This document provides an overview of Good Distribution Practices (GDP) for pharmaceutical products. It discusses that GDP aims to ensure quality and identity of pharmaceuticals during distribution by establishing adequate controls over handling, storage and distribution. It outlines key requirements for GDP certification including personnel training, documentation, storage and transportation procedures to prevent issues like contamination or mixing of products. Obtaining GDP certification demonstrates a company's commitment to quality and safety standards across its entire pharmaceutical supply chain.
The European Commission Health and Consumers Directorate – General has published a draft “GUIDELINES ON THE PRINCIPLES OF GOOD DISTRIBUTION PRACTICES FOR ACTIVE SUBSTANCES FOR MEDICINAL PRODUCTS FOR HUMAN USE”.
The guideline addresses Quality systems, Personnel, Documentation, Order, Procedures, Records, Premises and Equipment, Receipts, Storage , Deliveries to Customers, Transfer of Information and Returns.
Following presentation is prepared by “ Drug Regulations” a non profit organization which provides free online resource to the Pharmaceutical Professional.
This presentation is aimed at providing information on automation in the GLP practices in the pharmaceutical industry.
-Standard Operating Procedures.
-Documentation in GALP.
-Logs and Related Forms.
The European Commission Health and Consumers Directorate – General has published a draft “GUIDELINES ON THE PRINCIPLES OF GOOD DISTRIBUTION PRACTICES FOR ACTIVE SUBSTANCES FOR MEDICINAL PRODUCTS FOR HUMAN USE”.
The guideline addresses Quality systems, Personnel, Documentation, Order, Procedures, Records, Premises and Equipment, Receipts, Storage , Deliveries to Customers, Transfer of Information and Returns.
Following presentation is prepared by “ Drug Regulations” a non profit organization which provides free online resource to the Pharmaceutical Professional.
This presentation is aimed at providing information on automation in the GLP practices in the pharmaceutical industry.
-Standard Operating Procedures.
-Documentation in GALP.
-Logs and Related Forms.
FDA WARNING LETTER IS A OFFICIAL LETTER FROM USFDA TO A MANUFACTURING FIRM TO NOTICE THE SERIOUS VIOLATION FOUND AT THE FDA INSPECTION AT FIRM AND THE CORRECTIVE ACTION SHOULD TO TAKEN BY FIRM TO OVERCOME THE VIOLATION FOR FDA APPROVAL
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
Lean what 21 CFR Parts 210 and 211 are and how you an implement these regulations in your organization. For more information and tips on compliance go to http://compliance-insight.com/fda-gcp-and-gmp-training/21-cfr-210-211/
labelling of drugs and cosmetics in European UnionBindu Kshtriya
labelling of pharmaceutical drug products and cosmetics, with special emphasis on font size, type, and other recommendations such as particulars to be mentioned and legal framework for labelling
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
Greeting From Virtue Insight,
I am happy to invite you and your colleagues to be a sponsor/ delegate for our upcoming “9th Pharmacovigilance 2015” The conference will be held on 2nd September 2015, Kohinoor Continental Hotel, Mumbai, India.
KEY SPEAKERS:-
• V. Kalaiselvan, Principal Scientific Officer, Indian Pharmacopoeia Commission Ministry of Health and Family Welfare Govt. of India
• Arun Bhatt, President, ClinInvent Research
• Deepa Arora, Vice President - Pharmacovigilance & Global Head - Drug Safety & Risk Management, Lupin
• Bhaswat Chakraborty, Senior Vice President, Cadila
• Babita Kirodian, Head of Country Pharmacovigilance, Bristol Myers Squibb
• Nipom Deka, Regional Pharmacovigilance Manager, Asia, Africa & Middle East, Abbott
• Shashidhar Swamy, Head Pharmacovigilance, Wockhardt
• Mohammad Salim, Country Safety Lead, Pfizer
• Manish Verma, Director Medical Affairs, Sanofi
• Karthik Babu, Affiliate Pharmacovigilance Head, Sanofi
• Chirag Trivedi, Director & Head of Clinical Study Unit, Sanofi
• Priya Chatterjee, Director - Regulatory Affairs, Merck Serono
• Milind Antani, Partner In-Charge - Pharma LifeSciences, Nishith Desai Associate
• Anand Harugeri, Patient Safety and Regulatory Affairs Manager, Astrazeneca
• Deepti Sanghavi, Assistant Manager - Medical Writing, Tata Consultancy Services
• Sandeep Sewlikar, Manager – Clinical Affairs, Johnson and Johnson
• Girish Parhate, Head Regulatory Affairs, Bayer Pharmaceuticals
• Rajashri Survase Ojha, Founder and MD, Raaj GPRAC
• Vandana Jolad, Director, VIaTal Pharma
Plus Many More...
CONFERENCE BOOKING DETAILS:-
• Early Bird Discounted Price - Conference Delegate Pass (INR 6,000 + Tax (14%) per delegate) - Book and Pay before 20th July 2015 avail the early bird discounted price. You can simply email or call and book your conference delegate seats on TEL: +91 9940043915. Email – swetha@virtueinsight.co.in
• Standard Price after Early Bird Discounted Time – 1 or 2 Delegates (INR 7,000 + Tax (14%) per delegate) - You can simply email or call and book your conference delegate seats on TEL: +91 9940043915. Email – swetha@virtueinsight.co.in
• Group Discounts – 3 or 4 Delegates - (INR 6,500 + Tax (14%) per delegate)
• Group Discounts – 5 or more Delegates - (INR 5,000 + Tax (14%) per delegate)
• Conference Sponsor & Exhibition Stall - Should you wish to Sponsor, or purchase a Exhibition Stall (Booth) or a paid Speaker Slot, you can simply email your interest and queries to TEL: +91 44 65515695, +91 9940043915 or swetha@virtueinsight.co.in
In case you or any of your colleagues might be interested in participating in the same, please let me know and I will be happy to call you and help you with the registration.
Thank you for your time and consideration. I look forward to hearing from you
Thanks,
Swetha
FDA WARNING LETTER IS A OFFICIAL LETTER FROM USFDA TO A MANUFACTURING FIRM TO NOTICE THE SERIOUS VIOLATION FOUND AT THE FDA INSPECTION AT FIRM AND THE CORRECTIVE ACTION SHOULD TO TAKEN BY FIRM TO OVERCOME THE VIOLATION FOR FDA APPROVAL
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
Lean what 21 CFR Parts 210 and 211 are and how you an implement these regulations in your organization. For more information and tips on compliance go to http://compliance-insight.com/fda-gcp-and-gmp-training/21-cfr-210-211/
labelling of drugs and cosmetics in European UnionBindu Kshtriya
labelling of pharmaceutical drug products and cosmetics, with special emphasis on font size, type, and other recommendations such as particulars to be mentioned and legal framework for labelling
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
Greeting From Virtue Insight,
I am happy to invite you and your colleagues to be a sponsor/ delegate for our upcoming “9th Pharmacovigilance 2015” The conference will be held on 2nd September 2015, Kohinoor Continental Hotel, Mumbai, India.
KEY SPEAKERS:-
• V. Kalaiselvan, Principal Scientific Officer, Indian Pharmacopoeia Commission Ministry of Health and Family Welfare Govt. of India
• Arun Bhatt, President, ClinInvent Research
• Deepa Arora, Vice President - Pharmacovigilance & Global Head - Drug Safety & Risk Management, Lupin
• Bhaswat Chakraborty, Senior Vice President, Cadila
• Babita Kirodian, Head of Country Pharmacovigilance, Bristol Myers Squibb
• Nipom Deka, Regional Pharmacovigilance Manager, Asia, Africa & Middle East, Abbott
• Shashidhar Swamy, Head Pharmacovigilance, Wockhardt
• Mohammad Salim, Country Safety Lead, Pfizer
• Manish Verma, Director Medical Affairs, Sanofi
• Karthik Babu, Affiliate Pharmacovigilance Head, Sanofi
• Chirag Trivedi, Director & Head of Clinical Study Unit, Sanofi
• Priya Chatterjee, Director - Regulatory Affairs, Merck Serono
• Milind Antani, Partner In-Charge - Pharma LifeSciences, Nishith Desai Associate
• Anand Harugeri, Patient Safety and Regulatory Affairs Manager, Astrazeneca
• Deepti Sanghavi, Assistant Manager - Medical Writing, Tata Consultancy Services
• Sandeep Sewlikar, Manager – Clinical Affairs, Johnson and Johnson
• Girish Parhate, Head Regulatory Affairs, Bayer Pharmaceuticals
• Rajashri Survase Ojha, Founder and MD, Raaj GPRAC
• Vandana Jolad, Director, VIaTal Pharma
Plus Many More...
CONFERENCE BOOKING DETAILS:-
• Early Bird Discounted Price - Conference Delegate Pass (INR 6,000 + Tax (14%) per delegate) - Book and Pay before 20th July 2015 avail the early bird discounted price. You can simply email or call and book your conference delegate seats on TEL: +91 9940043915. Email – swetha@virtueinsight.co.in
• Standard Price after Early Bird Discounted Time – 1 or 2 Delegates (INR 7,000 + Tax (14%) per delegate) - You can simply email or call and book your conference delegate seats on TEL: +91 9940043915. Email – swetha@virtueinsight.co.in
• Group Discounts – 3 or 4 Delegates - (INR 6,500 + Tax (14%) per delegate)
• Group Discounts – 5 or more Delegates - (INR 5,000 + Tax (14%) per delegate)
• Conference Sponsor & Exhibition Stall - Should you wish to Sponsor, or purchase a Exhibition Stall (Booth) or a paid Speaker Slot, you can simply email your interest and queries to TEL: +91 44 65515695, +91 9940043915 or swetha@virtueinsight.co.in
In case you or any of your colleagues might be interested in participating in the same, please let me know and I will be happy to call you and help you with the registration.
Thank you for your time and consideration. I look forward to hearing from you
Thanks,
Swetha
Greetings from Virtue Insight,
I am happy to invite you and your colleagues to be a sponsor/ delegate for our upcoming “9th Pharmacovigilance 2015” The conference will Be held on 2nd September 2015, Kohinoor Continental Hotel, Mumbai, India. Please find the detailed agenda for the same with this email.
FMD:- + 91 9171350244 or deepak@virtueinsight.co.in, deepakrajvirtueinsight@gmail.com
Quality Perspective of ‘Good Distribution Practices’ in Indian Pharmaceutical...iosrjce
The operation of Supply Chain of Management (SCM) is predominantly perceived from commercial facet of a
business. Pharmaceutical products affect the health of the user hence it is obligatory to produce and deliver the
products of predetermined quality standards. This can only be achieved by designing quality centric procedures
and pursue them at each stage during distribution process. Quality is considered as the most sensitive aspect of
pharmaceutical business during manufacturing as well as distribution. Quality of medicinal products is
concurrent to its objective of curing the patients. Many drug regulatory agencies have issued guidance ‘Good
distribution practices (GDP)’for pharmaceutical manufactures. The Good Distribution Practices (GDP) is
considered an essential basis of pharmaceutical SCM to ensure systematic distribution of medicinal products.
Due to lack of proper understanding and commitment, product quality issues are noticed by manufacturer’s
quality assurance department. Since most of the quality aspects of pharmaceutical products are not known to
the common patients, the survey to characterise them with help of quality professionals has been found useful.
This research study finds that there is an enhanced need of control over the supply chain management
operations to align its procedure and practices with quality objectives of pharmaceutical ‘Good Manufacturing
Practices (GMP)’
Devices Sponsor Information Day: 5 - Post-market - Advertising therapeutic go...TGA Australia
Presentations by TGA and Industry (combined) to help sponsors and manufacturers better understand the regulation of medical devices and in-vitro diagnostic medical devices
The Strategic for Formation of Inter Organizational Network towards Global Ma...ijtsrd
This paper examined the effect of cooperative strategy in improving the company's competitiveness in the globally targeted markets. The strategic management is essential for dealing with the continuous stream of changes that organizations face. The rapid increase of food quality and safety standards in developed nations can be stated as one of the major challenges of fish exporters. This paper is to apply networking concept for it enables the firm to obtain the required resources from external partners, gather the necessary information about their markets and customers. Dr. Le Nguyen Doan Khoi "The Strategic for Formation of Inter-Organizational Network towards Global Market" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-5 | Issue-6 , October 2021, URL: https://www.ijtsrd.com/papers/ijtsrd47523.pdf Paper URL : https://www.ijtsrd.com/management/strategic-management/47523/the-strategic-for-formation-of-interorganizational-network-towards-global-market/dr-le-nguyen-doan-khoi
On September 24, 2013, the U.S. Food and Drug Administration announced the new requirement to identify medical devices that affect its safe and effective use through the use of UDI. Explore on how Freyr can help medical device companies achieve UDI compliance.
Pharmacovigilance is the approach related to making an assessment, detection, understanding and prevention of inappropriate effects or any other problems to drug-related . So those working in the field of pharmacovigilance must have a good working knowledge of the principles of drug safety, regulations and proactive strategies for risk management. So people who want to pursue a clinical research career, can take up Pharmacovigilance training for adding value to their qualification.
4th annual Pharma Anti-Counterfeiting 2015Dinesh T
4th Annual Pharma Anti-Counterfeiting 2015 taking place on 08th & 09th September 2015, London, UK
Please contact me :-Dinesh:- dinesh@virtueinsight.co.in
Similar to Good distribution practices white paper (20)
ISO/TS 29001:2010 defines the quality management system requirements for the design, development, production, installation and service of products for the petroleum, petrochemical and natural gas industries.
Risk management is an increasingly important business driver and stakeholders have become much more concerned about risk. Risk may be a driver of strategic decisions, it may be a cause of uncertainty in the organization or it may simply be embedded in the activities of the organization.
The ISO 22000:2005 FSMS is designed to enable organizations to control food safety hazards along the food chain in order to ensure that food is safe at the time of consumption.
ISO 17020, entitled "General Criteria for the Operation of Various Types of Bodies Performing Inspection", is an internationally recognized standard for the competence of inspection bodies. ISO 17020 should not be confused with ISO 9001, which is specific to quality management systems. ISO 9001 does not require evaluation of the technical competence of an inspection body and it should not be regarded as an 'acceptable' alternative to ISO 17020.
"ISO 14001 environmental management standards exist to help organizations minimize how their operations
negatively affect the environment. The major objective of the ISO 14000 series of norms is "to promote more
effective and efficient environmental management in organizations and to provide useful and usable tools - ones
that are cost effective, system-based, and flexible and reflect the best organizational practices available for
gathering, interpreting and communicating environmentally relevant information"".
ISO 27001 is applicable to any organization where the
misuse, corruption, or loss of its business or customer
information could result in financial, continuity, or legal
implications. The information may be printed or written
on paper, stored electronically, transmitted by post or
email, shown on films, or spoken in conversation,
whatever form the information takes, or means by which
it is shared or stored.
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
Recomendações da OMS sobre cuidados maternos e neonatais para uma experiência pós-natal positiva.
Em consonância com os ODS – Objetivos do Desenvolvimento Sustentável e a Estratégia Global para a Saúde das Mulheres, Crianças e Adolescentes, e aplicando uma abordagem baseada nos direitos humanos, os esforços de cuidados pós-natais devem expandir-se para além da cobertura e da simples sobrevivência, de modo a incluir cuidados de qualidade.
Estas diretrizes visam melhorar a qualidade dos cuidados pós-natais essenciais e de rotina prestados às mulheres e aos recém-nascidos, com o objetivo final de melhorar a saúde e o bem-estar materno e neonatal.
Uma “experiência pós-natal positiva” é um resultado importante para todas as mulheres que dão à luz e para os seus recém-nascidos, estabelecendo as bases para a melhoria da saúde e do bem-estar a curto e longo prazo. Uma experiência pós-natal positiva é definida como aquela em que as mulheres, pessoas que gestam, os recém-nascidos, os casais, os pais, os cuidadores e as famílias recebem informação consistente, garantia e apoio de profissionais de saúde motivados; e onde um sistema de saúde flexível e com recursos reconheça as necessidades das mulheres e dos bebês e respeite o seu contexto cultural.
Estas diretrizes consolidadas apresentam algumas recomendações novas e já bem fundamentadas sobre cuidados pós-natais de rotina para mulheres e neonatos que recebem cuidados no pós-parto em unidades de saúde ou na comunidade, independentemente dos recursos disponíveis.
É fornecido um conjunto abrangente de recomendações para cuidados durante o período puerperal, com ênfase nos cuidados essenciais que todas as mulheres e recém-nascidos devem receber, e com a devida atenção à qualidade dos cuidados; isto é, a entrega e a experiência do cuidado recebido. Estas diretrizes atualizam e ampliam as recomendações da OMS de 2014 sobre cuidados pós-natais da mãe e do recém-nascido e complementam as atuais diretrizes da OMS sobre a gestão de complicações pós-natais.
O estabelecimento da amamentação e o manejo das principais intercorrências é contemplada.
Recomendamos muito.
Vamos discutir essas recomendações no nosso curso de pós-graduação em Aleitamento no Instituto Ciclos.
Esta publicação só está disponível em inglês até o momento.
Prof. Marcus Renato de Carvalho
www.agostodourado.com
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
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.
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!
- Video recording of this lecture in English language: https://youtu.be/lK81BzxMqdo
- Video recording of this lecture in Arabic language: https://youtu.be/Ve4P0COk9OI
- Link to download the book free: https://nephrotube.blogspot.com/p/nephrotube-nephrology-books.html
- Link to NephroTube website: www.NephroTube.com
- Link to NephroTube social media accounts: https://nephrotube.blogspot.com/p/join-nephrotube-on-social-media.html
HOT NEW PRODUCT! BIG SALES FAST SHIPPING NOW FROM CHINA!! EU KU DB BK substit...GL Anaacs
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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.
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
Acute scrotum is a general term referring to an emergency condition affecting the contents or the wall of the scrotum.
There are a number of conditions that present acutely, predominantly with pain and/or swelling
A careful and detailed history and examination, and in some cases, investigations allow differentiation between these diagnoses. A prompt diagnosis is essential as the patient may require urgent surgical intervention
Testicular torsion refers to twisting of the spermatic cord, causing ischaemia of the testicle.
Testicular torsion results from inadequate fixation of the testis to the tunica vaginalis producing ischemia from reduced arterial inflow and venous outflow obstruction.
The prevalence of testicular torsion in adult patients hospitalized with acute scrotal pain is approximately 25 to 50 percent
The prostate is an exocrine gland of the male mammalian reproductive system
It is a walnut-sized gland that forms part of the male reproductive system and is located in front of the rectum and just below the urinary bladder
Function is to store and secrete a clear, slightly alkaline fluid that constitutes 10-30% of the volume of the seminal fluid that along with the spermatozoa, constitutes semen
A healthy human prostate measures (4cm-vertical, by 3cm-horizontal, 2cm ant-post ).
It surrounds the urethra just below the urinary bladder. It has anterior, median, posterior and two lateral lobes
It’s work is regulated by androgens which are responsible for male sex characteristics
Generalised disease of the prostate due to hormonal derangement which leads to non malignant enlargement of the gland (increase in the number of epithelial cells and stromal tissue)to cause compression of the urethra leading to symptoms (LUTS
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
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Are There Any Natural Remedies To Treat Syphilis.pdf
Good distribution practices white paper
1. Sterling International Consulting FZE
White Paper on GDP – Good Distribution Practices
Level 6, Office 605 – The Fairmont, Sheikh Zayed Road, PO BOX 27363, Dubai, UAE
I 24 Hours Customer Care: +971 562014736 I Phone +971 4 455 8677 I Web: www.uaeiso.com I Email: kaushal@uaeiso.com I
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Introduction
Distribution is an important activity in the integrated supply-chain management of pharmaceutical
products. Various people and entities are generally responsible for the handling, storage and
distribution of such products.
Various individuals and entities are generally responsible for
the handling, storage and distribution of such products. So
it’s very important to have adequate controls over the entire
chain of distribution. To maintain the original quality of
pharmaceutical products, every party involved in the
distribution chain has to comply with the applicable
requirement. Each activity in the distribution of
pharmaceutical products shall be carried out according to the
principles of Good Distribution Practices (GDP) as
applicable.
The nature of the risks involved is likely to be similar to that
for risks encountered in the manufacturing environment, e.g.
mix-ups, adulteration, contamination, cross-contamination,
spurious. Further, the involvement of unauthorized entities in
the distribution and sale of pharmaceutical products is a
particular concern.
Only a joint approach of all parties involved in the supply chain can be successful in the fight
against spurious/sub-standard pharmaceutical products. Therefore, all parties in supply chain shall
take an active part in collaborative activities to protect the pharmaceutical supply chain against the
penetration of spurious/substandard pharmaceutical products.
The objective of the GDP guideline is to assist in ensuring the quality and identity of pharmaceutical
products during all aspects of the distribution process. These aspects include, but are not limited
to, procurement, purchasing, storage, distribution, transportation, repackaging, re-labelling,
documentation and record-keeping practices.
GDP sets out appropriate steps to assist in fulfilling the responsibilities involved in the different
aspects of the distribution process within the supply chain and to avoid the introduction of
counterfeits into the marketplace via the distribution chain. It regulates the distribution of health
care products from the premises of the manufacture to the end user and is therefore part of the
entire quality assurance process. It ensures the that products are consistently stored , transported,
and handed under suitable conditions as required by the marketing authorization or product
specifications during all aspects of the distribution process.
2. Sterling International Consulting FZE
White Paper on GDP – Good Distribution Practices
Level 6, Office 605 – The Fairmont, Sheikh Zayed Road, PO BOX 27363, Dubai, UAE
I 24 Hours Customer Care: +971 562014736 I Phone +971 4 455 8677 I Web: www.uaeiso.com I Email: kaushal@uaeiso.com I
U.S.A Greece India Maldives Kuwait Saudi Arabia Europe Africa New Zealand UAE
Application of GDP
GDP extends to sourcing materials from approved suppliers and continues through manufacturing
(under GMP) and on to delivery of the product to the final customer or patient.
Hence these guidelines are intended to be applicable to all persons and outlets involved in any
aspect of the distribution of pharmaceutical products from the premises of the manufacturer of the
product to the person dispensing or providing pharmaceutical products directly to a patient or his
or her agent. This includes all parties involved in trade and distribution of medicines,
pharmaceutical manufacturers, including the manufacturers of finished products and
pharmaceutical wholesalers as well as other parties such as brokers, suppliers, distributors,
logistics providers, traders, transport companies and forwarding agents and their employees.
The relevant sections of these guidelines should also be considered for implementation by
governments, regulatory bodies, international procurement organizations, donor agencies and
certifying bodies, as well as all parties involved in any aspect of the trade and distribution of
pharmaceutical products, including health care workers. The guidelines can also be used as a tool
in the prevention of the distribution of counterfeit pharmaceutical products.
3. Sterling International Consulting FZE
White Paper on GDP – Good Distribution Practices
Level 6, Office 605 – The Fairmont, Sheikh Zayed Road, PO BOX 27363, Dubai, UAE
I 24 Hours Customer Care: +971 562014736 I Phone +971 4 455 8677 I Web: www.uaeiso.com I Email: kaushal@uaeiso.com I
U.S.A Greece India Maldives Kuwait Saudi Arabia Europe Africa New Zealand UAE
Benefits of GDP
Good Distribution Practices (GDP) is a quality system for warehouse and distribution
centers dedicated for medicines. Internationally accepted pharmaceutical GDP
regulations stipulate that distributors of pharmaceutical products must align their
operations with the standards.
Maintaining product safety and quality during distribution is of utmost importance in the
pharmaceutical industry. Good Distribution Practices (GDP) Certification for
Pharmaceuticals demonstrates your dedication to good distributive practices and quality
in every aspect of your service.
The scheme ensures that consistent quality management systems are in place
throughout your entire supply chain, from the early delivery of raw materials to the
manufacturing plants, to the final shipment of finished drugs to the end user. An
independent assessment of compliance against international GDP requirements is the
most effective way to establish that your quality management system aligns with GDP
guidance.
Good Distribution Practices mean:
Compliant and consistent Supply Chain of Pharmaceutical products
Reduced counterfeit risks
Reduced transport and storage risks
More safety for the final consumer
4. Sterling International Consulting FZE
White Paper on GDP – Good Distribution Practices
Level 6, Office 605 – The Fairmont, Sheikh Zayed Road, PO BOX 27363, Dubai, UAE
I 24 Hours Customer Care: +971 562014736 I Phone +971 4 455 8677 I Web: www.uaeiso.com I Email: kaushal@uaeiso.com I
U.S.A Greece India Maldives Kuwait Saudi Arabia Europe Africa New Zealand UAE
Guidelines on Good Distribution Practice of Medicinal Products for Human Use
Personnel
A management representative should be appointed in each distribution point, who should
have defined authority and responsibility for ensuring that a quality system is implemented
and maintained.
He should fulfil his responsibilities personally. This person should be appropriately qualified:
although a degree in Pharmacy is desirable, the qualification requirements may be
established by the Member State on whose territory the wholesaler is located.
Documentation
All documentation should be made available on request of competent authorities.
Orders
Orders from wholesalers should be addressed only to persons authorised to supply
medicinal products as wholesalers or holders of a manufacturing or importing authorisation
Procedures
Written procedures should describe the different operations which may affect the quality of
the products or of the distribution activity: receipt and checking of deliveries, storage,
cleaning and maintenance of the premises (including pest control), recording of the storage
conditions, security of stocks on site and of consignments in transit, withdrawal from
saleable stock, records, including records of clients orders, returned products, recall plans,
etc. These procedures should be approved, signed and dated by the person responsible for
the quality system.
Records
Records should be made at the time each operation is taken and in such a way that all
significant activities or events are traceable. Records should be clear and readily available.
They should be retained for a period of five years at least.
Premises and equipment
Premises and equipment should be suitable and adequate to ensure proper conservation
and distribution of medicinal products. Monitoring devices should be calibrated.
Receipt
Receiving bays should protect deliveries from bad weather during unloading. The reception
area should be separate from the storage area. Deliveries should be examined at receipt in
order to check that containers are not damaged and that the consignment corresponds to
the order.
5. Sterling International Consulting FZE
White Paper on GDP – Good Distribution Practices
Level 6, Office 605 – The Fairmont, Sheikh Zayed Road, PO BOX 27363, Dubai, UAE
I 24 Hours Customer Care: +971 562014736 I Phone +971 4 455 8677 I Web: www.uaeiso.com I Email: kaushal@uaeiso.com I
U.S.A Greece India Maldives Kuwait Saudi Arabia Europe Africa New Zealand UAE
Medicinal products subject to specific storage measures (e.g. narcotics, products requiring
a specific storage temperature) should be immediately identified and stored in accordance
with written instructions and with relevant legislative provisions.
Storage
Medicinal products should normally be stored apart from other goods and under the
conditions specified by the manufacturer in order to avoid any deterioration by light, moisture
or temperature.
Temperature should be monitored and recorded periodically. Records of temperature
should be reviewed regularly.
Medicinal products with broken seals, damaged packaging, or suspected of possible
contamination should be withdrawn from saleable stock, and if not immediately destroyed,
they should be kept in a clearly separated area so that they cannot be sold in error or
contaminate other goods.
Deliveries to customers
Deliveries should be made only to other authorised wholesalers or to persons authorised to
supply medicinal products to the public in the Member State concerned.
Returns
Non-defective medicinal products which have been returned should be kept apart from
saleable stock to prevent redistribution until a decision has been reached regarding their
disposal.
Records of returns should be kept. The responsible person should formally release goods
to be returned to stock. Products returned to saleable stock should be placed such that the
"first in first out" system operates effectively.
Emergency plan and recalls
An emergency plan for urgent recalls and a non-urgent recall procedure should be described
in writing. A person should be designated as responsible for execution and co-ordination of
recalls.
Counterfeit medicinal products
Counterfeit medicinal products found in the distribution network should be kept apart from
other medicinal products to avoid any confusion. They should be clearly labelled as not for
sale and competent authorities and the holder of marketing authorisation of the original
product should be informed immediately
6. Sterling International Consulting FZE
White Paper on GDP – Good Distribution Practices
Level 6, Office 605 – The Fairmont, Sheikh Zayed Road, PO BOX 27363, Dubai, UAE
I 24 Hours Customer Care: +971 562014736 I Phone +971 4 455 8677 I Web: www.uaeiso.com I Email: kaushal@uaeiso.com I
U.S.A Greece India Maldives Kuwait Saudi Arabia Europe Africa New Zealand UAE
Special provisions concerning products classified as not for sale
Any return, rejection, and recall operation and receipt of counterfeit products should be
recorded at the time it is carried out and records should be made available to the competent
authorities. In each case, a formal decision should be taken on the disposal of these
products and the decision should be documented and recorded. The person responsible for
the quality system of the wholesaler and, where relevant, the holder of the marketing
authorisation should be involved in the decision making process.
Self inspections
Self-inspections should be conducted (and recorded) in order to monitor the implementation
of and compliance with this guideline.
Provision of information to Member States in relation to wholesale activities
Wholesalers wishing to distribute or distributing medicinal products in Member State(s) other
than the Member State in which the authorisation was granted should make available on
request to the competent authorities of the other Member State(s) any information in relation
to the authorisation granted in the Member State of origin, namely the nature of the
wholesaling activity, the address of sites of storage and distribution point(s) and, if
appropriate, the area covered. Where appropriate, the competent authorities of this (these)
other Member State(s) will inform the wholesaler of any public service obligation imposed
on wholesalers operating on their territory.
7. Sterling International Consulting FZE
White Paper on GDP – Good Distribution Practices
Level 6, Office 605 – The Fairmont, Sheikh Zayed Road, PO BOX 27363, Dubai, UAE
I 24 Hours Customer Care: +971 562014736 I Phone +971 4 455 8677 I Web: www.uaeiso.com I Email: kaushal@uaeiso.com I
U.S.A Greece India Maldives Kuwait Saudi Arabia Europe Africa New Zealand UAE
Certification
Once the GDP requirements are in place and the organization is confident of having met all the
requirements, the external audit and certification process can be initiated. This process requires
multiple steps:
A site visit is conducted by the certification body to audit the company with respect to the
requirements of the standard. The audit includes interview, inspections of facilities and records.
The time requirement for a small company is as little as one day. Larger organizations can
expect the audit to be conducted within several days.
After the site visit, an audit report will be submitted to top-management including the results and
recommendations for improvements.
The last step is the issue of the certificate. The certificate is valid for three years. After conducting
the first audit and the certificate is issued, the certification body will conduct surveillance audits
on a regular basis (yearly follow-ups).
What We Offer?
With a team of highly qualified consultants and trainers having vast industrial experience,
Sterling International Consulting FZE partners organizations across the world to implement and
achieve GDP certification.
Our consulting approach is highly professional, time bound and effective resulting in ease of
implementation and adds value to the business processes of the client organization.
Contact us at kaushal@uaeiso.com to get your organization GDP certified.