Quality Assurance and Regulatory Compliance for Pharmaceutical Product, Prof. Dr. Basavaraj K. Nanjwade, KLE University College of Pharmacy, Belgaum/Belagavi
GLP applies to nonclinical studies conducted for the assessment of the safety or efficacy of chemicals (including pharmaceuticals).
GLP helps assure regulatory authorities that the data submitted are a true.
Quality Assurance and Regulatory Compliance for Pharmaceutical Product, Prof. Dr. Basavaraj K. Nanjwade, KLE University College of Pharmacy, Belgaum/Belagavi
GLP applies to nonclinical studies conducted for the assessment of the safety or efficacy of chemicals (including pharmaceuticals).
GLP helps assure regulatory authorities that the data submitted are a true.
Introduction :
Antibiotics are antimicrobial agents produced naturally by other microbes (usually fungi or bacteria)
The first antibiotic was discovered in 1896 by Ernest Duchesne and in 1928 "rediscovered" by Alexander Fleming from the filamentous fungus Penicilium notatum.
The antibiotic substance, named penicillin, was not purified until the 1940s (by Florey and Chain), just in time to be used at the end of the second world war.
Penicillin was the first important commercial product produced by an aerobic, submerged fermentation
In this slide contains Investigation, reason, case study of OOS.
Presented by: K Venkatsai Preasad. (Department of pharmaceutical analysis and quality assurance).
RIPER, anantapur.
This presentation gives an overview of : Validation of microbiological methods , Considering some of the limitations and
Key criteria that may be applicable for assessment.
Circular Dichroism Spectroscopy
Introduction
Amino Acid Structure & Polarity
Protein Structures
Polarization of Light
Circular Dichroism
Measurement of Circular Dichroism
Instrumentation For CD Spectropolarimeter
CD Spectrum
CD Spectra of Protein Secondary Structures
Other - CD Based Techniques
Conclusion
References
Introduction :
Antibiotics are antimicrobial agents produced naturally by other microbes (usually fungi or bacteria)
The first antibiotic was discovered in 1896 by Ernest Duchesne and in 1928 "rediscovered" by Alexander Fleming from the filamentous fungus Penicilium notatum.
The antibiotic substance, named penicillin, was not purified until the 1940s (by Florey and Chain), just in time to be used at the end of the second world war.
Penicillin was the first important commercial product produced by an aerobic, submerged fermentation
In this slide contains Investigation, reason, case study of OOS.
Presented by: K Venkatsai Preasad. (Department of pharmaceutical analysis and quality assurance).
RIPER, anantapur.
This presentation gives an overview of : Validation of microbiological methods , Considering some of the limitations and
Key criteria that may be applicable for assessment.
Circular Dichroism Spectroscopy
Introduction
Amino Acid Structure & Polarity
Protein Structures
Polarization of Light
Circular Dichroism
Measurement of Circular Dichroism
Instrumentation For CD Spectropolarimeter
CD Spectrum
CD Spectra of Protein Secondary Structures
Other - CD Based Techniques
Conclusion
References
Microbial Assay of Antibiotics
STANDARD PREPARATION AND UNITS OF ACTIVITY
Preparation of media
Buffer solutions
Standard solution
Sample solution
Test organisms
Preparation of inoculum Method -1
Method 2
Method 3
Method 4
Determination of Inoculum
Apparatus
Assay design
Assay method
cylinder plate method
One level assay with standard curve
Estimation of potency
Turbidimetric method
Health & Dimensions of Health
Health
Dimensions of Health
WHO
OPERATIONAL DEFINITION
Broad Sense
Narrow sense
PHYSICAL DIMENSION
MENTAL DIMENSION
Features of mentally healthy person
SOCIAL DIMENSION
SPIRITUAL DIMENSION
Socio Cultural Factors Related to Health and Disease Aditya Sharma
Socio Cultural Factors Related to Health and Disease
PPT
Heredity
Environment
Lifestyle
Socio-economic conditions
Health services
Education
Income
Housing
Residual solvents
USP <467>
ICH Q3C
Classification of Residual Solvents by Risk Assessment
Options for Determining Levels of Class 2 Residual Solvents
Methods For Establishing Exposure Limits
Analytical Procedures
Taxol and Derivatives in Therapy
Introduction
Mechanism of Action
Structure-Activity Relationship of Taxol
Side Effects of Taxol
Paclitaxel/Taxol In Cancer Therapy
Docetaxel
Drug Interactions of Docetaxel
Taxanes: Complicating Factors
References
National Programme for Prevention and Control of Deafness (NPPCD)Aditya Sharma
National Programme for Prevention and Control of Deafness (NPPCD)
Introduction
Programme Execution & Expansion
Objectives of the Programme
Components of the Programme
Strategies
Expected Benefits of the Programme
NMR Instrumentation
ppt
Magnet
Permanent and conventional electromagnets
The Magnetic Field Sweep
Sweep Generator
frequency sweep method
field sweep method
The Sample Holder
The Sample Probe
Radio Frequency Generator
Oscillator
Radio Frequency Receiver
Amplifier
The Signal Detector and Recording System
NMR Instrumentation
ppt
Magnet
Permanent and conventional electromagnets
The Magnetic Field Sweep
Sweep Generator
frequency sweep method
field sweep method
The Sample Holder
The Sample Probe
Radio Frequency Generator
Oscillator
Radio Frequency Receiver
Amplifier
The Signal Detector and Recording System
PRINCIPLES of FT-NMR & 13C NMR
Fourier Transform
FOURIER TRANSFORM NMR SPECTROSCOPY
THEORY OF FT-NMR
13C NMR SPECTROSCOPY
Principle
Why C13-NMR is required though we have H1-NMR?
CHARACTERISTIC FEATURES OF 13 C NMR
Chemical Shifts
NUCLEAR OVERHAUSER ENHANCEMENT
Short-Comings of 13C-NMR Spectra
Stability and Shelf Life
Introduction
Stability Testing Methods:
Real Time Stability Testing
Accelerated Stability Testing
Retained Sample Stability Testing
Cyclic Temperature Stress Testing
Expiration Date/Shelf Life
Estimation of Shelf Life
Qualification of HVAC Systems As Per WHOAditya Sharma
Qualification of HVAC Systems As Per WHO
Documentation requirements to assist in commissioning, qualification and maintenance
Objectives
Commissioning
Qualification
Design conditions and normal operating ranges set to achievable limits
OOS results recorded
Qualification – examples of aspects to consider
Schedule of tests to demonstrate continuing compliance
Cleanroom monitoring program (1)
Cleanroom monitoring program (2)Particles and Microbiological contaminants
Definition of Conditions
examples of aspects to consider in qualification (OQ, PQ)
Maintenance
Inspecting the air handling system
Quality Management Principles
Quality Management System(QMS)
Total Quality Management(TQM)
ISO
ISO 9000
PPT
Seven Quality Management Principles
Customer Focus
Leadership
Engagement of People
Process Approach
Improvement
Evidence-Based Decision Making
Relationship Management
Statement
Rationale
Key benefits
quality assurance
quality control
gmp
Limit tests, Introduction, Definition,
Limit Test For Chlorides
Limit Test For Sulphates
Limit Test For Iron
Limit Test For Lead
Limit Test For Arsenic
Bioavailability & Bioequivalence ppt, Objectives, Improving bioavailability, Assessment of bioavailability, Urinary excretion studies, Blood serum studies, in vitro drug dissolution testing, need for dissolution testing, in vitro drug dissolution testing models, Bioequivalence, Therapeutic equivalence, Types of bioequivalence studies, Pharmacokinetic studies, Methods to enhance dissolution rate.
Model Attribute Check Company Auto PropertyCeline George
In Odoo, the multi-company feature allows you to manage multiple companies within a single Odoo database instance. Each company can have its own configurations while still sharing common resources such as products, customers, and suppliers.
The Indian economy is classified into different sectors to simplify the analysis and understanding of economic activities. For Class 10, it's essential to grasp the sectors of the Indian economy, understand their characteristics, and recognize their importance. This guide will provide detailed notes on the Sectors of the Indian Economy Class 10, using specific long-tail keywords to enhance comprehension.
For more information, visit-www.vavaclasses.com
Palestine last event orientationfvgnh .pptxRaedMohamed3
An EFL lesson about the current events in Palestine. It is intended to be for intermediate students who wish to increase their listening skills through a short lesson in power point.
Ethnobotany and Ethnopharmacology:
Ethnobotany in herbal drug evaluation,
Impact of Ethnobotany in traditional medicine,
New development in herbals,
Bio-prospecting tools for drug discovery,
Role of Ethnopharmacology in drug evaluation,
Reverse Pharmacology.
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.
Read| The latest issue of The Challenger is here! We are thrilled to announce that our school paper has qualified for the NATIONAL SCHOOLS PRESS CONFERENCE (NSPC) 2024. Thank you for your unwavering support and trust. Dive into the stories that made us stand out!