Process Analytical Technology
• Hardness monitoring
• Moisture distribution mapping
• Powder drying process monitoring and end point determination
• Capsule content examination
• Particle size monitoring
• Detection of foreign objects in powders
Nabl calibration PRISM CALIBRATION CENTRE IN AHMEDABADparthiv kinariwala
NABL ACCREDITED CALIBRATION LAB IN AHMEDABAD
PRISM IS NABL APPROVED LAB FOR THERMAL, MECHANICAL AND ELECTRO TECHNICAL FIELD.
PRISM CAN PROVIDE ONSITE CALIBRATION, VALIDATION, ENVIRONMENT SUPPLY AND INSTRUMENT SUPPLY.
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.
Process Analytical Technology
• Hardness monitoring
• Moisture distribution mapping
• Powder drying process monitoring and end point determination
• Capsule content examination
• Particle size monitoring
• Detection of foreign objects in powders
Nabl calibration PRISM CALIBRATION CENTRE IN AHMEDABADparthiv kinariwala
NABL ACCREDITED CALIBRATION LAB IN AHMEDABAD
PRISM IS NABL APPROVED LAB FOR THERMAL, MECHANICAL AND ELECTRO TECHNICAL FIELD.
PRISM CAN PROVIDE ONSITE CALIBRATION, VALIDATION, ENVIRONMENT SUPPLY AND INSTRUMENT SUPPLY.
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.
This PDF describes demo of GMP documents kit which are primary documentation requirements. This document is intended to provide guidance regarding Good Manufacturing Practice (GMP) for the manufacturing of active pharmaceutical ingredients (APIs) under an appropriate system for managing quality.
Qms NATIONAL ACCREDITATION BOARD FOR TESTING AND CALIBRATION LABORATORIES (...Dr Ajay Kumar Tiwari
Fundamental knowledge on pharmaceutical
product development and translation from laboratory to market.
Quality management systems: Quality management & Certifications.
1. Introduction to NABL
2. NABL and ISO Principles
3. Need of NABL
4. Recognition of NABL in International Level
5. Scope of NABL
6. Advantages of NABL
standard operating procedure are the important document for pharmaceutical company & organization which may follow reference copy of the manufacturing batch or lot.
Process Analytical Technology (PAT) - By Kaleem PetkarKaleem Petkar
Process analytical technology (PAT) has been defined by the United States Food and Drug Administration (FDA) as a mechanism to design, analyze, and control pharmaceutical manufacturing processes through the measurement of critical process parameters (CPP) which affect the critical quality attributes (CQA).
This PDF describes demo of GMP documents kit which are primary documentation requirements. This document is intended to provide guidance regarding Good Manufacturing Practice (GMP) for the manufacturing of active pharmaceutical ingredients (APIs) under an appropriate system for managing quality.
Qms NATIONAL ACCREDITATION BOARD FOR TESTING AND CALIBRATION LABORATORIES (...Dr Ajay Kumar Tiwari
Fundamental knowledge on pharmaceutical
product development and translation from laboratory to market.
Quality management systems: Quality management & Certifications.
1. Introduction to NABL
2. NABL and ISO Principles
3. Need of NABL
4. Recognition of NABL in International Level
5. Scope of NABL
6. Advantages of NABL
standard operating procedure are the important document for pharmaceutical company & organization which may follow reference copy of the manufacturing batch or lot.
Process Analytical Technology (PAT) - By Kaleem PetkarKaleem Petkar
Process analytical technology (PAT) has been defined by the United States Food and Drug Administration (FDA) as a mechanism to design, analyze, and control pharmaceutical manufacturing processes through the measurement of critical process parameters (CPP) which affect the critical quality attributes (CQA).
PAT and QbD concepts in designing the LiMS and other Electronic systems in La...balakrishna t
tQmlab® is the premier management system for GxP operations and for supporting regulatory submissions. It delivers transformational productivity for QA/QC labs supporting customised workflows for quality control of drugs, stability testing, product release testing and post-release quality testing.
Master of Good Manufacturing Practice - Course Detailsutspharmacy
Staff who hold postgraduate degrees in Good Manufacturing Practice (GMP) are essential for many pharmaceutical, biologic, medical device and food manufacturing companies.
This presentation provides an overview of the Master of Good Manufacturing Practice offered at the University of Technology, Sydney (UTS) in Australia. For more information visit www.gmp.uts.edu.au
Webinar validation of pharmaceutical manufacturing processesDr. Ganesh Prasad
This is a one hour presentation on the recent concepts of pharmaceutical manufacturing process validation in line with the 2011 FDA and EMA guidelines.
In this slide contains QbD approach in Pharmaceutical development.
Presented by: V NABI RASOOL (Department of pharmaceutical analysis and quality assurance).RIPER, anantapur
Quality by Design is a systematic approach to development that begins with predefined objectives and emphasizes understanding of the product and process, efficient process control, and quality risk management to improve the overall manufacturing quality. Implementing the Quality by Design (QbD) principles in manufacturing has resulted in reduced operating costs, highly efficient manufacturing processes and better positioning companies to meet increasing regulatory expectations.
QbD explains how to prioritize process parameters for screening designs, design robust processes using statistical design of experiments (DoE), bridge the bench and the commercial design spaces using mixing and scale-up calculations, quantify process risk, select suitable process analytical technology tools (PAT) and more.
To know more about Quality by Design training worldwide,
please contact us at -
Email: support@invensislearning.com
Phone - US +1-910-726-3695,
Website: https://www.invensislearning.com
Analytical Target Profile (ATP) - Structure and Application Throughout the An...pi
ICH Q2: Validation of Analytical Procedures describes the current concepts of validation, verification and transfer of procedures. This approach addresses portions of the analytical lifecycle but also has a number of downsides. As an alternative to this approach, predefined criteria can be established in the form of an Analytical Target Profile (ATP).
In this slide contains Calibration vs Qualification and phases of qualification.
Presented by: A.Siddartha Tharun Teja. (Department of industrial pharmacy).
RIPER, anantapur.
standard operating procedure -SOP ( a detail discussion )martinshaji
Standard Operating Procedures (SOPs) are an integral part of Good Manufacturing Practices. Without SOPs its really tough to run such big infrastructures of Pharma Manufacturing Units. SOPs are also required as regulatory requirements & every worker must be aware of the SOPs related to his/her job function.
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Instructions for Submissions thorugh G- Classroom.pptxJheel Barad
This presentation provides a briefing on how to upload submissions and documents in Google Classroom. It was prepared as part of an orientation for new Sainik School in-service teacher trainees. As a training officer, my goal is to ensure that you are comfortable and proficient with this essential tool for managing assignments and fostering student engagement.
The French Revolution, which began in 1789, was a period of radical social and political upheaval in France. It marked the decline of absolute monarchies, the rise of secular and democratic republics, and the eventual rise of Napoleon Bonaparte. This revolutionary period is crucial in understanding the transition from feudalism to modernity in Europe.
For more information, visit-www.vavaclasses.com
The Roman Empire A Historical Colossus.pdfkaushalkr1407
The Roman Empire, a vast and enduring power, stands as one of history's most remarkable civilizations, leaving an indelible imprint on the world. It emerged from the Roman Republic, transitioning into an imperial powerhouse under the leadership of Augustus Caesar in 27 BCE. This transformation marked the beginning of an era defined by unprecedented territorial expansion, architectural marvels, and profound cultural influence.
The empire's roots lie in the city of Rome, founded, according to legend, by Romulus in 753 BCE. Over centuries, Rome evolved from a small settlement to a formidable republic, characterized by a complex political system with elected officials and checks on power. However, internal strife, class conflicts, and military ambitions paved the way for the end of the Republic. Julius Caesar’s dictatorship and subsequent assassination in 44 BCE created a power vacuum, leading to a civil war. Octavian, later Augustus, emerged victorious, heralding the Roman Empire’s birth.
Under Augustus, the empire experienced the Pax Romana, a 200-year period of relative peace and stability. Augustus reformed the military, established efficient administrative systems, and initiated grand construction projects. The empire's borders expanded, encompassing territories from Britain to Egypt and from Spain to the Euphrates. Roman legions, renowned for their discipline and engineering prowess, secured and maintained these vast territories, building roads, fortifications, and cities that facilitated control and integration.
The Roman Empire’s society was hierarchical, with a rigid class system. At the top were the patricians, wealthy elites who held significant political power. Below them were the plebeians, free citizens with limited political influence, and the vast numbers of slaves who formed the backbone of the economy. The family unit was central, governed by the paterfamilias, the male head who held absolute authority.
Culturally, the Romans were eclectic, absorbing and adapting elements from the civilizations they encountered, particularly the Greeks. Roman art, literature, and philosophy reflected this synthesis, creating a rich cultural tapestry. Latin, the Roman language, became the lingua franca of the Western world, influencing numerous modern languages.
Roman architecture and engineering achievements were monumental. They perfected the arch, vault, and dome, constructing enduring structures like the Colosseum, Pantheon, and aqueducts. These engineering marvels not only showcased Roman ingenuity but also served practical purposes, from public entertainment to water supply.
Biological screening of herbal drugs: Introduction and Need for
Phyto-Pharmacological Screening, New Strategies for evaluating
Natural Products, In vitro evaluation techniques for Antioxidants, Antimicrobial and Anticancer drugs. In vivo evaluation techniques
for Anti-inflammatory, Antiulcer, Anticancer, Wound healing, Antidiabetic, Hepatoprotective, Cardio protective, Diuretics and
Antifertility, Toxicity studies as per OECD guidelines
Acetabularia Information For Class 9 .docxvaibhavrinwa19
Acetabularia acetabulum is a single-celled green alga that in its vegetative state is morphologically differentiated into a basal rhizoid and an axially elongated stalk, which bears whorls of branching hairs. The single diploid nucleus resides in the rhizoid.
Embracing GenAI - A Strategic ImperativePeter Windle
Artificial Intelligence (AI) technologies such as Generative AI, Image Generators and Large Language Models have had a dramatic impact on teaching, learning and assessment over the past 18 months. The most immediate threat AI posed was to Academic Integrity with Higher Education Institutes (HEIs) focusing their efforts on combating the use of GenAI in assessment. Guidelines were developed for staff and students, policies put in place too. Innovative educators have forged paths in the use of Generative AI for teaching, learning and assessments leading to pockets of transformation springing up across HEIs, often with little or no top-down guidance, support or direction.
This Gasta posits a strategic approach to integrating AI into HEIs to prepare staff, students and the curriculum for an evolving world and workplace. We will highlight the advantages of working with these technologies beyond the realm of teaching, learning and assessment by considering prompt engineering skills, industry impact, curriculum changes, and the need for staff upskilling. In contrast, not engaging strategically with Generative AI poses risks, including falling behind peers, missed opportunities and failing to ensure our graduates remain employable. The rapid evolution of AI technologies necessitates a proactive and strategic approach if we are to remain relevant.
June 3, 2024 Anti-Semitism Letter Sent to MIT President Kornbluth and MIT Cor...Levi Shapiro
Letter from the Congress of the United States regarding Anti-Semitism sent June 3rd to MIT President Sally Kornbluth, MIT Corp Chair, Mark Gorenberg
Dear Dr. Kornbluth and Mr. Gorenberg,
The US House of Representatives is deeply concerned by ongoing and pervasive acts of antisemitic
harassment and intimidation at the Massachusetts Institute of Technology (MIT). Failing to act decisively to ensure a safe learning environment for all students would be a grave dereliction of your responsibilities as President of MIT and Chair of the MIT Corporation.
This Congress will not stand idly by and allow an environment hostile to Jewish students to persist. The House believes that your institution is in violation of Title VI of the Civil Rights Act, and the inability or
unwillingness to rectify this violation through action requires accountability.
Postsecondary education is a unique opportunity for students to learn and have their ideas and beliefs challenged. However, universities receiving hundreds of millions of federal funds annually have denied
students that opportunity and have been hijacked to become venues for the promotion of terrorism, antisemitic harassment and intimidation, unlawful encampments, and in some cases, assaults and riots.
The House of Representatives will not countenance the use of federal funds to indoctrinate students into hateful, antisemitic, anti-American supporters of terrorism. Investigations into campus antisemitism by the Committee on Education and the Workforce and the Committee on Ways and Means have been expanded into a Congress-wide probe across all relevant jurisdictions to address this national crisis. The undersigned Committees will conduct oversight into the use of federal funds at MIT and its learning environment under authorities granted to each Committee.
• The Committee on Education and the Workforce has been investigating your institution since December 7, 2023. The Committee has broad jurisdiction over postsecondary education, including its compliance with Title VI of the Civil Rights Act, campus safety concerns over disruptions to the learning environment, and the awarding of federal student aid under the Higher Education Act.
• The Committee on Oversight and Accountability is investigating the sources of funding and other support flowing to groups espousing pro-Hamas propaganda and engaged in antisemitic harassment and intimidation of students. The Committee on Oversight and Accountability is the principal oversight committee of the US House of Representatives and has broad authority to investigate “any matter” at “any time” under House Rule X.
• The Committee on Ways and Means has been investigating several universities since November 15, 2023, when the Committee held a hearing entitled From Ivory Towers to Dark Corners: Investigating the Nexus Between Antisemitism, Tax-Exempt Universities, and Terror Financing. The Committee followed the hearing with letters to those institutions on January 10, 202
1. • PRESENTD BY :-
• PATIL PRANJAY SADASHIV.
• FIRST YEAR M.PHARM.
• DEPARTMENT OF QUALITY ASSURANCE.
H. R. Patel Institute of Pharmaceutical Education
and Research, Shirpur
Process anaytical technology (pat)
3. What is
PAT ????
3
“A system for designing, analyzing & controlling
manufacturing through timely measurements (i.e.
during processing) of critical quality & performance
attributes for raw & in-process materials & processes
with the goal of ensuring final product quality.”
5. what is the goal
of PAT??
5
Building quality into products.
To enhance understanding and control the
manufacturing process.
The goal is to reduce variation in our processes.
To enhance process safety.
6. How PAT works??
Selection of Process
Selection of suitable PATsystem.
Identification of CPP (critical process p) Design Proc
On-line Test In-line Test
6
7. Types of PAT
Implementation
7
Initial phase- Process Optimization
Scale-up phase- Comparing data
Temporary process- gaining process info. &
understanding process.
Permanent process- Actual process monitoring &
control.
8. Why PAT Analysis is better than Lab. Analysis ??
8
Control environment-
Speed-
Operator error-
Safety-
Sample integrity-
9. Applications
9
Process Steps PAT Tech. in-line, off-line Testing
Raw material, Dispensing NIR, Raman
Reaction monitoring Mid- IR,N-IR, UV-visible.
Crystallization Mid-IR, Raman
API drying N-IR
Wet granulation N-IR
Fluid bed drying N-IR
Blending N-IR, Raman
Lubrication N-IR
coating N-IR
10. Profile of a Process Analytical
Scientist-
10
Technical-
Interpersonal effectiveness-
Initiative-
Business focus-
Innovative-
Learning
Overall leadership-
11. Advantages
11
Reduction in production cycletime-
Preventing reprocessing & rejection-
Increase automation-
Improve operatorsafety-
Reduce human error-
Improving energy & material use & increase capacity-
Continuous process-
Controlling variability-
Continuous improvement & knowledge management-
13. PAT regulatory
approach
13
PATcan be implemented under CGMP
inspections by PATteam or PATcertified
investigator .
A supplement can be submitted to the agency.
A protocol can be submitted to theagency.
After approval of protocol by agency then
manufacturer may request to a FDA PAT team for
inspection of preoperational review of a PAT
implementation.
14. PAT regulatory guidance
14
Regulatory agencies like US-FDA, ICH, ASTM etc.
who has been active in the area of PATin the
development of standards for use of PATin
pharmaceutical industry internationally in their
standards committee E55.
US-FDA was published PAT final guidance in SEP
2004