The document discusses key aspects of current good manufacturing practices (cGMP) for pharmaceuticals. It defines cGMP and explains that the "C" stands for "current," meaning manufacturers must use up-to-date technologies and systems. cGMP covers all aspects of production from facilities, equipment, personnel, packaging, quality control, and documentation. Following cGMP is important because it helps ensure the quality, safety and effectiveness of drugs. Historical incidents like the thalidomide tragedy and Tylenol tampering case demonstrate how non-compliance with GMP can put patients' lives at risk.
Indian GMP Certification & WHO GMP CertificationVishal Shelke
Indian GMP Certification & WHO GMP Certification by Mr. Vishal Shelke
https://youtube.com/vishalshelke99
https://instagram.com/vishal_stagram
Sub :- Drug Regulatory Affairs
M.Pharm Sem II
Savitribai Phule Pune University
A brief presentation on the current good manufacturing practices employed in the manufacture of pharmaceuticals in the US.
Comprises of all aspects of good manufacturing practices
This presentation contain introduction to Good Distribution Practices Guideline. and Legal GDP requirements put worldwide.
Good distribution practice (GDP) describes the minimum standards that a wholesale distributor must meet to ensure that the quality and integrity of medicines is maintained throughout the supply chain
Each participant in the distribution chain must agree by the relevant requirements in order to retain the original quality of pharmaceutical products.
Each activity in the distribution of pharmaceutical products shall be carried out according to the principles of Good Distribution Practices (GDP) as applicable.
The risks involved are likely to be of a nature comparable to those that are present in the industrial environment, such as mix-ups, adulteration, contamination, cross-contamination, and spurious.
The guideline addresses
Personnel
Quality System
Premises Warehousing and Storage
Documentation
Traceability
Complaints and Returns
Transportation
Indian GMP Certification & WHO GMP CertificationVishal Shelke
Indian GMP Certification & WHO GMP Certification by Mr. Vishal Shelke
https://youtube.com/vishalshelke99
https://instagram.com/vishal_stagram
Sub :- Drug Regulatory Affairs
M.Pharm Sem II
Savitribai Phule Pune University
A brief presentation on the current good manufacturing practices employed in the manufacture of pharmaceuticals in the US.
Comprises of all aspects of good manufacturing practices
This presentation contain introduction to Good Distribution Practices Guideline. and Legal GDP requirements put worldwide.
Good distribution practice (GDP) describes the minimum standards that a wholesale distributor must meet to ensure that the quality and integrity of medicines is maintained throughout the supply chain
Each participant in the distribution chain must agree by the relevant requirements in order to retain the original quality of pharmaceutical products.
Each activity in the distribution of pharmaceutical products shall be carried out according to the principles of Good Distribution Practices (GDP) as applicable.
The risks involved are likely to be of a nature comparable to those that are present in the industrial environment, such as mix-ups, adulteration, contamination, cross-contamination, and spurious.
The guideline addresses
Personnel
Quality System
Premises Warehousing and Storage
Documentation
Traceability
Complaints and Returns
Transportation
Documentation relating to product development,sop's,cleaning methods,quality ...swrk
COMPLAINT HANDLING IN PHARMACEUTICAL COMPANIES,PRODUCT RECALL,RETENTION RECORDS, DISTRIBUTION RECORDS.prepared by s.susena,m.pharmacy pharmaceutical analysis&QA,ssj college of pharmacy
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.
COPP/CPP it certification of pharmaceutical product for reviewing QSE i.e. Quality, Sefty,Efficacy of product. it important certification for exporting it may required by importing country.
21 CFR-FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES...ICHAPPS
TRAINING PROGRAMME ON
21CFR PARTS-210 AND 211
QUALITY ASSURANCE
Slideshow About 21 CFR
“Every product must be fit for its intended purpose”
“Every product must be fit for its intended purpose”
FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES- UNITED STATES OF AMERICA
Herbal medicines are popular because of experience and the abundant
availability of plants in India due to its varied climatic zones. India has
around 45,000 species of plants, out of which 15,000–20,000 plants have
proven medicinal value.
Documentation relating to product development,sop's,cleaning methods,quality ...swrk
COMPLAINT HANDLING IN PHARMACEUTICAL COMPANIES,PRODUCT RECALL,RETENTION RECORDS, DISTRIBUTION RECORDS.prepared by s.susena,m.pharmacy pharmaceutical analysis&QA,ssj college of pharmacy
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.
COPP/CPP it certification of pharmaceutical product for reviewing QSE i.e. Quality, Sefty,Efficacy of product. it important certification for exporting it may required by importing country.
21 CFR-FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES...ICHAPPS
TRAINING PROGRAMME ON
21CFR PARTS-210 AND 211
QUALITY ASSURANCE
Slideshow About 21 CFR
“Every product must be fit for its intended purpose”
“Every product must be fit for its intended purpose”
FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES- UNITED STATES OF AMERICA
Herbal medicines are popular because of experience and the abundant
availability of plants in India due to its varied climatic zones. India has
around 45,000 species of plants, out of which 15,000–20,000 plants have
proven medicinal value.
Good Manufacturing Practice (GMP) | Arrelic InsightsArrelic
Good manufacturing practice (GMP) is that part of quality assurance which ensures that products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the marketing authorization. GMP is aimed primarily at diminishing the risks inherent in any pharmaceutical production, which may broadly be categorized in two groups: cross contamination/mix-ups and false labeling. Above all, manufacturers must not place patients at risk due to inadequate safety, quality or efficacy; for this reason, risk assessment has come to play an important role in WHO quality assurance guidelines.
Good Manufacturing Practice (GMP) 2day course Jo Havemann
The following topics were presented to the participants through lectures, group discussions and exercises during 16 hours:
- Core values and guidelines of Good Laboratory Practice (GLP)
- Factors that might lead to questionable research & manufacturing practices and their impact
- GMP compliance, national & international regulations, guidelines and authorities
- Quality Management and Assessment
- Digital GMP Solutions
Ethanol (CH3CH2OH), or beverage alcohol, is a two-carbon alcohol
that is rapidly distributed in the body and brain. Ethanol alters many
neurochemical systems and has rewarding and addictive properties. It
is the oldest recreational drug and likely contributes to more morbidity,
mortality, and public health costs than all illicit drugs combined. The
5th edition of the Diagnostic and Statistical Manual of Mental Disorders
(DSM-5) integrates alcohol abuse and alcohol dependence into a single
disorder called alcohol use disorder (AUD), with mild, moderate,
and severe subclassifications (American Psychiatric Association, 2013).
In the DSM-5, all types of substance abuse and dependence have been
combined into a single substance use disorder (SUD) on a continuum
from mild to severe. A diagnosis of AUD requires that at least two of
the 11 DSM-5 behaviors be present within a 12-month period (mild
AUD: 2–3 criteria; moderate AUD: 4–5 criteria; severe AUD: 6–11 criteria).
The four main behavioral effects of AUD are impaired control over
drinking, negative social consequences, risky use, and altered physiological
effects (tolerance, withdrawal). This chapter presents an overview
of the prevalence and harmful consequences of AUD in the U.S.,
the systemic nature of the disease, neurocircuitry and stages of AUD,
comorbidities, fetal alcohol spectrum disorders, genetic risk factors, and
pharmacotherapies for AUD.
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Ve...kevinkariuki227
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Verified Chapters 1 - 19, Complete Newest Version.pdf
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Verified Chapters 1 - 19, Complete Newest Version.pdf
NVBDCP.pptx Nation vector borne disease control programSapna Thakur
NVBDCP was launched in 2003-2004 . Vector-Borne Disease: Disease that results from an infection transmitted to humans and other animals by blood-feeding arthropods, such as mosquitoes, ticks, and fleas. Examples of vector-borne diseases include Dengue fever, West Nile Virus, Lyme disease, and malaria.
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We specializes in exporting high quality Research chemical, medical intermediate, Pharmaceutical chemicals and so on. Products are exported to USA, Canada, France, Korea, Japan,Russia, Southeast Asia and other countries.
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
Flu Vaccine Alert in Bangalore Karnatakaaddon Scans
As flu season approaches, health officials in Bangalore, Karnataka, are urging residents to get their flu vaccinations. The seasonal flu, while common, can lead to severe health complications, particularly for vulnerable populations such as young children, the elderly, and those with underlying health conditions.
Dr. Vidisha Kumari, a leading epidemiologist in Bangalore, emphasizes the importance of getting vaccinated. "The flu vaccine is our best defense against the influenza virus. It not only protects individuals but also helps prevent the spread of the virus in our communities," he says.
This year, the flu season is expected to coincide with a potential increase in other respiratory illnesses. The Karnataka Health Department has launched an awareness campaign highlighting the significance of flu vaccinations. They have set up multiple vaccination centers across Bangalore, making it convenient for residents to receive their shots.
To encourage widespread vaccination, the government is also collaborating with local schools, workplaces, and community centers to facilitate vaccination drives. Special attention is being given to ensuring that the vaccine is accessible to all, including marginalized communities who may have limited access to healthcare.
Residents are reminded that the flu vaccine is safe and effective. Common side effects are mild and may include soreness at the injection site, mild fever, or muscle aches. These side effects are generally short-lived and far less severe than the flu itself.
Healthcare providers are also stressing the importance of continuing COVID-19 precautions. Wearing masks, practicing good hand hygiene, and maintaining social distancing are still crucial, especially in crowded places.
Protect yourself and your loved ones by getting vaccinated. Together, we can help keep Bangalore healthy and safe this flu season. For more information on vaccination centers and schedules, residents can visit the Karnataka Health Department’s official website or follow their social media pages.
Stay informed, stay safe, and get your flu shot today!
Title: Sense of Taste
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 structure and function of taste buds.
Describe the relationship between the taste threshold and taste index of common substances.
Explain the chemical basis and signal transduction of taste perception for each type of primary taste sensation.
Recognize different abnormalities of taste perception and their causes.
Key Topics:
Significance of Taste Sensation:
Differentiation between pleasant and harmful food
Influence on behavior
Selection of food based on metabolic needs
Receptors of Taste:
Taste buds on the tongue
Influence of sense of smell, texture of food, and pain stimulation (e.g., by pepper)
Primary and Secondary Taste Sensations:
Primary taste sensations: Sweet, Sour, Salty, Bitter, Umami
Chemical basis and signal transduction mechanisms for each taste
Taste Threshold and Index:
Taste threshold values for Sweet (sucrose), Salty (NaCl), Sour (HCl), and Bitter (Quinine)
Taste index relationship: Inversely proportional to taste threshold
Taste Blindness:
Inability to taste certain substances, particularly thiourea compounds
Example: Phenylthiocarbamide
Structure and Function of Taste Buds:
Composition: Epithelial cells, Sustentacular/Supporting cells, Taste cells, Basal cells
Features: Taste pores, Taste hairs/microvilli, and Taste nerve fibers
Location of Taste Buds:
Found in papillae of the tongue (Fungiform, Circumvallate, Foliate)
Also present on the palate, tonsillar pillars, epiglottis, and proximal esophagus
Mechanism of Taste Stimulation:
Interaction of taste substances with receptors on microvilli
Signal transduction pathways for Umami, Sweet, Bitter, Sour, and Salty tastes
Taste Sensitivity and Adaptation:
Decrease in sensitivity with age
Rapid adaptation of taste sensation
Role of Saliva in Taste:
Dissolution of tastants to reach receptors
Washing away the stimulus
Taste Preferences and Aversions:
Mechanisms behind taste preference and aversion
Influence of receptors and neural pathways
Impact of Sensory Nerve Damage:
Degeneration of taste buds if the sensory nerve fiber is cut
Abnormalities of Taste Detection:
Conditions: Ageusia, Hypogeusia, Dysgeusia (parageusia)
Causes: Nerve damage, neurological disorders, infections, poor oral hygiene, adverse drug effects, deficiencies, aging, tobacco use, altered neurotransmitter levels
Neurotransmitters and Taste Threshold:
Effects of serotonin (5-HT) and norepinephrine (NE) on taste sensitivity
Supertasters:
25% of the population with heightened sensitivity to taste, especially bitterness
Increased number of fungiform papillae
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.
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.
2. Definitions
6/24/20202
What is GMP?
GMP is a common term and its full form is
Good Manufacturing Practice
GMP is that part of Quality Assurance which
ensures that medicinal products are constantly
produced and controlled to the quality
standard appropriate to their intended use. It
is concerned with both Production and Quality
Control .
It’s a magic key that opens the door to
quality.
3. HOW MANY GMPs?
British GMP-Good Pharmaceutical Manufacturing
Practice (GMP)
United States GMP-Current Good Manufacturing
Practices for Finished Pharmaceuticals (cGMP)
WHO GMP-Good Practices in the Manufacture
and Quality Control of Drugs
ASEAN GMP-ASEAN Good Manufacturing
Practice of Drugs
6/24/20203
5. QA, GMP & QC inter-relationship
QA is the sum total of the organized
arrangements with the objective of ensuring that
products will be of the quality required for their
intended use.
GMP that part of Quality Assurance aimed at
ensuring that products are consistently
manufactured to a quality appropriate to their
intended use
QC is that part of GMP concerned with sampling,
specification & testing, documentation & release
procedures which ensure that the necessary &
relevant tests are performed & the product is released
for use only after ascertaining it’s quality 6/24/20205
6. Definitions
What is cGMP?
cGMP refers to Current Good Manufacturing Practices
regulation enforced by USFDA
According to FDA:
the "C" in cGMP stands for "current," requiring
companies to use technologies and systems that are up-to-
date in order to comply with the regulations. Systems and
equipment that may have been "top-of-the-line" to prevent
contamination, mix-ups, and errors 10 or 20 years ago
may be less than adequate by today's standards.
6/24/20206
7. Why c is small?
c is a variable in cGMP that’s why it is written in
small letter just like pH…p is variable potential in pH
6/24/20207
9. cGMP
6/24/20209
cGMP reminds manufacturer that they must employ
the technologies and systems which are up to date in
order to comply with the current regulations.
GMP has to be updated time to time in order to
comply with the standard guidelines.
cGMP is a unique term to define most recent
guidelines with improvement and additions.
10. cGMP
Even if any product meets the specification but cGMP
is not followed, the product is then considered
“adulterated” by the law.
It is important to note that cGMPs are minimum
requirements.
6/24/202010
11. 6/24/202011
The Code of Federal Regulations (CFR) is the codification of the general and permanent rules and
regulations (sometimes called administrative law) published in the Federal Register by the
executive departments and agencies of the federal government of the United States. The CFR is
divided into 50 titles that represent broad areas subject to federal regulation.
Title 21 is the portion of the Code of Federal Regulations that governs food and drugs within the
United States for the Food and Drug Administration (FDA), the Drug Enforcement Administration
(DEA), and the Office of National Drug Control Policy (ONDCP).
12. What is GxP?
A general term for Good Practice quality
guidelines and regulations. These guidelines are
used in many fields, including the pharmaceutical
and food industries.
The titles of these good practice guidelines
usually begin with "Good" and end in "Practice",
with the specific practice descriptor in between
6/24/202012
13. What is GxP?(continued…)
• GxP represents the abbreviations of these titles,
where x (a common symbol for a variable)
represents the specific descriptor.
• Good Automated Manufacturing Practice, or
GaMP
• Good Clinical Practice, or GCP
• Good Distribution Practice, or GDP
• Good Documentation Practice, or GDP
• Good Laboratory Practice, or GLP
• Good Manufacturing Practice, or GMP
• Good Storage Practice, or GSP 6/24/202013
14. Essence of cGMP for pharmaceuticals product
6/24/202014
Initially- the assurance of the quality of the
medicinal product.
Ultimately- the safety, well being and
protection of the patient.
15. History of GMP & cGMP
6/24/202015
THE 1940s AND 1950s
In 1941 nearly 300 people were killed or injured
by one company’s sulfathiazole tablets, a sulfa
drug contaminated with the sedative,
Phenobarbital. That incident caused FDA to
revise manufacturing and quality control
requirements, leading to what would later be
called GMPs.
16. History of GMP & cGMP (Continued…..)
6/24/202016
• 1963 GMPs for Drugs (28 FR 6385) Good
manufacturing practices for manufacturing,
processing, packing, or holding finished
pharmaceuticals were first published.
• 1975 CGMPs for Blood and Blood
Components Final Rule Established minimum
current good manufacturing practices for blood
collection, processing, compatibility testing,
storage and distribution.
17. History of GMP & cGMP (Continued……)
• 1976 Medical Device Amendments
Tragedy: the Dalkon Shield IUD seriously injures
many patients. Response: New law strengthens
FDA authority to oversee medical devices.
• 1978 cGMPs for Drugs and Devices (21
CFR 210–211 and 820)
A major rewrite for the drug GMPs and GMPs for
medical devices were published. These
regulations establish minimum current good
manufacturing practices for manufacturing,
processing, packing, or holding drug products
and medical devices. 6/24/202017
18. Importance of cGMP
GMP is important because it is related with the
well being of human life. It is developed to cure
people from illness. General people do not
understand much about drugs. So it is the
responsibility of the people involved with this
industry to produce quality and safe product and
make it available for the people.
It affects business and reputation. Some recent
incidents are mentioned on next slide.
6/24/202018
19. Importance of cGMP(continued…)
A Local GMP noncompliant incidence:
Paracetamol Tragedy in Bangladesh in 1991 and
2009
Miltefosine fraud in 2008
A very recent scenario in international arena:
A British based Multinational giant Pharma has to pay $ 750
million to settle the manufacturing fraud, October, 2010.
6/24/202019
20. Importance of cGMP(continued…)
GMP is important because it affects life. Some
incidents :
• 1960 : The Thalidomide case in Europe…..
Thalidomide first entered the German market in 1957 as an over-the-counter remedy, based
on the maker’s safety claims. They advertised their product as “completely safe” for
everyone, including mother and child, “even during pregnancy,” as its developers “could not
find a dose high enough to kill a rat.” By 1960, thalidomide was marketed in 46 countries,
with sales nearly matching those of aspirin.
• 1970: Following the thalidomide case few
regulation were released by congress that
company has to ensure not only safety but also
the efficacy of the intended use including clinical
trial reports. 6/24/202020
21. Importance of cGMP(continued…)
• 1980 & 1990: A 12 yrs old girl died after taking
Tylenol Acetaminophen capsule. Six other people
died for the same reason, 3 of them from the
same family. The mfg. company recalled 32
million bottles of the product. The investigation
revealed that, a criminal tampered had
intoxicated the bottles with Cyanide capsule.FDA
issued the tamper resistant packaging regulations
for all OTC drugs.
6/24/202021
57. Ten Principles of GMP
1. Design and construct the facilities and
equipments properly
2. Follow written procedures and Instructions
3. Document work (give more paper)
4. Validate work
5. Monitor facilities and equipment
6. Write step by step operating procedures
and work on instructions
7. Design ,develop and demonstrate job
competence
8. Protect against contamination
9. Control components and product related
processes 6/24/202057