TGA Presentation: GMP Clearance Information Session,5-7 September 2017TGA Australia
Provides an overview of the improvements made to the GMP clearance process including the revised guidance, the introduction of an application assistance tool, the redesigned application e-forms and the compliance verification process.
GMP Certification in Tanzania, which stands for good manufacturing practices, is a term that's frequently used to refer to the management and control of pharmaceutical product development, testing, and overall quality. It creates a set of standards for the quality assurance process. Products are manufactured in compliance with industry standards, thanks to GMP approval.
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
TGA Presentation: GMP Clearance Information Session,5-7 September 2017TGA Australia
Provides an overview of the improvements made to the GMP clearance process including the revised guidance, the introduction of an application assistance tool, the redesigned application e-forms and the compliance verification process.
GMP Certification in Tanzania, which stands for good manufacturing practices, is a term that's frequently used to refer to the management and control of pharmaceutical product development, testing, and overall quality. It creates a set of standards for the quality assurance process. Products are manufactured in compliance with industry standards, thanks to GMP approval.
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
Presentation: Update from the Medical Devices BranchTGA Australia
Under Recommendation 15 of the Review of Medicines and Medical Review Regulation (MMDR) the Government agreed to greater utilisation of marketing approvals by comparable overseas regulators to support assessments of medical devices in Australia. Legislative amendments in the Therapeutic Goods Amendment (2017 Measures No. 1) Act 2018 to enact this change also included clarifications regarding preliminary assessment of applications for pre-market authorisation. This presentation will review the implementation arrangements for these changes, covering the increased options for use of overseas approvals, and the evidence requirements to support applications.
Regulating the manufacture of therapeutic goodsTGA Australia
View this presentation for information on:
*how the manufacture of therapeutic goods is regulated
* how the quality of therapeutic goods is checked
* differences for higher, medium and lower risk products
* inspections of manufacturers, both in Australia and internationally
* international harmonisation.
The TGA Pharmacovigilance Inspection Pilot Program: 2015-2016TGA Australia
Firsthand overview of the TGA's Pharmacovigilance Inspection programme from the perspective of both the TGA and companies that have participated in the 'Pilot Inspection Programme'.
Rx-360 Mission: Protect patient safety by sharing information and developing processes related to the integrity of the healthcare supply chain and the quality of materials within the supply chain.
Rx-360’s Audit Programs allows companies to leverage their ever scarce resources to focus audits on the most critical and higher risk suppliers, while using a licensed audit to effectively monitor other suppliers, maintain compliance and augment their internal efforts.
Pharmaceutical Good Manufacturing PracticesPharmaceutical
When you are in healthcare, Then GMP is must. Regulatory philosophy for product Quality have been changed from "Quality by Testing QbT" to "Quality by Design QbD". Quality is to be built in product and that only can be done by GMP.
Overview of testing, certification, and record keeping requirements for consumer products, including children's products. Addresses initial certification testing, material change testing, and periodic testing if you have continued production. Presentation also addresses optional component part testing. A review of mandatory recordkeeping requirements and undue influence training is also discussed.
This presentation describes the principles of qualification and validation which are applicable to the facilities, equipment, utilities and processes used for the manufacture of medicinal products. It is a GMP requirement that manufacturer’s control the critical aspects of their particular operations through qualification and validation over the life cycle of the product and process. Any planned changes to the facilities, equipment, utilities and processes, which may affect the quality of the product, should be formally documented and the impact on the validated status or control strategy assessed.
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.
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Presentation: Update from the Medical Devices BranchTGA Australia
Under Recommendation 15 of the Review of Medicines and Medical Review Regulation (MMDR) the Government agreed to greater utilisation of marketing approvals by comparable overseas regulators to support assessments of medical devices in Australia. Legislative amendments in the Therapeutic Goods Amendment (2017 Measures No. 1) Act 2018 to enact this change also included clarifications regarding preliminary assessment of applications for pre-market authorisation. This presentation will review the implementation arrangements for these changes, covering the increased options for use of overseas approvals, and the evidence requirements to support applications.
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View this presentation for information on:
*how the manufacture of therapeutic goods is regulated
* how the quality of therapeutic goods is checked
* differences for higher, medium and lower risk products
* inspections of manufacturers, both in Australia and internationally
* international harmonisation.
The TGA Pharmacovigilance Inspection Pilot Program: 2015-2016TGA Australia
Firsthand overview of the TGA's Pharmacovigilance Inspection programme from the perspective of both the TGA and companies that have participated in the 'Pilot Inspection Programme'.
Rx-360 Mission: Protect patient safety by sharing information and developing processes related to the integrity of the healthcare supply chain and the quality of materials within the supply chain.
Rx-360’s Audit Programs allows companies to leverage their ever scarce resources to focus audits on the most critical and higher risk suppliers, while using a licensed audit to effectively monitor other suppliers, maintain compliance and augment their internal efforts.
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When you are in healthcare, Then GMP is must. Regulatory philosophy for product Quality have been changed from "Quality by Testing QbT" to "Quality by Design QbD". Quality is to be built in product and that only can be done by GMP.
Overview of testing, certification, and record keeping requirements for consumer products, including children's products. Addresses initial certification testing, material change testing, and periodic testing if you have continued production. Presentation also addresses optional component part testing. A review of mandatory recordkeeping requirements and undue influence training is also discussed.
This presentation describes the principles of qualification and validation which are applicable to the facilities, equipment, utilities and processes used for the manufacture of medicinal products. It is a GMP requirement that manufacturer’s control the critical aspects of their particular operations through qualification and validation over the life cycle of the product and process. Any planned changes to the facilities, equipment, utilities and processes, which may affect the quality of the product, should be formally documented and the impact on the validated status or control strategy assessed.
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.
Tom Selleck Health: A Comprehensive Look at the Iconic Actor’s Wellness Journeygreendigital
Tom Selleck, an enduring figure in Hollywood. has captivated audiences for decades with his rugged charm, iconic moustache. and memorable roles in television and film. From his breakout role as Thomas Magnum in Magnum P.I. to his current portrayal of Frank Reagan in Blue Bloods. Selleck's career has spanned over 50 years. But beyond his professional achievements. fans have often been curious about Tom Selleck Health. especially as he has aged in the public eye.
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Introduction
Many have been interested in Tom Selleck health. not only because of his enduring presence on screen but also because of the challenges. and lifestyle choices he has faced and made over the years. This article delves into the various aspects of Tom Selleck health. exploring his fitness regimen, diet, mental health. and the challenges he has encountered as he ages. We'll look at how he maintains his well-being. the health issues he has faced, and his approach to ageing .
Early Life and Career
Childhood and Athletic Beginnings
Tom Selleck was born on January 29, 1945, in Detroit, Michigan, and grew up in Sherman Oaks, California. From an early age, he was involved in sports, particularly basketball. which played a significant role in his physical development. His athletic pursuits continued into college. where he attended the University of Southern California (USC) on a basketball scholarship. This early involvement in sports laid a strong foundation for his physical health and disciplined lifestyle.
Transition to Acting
Selleck's transition from an athlete to an actor came with its physical demands. His first significant role in "Magnum P.I." required him to perform various stunts and maintain a fit appearance. This role, which he played from 1980 to 1988. necessitated a rigorous fitness routine to meet the show's demands. setting the stage for his long-term commitment to health and wellness.
Fitness Regimen
Workout Routine
Tom Selleck health and fitness regimen has evolved. adapting to his changing roles and age. During his "Magnum, P.I." days. Selleck's workouts were intense and focused on building and maintaining muscle mass. His routine included weightlifting, cardiovascular exercises. and specific training for the stunts he performed on the show.
Selleck adjusted his fitness routine as he aged to suit his body's needs. Today, his workouts focus on maintaining flexibility, strength, and cardiovascular health. He incorporates low-impact exercises such as swimming, walking, and light weightlifting. This balanced approach helps him stay fit without putting undue strain on his joints and muscles.
Importance of Flexibility and Mobility
In recent years, Selleck has emphasized the importance of flexibility and mobility in his fitness regimen. Understanding the natural decline in muscle mass and joint flexibility with age. he includes stretching and yoga in his routine. These practices help prevent injuries, improve posture, and maintain mobilit
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
- 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
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New Drug Discovery and Development .....NEHA GUPTA
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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.
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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.
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
Knee anatomy and clinical tests 2024.pdfvimalpl1234
This includes all relevant anatomy and clinical tests compiled from standard textbooks, Campbell,netter etc..It is comprehensive and best suited for orthopaedicians and orthopaedic residents.
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
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.
1. GMP Clearance Requirements for Medicines
Manufactured Overseas
Hongxia Jin
Director
Licensing & Certification, Manufacturing Quality Branch
Medical Devices and Product Quality Division, TGA
2017 ARCS Annual Conference
August 2017
2. Presentation
• Assessment of overseas manufacturers and GMP clearance
• Evidence requirements for desk top assessment
• Sponsor responsibilities
• Challenges
• Current initiatives
• Roadshows
GMP Clearance Requirements for Medicines Manufactured Overseas 1
3. Approval of Medicine Manufacturers
• All medicine manufacturers must receive an approval from the
TGA before manufacture and supply, subject to exemption
provisions and other requirements
• Approvals – demonstrate compliance to the principles of Good
Manufacturing practice
– Australian manufacturers - GMP licence
– Overseas manufacturers - GMP clearance to product sponsors
• An application must be lodged via the TGA business portal
(licence, GMP clearance or GMP certification)
GMP Clearance Requirements for Medicines Manufactured Overseas 2
4. Assessment of O/S Medicine Manufacturers
GMP clearance
• GMP Clearance process is a non-statutory mechanism used to verify
that overseas manufacturing sites comply with the principles of good
manufacturing practice
• GMP clearances are required for the purpose of ARTG registration and
listing, and continued supply once products are registered or listed
• GMP clearances are granted to Australian sponsors for a specific time period
• Two pathways to obtain a GMP clearance:
– Desk top based assessment
– TGA on-site inspection
GMP Clearance Requirements for Medicines Manufactured Overseas 3
6. GMP Clearance – Desk top assessment pathway
• If current evidence is available from a recognised regulator using an equivalent standard
and it covers the required scope, a GMP Clearance may be issued to the Australian
sponsor via desk top assessment pathway
The TGA reserves the right to undertake an inspection of an overseas manufacturing site,
irrespective of any other evidence supplied
• Evidence required will vary depending on the international agreements, location of the
manufacturer, the competent authority and complexity of the manufacturing process
– MRA assessment
– Compliance verification (CV) assessment
GMP Clearance Requirements for Medicines Manufactured Overseas 5
7. GMP Clearance - Desktop based assessment – MRA
Mutual Recognition Agreement (MRA):
• MRAs - treaties between Australia and other countries and are enforceable under
international law
• The parties to an MRA recognise and accept the certification issued by the relevant
regulatory agency in each country in relation to manufacturers located within that country.
• Evidence required for MRA assessment – GMP certificate
– The manufacturer must be located within the boarder of the MRA partner
– The manufacturer must be assessed against an equivalent GMP standard
– The inspection must be recent
– The inspection must cover the scope of the clearance application
– The manufacturer must be rated acceptable
GMP Clearance Requirements for Medicines Manufactured Overseas 6
8. GMP Clearance - Desktop based assessment – MRA
Countries which are recognised participants in an MRA (or equivalent) with Australia
Austria France Latvia Poland
Belgium Germany Liechtenstein Portugal
Canada Greece Luxembourg Singapore
Cyprus Hungary Malta Spain
Czech Republic Iceland Netherlands Sweden
Denmark Ireland New Zealand Slovak Republic
Finland Italy Norway Switzerland
United Kingdom
GMP Clearance Requirements for Medicines Manufactured Overseas 7
9. GMP Clearance - Desktop based assessment – MRA
Common “deficiencies” for MRA applications:
• Scope not supported by GMP certificate
• Human investigation medicinal GMP Certificate provided instead of human
medicines
• Expired certificate provided
• Manufacturer’s authorisation/Establishment licences provided instead of GMP
certificates
GMP Clearance Requirements for Medicines
Manufactured Overseas
8
10. GMP Clearance - Desktop based assessment – CV
Compliance Verification (CV) assessment
• Compliance verification assessments are permitted when there
is an international cooperation arrangement with the
competent authority:
MRA regulators outside own country
US FDA inspections
PIC/S authorities within own country
• Compliance Verification involves a detailed assessment by the TGA of specified
documentary evidence provided by the sponsor/manufacturer
GMP Clearance Requirements for Medicines Manufactured Overseas 9
11. GMP Clearance - Desktop based assessment – CV
CV – non sterile dosage form and non sterile APIs
• Current GMP Certificate
• a copy of the most recent inspection report
• A list of all regulatory inspections conducted within the past 3 years
• Details of any regulatory actions in the past 3 years
• Site Master File, Quality Manual or equivalent
• List of products intended for supply in Australia
• GMP agreement between the sponsor and the manufacturer*
• Copy of the procedures for release for supply of products included in the Clearance application*
GMP Clearance Requirements for Medicines Manufactured Overseas
10
12. GMP Clearance - Desktop based assessment – CV
CV – Additional Evidence for sterile/biotech APIs and Sterile Dosage forms
– Every document included in the previous slide
– Validation Master Plan
– Latest Product Quality
GMP Clearance Requirements for Medicines Manufactured Overseas 11
13. GMP Clearance - Desktop based assessment – CV
CV – Evidence for QC Testing Laboratories and Contract Sterilisers:
• Current GMP Certificate or relevant ISO certificate
• a copy of the most recent inspection report
• A list of all regulatory inspections conducted within the past 3 years
• Details of any regulatory actions in the past 3 years
• Quality Manual/Laboratory Manual or equivalent
• A list of tests a laboratory is authorised to perform
• GMP agreement between the sponsor and the contract testing laboratory or steriliser*
• For botanical ingredients, evidence that authenticated standard reference materials are used
GMP Clearance Requirements for Medicines Manufactured Overseas 12
14. GMP Clearance – Desk Top Assessment Pathway
Common “deficiencies” for CV applications:
• Incomplete application:
– GMP agreement, when applicable
– A copy of the most recent inspection report
– Latest Product Quality Review (PQR), when applicable
– List and details of regulatory Inspections in the last three years
– Manufacturer's declaration for APIs (when not covered during most
recent inspection), when applicable
• Inadequate evidence supporting the scope of applications
GMP Clearance Requirements for Medicines Manufactured Overseas 13
15. GMP Clearance – Desk Top Assessment Pathway
GMP clearance assessment outcome:
• Issue a GMP clearance
• Issue a GMP clearance with condition(s), or issue a GMP
clearance with reduced scope
• Not issue a GMP clearance
GMP Clearance Requirements for Medicines Manufactured Overseas 14
16. GMP Clearance Assessment Pathways
Product / Activity
MRA Regulator
(own country)
US FDA (all locations) or
PIC/s Regulator (own country) or
MRA Regulator (outside own
country)
PIC/s Regulator (outside
own country) or
All non-PIC/s regulators or
No Certification available
Non Sterile Medicines or
non Sterile API
MRA Clearance Compliance Verification – Type B TGA on-site inspection
Sterile Medicines or Sterile
API (including biotech)
MRA Clearance Compliance Verification – Type C TGA on-site inspection
Contract Testing
Laboratories
MRA Clearance Compliance Verification – Type C TGA on-site inspection
Contract Sterilisers MRA Clearance Compliance Verification – Type D TGA on-site inspection
GMP Clearance Requirements for Medicines Manufactured Overseas 15
17. GMP Clearance – sponsor responsibilities
• Maintain evidence of GMP compliance for all overseas manufacturing
sites used in the manufacture of their registered or listed medicine and
are responsible for these nominated sites at all times
• Prior to submission, ensure that:
– All information provided in the application is accurate, current and does not contradict the
corresponding information contained within the evidence provided
– The scope of the application is relevant to the activities carried out by the manufacturing site
and is reflected in the evidence provided
– All required evidence is attached when submitting the GMP certification or clearance application
or provided to TGA directly by the manufacturer
– For GMP clearance applications, that signed and effective GMP/Quality/Technical agreements
are in place and meet the relevant requirements, if required
GMP Clearance Requirements for Medicines Manufactured Overseas
16
18. GMP Clearance – sponsor responsibilities
• During processing, ensure that:
– Any additional information or clarification requested by the
TGA during the assessment of GMP certification or clearance
applications is provided within the specified timeframe
– Any updated evidence that becomes available while the
application is under review is provided to the TGA
GMP Clearance Requirements for Medicines Manufactured Overseas
17
19. GMP Clearance – sponsor responsibilities
• Post-approval, ensure that:
– You monitor regulatory actions by any competent overseas regulatory
authority (for example, recalls, unacceptable inspection findings,
warning letters, import alerts etc.) for manufacturing sites for which you
hold an active GMP clearance
– You maintain GMP / quality / technical agreements with your manufacturers
– You notify the TGA of these regulatory actions and of any significant changes to the
manufacturing site, quality management system (QMS), products or product range where the
changes could potentially impact the GMP compliance of the site
– You submit applications for renewal of a GMP clearance at least 6 months prior to the expiry of
the current clearance, or alternatively, if evidence for a renewal is not available, request TGA
certification
GMP Clearance Requirements for Medicines Manufactured Overseas
18
20. GMP Clearance Process Improvements
Initiatives implemented since June 2015
• Improved work management system (implemented June 2015) allowing better data
analysis
• Engaged additional staff with appropriate skill set and improved training process
• Updated internal guidance, work instructions and procedures
• Developed a forecasting tool for MRA applications to assist in managing processing
times
• Implemented a streamlined process for MRA applications
• Provided regular updates on the TGA website, via tBS and TIWGG
GMP Clearance Requirements for Medicines Manufactured Overseas 19
21. GMP Clearance Process Improvements
Achievements to date
• Reduced response time for emails received via GMP Clearance mailbox: from >3 weeks to ≤ 5
days
• Eliminated the MRA backlog of applications: from 800 to on average ~100-200
• Reduced MRA average processing timelines: from 18 weeks to ≤ 6 weeks
• Revised MRA processing target and consistently met the target timeline
• Eliminated the backlog of request for GMP Clearance extensions and transfers
• Eliminated the backlog of applications awaiting to be receipted: from >500 to on average ~50
• Reduced the total number of clearance applications in the system
GMP Clearance Requirements for Medicines Manufactured Overseas 20
22. GMP Clearance - Challenges
• Incomplete CV applications or inadequate evidence
• Inefficiency in processes:
• Unable to raise online invoices for CV assessment fee
• Multiple rounds of correspondence at receipt and assessment
phase
• Backlog of CV applications
GMP Clearance Requirements for Medicines Manufactured Overseas 21
23. GMP Clearance Data – Compliance Verification
Yet to be receipted
4%
Receipt In
Progress
1%
Awaiting Payment
7%
WOE
27%
Letters of Access
to be processed
8%
Yet to be assessed
- Total
35%
Assessment In
Progress - Total
18%
CV Applications
Data current as of 03rd July 2017
Total of ~1200 CV’s
WOE -
receipt
69%
WOE-
assessment
31%
Waiting on Evidence applications
332 applications are waiting on evidence
(almost 30% of all CV’s)
22
24. GMP Clearance Process Improvements
Current Initiatives
• clearly document requirements for GMP Clearance applications
GMP Clearance Guidance
• web based assistance tool to assist applicants preparing GMP Clearance applications
GMP Clearance Application Assistance Tool (CAAT)
• redesign of online GMP Clearance application forms
GMP Clearance Interim Solution
Streamline receipt and assessment processes for CV applications
Roadshows
GMP Clearance Requirements for Medicines Manufactured Overseas 23
25. GMP Clearance Process Improvements
Revised GMP Clearance Guidance – Key updates
• Structure, look and feel – readability, ease for future update
• Application submission - Step by step guide to submitting
applications with screenshots
• Evidence - additional information about evidence requirements
split into three headings:
− Why we require it
− What you should provide
− Take particular care
• Publication to coincide with launch of redesigned e-form and CAAT
GMP Clearance Requirements for Medicines Manufactured Overseas
24
26. Clearance Application Assistance Tool
(CAAT)
Scope & Timelines
• An interactive online tool to assist applicants in determining
the general evidence requirements for their GMP clearance
applications via desktop assessment pathways
• Complements the revised GMP Clearance Guidelines and
the redesigned e-forms
• Applicants will be able to access the tool directly from the
TGA website or via the new GMP Clearance application
forms
• Publication to coincide with launch of redesigned e-form and
revised GMP clearance guidance document
GMP Clearance Requirements for Medicines Manufactured Overseas 25
27. GMP Clearance Process Improvements
GMP Clearance Interim Solution – redesign of online application forms
• Improved user experience for applicants:
– reduce duplication in data entry - pre-populate information from Client database
– improved help functions
– More structured data entry
drop down lists/pick lists/radio buttons
– display evidence based on the application types
• Improved invoicing - all fees can be selected & paid at the time of submission
• Allowing extension requests to be submitted via TBS
• Improved application management by TGA
GMP Clearance Requirements for Medicines Manufactured Overseas 26
28. GMP Clearance Process Improvements
GMP Clearance Interim Solution – redesign of online application forms – Timelines
• Internal UAT completed by TGA staff in July 2017
• External UAT by industry representatives - 10th August 2017
• Aim to launch the new form in September, coincide with the publication of
revised GMP clearance guideline and CAAT
• Short outage before the new eforms go live
• Updates will be published on TGA website
GMP Clearance Requirements for Medicines Manufactured Overseas 27
29. GMP Clearance Roadshows
Industry Information sessions
Information sessions:
• Two half day sessions to be held in Melbourne and Sydney and 1 session in Brisbane between
5-7 September
• Provide updates to the GMP clearance guidance and redesign of the current GMP clearance e-
form
• Showcase the new web-based GMP clearance application assistance tool (CAAT) to provide
greater assistance to sponsors prior to submitting GMP clearance applications
REGISTER NOW through the TGA website – CLOSES COB Wednesday 23 August
GMP Clearance Requirements for Medicines Manufactured Overseas 28
30. GMP Clearance Roadshows
Industry Information sessions
Targeted audience:
• involved in submitting and/or preparing a GMP clearance application
for medicines or APIs via the desk top assessment pathway
• sponsoring or looking to sponsor medicines which are manufactured
(or partly manufactured) overseas and require GMP clearance for
your product registration or listing
• does not include sponsors of medical devices/biologicals or sponsors who obtain a GMP
clearance via an on-site TGA inspection of an overseas manufacturing site
GMP Clearance Requirements for Medicines Manufactured Overseas 29
31. Summary
• Overseas manufacturers must be verified for compliance against the principles of good
manufacturing practice
• GMP clearances are granted to Australian sponsors for a specific time period
• GMP Clearance can be obtained by:
− Desk top assessment pathway – MRA or compliance verification
− Successful on-site TGA Inspection
• Sponsors must be aware of their responsibilities
• Note key TGA initiatives, attend industry information sessions and keep an eye on
notices published on TGA website
GMP Clearance Requirements for Medicines Manufactured Overseas 30