“A GMP is a system for ensuring that products are consistently produced and controlled according to quality standards. It is designed to minimize the risks involved in any pharmaceutical production that cannot be eliminated through testing the final product”.
“A GMP is a system for ensuring that products are consistently produced and controlled according to quality standards. It is designed to minimize the risks involved in any pharmaceutical production that cannot be eliminated through testing the final product”.
Good Manufacturing Practice is a set of regulations, codes, and guidelines for the manufacture of drug substances and drug products, medical devices, in vivo and in vitro diagnostic products, and foods.
Good Manufacturing Practice (GMP) is a system for ensuring that products are consistently produced and controlled according to quality standards. It is designed to minimize the risks involved in any pharmaceutical production that cannot be eliminated through testing the final product.
Process Validation is Key important factor for the Pharmaceutical Industry to maintain Consistent Quality in product which claimed by the manufacturer.
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.
A Study on Documentation Maintenance in the Pharmaceutical Industry which includes the main records to be maintained and the quality attributes to be studied about the Quality Management System. Quality attributes include the study of quality audit, quality review, and quality documentation.
Documentation is an integral part of good manufacturing practices. It defines a system of information and control so that risks so inherent in misinterpretation and/or error in oral communication are minimized.
According to new syllabus of PCI M.Pharm 1st sem. students can directly utilize this ppt for their study. As per PCI new syllabus QA STUDENTS find this ppt very use full.
Objectives of CGMP
Layout of buildings, services, equipments & maintenance
Production organization
material management
handling and transportation
inventory management &control
Production and planning control
Sales forcasting
Budget and cost control
Industrial and personnel relationship
Total quality management
Introduction, Regulatory requirements for validation, Role of FDA, Code of Federal regulation, Validation life cycle, Significance of validation, Types of validation, Process valiadation, Phases of process validation, Process capability design, Process Qualification, Validation maintainance phase
Types of Process validation, Examples
Good Manufacturing Practice is a set of regulations, codes, and guidelines for the manufacture of drug substances and drug products, medical devices, in vivo and in vitro diagnostic products, and foods.
Good Manufacturing Practice (GMP) is a system for ensuring that products are consistently produced and controlled according to quality standards. It is designed to minimize the risks involved in any pharmaceutical production that cannot be eliminated through testing the final product.
Process Validation is Key important factor for the Pharmaceutical Industry to maintain Consistent Quality in product which claimed by the manufacturer.
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.
A Study on Documentation Maintenance in the Pharmaceutical Industry which includes the main records to be maintained and the quality attributes to be studied about the Quality Management System. Quality attributes include the study of quality audit, quality review, and quality documentation.
Documentation is an integral part of good manufacturing practices. It defines a system of information and control so that risks so inherent in misinterpretation and/or error in oral communication are minimized.
According to new syllabus of PCI M.Pharm 1st sem. students can directly utilize this ppt for their study. As per PCI new syllabus QA STUDENTS find this ppt very use full.
Objectives of CGMP
Layout of buildings, services, equipments & maintenance
Production organization
material management
handling and transportation
inventory management &control
Production and planning control
Sales forcasting
Budget and cost control
Industrial and personnel relationship
Total quality management
Introduction, Regulatory requirements for validation, Role of FDA, Code of Federal regulation, Validation life cycle, Significance of validation, Types of validation, Process valiadation, Phases of process validation, Process capability design, Process Qualification, Validation maintainance phase
Types of Process validation, Examples
Objectives and policies of c gmp, layout of building and servicesSharwari Sapate
Pharmaceutical Quality affects every individual. Therefore GMP is required to ensure the quality of the particular drug or dosage form. In this presentation you will go through some basic information about cGMP and layout of buildings.
The GMP Operations Manager is responsible for overseeing the implementation and sustained operations of world-class technical cleaning and sanitization programs to include cGMP space, semi-conductor, clean rooms, laboratory, data and other critical environments.
GMP Requirements & Drug & Cosmetic Act Provision.pptxEasy Concept
Good Manufacturing Practices (GMP) is that part of quality assurance, which ensures that products are regularly produced and controlled according to the quality standards suitable for their use.
(GMP) comes in Schedule M in D & C Act 1940 and Rules 1945.
GMPs are the requirements that the drug and methods/control /facilities used in their manufacturing, processing and packaging conforms to practice that will assure the safety and efficacy of the product.
Report Back from SGO 2024: What’s the Latest in Cervical Cancer?bkling
Are you curious about what’s new in cervical cancer research or unsure what the findings mean? Join Dr. Emily Ko, a gynecologic oncologist at Penn Medicine, to learn about the latest updates from the Society of Gynecologic Oncology (SGO) 2024 Annual Meeting on Women’s Cancer. Dr. Ko will discuss what the research presented at the conference means for you and answer your questions about the new developments.
These simplified slides by Dr. Sidra Arshad present an overview of the non-respiratory functions of the respiratory tract.
Learning objectives:
1. Enlist the non-respiratory functions of the respiratory tract
2. Briefly explain how these functions are carried out
3. Discuss the significance of dead space
4. Differentiate between minute ventilation and alveolar ventilation
5. Describe the cough and sneeze reflexes
Study Resources:
1. Chapter 39, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 34, Ganong’s Review of Medical Physiology, 26th edition
3. Chapter 17, Human Physiology by Lauralee Sherwood, 9th edition
4. Non-respiratory functions of the lungs https://academic.oup.com/bjaed/article/13/3/98/278874
Prix Galien International 2024 Forum ProgramLevi Shapiro
June 20, 2024, Prix Galien International and Jerusalem Ethics Forum in ROME. Detailed agenda including panels:
- ADVANCES IN CARDIOLOGY: A NEW PARADIGM IS COMING
- WOMEN’S HEALTH: FERTILITY PRESERVATION
- WHAT’S NEW IN THE TREATMENT OF INFECTIOUS,
ONCOLOGICAL AND INFLAMMATORY SKIN DISEASES?
- ARTIFICIAL INTELLIGENCE AND ETHICS
- GENE THERAPY
- BEYOND BORDERS: GLOBAL INITIATIVES FOR DEMOCRATIZING LIFE SCIENCE TECHNOLOGIES AND PROMOTING ACCESS TO HEALTHCARE
- ETHICAL CHALLENGES IN LIFE SCIENCES
- Prix Galien International Awards Ceremony
Couples presenting to the infertility clinic- Do they really have infertility...Sujoy Dasgupta
Dr Sujoy Dasgupta presented the study on "Couples presenting to the infertility clinic- Do they really have infertility? – The unexplored stories of non-consummation" in the 13th Congress of the Asia Pacific Initiative on Reproduction (ASPIRE 2024) at Manila on 24 May, 2024.
Ozempic: Preoperative Management of Patients on GLP-1 Receptor Agonists Saeid Safari
Preoperative Management of Patients on GLP-1 Receptor Agonists like Ozempic and Semiglutide
ASA GUIDELINE
NYSORA Guideline
2 Case Reports of Gastric Ultrasound
Title: Sense of Smell
Presenter: Dr. Faiza, Assistant Professor of Physiology
Qualifications:
MBBS (Best Graduate, AIMC Lahore)
FCPS Physiology
ICMT, CHPE, DHPE (STMU)
MPH (GC University, Faisalabad)
MBA (Virtual University of Pakistan)
Learning Objectives:
Describe the primary categories of smells and the concept of odor blindness.
Explain the structure and location of the olfactory membrane and mucosa, including the types and roles of cells involved in olfaction.
Describe the pathway and mechanisms of olfactory signal transmission from the olfactory receptors to the brain.
Illustrate the biochemical cascade triggered by odorant binding to olfactory receptors, including the role of G-proteins and second messengers in generating an action potential.
Identify different types of olfactory disorders such as anosmia, hyposmia, hyperosmia, and dysosmia, including their potential causes.
Key Topics:
Olfactory Genes:
3% of the human genome accounts for olfactory genes.
400 genes for odorant receptors.
Olfactory Membrane:
Located in the superior part of the nasal cavity.
Medially: Folds downward along the superior septum.
Laterally: Folds over the superior turbinate and upper surface of the middle turbinate.
Total surface area: 5-10 square centimeters.
Olfactory Mucosa:
Olfactory Cells: Bipolar nerve cells derived from the CNS (100 million), with 4-25 olfactory cilia per cell.
Sustentacular Cells: Produce mucus and maintain ionic and molecular environment.
Basal Cells: Replace worn-out olfactory cells with an average lifespan of 1-2 months.
Bowman’s Gland: Secretes mucus.
Stimulation of Olfactory Cells:
Odorant dissolves in mucus and attaches to receptors on olfactory cilia.
Involves a cascade effect through G-proteins and second messengers, leading to depolarization and action potential generation in the olfactory nerve.
Quality of a Good Odorant:
Small (3-20 Carbon atoms), volatile, water-soluble, and lipid-soluble.
Facilitated by odorant-binding proteins in mucus.
Membrane Potential and Action Potential:
Resting membrane potential: -55mV.
Action potential frequency in the olfactory nerve increases with odorant strength.
Adaptation Towards the Sense of Smell:
Rapid adaptation within the first second, with further slow adaptation.
Psychological adaptation greater than receptor adaptation, involving feedback inhibition from the central nervous system.
Primary Sensations of Smell:
Camphoraceous, Musky, Floral, Pepperminty, Ethereal, Pungent, Putrid.
Odor Detection Threshold:
Examples: Hydrogen sulfide (0.0005 ppm), Methyl-mercaptan (0.002 ppm).
Some toxic substances are odorless at lethal concentrations.
Characteristics of Smell:
Odor blindness for single substances due to lack of appropriate receptor protein.
Behavioral and emotional influences of smell.
Transmission of Olfactory Signals:
From olfactory cells to glomeruli in the olfactory bulb, involving lateral inhibition.
Primitive, less old, and new olfactory systems with different path
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ARTIFICIAL INTELLIGENCE IN HEALTHCARE.pdfAnujkumaranit
Artificial intelligence (AI) refers to the simulation of human intelligence processes by machines, especially computer systems. It encompasses tasks such as learning, reasoning, problem-solving, perception, and language understanding. AI technologies are revolutionizing various fields, from healthcare to finance, by enabling machines to perform tasks that typically require human intelligence.
New Directions in Targeted Therapeutic Approaches for Older Adults With Mantl...i3 Health
i3 Health is pleased to make the speaker slides from this activity available for use as a non-accredited self-study or teaching resource.
This slide deck presented by Dr. Kami Maddocks, Professor-Clinical in the Division of Hematology and
Associate Division Director for Ambulatory Operations
The Ohio State University Comprehensive Cancer Center, will provide insight into new directions in targeted therapeutic approaches for older adults with mantle cell lymphoma.
STATEMENT OF NEED
Mantle cell lymphoma (MCL) is a rare, aggressive B-cell non-Hodgkin lymphoma (NHL) accounting for 5% to 7% of all lymphomas. Its prognosis ranges from indolent disease that does not require treatment for years to very aggressive disease, which is associated with poor survival (Silkenstedt et al, 2021). Typically, MCL is diagnosed at advanced stage and in older patients who cannot tolerate intensive therapy (NCCN, 2022). Although recent advances have slightly increased remission rates, recurrence and relapse remain very common, leading to a median overall survival between 3 and 6 years (LLS, 2021). Though there are several effective options, progress is still needed towards establishing an accepted frontline approach for MCL (Castellino et al, 2022). Treatment selection and management of MCL are complicated by the heterogeneity of prognosis, advanced age and comorbidities of patients, and lack of an established standard approach for treatment, making it vital that clinicians be familiar with the latest research and advances in this area. In this activity chaired by Michael Wang, MD, Professor in the Department of Lymphoma & Myeloma at MD Anderson Cancer Center, expert faculty will discuss prognostic factors informing treatment, the promising results of recent trials in new therapeutic approaches, and the implications of treatment resistance in therapeutic selection for MCL.
Target Audience
Hematology/oncology fellows, attending faculty, and other health care professionals involved in the treatment of patients with mantle cell lymphoma (MCL).
Learning Objectives
1.) Identify clinical and biological prognostic factors that can guide treatment decision making for older adults with MCL
2.) Evaluate emerging data on targeted therapeutic approaches for treatment-naive and relapsed/refractory MCL and their applicability to older adults
3.) Assess mechanisms of resistance to targeted therapies for MCL and their implications for treatment selection
Explore natural remedies for syphilis treatment in Singapore. Discover alternative therapies, herbal remedies, and lifestyle changes that may complement conventional treatments. Learn about holistic approaches to managing syphilis symptoms and supporting overall health.
Lung Cancer: Artificial Intelligence, Synergetics, Complex System Analysis, S...Oleg Kshivets
RESULTS: Overall life span (LS) was 2252.1±1742.5 days and cumulative 5-year survival (5YS) reached 73.2%, 10 years – 64.8%, 20 years – 42.5%. 513 LCP lived more than 5 years (LS=3124.6±1525.6 days), 148 LCP – more than 10 years (LS=5054.4±1504.1 days).199 LCP died because of LC (LS=562.7±374.5 days). 5YS of LCP after bi/lobectomies was significantly superior in comparison with LCP after pneumonectomies (78.1% vs.63.7%, P=0.00001 by log-rank test). AT significantly improved 5YS (66.3% vs. 34.8%) (P=0.00000 by log-rank test) only for LCP with N1-2. Cox modeling displayed that 5YS of LCP significantly depended on: phase transition (PT) early-invasive LC in terms of synergetics, PT N0—N12, cell ratio factors (ratio between cancer cells- CC and blood cells subpopulations), G1-3, histology, glucose, AT, blood cell circuit, prothrombin index, heparin tolerance, recalcification time (P=0.000-0.038). Neural networks, genetic algorithm selection and bootstrap simulation revealed relationships between 5YS and PT early-invasive LC (rank=1), PT N0—N12 (rank=2), thrombocytes/CC (3), erythrocytes/CC (4), eosinophils/CC (5), healthy cells/CC (6), lymphocytes/CC (7), segmented neutrophils/CC (8), stick neutrophils/CC (9), monocytes/CC (10); leucocytes/CC (11). Correct prediction of 5YS was 100% by neural networks computing (area under ROC curve=1.0; error=0.0).
CONCLUSIONS: 5YS of LCP after radical procedures significantly depended on: 1) PT early-invasive cancer; 2) PT N0--N12; 3) cell ratio factors; 4) blood cell circuit; 5) biochemical factors; 6) hemostasis system; 7) AT; 8) LC characteristics; 9) LC cell dynamics; 10) surgery type: lobectomy/pneumonectomy; 11) anthropometric data. Optimal diagnosis and treatment strategies for LC are: 1) screening and early detection of LC; 2) availability of experienced thoracic surgeons because of complexity of radical procedures; 3) aggressive en block surgery and adequate lymph node dissection for completeness; 4) precise prediction; 5) adjuvant chemoimmunoradiotherapy for LCP with unfavorable prognosis.
MANAGEMENT OF ATRIOVENTRICULAR CONDUCTION BLOCK.pdfJim Jacob Roy
Cardiac conduction defects can occur due to various causes.
Atrioventricular conduction blocks ( AV blocks ) are classified into 3 types.
This document describes the acute management of AV block.
MANAGEMENT OF ATRIOVENTRICULAR CONDUCTION BLOCK.pdf
Principles of gmp
1. Good Manufacturing PracticeGood Manufacturing Practice
(GMP)(GMP)
Md.Mohsin Uddin Anwar
Sr. Executive, Production
Navana Pharmaceuticals Ltd.
2. What is GMP?What is GMP?
“GMP is the documented way
of using your common sense.”
Good manufacturing practice (GMP) is the
minimum standard that a medicines
manufacturer must meet in their production
processes. Products must:
be of consistent high quality
be appropriate to their intended use
meet the requirements of the marketing
authorisation (MA) or product specification
3. What is GMP?What is GMP?
Good Manufacturing
Practices are a set of
regulations, codes, and
guidelines for the manufacture
of:
- Drug substances and drug
products
- Medical devices
- In vivo and in vitro
diagnostic products
- Foods
4. A Time line of GMPA Time line of GMP
1902 - Development of the Biologic Control Act
1906 - Development of the Pure Food and Drug Act
1938 - Federal Food, Drug and Cosmetic Act
1941 - Initiation of GMP
1944 - Development of Public Health Services Act
1962 - Kefauver-Harris Drug Amendments released
1963 - Establishment of GMPs for Drugs
1975 - CGMPs for Blood and Components Final Rule
1976 - Medical Device Amendments
1978 - CGMPs for Drugs and Devices
1979 - GLPs Final Rule
1980 - Infant Formula Act is passed
5. ProvisionsProvisions
21 CFR Parts 210 and 211
(Drug Industry)
21 CFR Part 820
(Medical Device Industry)
21 CFR Part 110
(Food Industry)
21 CFR Part 606
(Blood Industry
6. Why GMP?Why GMP?
Provides a high level assurance that
medicines are manufactured in a way that
ensures their safety, efficacy and quality
Medicines are manufactured to comply
with their marketing authorization
Quality is built in
◦ Testing is part of GMP, but alone does not
provide a good level of quality assurance
8. cGMP Violations -- severecGMP Violations -- severe
ConsequencesConsequences
Product is “adulterated”
Shutdown of manufacturing facility
Seizure of product
Recall product
Front page press coverage
Competitive disadvantage
9. cGMP Violations -- severecGMP Violations -- severe
ConsequencesConsequences
GMP Hold on product applications
◦ International sites
Injunction / Consent decree
◦ Schering Plough ($500 Million)
◦ Abbott Laboratories ($100 Million)
◦ Wyeth–Ayerst Laboratories ($30 Million)
◦ Individual Defendants
Criminal Investigations and Indictments
Lawsuits
◦ United States ex rel. King
10. The ten commandments for GMP
• Write the procedure
• Follow the written procedure
• Document the work
• Validate the work
• Design the building, facilities & equipment's properly
• Personnel shall be Competent
• Maintenance of the building, facilities & Equipmets
• Shall be Clean
• Control for Quality
• Audit for compliance
11. Write the procedureWrite the procedure
All work/process must be written.
Write the SOPs, Spec., MOA, Protocol,
Report etc.
Documents should not be hand written.
All documents should be kept up-to-date.
12. Follow the written procedureFollow the written procedure
Written procedure has to follow 100%.
If it is difficult to follow written
procedure discuss with your supervisor
and make deviation note, if needed.
Violation of written procedure is a
crime.
13. Document the workDocument the work
Document the work means records &
reports. It should be
Accurate
Prompt
Legible
Clear
Consistent
Complete
Direct
Truthful
14. Document the workDocument the work
No written evidence No work.
All records should include date and
identity of people (Signature).
All records should include second check
Signature.
15. Validate the workValidate the work
Validation:
Establishing a documented evidence which
provides a high degree of assurance that any
procedure, process, equipment, material,
activity will consistently produce a product
meeting its pre-determined specification and
quality attributes.
16. Validate the workValidate the work
Types of Validation:
Process Validation
Cleaning Validation
Computer system validation
Analytical method Validation
System, facilities, equipment Validation
In accordance with GMP, each pharmaceutical
company should identify what qualification and
validation work is required to prove that the
critical aspects of their particular operation
are controlled.
17. Validate the workValidate the work
Validation of System, facilities, equipment also
called Qualification.
Design Qualification (DQ)
Installation Qualification (IQ)
Operation Qualification (OQ)
Performance Qualification (PQ)
18. Design the building, facilities & equipmentsDesign the building, facilities & equipments
properlyproperly
The layout and design of premises must aim to minimize the risk of
errors and permit effective cleaning and maintenance in order to
avoid cross-contamination, build-up of dust or dirt, and, in general,
any adverse effect on the quality of products.
Main consideration to good pharmaceutical factory design are-
Segregation of different types of operation
Grouping together of related types of activity or product
Internal layout- Logical flow of material and personnel
Appropriate plant services, systems & utilities
Protection from weather, pests, dust, dirt etc.
Easy to clean and sanitize
Rest and refreshment rooms should be separate from manufacturing
and control areas.
Proper Security
19. Design the building, facilities & equipmentDesign the building, facilities & equipment
properlyproperly
Plant services, systems & utilities include-
HVAC
Lighting (300 Lux - 500 Lux) FDA
Electricity
Water
Air
Dust control and collection system
Drains and waste disposal system
Steam
Cooling system etc.
20. Design the building, facilities &Design the building, facilities &
equipment properlyequipment properly
Equipment must be located, designed, constructed, adapted, and
maintained to suit the operations to be carried out. The layout and
design of equipment must aim to minimize the risk of errors and
permit effective cleaning and maintenance in order to avoid cross-
contamination, build-up of dust or dirt, and, in general, any adverse
effect on the quality of products.
Production equipment should not present any hazard to the products.
Laboratory equipment and instruments should be suited to the testing
procedures undertaken.
Washing, cleaning and drying equipment should be chosen and used so
as not to be a source of contamination.
Fixed pipework should be clearly labelled
21. Personnel shall be CompetentPersonnel shall be Competent
The manufacturer should have an adequate number of personnel with
the necessary qualifications and practical experience.
All responsible staff should have their specific duties recorded in
written descriptions and adequate authority to carry out their
responsibilities.
All personnel should be competent
Competent as a result of-
Education
Training
Experience
22. Personnel shall be CompetentPersonnel shall be Competent
Key personnel education should include the
study of an appropriate combination of:
(a) chemistry (analytical or organic) or
biochemistry;
(b) chemical engineering;
(c) microbiology;
(d) pharmaceutical sciences and technology;
(e) pharmacology and toxicology;
(f ) physiology;
(g) other related sciences.
23. Maintenance of the building, facilities &Maintenance of the building, facilities &
equipmentequipment
Premises should be carefully maintained, and
it should be ensured that repair and
maintenance operations do not present any
hazard to the quality of products.
Maintenance of the system to ensure that it
continues to operate to designed standard.
a) Preventive Maintenance
b)Maintenance after shutdown
For Preventive Maintenance there shall be
i) Maintenance schedule
ii) Written Maintenance procedure
24. Shall be CleanShall be Clean
Cleaning is required to prevent contamination
There shall be a written program and procedure for cleaning
Disinfectant shall be used on an alternating or rotating basis
Disinfectant should always be used as per instruction and at the right
dilution.
A high level of sanitation and hygiene should be practised in every aspect
of the manufacture of drug products. The scope of sanitation and hygiene
covers personnel, premises, equipment and apparatus, production
materials and containers, products for cleaning and disinfection, and
anything that could become a source of contamination to the product.
25. Control for QualityControl for Quality
There shall be well established Quality
control department
Quality control department should be
independent from production department
Materials are not released for use, nor
products released for sale or supply, until
their quality has been judge satisfactory
Control of quality is a combined effort of all
departments
Quality can not be controlled it should be
built into product.
26. Audit for complianceAudit for compliance
Quality Audit:
A systematic and independent examination to
determine whether quality activities and
related results comply with planned
arrangements and whether these
arrangements are implemented effectively
and are suitable to achieve objectives.
Two types-
a) Internal
b) External
27. Audit for complianceAudit for compliance
Self-Inspection-
- Follow a prearranged plan
- Inspection should be independent (unbiased)
- Conducted by competent person
- Results and findings should be recorded
- Report should contain all observations
- Recommend for corrective action
- Follow up
- Monitor for improvement
28. Audit for complianceAudit for compliance
Inspection Musts
Ensure that the
RIGHT PEOPLE
discuss the
RIGHT INFORMATION
at the
RIGHT TIME
in the RIGHT WAY!
29. ConclusionConclusion
Result of cGMP compliant
Compliant with regulatory authorities
Manufacture & Release quality products
in respect of Quality, Safety & Efficacy
Increase productivity
Increase company image
Customer satisfaction