COVID-19 pandemic has put manufacturers, affiliates and inspectors in a new and challenging situation where it is in the public interest to continue to supply medicines while ensuring demonstrated compliance. Regulatory agencies coming with the idea for conducting remote inspection across foreign manufacturing site
Equipment risk management - a quality systems approachPalash Das
Refer before performing risk assessment for pharmaceutical equipment. Can be considered before preparation of User Requirement Specification. in case of existing equipment can be prepare as a part of annual risk review.
A review article on visual inspection program for sterile injectable product ...Palash Das
Objective of this article is to conduct a thorough review and understanding on the manually
conduct visual inspection process for liquid Injectable products in liquid and lyophilized form
and to explore the complications identified during the routine process. Along with that
troubleshot to overcome from the challenges. Evaluation quality of product during batch
release and consider continuous process improvement opportunities.
This article will provide clarity on all below mentioned points,
FDA Audit - The Do and Don't List
How to Prepare for a FDA Inspection
FDA Basics for Industry > What should I expect during an inspection?
What to Expect When Being Inspected - FDA
FDA Inspections: Face the Challenge Through Proactive PreparationTips to Help You Prepare for an FDA Inspection
Inspection Readiness
US food and drug administration Indian site inspections: An experience
Dealing with a "difficult" FDA investigator
Strategies For Managing FDA Inspection Compliance Risks
Dear Readers,
Through PRES we are trying to connect with the Global Pharma community. Where we discussed, share and explore lots of pharmaceutical hot topics. Being a Pharma professional it is very difficult to get time for own to do something different other than routine responsibilities. Hope you all paraprofessionals are agreed with my views.
That’s you, the readers and followers of my blog, who always encouraged me a lot to do something different than my routine schedule. All the information are easily available web media, I am just trying too collate all those information in a single article.
I have collated the information’s broadly from the Pharmacompliancemonitor, FDA and other regulatory website for this article.
Once again I would like to thanks my readers, followers and seniors, who has encourage me a lot.
PRES Mission
To develop scientifically sound, practical, technical information and resources to advance science and regulation for the pharmaceutical industry
PRES Vision
To be the foremost global provider of science, technology, and regulatory information and education for the pharmaceutical community
Cleaning Validations Using Extraction TechniquesAnita Anzo
Scheduled On : Monday, November 4, 2013 at 1:00 PM EDT
Duration: 60 minutes
this webinar is recorded
visit us at https://www.compliancetrainings.com/SiteEngine/ProductDetailView.aspx?id=MD1141
QC Multi rules - Improving Laboratory Performance Through Quality ControlRandox
Randox Quality Control's latest educational guide examines and explains what QC Multi-Rules are, How to identify an out of control event with QC rules, How to use QC Multi-Rules, The different types of analytical errors, The tools to assist labs and how a lab can troubleshoot QC errors.
Design of Experiments, or DOE as it is commonly known in the industry, is defined as a “branch of applied statistics that deals with planning, conducting, analyzing, and interpreting controlled tests to evaluate the factors that control the value of a parameter or group of parameters” by ASQ. At a basic level, DOE is one of the most powerful data collection and analysis tools available, regarded as one of the best ways to predict process variability. Although DOE can be applied to experimental situations in any industry, it is especially useful in the medical device and pharmaceutical spaces...
Equipment risk management - a quality systems approachPalash Das
Refer before performing risk assessment for pharmaceutical equipment. Can be considered before preparation of User Requirement Specification. in case of existing equipment can be prepare as a part of annual risk review.
A review article on visual inspection program for sterile injectable product ...Palash Das
Objective of this article is to conduct a thorough review and understanding on the manually
conduct visual inspection process for liquid Injectable products in liquid and lyophilized form
and to explore the complications identified during the routine process. Along with that
troubleshot to overcome from the challenges. Evaluation quality of product during batch
release and consider continuous process improvement opportunities.
This article will provide clarity on all below mentioned points,
FDA Audit - The Do and Don't List
How to Prepare for a FDA Inspection
FDA Basics for Industry > What should I expect during an inspection?
What to Expect When Being Inspected - FDA
FDA Inspections: Face the Challenge Through Proactive PreparationTips to Help You Prepare for an FDA Inspection
Inspection Readiness
US food and drug administration Indian site inspections: An experience
Dealing with a "difficult" FDA investigator
Strategies For Managing FDA Inspection Compliance Risks
Dear Readers,
Through PRES we are trying to connect with the Global Pharma community. Where we discussed, share and explore lots of pharmaceutical hot topics. Being a Pharma professional it is very difficult to get time for own to do something different other than routine responsibilities. Hope you all paraprofessionals are agreed with my views.
That’s you, the readers and followers of my blog, who always encouraged me a lot to do something different than my routine schedule. All the information are easily available web media, I am just trying too collate all those information in a single article.
I have collated the information’s broadly from the Pharmacompliancemonitor, FDA and other regulatory website for this article.
Once again I would like to thanks my readers, followers and seniors, who has encourage me a lot.
PRES Mission
To develop scientifically sound, practical, technical information and resources to advance science and regulation for the pharmaceutical industry
PRES Vision
To be the foremost global provider of science, technology, and regulatory information and education for the pharmaceutical community
Cleaning Validations Using Extraction TechniquesAnita Anzo
Scheduled On : Monday, November 4, 2013 at 1:00 PM EDT
Duration: 60 minutes
this webinar is recorded
visit us at https://www.compliancetrainings.com/SiteEngine/ProductDetailView.aspx?id=MD1141
QC Multi rules - Improving Laboratory Performance Through Quality ControlRandox
Randox Quality Control's latest educational guide examines and explains what QC Multi-Rules are, How to identify an out of control event with QC rules, How to use QC Multi-Rules, The different types of analytical errors, The tools to assist labs and how a lab can troubleshoot QC errors.
Design of Experiments, or DOE as it is commonly known in the industry, is defined as a “branch of applied statistics that deals with planning, conducting, analyzing, and interpreting controlled tests to evaluate the factors that control the value of a parameter or group of parameters” by ASQ. At a basic level, DOE is one of the most powerful data collection and analysis tools available, regarded as one of the best ways to predict process variability. Although DOE can be applied to experimental situations in any industry, it is especially useful in the medical device and pharmaceutical spaces...
Acusera 24.7 Interlaboratory Data Management - June 17 LT244Randox
Acusera 24.7 Live Online version 2.0 is here! Faster, smarter and more efficient than ever before, this interlaboratory data management program will be sure to help streamline internal QC in all laboratories regardless of size.
Ethocle Reports has published its latest Market Research Report on Deep Brain Stimulators - Medical Devices Pipeline Assessment, 2016. Formulate significant competitor information, analysis, and insights to improve R&D strategies. Browse market data tables and figures.
Quality Control for Point of Care Testing - White PaperRandox
Point of care testing (POCT) refers to testing that is performed near or at the site of a patient with the result leading to a possible change in the care of the patient. Over the past few years, the popularity and demand of POCT has been growing rapidly. This should come as no surprise as there are many advantages to POCT, for example, the added convenience of being able to obtain a rapid result at the patient’s bedside, thus allowing immediate action, saving time and improving the potential outcome for the patient.
Ethocle Reports has published its latest Market Research Report on Cardiac Valve Repairs - Medical Devices Pipeline Assessment, 2016. Formulate significant competitor information, analysis, and insights to improve R&D strategies. Browse market data tables and figures.
RIQAS is the largest international External Quality Assessment (EQA)/ Proficiency Testing (PT) scheme, there are currently more than 45,000 participants in 133 countries.
Designing an appropriate QC procedure for your laboratoryRandox
Improving Laboratory Performance Through Quality Control - Five Simple Steps for QC Success.
It is easy to get caught up in an abundance of QC statistics and forget the fundamental reason why
QC exists in the first instance. QC is about detecting errors and ensuring that the results you
produce are accurate and reliable. All QC procedures should focus on reducing the risk of harm
to the patient. We are not examining statistics; we are examining real patients, real results and real
lives. Around 70% of all medical decisions are based on laboratory results, which is why it is of
utmost importance that each and every laboratory, has a well-designed QC procedure in place.
Ethocle Reports has published its latest Market Research Report on Cardiac Valve Repairs. Formulate significant competitor information, analysis, and insights to improve R&D strategies. Browse market data tables and figures.
Ethocle Reports has published its latest Market Research Report on Drug Eluting Stents (DES) - Medical Devices Pipeline Assessment, 2016. Formulate significant competitor information, analysis, and insights to improve R&D strategies. Browse market data tables and figures.
Ethocle Reports has published its latest Market Research Report on Peripheral Vascular Stents - Medical Devices Pipeline Assessment, 2016. Formulate significant competitor information, analysis, and insights to improve R&D strategies. Browse market data tables and figures.
http://MedicalDeviceEvents.com At the 10x Medical Device Conference in 2014, presenters Carrie Kuehn, Jorge Ochoa, and Robert Packard explained why, according to data from FDA, more than 58% of 510(k) submissions were refused under FDA’s Refuse to Accept (RTA) policy during its first year of implementation.
This presentation examined some of the reasons why industry got such a bad “grade.” We discussed the RTA requirements and some of the challenges from industry’s perspective on meeting the requirements of the RTA checklist and ended with recommendations on how industry can improve its odds of getting past the RTA hurdle on the first try.
How to establish QC reference ranges - Randox QC Educational GuideRandox
Establishing QC reference ranges is an important aspect of laboratory quality. Find out how to effectively set reference ranges with our educational guide.
Acusera 24.7 Interlaboratory Data Management - June 17 LT244Randox
Acusera 24.7 Live Online version 2.0 is here! Faster, smarter and more efficient than ever before, this interlaboratory data management program will be sure to help streamline internal QC in all laboratories regardless of size.
Ethocle Reports has published its latest Market Research Report on Deep Brain Stimulators - Medical Devices Pipeline Assessment, 2016. Formulate significant competitor information, analysis, and insights to improve R&D strategies. Browse market data tables and figures.
Quality Control for Point of Care Testing - White PaperRandox
Point of care testing (POCT) refers to testing that is performed near or at the site of a patient with the result leading to a possible change in the care of the patient. Over the past few years, the popularity and demand of POCT has been growing rapidly. This should come as no surprise as there are many advantages to POCT, for example, the added convenience of being able to obtain a rapid result at the patient’s bedside, thus allowing immediate action, saving time and improving the potential outcome for the patient.
Ethocle Reports has published its latest Market Research Report on Cardiac Valve Repairs - Medical Devices Pipeline Assessment, 2016. Formulate significant competitor information, analysis, and insights to improve R&D strategies. Browse market data tables and figures.
RIQAS is the largest international External Quality Assessment (EQA)/ Proficiency Testing (PT) scheme, there are currently more than 45,000 participants in 133 countries.
Designing an appropriate QC procedure for your laboratoryRandox
Improving Laboratory Performance Through Quality Control - Five Simple Steps for QC Success.
It is easy to get caught up in an abundance of QC statistics and forget the fundamental reason why
QC exists in the first instance. QC is about detecting errors and ensuring that the results you
produce are accurate and reliable. All QC procedures should focus on reducing the risk of harm
to the patient. We are not examining statistics; we are examining real patients, real results and real
lives. Around 70% of all medical decisions are based on laboratory results, which is why it is of
utmost importance that each and every laboratory, has a well-designed QC procedure in place.
Ethocle Reports has published its latest Market Research Report on Cardiac Valve Repairs. Formulate significant competitor information, analysis, and insights to improve R&D strategies. Browse market data tables and figures.
Ethocle Reports has published its latest Market Research Report on Drug Eluting Stents (DES) - Medical Devices Pipeline Assessment, 2016. Formulate significant competitor information, analysis, and insights to improve R&D strategies. Browse market data tables and figures.
Ethocle Reports has published its latest Market Research Report on Peripheral Vascular Stents - Medical Devices Pipeline Assessment, 2016. Formulate significant competitor information, analysis, and insights to improve R&D strategies. Browse market data tables and figures.
http://MedicalDeviceEvents.com At the 10x Medical Device Conference in 2014, presenters Carrie Kuehn, Jorge Ochoa, and Robert Packard explained why, according to data from FDA, more than 58% of 510(k) submissions were refused under FDA’s Refuse to Accept (RTA) policy during its first year of implementation.
This presentation examined some of the reasons why industry got such a bad “grade.” We discussed the RTA requirements and some of the challenges from industry’s perspective on meeting the requirements of the RTA checklist and ended with recommendations on how industry can improve its odds of getting past the RTA hurdle on the first try.
How to establish QC reference ranges - Randox QC Educational GuideRandox
Establishing QC reference ranges is an important aspect of laboratory quality. Find out how to effectively set reference ranges with our educational guide.
Writing SOPs or procedural documents can be challenging at times. However, writing SOPs is overall a straightforward process. However, enforcing what you already created and implemented in the pipeline is another story. The term SOP is very obvious. We have seen "clearly written description of how specific tasks are to be done." Another satisfactory definition would be "detailed written instructions that achieve the uniformity of the performance of a specific function." Is the firm doing what the regulations specify? Is the firm doing what their procedures specify? If you are medical device or a pharmaceutical manufacturer, these definitions come as no surprise because when it comes to FDA regulations and guidance documents "establish" means to define, to document (in writing or electronically) and to implement.
Making Life Easier for Investigators: A Shared Solution for Smarter, Faster C...Cognizant
The industry's Shared Investigator Platform significantly reduces the time and cost of clinical trials, simplifying work for investigators and bringing promising therapies to market more quickly.
Pharmaceutical qualification and validations trainingMarcep Inc.
INTRODUCTION
This summit outlines the general principles and approaches that FDA considers appropriate elements of process validation for the manufacturing of any pharmaceutical product, including APIs or drug item, referred to in this training summit as drugs. This training summit incorporates principles and approaches that all pharmaceutical manufacturers can use to validate manufacturing processes in their respective organizations
after attending the course.
Cloud Based Covid 19 Testing Management Systemijtsrd
Nowadays, COVID19 Testing Management System is one of the most essential tools that are mostly used in Testing Lab it is mostly used to manage COVID19 medical lab related activities. In this project we tried to develop a computerized and web based Cloud COVID19 Testing management system. Our main intention is to allow this application to be used in most retailing COVID19 lab, where a small point of customization will be required to each COVID19 lab in the implementation period. This system is designed to overcome all challenges related to the management of diagnostic that were used to be handled locally and manually. The system is an online COVID19 lab manager application that brings up various COVID19 test working online. Using this system, it will help us to records all transaction made at the daily tests recognize all customers, employees, etc. It will manage all activities around the COVID19 lab that increases productivity and maximize profit, it will also be minimizing the risk of getting loss because all transactions are recorded to the system. Rinzen Wangyal | Dr. Murugan R "Cloud Based Covid-19 Testing Management System" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-6 | Issue-3 , April 2022, URL: https://www.ijtsrd.com/papers/ijtsrd49741.pdf Paper URL: https://www.ijtsrd.com/engineering/software-engineering/49741/cloud-based-covid19-testing-management-system/rinzen-wangyal
On the occasion of Discussion Forum on ICH Q7 & ICH Q11 of more than 450 experienced practicing professionals gathering of pharmaceutical manufacturing industry scheduled at ICCBS, University of Karachi organized by CCK on 23 April 2017
Maetrics: The ROI of Good Quality & ComplianceGeneris
On October 5th, 2016 at the American Medical Device Summit in Chicago, Generis welcomed Maetrics to the speaker panel on Day One.
Ed Roach brings nearly 20 years of experience in the life sciences industry to the panel while adding his wealth of knowledge on Quality Systems and Quality Assurance, Validation, Corrective and Preventive Actions (CAPS), Root Cause Investigation, Change Management, and 483/Warning Letter Remediation to the American Medical Device Summit.
Generis is thrilled that Maetrics will be returning to Chicago for the American Medical Device Summit on October 4th and 5th in 2017.
Clinical evaluation and the latest 2016 guidelineGRCTS
This “General Guidance” document promotes a common approach to clinical evaluation for "medical devices regulated by directives 90/385/EEC and 93/42/EEC. It does not concern in vitro diagnostic devices. The depth and extent of clinical evaluations should be flexible and appropriate to the nature, intended purpose, and risks of the device in question.
On Monday, the FDA provided an update on its software precertification program known commonly as the Pre-Cert Program. This update comes over a year since the first working model of the pilot program was published by the agency, and nearly 3 years since the pilot was kicked off. With big-name participants like Apple, Fitbit, and Samsung being among the nine pilot participants, an update to this first of its kind program from the agency has been highly anticipated...
On Monday, the FDA provided an update on its software precertification program known commonly as the Pre-Cert Program. This update comes over a year since the first working model of the pilot program was published by the agency, and nearly 3 years since the pilot was kicked off. With big-name participants like Apple, Fitbit, and Samsung being among the nine pilot participants, an update to this first of its kind program from the agency has been highly anticipated...
Safety & Regulatory Solutions for Small and Medium-sized Life Science Organiz...Covance
A key issue for small and medium-sized enterprises is the optimal utilization of their limited resources for moving their product pipeline through clinical development, and launching and marketing their approved product(s). This is further heightened as both clinical trials and post-marketing activities continue to grow in complexity and scope due to stringent regulatory pressures, patient involvement and globalization. Yet companies face overwhelming pressure to get their product to market as quickly as possible.
Suddenly the risk-reward balance has shifted dramatically. Anyone with basic cold symptoms is being advised to stay home. And many people can no longer travel with COVID-19 in their community.
What if you can no longer visit your sites? Are you ready to use the tools at your disposal as contingency or risk-mitigation strategies to keep your studies going and ensure your patients can access their study medication and remain safely monitored?
During this virtual discussion forum were putting our minds together to combat the impact of the Coronavirus outbreak on clinical trials, and be better prepared in the future.
Similar to Hosting remote inspection at pharmaceutical facilities (20)
Sterilization mathematics (F0. Fphy, Fbio, Sterility Assurance (SAL) calculat...Palash Das
Sterile means free from viable microorganisms and sterilization is any physical or chemical process which destroys all life forms, with special regard to microorganisms (including bacteria and sporogenous forms) and inactivates viruses.
Therefore, the terms “sterile” and “sterilization”, in a strictly biological sense, describe the absence and, respectively, the destruction of all viable microorganisms. In other words, they are absolute terms: an object or system is either “sterile” or “non-sterile”.
The destruction of a microbial population subjected to a sterilization process follows a logarithmic progression: only a treatment of infinite duration can provide the absolute certainty that the entire microbial population has been destroyed, and that the system is sterile.
Root cause analysis is an important part for identifying failures during investigation. This article will provide you a number of examples of fish bone diagram, which will be useful for all
Pharmaceutical professional.
Version : 00
Guidance on gloves maintenance in Isolator and RABSPalash Das
A faulty glove or sleeve assembly represents a route of contamination and a critical breach of Isolator integrity. Within this article we will discuss about all these aspects.
Pharmaceutical Isolator technology in aseptic processingPalash Das
These articles describe different aspects of aseptic processing Isolator.
Isolators have been around the Pharmaceutical Industry since the early 1980s and in the Nuclear Industry (glovebox technology) since the 1950s. The intent of isolators is to create an airtight barrier or enclosure around a piece of equipment or process which provides absolute separation between the operator and product. The operator can perform tasks through half- suits or glove ports. Isolators provide a specific environment inside the isolator using HEPA filters. The environment can be positive pressure or negative, can have humidity control, oxygen control, use unidirectional airflow, and can either protect the product from the operator as with aseptic processes, or protect the operator from the product as with potent product handling. The earliest uses of aseptic isolators were for sterility testing. Sterility test isolators make up most of the aseptic isolators in use and are available in many different sizes and configurations. Sterility test isolators do not need to be installed in a classified area. No formal requirement exists for a Grade D environment, but the area should be controlled to allow only trained personnel.
Workshop On Risk Assesment by Palash Ch DasPalash Das
Risk management principles are effectively utilized in many areas of business and government including finance, insurance, occupational safety, public health, pharmacovigilance, and by agencies regulating these industries. Although there are some examples of the use of quality risk management in the pharmaceutical industry today, they are limited and do not represent the full contributions that risk management has to offer. In addition, the importance of quality systems has been recognized in the pharmaceutical industry and it is becoming evident that quality risk management is a valuable component of an effective quality system.
Pharmaceutical Company Facility PresentationPalash Das
This presentation is dedicated to all pharmaceutical organization. this can be use as a standard template for presenting your organization during audit. The concept is designed based on the sterile pharmaceutical facility.
Pharmaceutical HVAC (Heating, ventilating, and air conditioning; also heating...Palash Das
This slide is represent the HVAC design,qualification and operational approach. As we know HVAC is important system for maintaining clean room. This presentation is made based on the requirement of Pharmaceutical Industry. All parameter are considered based on the current guidelines aspect.
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 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
micro teaching on communication m.sc nursing.pdfAnurag Sharma
Microteaching is a unique model of practice teaching. It is a viable instrument for the. desired change in the teaching behavior or the behavior potential which, in specified types of real. classroom situations, tends to facilitate the achievement of specified types of objectives.
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 lecture slides, by Dr Sidra Arshad, offer a quick overview of physiological basis of a normal electrocardiogram.
Learning objectives:
1. Define an electrocardiogram (ECG) and electrocardiography
2. Describe how dipoles generated by the heart produce the waveforms of the ECG
3. Describe the components of a normal electrocardiogram of a typical bipolar leads (limb II)
4. Differentiate between intervals and segments
5. Enlist some common indications for obtaining an ECG
Study Resources:
1. Chapter 11, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 9, Human Physiology - From Cells to Systems, Lauralee Sherwood, 9th edition
3. Chapter 29, Ganong’s Review of Medical Physiology, 26th edition
4. Electrocardiogram, StatPearls - https://www.ncbi.nlm.nih.gov/books/NBK549803/
5. ECG in Medical Practice by ABM Abdullah, 4th edition
6. ECG Basics, http://www.nataliescasebook.com/tag/e-c-g-basics
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.
Factory Supply Best Quality Pmk Oil CAS 28578–16–7 PMK Powder in Stockrebeccabio
Factory Supply Best Quality Pmk Oil CAS 28578–16–7 PMK Powder in Stock
Telegram: bmksupplier
signal: +85264872720
threema: TUD4A6YC
You can contact me on Telegram or Threema
Communicate promptly and reply
Free of customs clearance, Double Clearance 100% pass delivery to USA, Canada, Spain, Germany, Netherland, Poland, Italy, Sweden, UK, Czech Republic, Australia, Mexico, Russia, Ukraine, Kazakhstan.Door to door service
Hot Selling Organic intermediates
Factory Supply Best Quality Pmk Oil CAS 28578–16–7 PMK Powder in Stock
Hosting remote inspection at pharmaceutical facilities
1. HOSTING REMOTE
INSPECTION AT
PHARMACEUTICAL FACILITIES
A Good Practice (GxP) inspections during the COVID-19 pandemic outbreak
Das, Palash Chandra
Palash.ds@gmail.com
Abstract
COVID-19 pandemic has put manufacturers, affiliates and inspectors in a new and challenging situation
where it is in the public interest to continue to supply medicines while ensuring demonstrated compliance.
Regulatory agencies coming with the idea for conducting remote inspection across foreign manufacturing
site.
2. P a g e 1 | 17
FROM THE AUTHOR'S DESK
Dear Readers/Followers,
PRES is not-for-profit association committed to connect with the Global
Pharmaceutical community. Through this forum we discussed, share and
explore lots of pharmaceutical hot topics. Being a Pharmaceutical
professional, it is quite difficult to get time to do something different from
the routine responsibilities. Hope all of you are agreed with my views.
However, that’s you, my “readers” and “followers” of my blog, always
inspire me for doing something different other than my routine
assignments.
We know most of the information’s now a days are easily available over
web media, but I am always trying to collate best information based on my
industrial experience in a single article.
Once again, I would like to thank my readers, followers and seniors, who
has encouraged me a lot.
PRES Mission
To develop scientifically sound, practical, technical information and
resources to advance science and regulation for the pharmaceutical
industry
PRES Vision
To be the foremost global provider of science, technology, and regulatory
information and education for the pharmaceutical community
Visit us at https://pres.net.in/
3. P a g e 2 | 17
ABOUT AUTHOR
Palash Chandra Das
M. Pharma
LinkedIn Link
Pharmaceutical Medicinal Chemistry
Core Technical Competency: Qualification & Validation, Sterility
Assurance, QMS, Investigation, Risk Management
Palash Chandra Das is the Technical Writer focuses on technical writing including investigative reports
and operating procedures. His passion for writing is displayed in the many writing sessions he hosts via
his Blogs at https://pres.net.in.
Mr. Palash Chandra Das is recognized as an expert in the field of aseptic manufacturing of parenteral
products and is a frequent presenter at several web conferences and technical training for Sterile Drug
Manufacturing.
He earned his master’s for Pharmaceutical medicinal chemistry from the University of West Bengal
University of technology in India.
Since 2011 Palash has associated with installation, qualification and operation of several production-lines
in standard Clean room Technology as well as in Isolator Technology at major regulatory facility across
India.
4. P a g e 3 | 17
CONTENTS
FROM THE AUTHOR'S DESK.......................................................................... 0
ABOUT AUTHOR................................................................................................ 2
Inspection Preparation:.............................................................................................. 5
During Inspection:..................................................................................................... 7
Discussion: .............................................................................................................. 8
Communication: ....................................................................................................... 8
Definitions:............................................................................................................... 8
Reference:............................................................................................................. 10
5. P a g e 4 | 17
Introduction
The COVID-19 pandemic presents an unprecedented challenge to healthcare, the pharmaceutical industry’s supply
chain and personnel movement. Globally different support functions like API, excipient and packaging patterners to
this industry are not able to respond with in pre-defined time frame. Apart from the third-party services like calibration
and annual maintenance also impacted due to travel and transportation restriction. Currently, it was big challenge for
industry to serve for the society with affordable and quality medicines. Even regulators are concerned with the standard
of the medicines produced and supplied across globe during this pandemic as currently it is not possible for conduct
onsite inspection for international travel restriction. COVID-19 pandemic has put manufacturers, affiliates and
inspectors in a new and challenging situation where it is in the public interest to continue to supply medicines while
ensuring demonstrated compliance.
Background
Major regulatory agencies are coming up with the strategy to audit/or inspect facility remotely to ensure continues
regulatory compliance and patient safety. Here we will discuss regarding the new regulation coming up with this new
strategy by few major regulatory bodies like US FDA, MHRA, TGA and European medicines agencies (EU).
Due to the COVID-19 pandemic, FDA announced that agency is temporarily postponing all domestic and foreign routine
surveillance facility inspections. These facility inspections are assigned biannually using a risk-based Site Selection
Model. FDA confirmed that they will continue the quality assessment of all applications per normal assessment
operations for all disciplines, where all manufacturing facilities will be evaluated using risk-based approach as per
existing guidelines. During this interim period, agency will be utilizing additional tools to determine the need for an on-
site inspection to support the application assessment such as reviewing a firm’s previous compliance history, using
information sharing from foreign governments as part of mutual recognition and confidentiality agreements, and
requesting records “in advance of or in lieu of” on-site drug inspections. 5
Nevertheless, there may be many challenges on an organization to support remote inspections. It is fundamental to
assess whether the inspectee meets the technical requirements to provide remote access to electronic systems and
maintain communication with and support to inspectors. The technical nuances of these systems as well as the IT
policies (of the inspectee and regulatory authority(ies) performing the inspection) are likely to cause additional
challenges and need to be duly taken into consideration.
However, there will be a preintimation from the regulators to make sure all the readiness can be done in well advance.
Expectation to set up a common cloud platform between inspectee and inspector, where organization can upload all
6. P a g e 5 | 17
requested documents before start of inspection. Organization managing electronic documentation can directly provide
authorization as viewer or auditor (read only) to review manufacturing, validation, testing or any development reports.
Remote inspection will take quite longer time related to routine inspection at your site. The initial success of the
inspection will be built up based on the flawless communication and compatibility between inspectee and inspector.
Both team members are setting together to understand well the process and practices and ensure patient safety; hence
the objective of the remote inspection will be the as onsite inspection.
Inspection Preparation
There will be a possibility where agencies will provide a detailed agenda with the name of auditor for inspection well in
advance. Addition to this prior inspection agencies can ask to provide few relevant documents to understand better.
Similarly, it may possible regulators can ask for consolidated list of SMEs from your organization, to whom they need
to interact. So, be ready with the SME list with primary contact and mentioned if secondary or additional SME is required
to support.
For example, suppose clean utility review is going on, where firm need to explain few questions regarding Compressed
Air (CA) system.
Question Validation Engineering Quality Control Production
How many sampling points are
available? Share and explain
current P&ID of compressed air
system
Secondary SME:
Validation can play
a support role in
this.
Primary SME:
Engineering will be
the primary contact
for the query.
N/A N/A
Explain the qualification of
compressed air system.
Primary SME
Secondary SME:
Engineering can play
a support role in this.
N/A N/A
What is the frequency of
chemical and microbial
testing?
N/A
Few firm engineering
performed chemical
testing with third
party.
Microbiology
team can
respond
regarding the
microbial testing
frequency.
Are user points of the
compressed air are conned
with 0.2 µ air filter? If yes, what
is the integrity/or replacement
frequency of the compressed
air filter connected with
product
processing/formulation?
N/A
Engineering can
support as secondary
SME.
N/A
As the discussion
regarding the
production user
point. Production
will be the primary
SME.
#Note: Quality and Plant head can intervene based on the requirement to connect the dots
7. P a g e 6 | 17
Time zone between inspectee and inspector can be concern, if immediate feedback not possible to provide that need
to be indicated to inspector deliberately. IT personnel will be an important part of remote inspection process to fix any
kind of technical glitch.
There are several software applications (apps), video conferencing systems, interactive tools for document sharing,
instant messaging apps, whiteboarding apps and meeting platforms providing the users with more real time interactive
communication tools that could enhance remote working. 1
Any recording (audio / video / screenshots) during the inspection process should be notified and agreed upfront
between all involved parties. 1
Figure 1: Remote inspection strategy during pandemic
6TGA clearly explained few requirements of remote inspection process and urge to firm to make it available during
inspection.
• The manufacturer should organize to have pre-recorded videos of the site and operations so that the
inspectors can be presented with a virtual tour of GMP relevant areas.
• If the manufacturer has electronic systems for QMS databases such as complaints, deviations, OOS/OOT
and other GMP relevant areas then it is requested to organize guest remote read only logins to the QMS
databases for inspectors’ use at the time of inspection.
• The manufacturer must have the ability to participate in and/or host virtual communication on a suitable and
agreed IT platform, with timely IT support during the remote inspection. This should include the ability to live
stream video if required.
Option 1:
Offline
approach
Option 3:
Hybrid
approach
Option 2:
Online
approach
Option 1- Offline inspection: Agency will ask
document and review offline. Query can be
resolved through telecommunication/ email or
web-based call.
Option 2-Online inspection: Agency conduct
web-based inspection program by using video
conferencing.
Option 3- Hybrid approach: It will be
combination of online and offline review and
inspection process. Will be conduct by agencies
as per predefined plan mutually agreed by
agency and firm.
8. P a g e 7 | 17
• Where time zone differences need to be taken into consideration staff including subject matter experts should
be made available at the pre-agreed real-time communication timeslots.
• The manufacturer should address any other requests during the remote inspection in a timely manner to
ensure a smooth process flow.
• Any information requested by inspector’s post-inspection should be provided by the manufacturer within the
requested timeframes.
However, we cover all the points in this articles and expectation of all the regulatory agency at this moment is same.
Regulators are quite flexible at this time to received positive response /or suggestion from firm as well.
Figure 2: Pre-approval inspection goal; USFDA
During Inspection
The inspectee should provide a list of attendees for the opening meeting. This process should be followed for any
subsequent meeting / session. Firm should follow their respective procedure for providing access to auditor and indicate
that the validity of the authorization will be valid till the completion of inspection. Any further extension of authorization
to be evaluated based on the additional request. Try to conclude every day meeting with meeting minutes (MOM), if
Onjective1: Readiness
for commercial
manufacturing
• Incoming materials
• Process, CPP's
• Equipment/ facility/ cleaning
• Personnel training & competence
Objective 2:
Conformance
to
application
Objective 3:
Data Integrity
9. P a g e 8 | 17
you leave any query or concern it can be consider as ignored /or not attended. Feel free to discuss /or clarify in case
you have any doubt.
MHRA aims to monitor the inspection by requesting electronic copies of documents and other information for review
off-site. Any follow-up will be conducted via email and teleconferences.2
PIC/S is a confidentiality arrangement between 53 global inspectorates, mutual recognition partners and other
regulators. The MHRA will rely on inspection information shared by the network to monitor international organizations
and their supply chains’ compliance.2
Discussion
Anyhow the reduction in inspectorate on-site presence, the Agency expects organizations to maintain GxP compliance
and be prepared to take “flexible and pragmatic approaches” to ensure the protection of public health. For
organizations awaiting licenses that usually require an on-site GxP inspection, it is not clear whether the agency will
issue licenses without an on-site inspection or if considerable delays should now be expected. As the situation evolves,
the agencies will continue to update organizations and their supply chains on its proposed approach.
Definition
7Remote audit:
Audit performed off-site through the use of information and communication technology. [Synonyms: eAudit, virtual
audit]
10. P a g e 9 | 17
Communications
FDA:
For additional questions about manufacturing changes, please email CDER-OPQ-Inquiries@fda.hhs.gov. Please
include “COVID-19 inquiry” in the subject line of the email.
MHRA:
If you have any questions to MHRA on GxP-related issues, please email to below mentioned email:
• Good Laboratory Practice: gxplabs@mhra.gov.uk
• Good Clinical Practice: ctdhelpline@mhra.gov.uk
• Good Manufacturing Practice: gmpinspectorate@mhra.gov.uk
• Good Distribution Practice: GDP.Inspectorate@mhra.gov.uk
• Good Pharmacovigilance Practice: gpvpinspectors@mhra.gov.uk
TGA:
The TGA is committed to working with Australian sponsors during this time. Our staff are available to assist via the
contact information below:
• For domestic and overseas inspections and general GMP enquiries, contact the Licensing and Certification
Section: GMP@health.cov.au
• For overseas GMP Clearance desk-top assessments and extensions to GMP Clearances, contact the GMP
Clearance section: GMPClearance@health.gov.au
11. P a g e 10 | 17
Reference
1. Guidance on remote GCP inspections during the COVID19 pandemic, EMA/INS/GCP/162006/2020
2. MHRA announces a risk-based prioritisation of on-site Good Practice inspections during COVID-19,
https://www.insideeulifesciences.com/2020/03/25/mhra-announces-a-risk-based-prioritisation-of-on-site-
good-practice-inspections-during-covid-19/
3. New arrangements for MHRA Good Practice (GxP) inspections due to coronavirus (COVID-
19),https://www.gov.uk/government/news/new-arrangements-for-mhra-good-practice-gxp-inspections-due-
to-coronavirus-covid-19--2
4. MHRA Good Practice (GxP) inspections during the COVID19 outbreak,
https://mhrainspectorate.blog.gov.uk/2020/03/23/mhra-good-practice-gxp-inspections-during-the-covid19-
outbreak/
5. Manufacturing, Supply Chain, and Drug Inspections; COVID-19, https://www.fda.gov/drugs/coronavirus-
covid-19-drugs/manufacturing-supply-chain-and-drug-inspections-covid-19
6. TGA expectations for overseas manufacturing sites hosting remote inspections during the COVID-19
pandemic; https://www.tga.gov.au/tga-expectations-overseas-manufacturing-sites-hosting-remote-
inspections-during-covid-19-pandemic
7. Extension and Expansion of Temporary extraordinary measures related to MDSAP audits during covid-19
quarantine orders and travel restrictions – Remote audits; https://www.fda.gov/media/136441/download
8. Regulator Develops Remote Inspection Process Due to Pandemic, https://www.pda.org/pda-letter-
portal/home/full-article/regulator-develops-remote-inspection-process-due-to-pandemic
9. Drug Compliance Programs; https://www.fda.gov/drugs/guidance-compliance-regulatory-information/drug-
compliance-programs
10. Approaches to GMP inspection; CDER Small Business - Regulatory Education for Industry (REdI);
https://www.fda.gov/media/89231/download
11. GMP inspection reliance, https://picscheme.org/docview/2475
12. P a g e 11 | 17
Annexure 1:
A comprehensive list of documents from Pharmaceutical quality system
1. Site Master plan with following additional enclosure,
o manufacturing site license and site GMP certificate (issued by local Authority)
o Description of the product XYZ , production flow – name, address and manufacturing stages for
each involved site.
o Information about quality agreements between involved sites and agreements status.
2. CA/PA for observations from the previous inspection and closure statement
3. Quality Management Review report (current)
4. Current Annual Product Review (APQR) for product to be inspect (should considered mentioned sections:
review of finish drug product quality, review of complaints, review of deviations, review of changes).
5. List of standard operating procedure from all departments
6. Procedure for product release. List of persons who performs product release.
7. Procedure for change control management and list of major changes for the Product form current to last 2
year
8. Procedure for deviation management (planned/ unplanned) and list of deviations for the Product form
current to last 2 year
9. Self-inspection procedure. List of persons who perform self-inspection. Information about self-inspections for
the production facility (rooms) used in Product manufacturing process with status of self-inspections (dates,
conclusions, responsible auditors)
10. Procedure for complaints management. List of complaints for the Product form current to last 2 year
11. Procedure for recalls management. List of recalls for the Product form current to last 2 year
12. List of approved suppliers of materials for Product
13. Job description for key personnel: Head of manufacturing, Head of Quality Control
14. Detailed layout of manufacturing facility with indication of rooms AHU’s, classification, pressure differential,
personnel & material flows, equipment location, indication of manufacturing line used for manufacturing of
Product (current)
15. Detailed layout of QC laboratories (chemical and microbiology) used for Product testing
16. Detailed layout of warehouses involved in Product manufacturing
17. Procedure for handling of intermediate and finished products on warehouse (receiving, storage)
18. Copy of Master Batch Record for product
13. P a g e 12 | 17
19. In-process controls of Product manufacturing process (procedure that defines performing of In-process
controls)
20. SOP for Storage conditions for Product
21. List of planned validation and qualification activities for current and last 2-year 24 Report and protocol of
qualification of production rooms used for Product XYZ manufacturing
22. Current qualification documents (Report and protocol) for all critical equipment / instrument / and clean
utilities (purified water, WFI, pure steam or compressed gases) involved in Product manufacturing.
23. SOP deals with laboratory instrument calibration and periodic verification.
24. SOP deals with access control, backup, audit trial, password management and disaster management of
equipment’s.
25. Handling and assessment of Breakdown and preventive maintenance
26. Specification for intermediate and finish product
27. Stability study report for Product including data along all product shelf life.
28. SOP deals Procedure for products stability study. Stability planner
29. Analytical methods validation (or methods transfer report) for Product XYZ (methods will be selected after
specification receiving)
30. Procedure for OOS management. List of OOS for last 2 year. Arrange a list here OOS invalidated based on
the identification of laboratory error.
14. P a g e 13 | 17
Annexure 2:
A comprehensive list of documents for clean Utilities
Water:
• Diagram containing purification steps: A clear diagram is required showing each step for purifications.
• Distribution system, using and sampling points: All the sampling point details. System maintenance.
Pure Steam:
• Points of use, Specification,
• Routine Monitoring Program (Micro and Chemical) and
• Last Annual Review. System maintenance.
Water system documentation:
• Specifications of the different water grades used by the company.
• Routine monitoring procedure and results obtained last year.
• Trend analysis.
• Sanitization procedures and records.
HVAC:
• AHU distribution,
• Pressures differential;
• diagram showing rooms classification and
• Activities performed in every room.
• System maintenance.
Environmental monitoring:
• Frequencies,
• Sampling points,
• Sampling techniques,
• Testing,
• Evaluation and results obtained within last year.
• Specifications for viable and non-viable contamination.
• Trend analyses.
• Periodical Re-qualification approach and records.
Gases for pharmaceutical purposes:
• List of Gases that are in direct contact with products.
• Specifications and Routine Monitoring Program (Microbiological and Physicochemical).
• System maintenance.
15. P a g e 14 | 17
Annexure 3:
Example- Declared List of products to be considered for inspection
Sr. No.
Product
Name
Strength
Manufacturing
line
Formulation
Validation document
reference No.
1. ABCD 2 mg Line 1 Tablet
Process:
Cleaning:
APQR:
Stability:
IP/FP specification:
2. ABCD 1 mg Line 1 Tablet
Process:
Cleaning:
APQR:
Stability:
IP/FP specification:
3.
16. P a g e 15 | 17
Annexure 4:
Example- Identify Subject matter list
Topic SME_1 SME_2 SME_2
APQR
Site Master File
Validation Master Plan
Cleaning validation plan
Process validation
Media fill
Facility Layout
Water System
HVAC
Batch manufacturing and packaging
record (BMR/BPR)
Environmental monitoring
Gases for pharmaceutical purposes
<mentioned topics here>
17. P a g e 16 | 17
Annexure 5:
Example- Detailed list of critical equipment’s product wise
Product Name:
ABCD, 2 mg
Equipment list:
Sr.
No.
Equipment
Name
Equipment
No.
Make Model
Serial
No.
Capacity
Installed
at
Validation
details
18. P a g e 17 | 17
Annexure 6:
Example- Manufacturing flow of Product XXXX
Note: Flow demonstrated liquid/lyophilized injectable process flow
Visit Us:
https://pres.net.in/
Pharmaceutical resources and educational services