granulation #Scale-Up of Fluid bed Granulation #High share granulation-Fundamentals, Audit and Scale-Up #Overview and Comparison of Different Granulating Techniques #Audit of Mixing and Blending, Wet granulation, Wet milling, Drying, Milling #Conclusion #References Thanks For Help and Guidance of Mr. D.P.Mali Sir

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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.

Deep Software Variability and Frictionless Reproducibility

University of Rennes, INSA Rennes, Inria/IRISA, CNRS

The ability to recreate computational results with minimal effort and actionable metrics provides a solid foundation for scientific research and software development. When people can replicate an analysis at the touch of a button using open-source software, open data, and methods to assess and compare proposals, it significantly eases verification of results, engagement with a diverse range of contributors, and progress. However, we have yet to fully achieve this; there are still many sociotechnical frictions. Inspired by David Donoho's vision, this talk aims to revisit the three crucial pillars of frictionless reproducibility (data sharing, code sharing, and competitive challenges) with the perspective of deep software variability. Our observation is that multiple layers — hardware, operating systems, third-party libraries, software versions, input data, compile-time options, and parameters — are subject to variability that exacerbates frictions but is also essential for achieving robust, generalizable results and fostering innovation. I will first review the literature, providing evidence of how the complex variability interactions across these layers affect qualitative and quantitative software properties, thereby complicating the reproduction and replication of scientific studies in various fields. I will then present some software engineering and AI techniques that can support the strategic exploration of variability spaces. These include the use of abstractions and models (e.g., feature models), sampling strategies (e.g., uniform, random), cost-effective measurements (e.g., incremental build of software configurations), and dimensionality reduction methods (e.g., transfer learning, feature selection, software debloating). I will finally argue that deep variability is both the problem and solution of frictionless reproducibility, calling the software science community to develop new methods and tools to manage variability and foster reproducibility in software systems. Exposé invité Journées Nationales du GDR GPL 2024

Phenomics assisted breeding in crop improvement

IshaGoswami9

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.

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原版制作(carleton毕业证书)卡尔顿大学毕业证硕士文凭原版一模一样

yqqaatn0

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ANNUAL PRODUCT REVIEW

1. Raghavendra Institute of Pharmaceutical Education and Research - Autonomous K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 ANNUAL PRODUCT REVIEW Presented by Ravi Shankar babu .D.V. (20L81S0403) I-M pharmacy Quality Assurance Subject-Quality Management System Under the guidance of Dr. Nawaz M.Pharm, Ph.D. Associate Professor of Pharmaceutical Quality Assurance

2. RIPER AUTONOMOUS NAAC & NBA (UG) SIRO- DSIR Raghavendra Institute of Pharmaceutical Education and Research - Autonomous K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 2 Definition Importance of APR Basic contents of APR Why do APR required Benefits Analytical and Inspection data FDA inspections Contents

3. RIPER AUTONOMOUS NAAC & NBA (UG) SIRO- DSIR Raghavendra Institute of Pharmaceutical Education and Research - Autonomous K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 3 Evaluations conducted anually to verify the quality standard of drug product and consistency of the process To implement any changes if required Importance of APR: • To verify the consistency of the process • To detect the product quality and process defects • To eiew qualiyt of raw materials and packaging material use for the product Definition:

4. RIPER AUTONOMOUS NAAC & NBA (UG) SIRO- DSIR Raghavendra Institute of Pharmaceutical Education and Research - Autonomous K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 4 • To detect process quality Basic contents of APR: To review -raw material and packaging material -change control process -results of stability monitoring programme and adverse events -product returns -qualification status of relevant equipment

5. RIPER AUTONOMOUS NAAC & NBA (UG) SIRO- DSIR Raghavendra Institute of Pharmaceutical Education and Research - Autonomous K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 5 For the review of - returns and recalls - investigations - every batch Benefits: • Can assess the required changes in -product specification -manufacturing/control procedures • To detect product improvement & opportunity of cost reduction • Provides a preparation tool for FDA inspection Why APR required

6. RIPER AUTONOMOUS NAAC & NBA (UG) SIRO- DSIR Raghavendra Institute of Pharmaceutical Education and Research - Autonomous K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 6 They use to complie percentage yield at all stages FDA Inspections: They develop a standard/comprehensive SOP Follow up SOP If fails to follow receives concerns from investigators Review of yield:

7. RIPER AUTONOMOUS NAAC & NBA (UG) SIRO- DSIR Raghavendra Institute of Pharmaceutical Education and Research - Autonomous K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 7 That include all required elements into APR Identify and implement corrective/improvement actions Assures that quality unit reviews (QA) &approves the APR

8. RIPER AUTONOMOUS NAAC & NBA (UG) SIRO- DSIR Raghavendra Institute of Pharmaceutical Education and Research - Autonomous K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 8 Summary: For obtaining the better results regarding our prepared product (stability studies) and also to detect any change control of our process (consistency of process), APR is suitable in such a way that quality of products that had been manufactured during a year can be determined in a statistical way.

9. RIPER AUTONOMOUS NAAC & NBA (UG) SIRO- DSIR Raghavendra Institute of Pharmaceutical Education and Research - Autonomous K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 9 Reference: • Pharmaguideline, “Importance of Annual Product Quality Review”, http://www.pharmaguideline.com/2013/11/importanc e-of-annual-product-quality- review-apqr-aprpqr.html (Last accessed on 8/1/2015) • Health Sciences Authority, “Guidance notes on Product Quality Review”, January 2013, http://www.hsa.gov.sg/content/dam/HSA/HPRG/Ma nufacturing- Importation-Distribution/Overview-Framework-Policies/GUIDE-MQA-024- 004.pdf. [accessed on 8 January 2015] • PharmaManufacturing.com, “Annual Product Reviews: How to Conduct an Effective Annual Product Quality Review”, February 2012, http://www.pharmamanufacturing.com/articles/2012/ 018/ (Last accessed on 9/1/2015)

10. RIPER AUTONOMOUS NAAC & NBA (UG) SIRO- DSIR Raghavendra Institute of Pharmaceutical Education and Research - Autonomous K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 10

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