In this presentation from, Janeen Santorosa discusses the best practices for harmonization of GMP auditing, domestic and international regulations for supplier auditing, integration of risk-based practices, and supplier audit practice tools.
This presentation from the Institute of Validation Technology's first annual Validation and cGMP Compliance Week Singapore discusses the obstacles to quality such, the key components to improve quality, and the tools for strategic teamwork.
This workshop examines the approach to Continued Process Verification and demonstrating that your product and process are operating in a state of control and continue to do so over the life of the product. Without any prior coordination, the theme was elaborated by the afternoon speakers once the conference itself was underway. The concept of “step up step down” for adjusting the level of product scrutiny both for process parameters monitoring and for sampling and testing quality attributes was explored and developed.
A comprehensive presentation on GMP systems and integration. This includes validations, vendor qualification, preventative maintenance, audits, CAPA, and utilization of system results.
Regulatory inspections have had a significant impact on the number of drug shortages and companies facing adverse regulatory actions.
Review of the inspection trends can be useful in assessing the regulatory status of your own company and help aid in the preparation for upcoming inspections. This session from IVT's Contamination and Control Week provides an in-depth, practical look at some of the recent Warning Letters and discusses current trends.
In this presentation from IVT's GMP Week, Journal of Validation Technology Editor-in-Chief, Paul Pluta, Ph.D., asks "can compliance be improved by using quality by design [QbD] concepts?" Pluta discussed the QbD application, development of validation master plans, and the lifecycle approach to process validation. Furthermore, he discusses how to incorporate these essential parts of the validation process to implement effective, and efficient, compliance by design into the quality system.
This presentation from the Institute of Validation Technology's first annual Validation and cGMP Compliance Week Singapore discusses the obstacles to quality such, the key components to improve quality, and the tools for strategic teamwork.
This workshop examines the approach to Continued Process Verification and demonstrating that your product and process are operating in a state of control and continue to do so over the life of the product. Without any prior coordination, the theme was elaborated by the afternoon speakers once the conference itself was underway. The concept of “step up step down” for adjusting the level of product scrutiny both for process parameters monitoring and for sampling and testing quality attributes was explored and developed.
A comprehensive presentation on GMP systems and integration. This includes validations, vendor qualification, preventative maintenance, audits, CAPA, and utilization of system results.
Regulatory inspections have had a significant impact on the number of drug shortages and companies facing adverse regulatory actions.
Review of the inspection trends can be useful in assessing the regulatory status of your own company and help aid in the preparation for upcoming inspections. This session from IVT's Contamination and Control Week provides an in-depth, practical look at some of the recent Warning Letters and discusses current trends.
In this presentation from IVT's GMP Week, Journal of Validation Technology Editor-in-Chief, Paul Pluta, Ph.D., asks "can compliance be improved by using quality by design [QbD] concepts?" Pluta discussed the QbD application, development of validation master plans, and the lifecycle approach to process validation. Furthermore, he discusses how to incorporate these essential parts of the validation process to implement effective, and efficient, compliance by design into the quality system.
In Industry there are lots failures related to the routine process, Equipment and System by one or other means.
So one must analyze control such failures in manner that it will not affect your ultimate output and obviously that is your Product and its Quality.
Regulatory aspect of pharmaceutical change control systemDeveshDRA
CHANGE CONTROL,BENEFITS OF CHANGE CONTROL SYSTEM,MANAGEMENT OF CHANGE AND CONTINUOUS IMPROVEMENT(Prepare a Change Proposal,Classify & Approve Proposed Changes,Develop an Implementation Plan, Install the Change,Verify Installation,Close out the change
) FLOW CHART OF CHANGE MANAGEMENT,HANDLING AND CONTROLLING CHANGES,SOP ON CHANGE CONTROL SYSTEM,
CATEGORY OF CHANGES(Major Changes,Moderate changes,Minor changes),ENSURING TRAINING & PROCEDURES IN A MANAGEMENT OF CHANGE PROGRAM,LEVEL OF APPROVAL,REGULATOR PROSPECTIVE OF CHANGE CONTROL(21 CFR Part 211: Sec. 211.100,21 CFR Part 211.194 (Laboratory Records),ICH Q7A,USFDA Guidance for Industry: Change to an approved NDA or ANDA ( April 2004- Revison-1)),CONCLUSION
,
The Validation Master Plan is a a valuable opportunity to provide an overview of your company’s validation process, including organization structure, content, and planning.
In this presentation from the Institute of Validation Technology's Life Sciences Aseptic Processing, Kim Van Antwerpen discusses collecting environmental data, methods for trending, and interpreting and sharing environmental monitoring data.
Almost all the regulatory bodies are expected to have Risk Based Quality System. Quality Risk and its assessment has tremendous output and benefits towards the Patient Safety.
Pharmaceutical Validation, its scope and types. Validation Team. validation Master plan. Validation protocols. Elements of Validation. Approaches of Validation. Dosage form Validation along with example of Validation of Tablet Dosage form.
A brief introduction of validation concept, its scope, advantage. Types of validation, stages of validation, Consideration in principle of validation. Prerequisites of validation, validation protocol, process validation, strategy of process validation of solid dosage form, validation report.
Analytical method validation.
In Industry there are lots failures related to the routine process, Equipment and System by one or other means.
So one must analyze control such failures in manner that it will not affect your ultimate output and obviously that is your Product and its Quality.
Regulatory aspect of pharmaceutical change control systemDeveshDRA
CHANGE CONTROL,BENEFITS OF CHANGE CONTROL SYSTEM,MANAGEMENT OF CHANGE AND CONTINUOUS IMPROVEMENT(Prepare a Change Proposal,Classify & Approve Proposed Changes,Develop an Implementation Plan, Install the Change,Verify Installation,Close out the change
) FLOW CHART OF CHANGE MANAGEMENT,HANDLING AND CONTROLLING CHANGES,SOP ON CHANGE CONTROL SYSTEM,
CATEGORY OF CHANGES(Major Changes,Moderate changes,Minor changes),ENSURING TRAINING & PROCEDURES IN A MANAGEMENT OF CHANGE PROGRAM,LEVEL OF APPROVAL,REGULATOR PROSPECTIVE OF CHANGE CONTROL(21 CFR Part 211: Sec. 211.100,21 CFR Part 211.194 (Laboratory Records),ICH Q7A,USFDA Guidance for Industry: Change to an approved NDA or ANDA ( April 2004- Revison-1)),CONCLUSION
,
The Validation Master Plan is a a valuable opportunity to provide an overview of your company’s validation process, including organization structure, content, and planning.
In this presentation from the Institute of Validation Technology's Life Sciences Aseptic Processing, Kim Van Antwerpen discusses collecting environmental data, methods for trending, and interpreting and sharing environmental monitoring data.
Almost all the regulatory bodies are expected to have Risk Based Quality System. Quality Risk and its assessment has tremendous output and benefits towards the Patient Safety.
Pharmaceutical Validation, its scope and types. Validation Team. validation Master plan. Validation protocols. Elements of Validation. Approaches of Validation. Dosage form Validation along with example of Validation of Tablet Dosage form.
A brief introduction of validation concept, its scope, advantage. Types of validation, stages of validation, Consideration in principle of validation. Prerequisites of validation, validation protocol, process validation, strategy of process validation of solid dosage form, validation report.
Analytical method validation.
This full day presentation gives an overview of the process validation lifecycle approach, the FDA PV Guidance, the lifecycle approach to cleaning validation, equipment qualification, and validation quality systems.
Pharmaceutical Product & Process Design & QualityAjaz Hussain
A reflection on progress made, and challenges to be addressed, in realizing the desired state articulated by the the FDA Initiative on Pharmaceutical Quality for the 21st Century.
This Annex describes the principles of qualification and validation which are applicable to the facilities, equipment, utilities and processes used for the manufacture of medicinal products and may also be used as supplementary optional guidance for active substances without introduction of additional requirements to EudraLex, Volume 4, Part II. It is a GMP requirement that manufacturers 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. Computerised systems used for the manufacture of medicinal products should also be validated according to the requirements of Annex 11. The relevant concepts and guidance presented in ICH Q8, Q9, Q10 and Q11 should also be taken into account.
Highlights of the guidance are given in following presentation.
FDA Process Validation Guidance (Guidance for Industry: Process Validation- General Principles and Practices, Jan. 2011) outlines process validation activities in three stages - Stage 1: Process Design, Stage 2: Process Qualification and Stage 3: Continued Process Verification. Completion of Stage 2 subsequent to Stage 1 is a major milestone in the Process Validation Lifecycle as it confirms the process design and demonstrates the expected consistent performance of the manufacturing process. Knowledge and information gained from the design stage through the process qualification stage is used to complete this assessment. Stage 2 demonstrates suitability for successful commercial distribution where the data indicates that the process meets the conditions established in the protocol. Continued Process Verification is initiated for the subsequent commercial batches. Stage 3 assures that the process remains in a state of control during commercial manufacture.
This presentation gives a practical approach to implement the stage 3 of the FDA Process Validation Guide.
Pharmaceutical quality decisions are made by multidisciplinary teams (a range of maturity), at different times and in various organizations; understanding of the QbD paradigm and methodology is derived experientially -One Quality Voice is hard to achieve!
Legacy challenges, various ontological assumptions, and weak epistemology curtails knowledge sharing, delays consensus and keeps us trapped in a reactive mode (3rd Order)
The risk of irrational decision making needs to be accounted. ”Cut-paste” or “check-the-box” practices are reminders that we are not achieving an optimal integration or practicing systems thinking.
A reactive approach (3rd Order) to filling the noted gaps poses risk of continued erosion in the confidence the public should have in our assurance of pharmaceutical quality
We need a thoughtful, planned approach to filling these gaps –NIPTE should take on this challenge! Will it?
Define, select, and apply various techniques including supplier qualification, certification, evaluation, ratings, performance
improvement, and so on.
The #DROOS_FLGAWDA channel is dedicated to providing scientific content that effectively contributes to building knowledge among interested and quality workers as well as manufacturers and service providers so that they can achieve their products better, faster and at the lowest cost.
Simply channel #DROOS_FLGAWDA... will change your life for the better
JOIN-US FOR FREE
https://goo.gl/4S8PQ8
SAI Global Webinar: BRC Food Safety Issue 8Switzerland09
In August 2018, the BRC Global Standard for Food Safety will move from issue 7 to issue 8. This is the slide deck from a live webinar on July 9th which shares insight into the changes.
Quality audit is defined as a systematic and independent examination to determine whether activities and related results comply with planned arrangements and whether these arrangements are implemented effectively and are suitable to achieve objectives Quality audit means a systematic examination of a quality system
Quality audits are typically performed at defined intervals
.Definition
Objectives
Difference between Quality audit and Periodic evaluation
Self inspection
Types of Quality Audit
Role OF GMP Audit in QA and QC programmes
Elements of a Systemic Audit program
Dr. V. S. Kashikar
U.S.F.D.A. was the pioneer in the concept of process validation.
Validation had proven to be an important tool for quality management of pharmaceutical according to ISO 9000:2000.
U.S.F.D.A. was the pioneer in the concept of process validation.
Validation had proven to be an important tool for quality management of pharmaceutical according to ISO 9000:2000.
Introduction types, Objectives, Management of audit, Responsibilities, Planni...Kunal10679
Audit and regulatory Compliance M.pharmacy Quality Assurance department Sem. 2 Introduction types, Objectives, Management of audit, Responsibilities, Planning Process, Information Gathering, Classifications of Deficiencies of auditing
The three-day course, "Introduction to CMMI", introduces participants to the fundamental concepts of the CMMI model. The course assists companies in integrating best practices from proven discipline-specific process improvement models, including systems engineering, software engineering, integrated product and process development and supplier sourcing.
The course is composed of lectures and class exercises with ample opportunity for participant questions and discussions. After attending the course, participants will be able to describe the components of CMMI, discuss the process areas in CMMI, and locate relevant information in the model.
The workshop will help the participants to:
Understand the CMMI framework
Understand the detailed requirements of the process areas in the CMMI V1.3
Make valid judgments regarding the organization's implementation of process areas
Identify issues that should be addressed in performing process improvements using the CMMI V1.3
In this presentation from IVT's 4th Annual Validation Week EU, Paul Pluta, discussed the differences between the traditional approach to cleaning validation and the lifecycle approach, applicable regulatory guidance, current industry trends, the necessary phases of the lifecycle approach (design and definition, cycle development, validation, and implementation), how to continously monitor the process, change control, and common obstacles to compliance.
This session from the Institute of Validation Technology's 14th Annual CSV Conference looks at B. Braun’s journey in moving from an in-house validated training tracking system to learning management in the cloud.
In this session from the Institute of Validation Technology's Validation Week Europe, Kurtis Epp and John Kandl discuss how to implement QbD to all three stages of process validation.
This session from the Institute of Validation Technology's Contamination and Control Week discusses regulatory expectations and industry drivers for aseptic cleaning and environmental monitoring, regulatory expectations for cleanrooms, and current FDA and EU expectations during inspection of sterile and aseptic operations.
Regulatory guidelines on stability testing are mainly designed to address studies that will be applied to support NDAs. However, in any pharmaceutical development program, a number of other stability studies are also required, for example, to help select appropriate formulations and to support regulatory applications for clinical programs. This session from the Institute of Validation Technology's Stability Programs Forum outlines a number of examples of early development stability studies.
This presentation from IVT's 4th Annual reviews what to do when you have an exception, critical vs. non-critical exceptions, and learning how to prevent exceptions.
This presentation from IVT's 4th Annual Validation Week Europe provided a thorough explanation of developing a gap analysis, areas in validation that are issues of concern, and FDA expectations of a manufacturer's gap analysis.
In this presentation from Validation Week Europe, Karen Ginsbury discusses the rigors, preparations, strategies, and the do's and the don't of the FDA Inspection process.
This presentation from IVT's 2nd Annual Validation Week Canada covers the 2011 FDA Process validation and the subsequent statistical processes. Statistics in process validation is introduced as well as the integration with six sigma and solutions to common mistakes.
This presentation from IVT Network's Method Validation Conference covers required and suggested regulations and guidances for biological process specifications. It also covers dosage form considerations and specifications for other components.
This presentation from the Institute of Validation Technology's 7th Annual Method Validation covers regulatory expectations for deviations and out-of-specification results and protocol exceptions, change control, handing investigations and CAPAs, and avoiding common pitfalls.
In this presentation from IVT's Qualifying and Validating Cloud and Virtualized IT Infrastructures, Chris Wubbolt and John Patterson focus on current trends in cloud computing environments, including aspects of cloud computing and Software-as-a-Service (SaaS) providers that may be of interest to US Food and Drug Administration investigators during an FDA inspection. Important compliance related points to consider for software vendors as they shift to becoming SaaS providers are discussed. The presentation also reviews the pros and cons of cloud computing from a business and compliance perspective, including differences between traditional computing environments and private/public clouds. Examples of issues to consider when using cloud computing environments and SaaS providers are also discussed.
The FDA now defines process validation as “the collection and evaluation of data, from the process design stage throughout production, which establishes scientific evidence that a process is capable of consistently delivering quality products.” On-going process validation is therefore the most important practical outcome of any QbD program. This sessions helps make the connection between process validation and QbD and why QbD starts in process development and doesn’t end in manufacturing.
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
Anti ulcer drugs and their Advance pharmacology ||
Anti-ulcer drugs are medications used to prevent and treat ulcers in the stomach and upper part of the small intestine (duodenal ulcers). These ulcers are often caused by an imbalance between stomach acid and the mucosal lining, which protects the stomach lining.
||Scope: Overview of various classes of anti-ulcer drugs, their mechanisms of action, indications, side effects, and clinical considerations.
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!
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
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
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
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
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
2. Presentation Overview
• Best Practices for harmonization
• Domestic and international guidances,
standards and regulations
• Integrating valuable risk based and
sustainable practices
• Supplier audit practice tools
Copyright Nelson Laboratories
2011
2
3. Harmonization Objectives
FDA’s goals in participating in international
harmonization include:
• To safeguard U.S. public health
• To assure that consumer protection standards and
requirements are met
• To facilitate the availability of safe and effective
products
• To develop and utilize product standards and other
requirements more effectively
• To minimize or eliminate inconsistent standards
internationally
Copyright Nelson Laboratories
2011
3
4. Benefits…
• We are ultimately responsible for assuring the
quality and compliance of our products.
• Aligning goals = reaching high levels of
performance without excessive costs or
redundant or conflicting requirements.
• Avoid the risk of service/product failures.
• Ensure specifications match supplier capabilities
to avoid issues.
• Supplier Benefit: Increased knowledge and better
understanding of customer expectations.
Copyright Nelson Laboratories
2011
4
5. Harmonized Requirements
• Comparison Chart outlining supplier qualification
• Similarities but with different applications
include:
• ICH-Manufacturers of intermediates and/or API’s should
have a system(s) in place for evaluating suppliers of
critical material. Materials should be purchased against
an agreed specification from supplier or suppliers
approved by the quality units.
• GHTF-When selecting potential suppliers the
manufacturer should investigate their business and
operational capability. Select potential suppliers
according to predefined criteria and the results of
capability investigations.
Copyright Nelson Laboratories
2011
5
6. Best Practices
• Developing a risk based sustainable approach
• Systems for managing and controlling
suppliers include:
• Qualification
• Audits (paper/onsite), third-party certification)
• Assessments (intervals)
• Agreements (quality/change)
• Monitoring (continuous)
Copyright Nelson Laboratories
2011
6
7. Audits
• Comparison Chart outlining supplier audits
• Similarities but with different applications
include:
• GHTF - Depending on the risk of the supplied
product/service, the manufacturer may plan and
perform periodic supplier re-evaluations,
regardless of whether problems have been
identified.
• TGA - Period Review: As part of the qualification
process a program for Periodic Review should be
established.
Copyright Nelson Laboratories
2011 7
8. Audits
Base supplier audits on type of risk (e.g. service
provided, supplies purchased, third party
certifications).
Definitions:
• GHTF/SG4/N33 “critical supplier” is a supplier delivering materials,
components, or services that may influence the safety and
performance of the product.
• ICH Q7: “Critical describes a process step, process condition, test
requirement, or other relevant parameter or item that must be
controlled within predetermined criteria to ensure that the API
meets its specification”.
• ICH Q9: “Risk is the combination of the probability of occurrence of
harm and the severity of the harm to the patient or consumer”.
Copyright Nelson Laboratories
2011
8
9. Audits
• Rate supplier audits on risk-based process
approach.
• Risk level drives the relation of supply/supplier.
The level of action addresses the supplier
situation individually and provides measureable
controls around the supplier.
• Tailor internal resources: Identify supplier risk
during receipt inspection, QC verification,
in-process inspection and final inspection.
Copyright Nelson Laboratories
2011
9
10. Audits
Example of Risk Levels:
• Level 1: The highest risk suppliers that have a
critical impact on the quality or availability of your
product
• Level 2: Significant risk suppliers that have a direct
impact on your product, alternatives are available
• Level 3: Moderate risk suppliers that have an
indirect impact on the product
• Level 4: Low risk suppliers that have no product
impact
10
Copyright Nelson Laboratories
2011
11. Audits
Example: Supplier audits based on
risk level – Action
Copyright Nelson Laboratories
2011
11
Level 1 Action
High risk supplier/service provider On-site audit
Level 3 Action
Moderate risk supplier Written audit
Level 4 Action
Low risk supplier Limited assessment / Audit not
applicable
12. Audits
Audit Frequency
Audit frequency is established based on risk and
performance (annual, biennial, triennial)
Frequency may change based on detection inputs from
assessment tools.
Increase audit frequency for adverse findings
Dependent on the status of third party certifications
Monitor supplier certifications = ensure
qualification programs are maintained
Copyright Nelson Laboratories
2011
12
14. Assessments
• Comparison Chart outlining supplier assessments
• Similarities but with different applications
include:
• ICH Q10-Monitor and review the performance of the
contract acceptor or the quality of the material from
the provider
• EU Volume 4 Part II-Have system for evaluating
suppliers of critical materials, monitor
• GHTF-Depending on risk of suppliers may plan and
perform periodic re-evaluations
Copyright Nelson Laboratories
2011
14
15. Agreements
• Agreements ensure the quality of purchased
products/services.
• Quality Agreements = Agree to the QMS
expectations, define responsibility
• Change Agreements = Notification requirements
of changes in order to assess impact to your
process/product.
• Service Agreements
• Purchase Order
Copyright Nelson Laboratories
2011
15
16. Agreements
• Comparison Chart outlining supplier agreements
• Similarities but with different applications
include:
• EU Volume 4 Part II-Formal agreement that defines/details
GMP responsibilities, quality measures of each party
• 21 CFR 820.50-Establish and maintain purchasing data with
specified requirements, notification of change agreements
• Health Canada-Written agreement outlining the specific
responsibilities of each party involved. Specify that the raw
material vendor must inform the drug fabricator of any
changes in the processing or specifications of the raw
material.
Copyright Nelson Laboratories
2011
16
17. Supplier Rating
• Supplier Scorecard results in improved supplier
performance, minimizes risk and sustains the
supply base.
• Develop scorecards with corporate
goals/objectives in mind.
• Quality, compliance, service, on-time delivery, cost
• “Where performance is measured, performance
improves”.
Copyright Nelson Laboratories
2011
17
18. Supplier Rating
• Supplier scorecards are used to measure and
monitor supplier performance.
• Identify attributes, agreements, factors and attribute
ratings
• Ensure the “highest factor” is what is most important
to your business needs
• Establish ratings: 90-100=Excellent,
75-89=Satisfactory, less than
75=Unsatisfactory
• Identify corrective action if applicable
Copyright Nelson Laboratories
2011
18
20. Integrating valuable risk based and
sustainable practices
• Ensure process is sustainable with growth of
supplier base and adheres to standards
necessary to support quality and compliance.
• Pre-defined decision tree for consistent
determinations and justifications
• Risk based decision tree helps maintain
consistency and provides justification as to why
the audit type, or lack thereof is chosen.
Copyright Nelson Laboratories
2011
20
21. Integrating valuable risk based and
sustainable practices
Example: Decision Tree
•EXAMPLE
Copyright Nelson Laboratories
2011
21
Risk Assessment for Calibration Subcontractor Action
Certified to ISO 17025? Yes= Obtain cert for file
No= Written audit
Risk Assessment for Critical Component Action
Custom Built product? Yes=On-site audit
No= Go to next question
Certified to ISO? (applicable standard) Yes= Obtain cert for file
No= Written audit
22. Summary of Tools
• Objectives and goals
• Audits, assessments, agreements
• Risk Management: Ongoing supplier monitoring
• Audit selection based on supplier risk profile
• Supplier rating (Scorecard)
• Comparison tables
• Domestic and international reference tool
Copyright Nelson Laboratories
2011
22
23. Domestic and International
References
• GHTF/SG3/N17:2008- Control of Suppliers
• GHTF/SG3/N15R8- Risk Management Principles in a QMS
• GHTF/SG4/N84:2010 Guidelines for Regulatory Auditing of Quality Management Systems of
Medical Device Manufacturers Part 5: Audits of Manufacturer Control of Suppliers
• Health Canada - Good Manufacturing Practices (GMP) Guidelines GUI-001
• ICH Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients
• ICH Q10 Pharmaceutical Quality System
• EU Guidelines to GMP Part II Basic Requirements for Active Substances used as Starting
Materials
• ISO 13485 (Harmonized quality system standard adopted in Europe for medical devices)
• ISO 9000:2008 Principle 8: Mutually beneficial supplier relationships
• Japan Pharmaceutical Affairs Law (JPAL Ordinance 169)
• 21 CFR Part 210/211 21 CFR 820 Quality System Regulation(QSR)
• FDA’s “Guidance for Industry Quality Systems Approach to Pharmaceutical cGMP Regulations,
• Australian Government- Technical Guidance on the Interpretation of Manufacturing
Standards
• PIC/S Guide to Good Manufacturing Practice for Medicinal Products
Copyright Nelson Laboratories
2011
23