This presentation is compiled by Drug Regulations, a nonprofit organization that provides online pharmaceutical resources. It discusses FDA guidance on data integrity and compliance with cGMP regulations. The guidance clarifies FDA's expectations around the creation and handling of data to ensure its reliability and accuracy according to cGMP standards.
Data Integrity app Link: https://play.google.com/store/apps/details?id=com.innovativeapps.dataintegrity&hl=en
One Step Ahead in Pharma Compliance
Across the internet, there are millions of resources are available which provide information about Computer System Validation.
Refer above Data Integrity app which helps you to understand current regulatory agencies thinking on Data Integrity.
Data integrity is a Fundamental in a pharmaceutical quality system. It ensures that medicines are of required quality. This presentation is based on MHRA Guidance and provides MHRA expectations. Guidance complements existing EU GMP relating to active substances and dosage forms. This guidance should be d in conjunction with national medicines legislation and the GMP standards published in Eudralex volume 4.
Presentation on data integrity in Pharmaceutical IndustrySathish Vemula
Presentation on data integrity in Pharmaceutical Industry
Contents:
- Definition & Basics
- Criteria for integrity of laboratory data
- Regulatory Requirements
- Barriers to Complete Data
- Possible data integrity problems
- Previous observations
- FDA Warning Letters – 2013
- FDA Warning Letters – 2014
- FDA 483’s related to data integrity
- EU – Non compliance Reports
- WHO - Notice of Concern
- Summary of Data Integrity issues
- Consequences- Rebuilding Trust
- Conclusion
Data Integrity app Link: https://play.google.com/store/apps/details?id=com.innovativeapps.dataintegrity&hl=en
One Step Ahead in Pharma Compliance
Across the internet, there are millions of resources are available which provide information about Computer System Validation.
Refer above Data Integrity app which helps you to understand current regulatory agencies thinking on Data Integrity.
Data integrity is a Fundamental in a pharmaceutical quality system. It ensures that medicines are of required quality. This presentation is based on MHRA Guidance and provides MHRA expectations. Guidance complements existing EU GMP relating to active substances and dosage forms. This guidance should be d in conjunction with national medicines legislation and the GMP standards published in Eudralex volume 4.
Presentation on data integrity in Pharmaceutical IndustrySathish Vemula
Presentation on data integrity in Pharmaceutical Industry
Contents:
- Definition & Basics
- Criteria for integrity of laboratory data
- Regulatory Requirements
- Barriers to Complete Data
- Possible data integrity problems
- Previous observations
- FDA Warning Letters – 2013
- FDA Warning Letters – 2014
- FDA 483’s related to data integrity
- EU – Non compliance Reports
- WHO - Notice of Concern
- Summary of Data Integrity issues
- Consequences- Rebuilding Trust
- Conclusion
CCK Discussion Forum held at ICCBS, University of Karachi, attended by over hundred of registered experienced pharmaceutical professionals participants belonging from dozen of pharmaceutical manufacturing facilities
Data integrity, Pharmaceutical industry, Good Manufacturing Practice, GMP, Guidelines, Data management, DI and GMP Compliance, paper and electronic data, Archive and back up
Data integrity is critical throughout the CGMP data life cycle, including in the creation, modification, processing, maintenance, archival, retrieval, transmission, and disposition of data after the record’s retention period ends. It would be helpful for data management.
This presentation is aimed at providing information on automation in the GLP practices in the pharmaceutical industry.
-Standard Operating Procedures.
-Documentation in GALP.
-Logs and Related Forms.
Trends changed from Non compliance to RR --> Gap to RR --> Data Integrity --> DIB --> Smart Audit & Smart Data.
RR = Regulatory Requirements
DIB = Data Integrity Breach
Take a serious Note for Data Integrity whether you are small or big organization. Your Data is the Heart of your business. Regulatory bodies are highly conscious about such issues. For beginners in this path, my small note can help you a lot.
This presentation describes approaches for software validation used to automate laboratory research procedures, consolidate data collection and analysis and/or run sophisticated QC or manufacturing operations.
Several approaches to software validation exist and may be appropriate for a specific project.
The scope of any validation effort depends upon a number of factors
Size and complexity of the software,
Origin of the software (custom vs. off-the-shelf) and
Whether the functions are critical or non-critical in nature.
By effectively planning the process, validation time and resources can be reduced while meeting regulatory requirements.
What is 21 CFR Part 11?:
21 CFR Part 11:
Allow the industry to use electronic records and signatures alternatively to paper records and hand-written signatures
21 CFR Part 11 applies:
To all FDA regulated environments
When using computers in the creation, modification, archiving, retrieval or transmission of data or records
To records required by predicate rules – GLP, GCP, GMP – that impact patient safety
To new and old systems
Purpose of Part 11
Ensure data is not corrupted or lost
Data is secure
Approvals cannot be repudiated
Changes to data can be traced
Attempts to falsify records are made difficult and can be detected
Types of Systems
Two types of systems that come under 21 CFR Part 11 – closed and open systems
Closed and Open Systems:
What is a Closed system?
A system to which access is controlled by person responsible for electronic records stored on it
What is an Open system?
A system to which access is not controlled by those responsible for the electronic records stored on it
21 CFR Part 11 Requirements:
21 CFR Part 11 lists the following controls for closed systems:
Validation
Device checks
Operational system checks
Accurate and complete copies
Accurate and steady retrieval
Limited access to systems and data
Authority checks
Electronic audit trail
Training/qualification of personnel
Accountability of signatures
Control over system documentation
Digital Signatures :
Use of digital signatures for open systems
Electronic Signatures
Requirements for signed electronic records
Linking records to signatures
Data integrity is assuming greater importance in current Good Manufacturing Practices in FDA regulated industry with increased emphasis by other regulatory agencies like the EMA. Data integrity and security infractions are not only 21 Code of Federal Regulations (CFR) Part 11 issues but also severe CGMP violations. As FDA increases its focus on data integrity and reliability, inspectors are examining data based on multiple regulations and standards including CGMP, Good Laboratory Practices (GLP), Good Clinical Practices (GCP) and the Application Integrity Policy (AIP) in addition to FDA-recognized consensus standards.
This presentation discusses data integrity regulations and enforcement trends that have led to increased scrutiny of pharmaceutical laboratories by inspectors.
CCK Discussion Forum held at ICCBS, University of Karachi, attended by over hundred of registered experienced pharmaceutical professionals participants belonging from dozen of pharmaceutical manufacturing facilities
Data integrity, Pharmaceutical industry, Good Manufacturing Practice, GMP, Guidelines, Data management, DI and GMP Compliance, paper and electronic data, Archive and back up
Data integrity is critical throughout the CGMP data life cycle, including in the creation, modification, processing, maintenance, archival, retrieval, transmission, and disposition of data after the record’s retention period ends. It would be helpful for data management.
This presentation is aimed at providing information on automation in the GLP practices in the pharmaceutical industry.
-Standard Operating Procedures.
-Documentation in GALP.
-Logs and Related Forms.
Trends changed from Non compliance to RR --> Gap to RR --> Data Integrity --> DIB --> Smart Audit & Smart Data.
RR = Regulatory Requirements
DIB = Data Integrity Breach
Take a serious Note for Data Integrity whether you are small or big organization. Your Data is the Heart of your business. Regulatory bodies are highly conscious about such issues. For beginners in this path, my small note can help you a lot.
This presentation describes approaches for software validation used to automate laboratory research procedures, consolidate data collection and analysis and/or run sophisticated QC or manufacturing operations.
Several approaches to software validation exist and may be appropriate for a specific project.
The scope of any validation effort depends upon a number of factors
Size and complexity of the software,
Origin of the software (custom vs. off-the-shelf) and
Whether the functions are critical or non-critical in nature.
By effectively planning the process, validation time and resources can be reduced while meeting regulatory requirements.
What is 21 CFR Part 11?:
21 CFR Part 11:
Allow the industry to use electronic records and signatures alternatively to paper records and hand-written signatures
21 CFR Part 11 applies:
To all FDA regulated environments
When using computers in the creation, modification, archiving, retrieval or transmission of data or records
To records required by predicate rules – GLP, GCP, GMP – that impact patient safety
To new and old systems
Purpose of Part 11
Ensure data is not corrupted or lost
Data is secure
Approvals cannot be repudiated
Changes to data can be traced
Attempts to falsify records are made difficult and can be detected
Types of Systems
Two types of systems that come under 21 CFR Part 11 – closed and open systems
Closed and Open Systems:
What is a Closed system?
A system to which access is controlled by person responsible for electronic records stored on it
What is an Open system?
A system to which access is not controlled by those responsible for the electronic records stored on it
21 CFR Part 11 Requirements:
21 CFR Part 11 lists the following controls for closed systems:
Validation
Device checks
Operational system checks
Accurate and complete copies
Accurate and steady retrieval
Limited access to systems and data
Authority checks
Electronic audit trail
Training/qualification of personnel
Accountability of signatures
Control over system documentation
Digital Signatures :
Use of digital signatures for open systems
Electronic Signatures
Requirements for signed electronic records
Linking records to signatures
Data integrity is assuming greater importance in current Good Manufacturing Practices in FDA regulated industry with increased emphasis by other regulatory agencies like the EMA. Data integrity and security infractions are not only 21 Code of Federal Regulations (CFR) Part 11 issues but also severe CGMP violations. As FDA increases its focus on data integrity and reliability, inspectors are examining data based on multiple regulations and standards including CGMP, Good Laboratory Practices (GLP), Good Clinical Practices (GCP) and the Application Integrity Policy (AIP) in addition to FDA-recognized consensus standards.
This presentation discusses data integrity regulations and enforcement trends that have led to increased scrutiny of pharmaceutical laboratories by inspectors.
A primary mission of the Food and Drug Administration is to conduct comprehensive regulatory coverage of all aspects of production and distribution of drugs and drug products to assure that such products meet the 501(a)(2)(B) requirements of the Act. FDA has developed two basic strategies:
. 1) evaluating through factory inspections, including the collection and analysis of associated samples, the conditions and practices under which drugs and drug products are manufactured, packed, tested and held, and
. 2) monitoring the quality of drugs and drug products through surveillance activities such as sampling and analyzing products in distribution.
FDA compliance program “ Drug Manufacturing Inpsections” (7356.002) is designed to provide guidance for implementing the first strategy. Products from production and distribution facilities covered under this program are consistently of acceptable quality if the firm is operating in a state of control.
The inspectional guidance in this program is structured to provide for efficient use of resources devoted to routine surveillance coverage, recognizing that in-depth coverage of all systems and all processes is not feasible for all firms on a biennial basis. It also provides for follow-up compliance coverage as needed.
“Drug Regulations” has prepared a summary from the compliance programme and is given below in the presentation.
WHO has recently issued draft document titled "Guidelines on Validation". These guidelines (i.e., the main text included in this working document) cover the general principles of validation and qualification.
These guidelines focus mainly on the overall concept of validation and are not intended to be prescriptive in specific validation requirements. This document serves as general guidance only and the principles may be considered useful in its application in the manufacture and control of starting materials and finished pharmaceutical products (FPPs), as well as other areas. Validation of specific processes and systems, for example, in sterile product manufacture, requires much more consideration and a detailed approach that is beyond the scope of this document. The general text in this document may be applicable to validation and qualification of premises, equipment, utilities, systems, processes, and procedures.
The draft on the specific topics, the appendices to this main text, will follow. The following is an overview on the appendices that are intended to complement the text of this working document:
Appendix 1: Validation of heating, ventilation and air-conditioning systems - will be replaced by cross reference to WHO Guidelines on GMP for HVAC systems for considerations in qualification of HVAC systems (update - working document QAS/15.639/Rev. 1)
Appendix 2: Validation of water systems for pharmaceutical use - will be replaced by cross-reference to WHO Guidelines on water for pharmaceutical use for consideration in qualification of water purification systems
Appendix 3: Cleaning validation - consensus to retain
Appendix 4: Analytical method validation - update in process
Appendix 5: Validation of computerized systems - update in process
Appendix 6: Qualification of systems and equipment - update in process
Appendix 7: Non-sterile process validation - update already published as Annex 3, WHO Technical Report Series, No. 992, 2015
Comments on this draft document are due by July 12, 2016.
A presentation on this guidance is given below:
Presentation on New WHO Guidance on Validations
In March 2011, the EMA and FDA launched a pilot program that aims at a parallel assessment by both agencies of certain quality/CMC sections which are relevant to Quality by Design (QbD). This voluntary pilot program is open. This presentation gives a summary of the FDA and EMA expectation for QbD submissions based on the pilot programme.
Data Integrity in a GxP-regulated Environment - Pauwels Consulting AcademyPauwels Consulting
On Tuesday, December 6, 2016, our colleague Angelo Rossi, Senior Regulatory Compliance Consultant, gave an interesting presentation about “Data Integrity in a GxP-regulated Environment” at the Brussels Office of Pauwels Consulting in Diegem.
In his presentation, Angelo covered definitions and concepts of data integrity, the change in regulatory focus, lessons learned from recent FDA warning letters, importants highlights of regulations and guidelines. Angelo also presented a practical example of data integrity for a computerized system.
Please contact us at contact@pauwelsconsulting.com or +32 9 324 70 80 if you have any further questions regarding our consulting services in this area.
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.
This presentation covers the manufacture and testing of all sterile drug products, including drugs that are sterilized by filtration or other means and aseptically processed, and drug products that are terminally sterilized. The type of products covered include sterile bulk drugs, ophthalmic drugs, otic dosage forms, small volume parenteral (SVS) products for small molecule and licensed biological
therapeutic drug products, large volume parenteral (LVP) products, and any other drug products required to be sterile or labeled as sterile. Center for Biologics Evaluation and Research (CBER) regulated products and veterinary drug products are excluded from coverage under this program.
The guidance information is tailored to sterile manufacturing operations and should be used in conjunction with the Compliance Program for Drug Manufacturing Inspections (CP 7356.002).
Provide recommendations and background information concerning computerised systems
Information will be of assistance to inspectors for training purposes and during the inspection
Where automated systems and electronic records are used in warehouses and similar establishments where GDP requirements are applicable, controls and disciplines outlined in this document, or a best practice alternatives are expected to be in place.
Vertically integrated companies (R&D, manufacturing and distribution) will already apply such controls and compliance measures.
International regulatory agencies have collaborated to produce this guidance.
Intended as a reference for regulated users, including their suppliers, in addition to regulatory inspectors and investigators.
Provides a logical explanation of the basic requirements for the implementation, validation and operation of computerised systems.
May be adapted to identify the criteria for a regulated user, or a regulatory agency, in an inspection of GxP computer systems.
National legislation should to be referred to when determining the extent to which the provisions laid down in this document may be applicable.
This presentation gives a summary of this guidance.
21CFR regulations & its applicability in the industry and FDA perspective on the same and FDA check points on 21CFR regulations during their inspection.
This presentation highlights the reasons which lead to the withdrawal of the 2002 Guidance of the FDA and the current issue with Blend Uniformity and Content Uniformity Determinations.
Environmental Monitoring describes the microbiological testing under- taken in order to detect changing trends of microbial counts and micro- flora growth within cleanroom or controlled environments. The results obtained provide information about the physical construction of the room, the performance of the Heating, Ventilation, and Air-Conditioning (HVAC) system, personnel cleanliness, gowning practices, the equipment, and cleaning operations.
Over the past decade, environmental monitoring has become more sophisticated in moving from random sampling, using an imaginary grid over the room and testing in each grid, to the current focus on risk assessment and the use of risk assessment tools to determine the most appropriate methods for environmental monitoring.
This presentation gives current trends in the application of risk assessment to the practice of environmental monitoring.
This presentation is compiled from freely available resources like the websites of FDA, EMA ,WHO and research papers published by experts in this field like Sandle, T Reinmüller, B , Hyde, W,, Costello, E.K., Lauber, C. L., Hamady, M., Fierer, N., Gordon, J.I., Knight, R.
Paper published by T. Sandle on clean room contamination was referred extensively for this presentation. “Drug Regulations” is a non profit organization which provides free online resource to the Pharmaceutical Professional.
Visit http://www.drugregulations.org for latest information from the world of Pharmaceuticals.
This presentation gives an overview of : Validation of microbiological methods , Considering some of the limitations and
Key criteria that may be applicable for assessment.
MANAGEMENT OF ATRIOVENTRICULAR CONDUCTION BLOCK.pdfJim Jacob Roy
Cardiac conduction defects can occur due to various causes.
Atrioventricular conduction blocks ( AV blocks ) are classified into 3 types.
This document describes the acute management of AV block.
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.
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
Lung Cancer: Artificial Intelligence, Synergetics, Complex System Analysis, S...Oleg Kshivets
RESULTS: Overall life span (LS) was 2252.1±1742.5 days and cumulative 5-year survival (5YS) reached 73.2%, 10 years – 64.8%, 20 years – 42.5%. 513 LCP lived more than 5 years (LS=3124.6±1525.6 days), 148 LCP – more than 10 years (LS=5054.4±1504.1 days).199 LCP died because of LC (LS=562.7±374.5 days). 5YS of LCP after bi/lobectomies was significantly superior in comparison with LCP after pneumonectomies (78.1% vs.63.7%, P=0.00001 by log-rank test). AT significantly improved 5YS (66.3% vs. 34.8%) (P=0.00000 by log-rank test) only for LCP with N1-2. Cox modeling displayed that 5YS of LCP significantly depended on: phase transition (PT) early-invasive LC in terms of synergetics, PT N0—N12, cell ratio factors (ratio between cancer cells- CC and blood cells subpopulations), G1-3, histology, glucose, AT, blood cell circuit, prothrombin index, heparin tolerance, recalcification time (P=0.000-0.038). Neural networks, genetic algorithm selection and bootstrap simulation revealed relationships between 5YS and PT early-invasive LC (rank=1), PT N0—N12 (rank=2), thrombocytes/CC (3), erythrocytes/CC (4), eosinophils/CC (5), healthy cells/CC (6), lymphocytes/CC (7), segmented neutrophils/CC (8), stick neutrophils/CC (9), monocytes/CC (10); leucocytes/CC (11). Correct prediction of 5YS was 100% by neural networks computing (area under ROC curve=1.0; error=0.0).
CONCLUSIONS: 5YS of LCP after radical procedures significantly depended on: 1) PT early-invasive cancer; 2) PT N0--N12; 3) cell ratio factors; 4) blood cell circuit; 5) biochemical factors; 6) hemostasis system; 7) AT; 8) LC characteristics; 9) LC cell dynamics; 10) surgery type: lobectomy/pneumonectomy; 11) anthropometric data. Optimal diagnosis and treatment strategies for LC are: 1) screening and early detection of LC; 2) availability of experienced thoracic surgeons because of complexity of radical procedures; 3) aggressive en block surgery and adequate lymph node dissection for completeness; 4) precise prediction; 5) adjuvant chemoimmunoradiotherapy for LCP with unfavorable prognosis.
Tom Selleck Health: A Comprehensive Look at the Iconic Actor’s Wellness Journeygreendigital
Tom Selleck, an enduring figure in Hollywood. has captivated audiences for decades with his rugged charm, iconic moustache. and memorable roles in television and film. From his breakout role as Thomas Magnum in Magnum P.I. to his current portrayal of Frank Reagan in Blue Bloods. Selleck's career has spanned over 50 years. But beyond his professional achievements. fans have often been curious about Tom Selleck Health. especially as he has aged in the public eye.
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Introduction
Many have been interested in Tom Selleck health. not only because of his enduring presence on screen but also because of the challenges. and lifestyle choices he has faced and made over the years. This article delves into the various aspects of Tom Selleck health. exploring his fitness regimen, diet, mental health. and the challenges he has encountered as he ages. We'll look at how he maintains his well-being. the health issues he has faced, and his approach to ageing .
Early Life and Career
Childhood and Athletic Beginnings
Tom Selleck was born on January 29, 1945, in Detroit, Michigan, and grew up in Sherman Oaks, California. From an early age, he was involved in sports, particularly basketball. which played a significant role in his physical development. His athletic pursuits continued into college. where he attended the University of Southern California (USC) on a basketball scholarship. This early involvement in sports laid a strong foundation for his physical health and disciplined lifestyle.
Transition to Acting
Selleck's transition from an athlete to an actor came with its physical demands. His first significant role in "Magnum P.I." required him to perform various stunts and maintain a fit appearance. This role, which he played from 1980 to 1988. necessitated a rigorous fitness routine to meet the show's demands. setting the stage for his long-term commitment to health and wellness.
Fitness Regimen
Workout Routine
Tom Selleck health and fitness regimen has evolved. adapting to his changing roles and age. During his "Magnum, P.I." days. Selleck's workouts were intense and focused on building and maintaining muscle mass. His routine included weightlifting, cardiovascular exercises. and specific training for the stunts he performed on the show.
Selleck adjusted his fitness routine as he aged to suit his body's needs. Today, his workouts focus on maintaining flexibility, strength, and cardiovascular health. He incorporates low-impact exercises such as swimming, walking, and light weightlifting. This balanced approach helps him stay fit without putting undue strain on his joints and muscles.
Importance of Flexibility and Mobility
In recent years, Selleck has emphasized the importance of flexibility and mobility in his fitness regimen. Understanding the natural decline in muscle mass and joint flexibility with age. he includes stretching and yoga in his routine. These practices help prevent injuries, improve posture, and maintain mobilit
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!
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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
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
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.
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
1. This presentation is compiled by “ Drug Regulations” a
non profit organization which provides free online
resource to the Pharmaceutical Professional.
Visit http://www.drugregulations.org for latest
information from the world of Pharmaceuticals.
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2. This presentation is compiled from freely
available resources like the websites of FDA,
specifically the draft guidance issued by FDA
titled Data Integrity & compliance with cGMP
“Drug Regulations” is a non profit organization
which provides free online resource to the
Pharmaceutical Professional.
Visit http://www.drugregulations.org for latest
information from the world of Pharmaceuticals.
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4. The purpose of this guidance is to clarify
the role of data integrity
in
current good manufacturing practice
(CGMP) for drugs, as required in 21 CFR
parts 210, 211, and 212.
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5. Part 210
Covers Current Good Manufacturing
Practice in Manufacturing, Processing,
Packing, or Holding of Drugs;
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6. Part 211
Covers Current Good Manufacturing
Practice for Finished Pharmaceuticals;
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7. Part 212
Covers Current Good Manufacturing
Practice for Positron Emission Tomography
Drugs.
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8. This guidance provides the
Agency’s current thinking on the creation
and handling of data in accordance with
CGMP requirements.
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9. FDA expects that data be reliable and accurate
◦ (see the “Background” section).
CGMP regulations and guidance allow for flexible and risk-based
strategies to prevent and detect data integrity issues.
Firms should implement meaningful and effective strategies to
manage their data integrity risks
This should be based upon their process understanding and
knowledge management of technologies and business models.
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11. In recent years, FDA has increasingly observed CGMP
violations involving data integrity during CGMP
inspections.
This is troubling because ensuring data integrity is an
important component of
◦ Industry’s responsibility to ensure the safety, efficacy, and
quality of drugs, and
◦ Of FDA’s ability to protect the public health.
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12. These data integrity-related CGMP violations have led to numerous regulatory actions,
including warning letters, import alerts, and consent decrees.
The underlying premise in §§ 210.1 and 212.2 is that CGMP sets forth minimum
requirements to assure that drugs meet the standards of the FD&C Act regarding
Safety,
Identity,
Strength,
Quality, and
Purity.
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13. Electronic signature and record-keeping requirements are laid out in
21 CFR part 11
They apply to certain records subject to records requirements set
forth in Agency regulations, including parts 210, 211, and 212.
For more information, see guidance for industry Part 11, Electronic
Records;
Electronic Signatures — Scope and Application.
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14. The guidance outlines FDA’s current thinking regarding the narrow
scope and application of part 11 pending FDA’s reexamination of
part 11 as it applies to all FDA-regulated products.
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16. Data integrity refers to following attributes of data
Completeness,
Consistency, and
Accuracy
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17. This data should be (ALCOA)
◦ Attributable,
◦ Legible,
◦ Contemporaneously recorded,
◦ Original or a true copy, and
◦ Accurate
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18. Metadata is the contextual information
required to understand data.
A data value is by itself meaningless
without additional information about the
data.
Metadata is often described as data about
data.
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19. Metadata is structured information that
describes, explains, or otherwise makes it
easier to retrieve, use, or manage data.
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20. For example, the number “23” is meaningless without
metadata, such as an indication of the unit “mg.”
Among other things, metadata for a particular piece of
data could include
◦ Date/time stamp for when the data were acquired
◦ User ID of the person who conducted the test or analysis that
generated the data
◦ Instrument ID used to acquire the data
◦ Audit trails
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21. Data should be maintained throughout the record’s
retention period
This should be done with all associated metadata
required to reconstruct the CGMP activity
◦ (e.g., §§ 211.188 and 211.194).
The relationships between data and their metadata
should be preserved in a secure and traceable
manner.
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22. Audit trail means
◦ A secure
◦ Computer-generated
◦ Time-stamped
◦ Electronic record
This record should allow for reconstruction of the
course of events relating to the creation,
modification, or deletion of an electronic record.
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23. An audit trail is a chronology of the record.
“who,
what,
when, and
why”
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24. For example,
The audit trail for a high performance liquid
chromatography (HPLC) run could include
◦ The user name,
◦ Date/time of the run,
◦ The integration parameters used, and
◦ Details of a reprocessing, if any,
◦ Change justification for the reprocessing.
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25. Electronic audit trails include those that track
creation, modification, or deletion of data
◦ (such as processing parameters and results)
And
Those that track actions at the record or system
level
◦ such as attempts to access the system or rename or delete
a file
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26. How does FDA use the terms “static” and “dynamic”
as they relate to record formats?
Static is used to indicate a fixed-data document
such as a paper record or an electronic image,
Dynamic means that the record format allows
interaction between the user and the record
content.
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27. For example,
A dynamic chromatographic record allows the user
to
◦ Change the baseline and
◦ Reprocess chromatographic data so that the resulting
peaks may appear smaller or larger.
◦ Modify formulas or entries in a spreadsheet used to
compute test results or other information such as
calculated yield.
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28. How does FDA use the term “backup” in §
211.68(b)?
FDA uses the term backup in § 211.68(b) to refer
to a true copy of the original data
This should be maintained securely throughout the
records retention period
◦ (for example, § 211.180).
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29. The backup file should
◦ contain the data
(which includes associated metadata)
and
◦ Should be in the original format or in a format compatible
with the original format.
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30. This should not be confused with backup copies
These are created during normal computer use
They are temporarily maintained for disaster recovery
◦ (e.g., in case of a computer crash or other interruption).
Such temporary backup copies would not satisfy the
requirement in § 211.68(b) to maintain a backup file of
data.
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31. What are the “systems” in “computer or related
systems” in § 211.68?
The American National Standards Institute (ANSI)
defines systems as following organized to
accomplish a set of specific functions.
◦ People,
◦ Machines, and
◦ Methods
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32. Computer or related systems can refer to
◦ Computer hardware
◦ Software
◦ Peripheral devices
◦ Networks
◦ Cloud infrastructure
◦ Operators
◦ Associated documents
(e.g., user manuals and standard operating procedures).
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33. When is it permissible to exclude CGMP data from
decision making?
Any data created as part of a CGMP record must be
◦ Evaluated by the quality unit as part of release criteria
(see §§ 211.22 and 212.70) and
◦ Maintained for CGMP purposes
(e.g., § 211.180).
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34. Electronic data generated to fulfill CGMP
requirements should include relevant metadata.
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35. To exclude data from the release criteria decision-
making process, there must be a valid,
documented, scientific justification for its
exclusion: See
◦ The guidance for industry Investigating Out-of-
Specification (OOS) Test Results for Pharmaceutical
Production, and
◦ §§ 211.188, 211.192, and 212.71(b)).
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36. The requirements for record retention and review
do not differ depending on the data format;
Paper-based and electronic data record-keeping
systems are subject to the same requirements.
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37. Does each workflow on our computer system need
to be validated?
◦ Yes
A workflow, such as creation of an electronic
master production and control record (MPCR), is an
intended use of a computer system
◦ This should be checked through validation
(see§§ 211.63, 211.68(b), and 211.110(a)).
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38. If computer system is validated, but not its intended
use, we cannot know if workflow runs correctly.
For example, qualifying the Manufacturing Execution
System (MES) platform, a computer system, ensures that
it meets specifications;
However, it does not demonstrate that a given MPCR
generated by the MES contains the correct calculations.
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39. In this example, validating the workflow ensures that
the intended steps, specifications, and calculations in
the MPCR are accurate.
This is similar to reviewing a paper MPCR and ensuring
all supporting procedures are in place before the MPCR
is implemented in production. See
◦ §§ 211.100, 211.186, and 212.50(b), and
◦ The guidance for industry PET Drugs — Current Good
Manufacturing Practice (CGMP)
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40. FDA recommends you implement appropriate
controls to manage risks associated with each
element of the system.
Controls that are appropriately designed to validate
a system for its intended use address software,
hardware, personnel, and documentation.
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41. How should access to CGMP computer systems be
restricted?
FDA recommends
◦ To exercise appropriate controls to assure that changes to
computerized MPCRs, or other records, or input of
laboratory data into computerized records, can be made
only by authorized personnel (§ 211.68(b)).
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42. How should access to CGMP computer systems be
restricted?
FDA recommends
◦ To restrict the ability to alter specifications,
process parameters, or manufacturing or testing
methods by technical means where possible
(for example, by limiting permissions to change
settings or data).
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43. How should access to CGMP computer systems be restricted?
FDA recommends
◦ That the system administrator role, including any rights to
alter files and settings, be assigned to personnel
independent from those responsible for the record content.
◦ To maintain a list of authorized individuals and their access
privileges for each CGMP computer system in use.
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44. These independent security role assignments may not be
practical for small operations or facilities with few employees
◦ PET or
◦ Medical gas facilities
FDA recommends alternate control strategies to be
implemented.
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45. For example
In a rare instance if same person is required to hold the
system administrator role and to be responsible for the
content of the records
◦ FDA suggests having a second person review settings and content.
If second-person review is not possible
◦ the Agency recommends that the person recheck settings and his or her
own work.
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46. Why is FDA concerned with the use of shared login accounts
for computer systems?
FDA Recommends
◦ To exercise appropriate controls to assure that only authorized personnel
make changes to computerized MPCRs, or other records, or input
laboratory data into computerized records, and
◦ To implement documentation controls that ensure actions are attributable
to a specific individual
See §§ 211.68(b), 211.188(b)(11), 204 211.194(a)(7) and (8), and 212.50(c)(10)
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47. When login credentials are shared, a unique individual cannot
be identified through the login
Therefore the system would thus not conform to the CGMP
requirements in parts 211 and 212.
FDA requires that systems controls, including documentation
controls, be designed to follow CGMP to assure product
quality
◦ for example, §§ 211.100 and 212.50
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48. How should blank forms be controlled?
There must be document controls in place to assure product
quality
◦ (see §§ 211.100,213 211.160(a), 211.186, 212.20(d), and 212.60(g)).
FDA recommends that, if used, blank forms be controlled by
the quality unit or by another document control method.
Blank forms include but not limited to, worksheets, laboratory
notebooks, and MPCRs
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49. For example, numbered sets of blank forms may be issued as
appropriate and should be reconciled upon completion of all
issued forms.
Incomplete or erroneous forms should be kept as part of the
permanent record along with written justification for their
replacement
◦ for example, see §§ 211.192, 211.194, 212.50(a), and 212.70(f)(1)(vi)
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50. Similarly, bound paginated notebooks, stamped for official
use by a document control group, allow detection of
unofficial notebooks as well as of any gaps in notebook
pages.
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51. How often should audit trails be reviewed?
FDA recommends that audit trails that capture changes to
critical data be reviewed with each record and before final
approval of the record.
Audit trails subject to regular review should include, but are
not limited to, the following:
◦ The change history of finished product test results,
◦ Changes to sample run sequences,
◦ Changes to sample identification, and
◦ Changes to critical process parameters.
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52. FDA recommends routine scheduled audit trail review based
on the complexity of the system and its intended use.
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53. Who should review audit trails?
Audit trails are considered part of the associated records.
Personnel responsible for record review under CGMP should
review the audit trails
These should capture changes to critical data associated with
the record as they review the rest of the record
◦ for example, §§ 211.22(a), 211.101(c), 211.194(a)(8), and 212.20(d)
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54. For example,
All production and control records, which includes audit
trails, must be reviewed and approved by the quality unit
◦ § 211.192
This is similar to the expectation that cross-outs on paper be
assessed when reviewing data.
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55. Can electronic copies be used as accurate reproductions of
paper or electronic records?
Yes.
Electronic copies can be used as true copies of paper or
electronic records
This is provided the copies preserve the content and meaning
of the original data,
◦ Which should include associated metadata and the static or dynamic
nature of the original records.
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56. True copies of dynamic electronic records may be made and
maintained in the format of the original records or in a
compatible format,
This is provided that
◦ The content and meaning of the original records are preserved and
◦ That a suitable reader and copying equipment (for example, software and
hardware, including media readers) are readily available
§§ 211.180(d) and 212.110
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57. Is it acceptable to retain paper printouts or static records
instead of original electronic records from stand-alone
computerized laboratory instruments, such as an FT-IR
instrument?
A paper printout or static record may satisfy retention
requirements if it is a complete copy of the original record
◦ (see §§ 211.68(b), 211.188, 211.194, and 212.60).
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58. For example, pH meters and balances may create a paper
printout or static image during data acquisition as the
original record.
In this case, the paper printout or static image created during
acquisition, or a true copy, should be retained (§ 211.180).
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59. However, electronic records from certain types of laboratory
instruments are dynamic records,
In this case a printout or a static record does not preserve the
dynamic format which is part of the complete original record.
For example, the spectral file created by FT-IR can be
reprocessed,
However a static record or printout is fixed, which would not
satisfy CGMP requirements to retain original records or true
copies (§ 211.180(d)).
Also, if the full spectrum is not displayed, contaminants may be
excluded.
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60. Control strategies must ensure that original laboratory
records, including paper and electronic records, are subject
to second-person review (§ 211.194(a)(8)) to make certain
that all test results are appropriately reported.
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61. For PET drugs, see the guidance for industry PET Drugs —
Current Good Manufacturing Practice (CGMP) for discussion of
equipment and laboratory controls, including regulatory
requirements for records.
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62. Can electronic signatures be used instead of
handwritten signatures for master production and
control records?
Yes,
Electronic signatures with the appropriate controls
can be used instead of handwritten signatures or
initials in any CGMP required record.
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63. § 211.186(a) specifies a “full signature,
handwritten,”
◦ However the Federal Register on September 29, 1978 (43 FR
45069) explains that part of the intent of the full signature
requirement is to be able to clearly identify the individual
responsible for signing the record.
◦ An electronic signature with the appropriate controls to securely
link the signature with the associated record fulfills this
requirement.
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64. § 211.186(a) specifies a “full signature,
handwritten,”
◦ This comports with part 11, which establishes criteria for when electronic
signatures are considered the legally binding equivalent of handwritten
signatures.
◦ Firms using electronic signatures should document the controls used to
ensure that they are able to identify the specific person who signed the
records electronically.
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65. There is no requirement for a handwritten
signature for the MPCR in the PET CGMP
regulations (21 CFR part 212).
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66. When does electronic data become a CGMP record?
◦ When generated to satisfy a CGMP requirement, all data
become a CGMP record.
◦ This data must be documented, or saved at the time of
performance to create a record incompliance with CGMP
requirements,
Including, but not limited to, §§ 211.100(b) and 211.160(a).
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67. FDA expects processes to be designed so that
quality data required to be created and maintained
cannot be modified.
For example,
◦ Chromatograms should be sent to long-term storage upon
run completion instead of at the end of a day’s runs.
Archiving or a permanent record
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68. It is not acceptable
◦ To record data on pieces of paper that will be discarded after
the data are transcribed to a permanent laboratory notebook
see §§ 211.100(b), 211.160(a), and 211.180(d)
◦ To store data electronically in temporary memory, in a manner
that allows for manipulation, before creating a permanent
record.
Electronic data that are automatically saved into
temporary memory do not meet CGMP documentation
or retention requirements.
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69. A combination of technical and procedural controls may be
employed to meet CGMP documentation practices for
electronic systems.
For example
◦ A computer system, such as a Laboratory Information Management
System (LIMS) or an Electronic Batch Record (EBR) system, can be
designed to automatically save after each separate entry.
◦ This would be similar to recording each entry contemporaneously on a
paper batch record to satisfy CGMP requirements.
◦ The computer system could be combined with a procedure requiring
data be entered immediately when generated.
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70. For PET drugs, see the “Laboratory Controls” section of the
guidance for industry PET Drugs — Current Good
Manufacturing Practice (CGMP).
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71. Why has the FDA cited use of actual samples during “system
suitability” or test, prep, or equilibration runs in warning
letters?
◦ FDA prohibits sampling and testing with the goal of achieving a specific
result or to overcome an unacceptable result
e.g., testing different samples until the desired passing result is obtained
◦ This practice is also referred to as testing into compliance,
◦ This is not consistent with CGMP
◦ See the guidance for industry Investigating Out-of-Specification (OOS)
Test Results for Pharmaceutical Production.
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72. In some situations, use of actual samples to perform system
suitability testing has been used as a means of testing into
compliance.
FDA considers it a violative practice to use an actual sample
in test, prep, or equilibration runs as a means of disguising
testing into compliance.
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73. System Suitability Tests : United States
Pharmacopeia (USP)
These should include replicate injections of a
standard preparation or other standard solutions to
determine if requirements for precision are
satisfied
◦ see USP General Chapter <621> Chromatography.
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74. System suitability tests, including the identity of
the preparation to be injected and the rationale for
its selection, should be performed according to the
firm’s established written procedures and the
approved application or applicable compendial
monograph
◦ (§§ 211.160 and 212.60).
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75. If an actual sample is to be used for system suitability testing,
it should be a properly characterized secondary standard.
Written procedures should be established and followed, and
the sample should be from a different batch than the
sample(s) being tested
◦ §§ 211.160, 211.165, and 212.60
All data should be included in the record that is retained
This should be subject to review unless there is documented
scientific justification for its exclusion.
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76. Is it acceptable to only save the final results from reprocessed
laboratory chromatography?
No.
◦ Analytical methods should be capable and stable.
◦ For most lab analyses, reprocessing data should not be regularly needed.
◦ If chromatography is reprocessed, written procedures must be established and
followed and each result retained for review
see §§367 211.160(a), 211.160(b), 211.165(c), 211.194(a)(4), and 212.60(a)).
FDA requires complete data in laboratory records
This includes raw data, graphs, charts, and spectra from
laboratory instruments (§§ 211.194(a) and 212.60(g)(3)).
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77. Can an internal tip regarding a quality issue, such as potential
data falsification, be handled informally outside of the
documented CGMP quality system?
No.
◦ Suspected or known falsification or alteration of records
required under parts 210,211, and 212 must be fully
investigated under the CGMP quality system
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78. The investigation should
◦ Determine the effect of the event on patient safety, product
quality, and data reliability;
◦ Determine the root cause; and
◦ Ensure the necessary corrective actions are taken
see §§ 211.22(a), 211.125(c), 211.192, 211.198, 211.204, and 212.100
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79. FDA invites individuals to report suspected data
integrity issues
◦ Issues that may affect the safety, identity, strength, quality,
or purity of drug products at DrugInfo@fda.hhs.gov.
◦ “CGMP data integrity” should be included in the subject line
of the email.
See also Application Integrity Policy, available at
http://www.fda.gov/ICECI/EnforcementActions/ApplicationIntegrityPolicy/de
fault.htm.
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80. Should personnel be trained in detecting data integrity
issues as part of a routine CGMP training program?
Yes.
◦ Training personnel to detect data integrity issues is consistent
with the personnel requirements under §§ 211.25 and 212.10,
◦ This states that personnel must have the education, training,
and experience, or any combination thereof, to perform their
assigned duties.
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81. Is the FDA investigator allowed to look at my electronic
records?
Yes.
All records required under CGMP are subject to FDA
inspection.
We must allow authorized inspection, review, and copying of
records,
This includes copying of electronic data (§§ 211.180(c) and
212.110(a) and (b)).
◦ See also section 704 of the FD&C Act.
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82. How does FDA recommend data integrity problems identified
during inspections, in warning letters, or in other regulatory
actions be addressed?
FDA encourages companies to demonstrate that they have
effectively remedied the problems by:
◦ Hiring a third party auditor,
◦ Determining the scope of the problem,
◦ Implementing a corrective action plan (globally), and
◦ Removing at all levels individuals responsible for problems from CGMP
positions. FDA may conduct an inspection to decide whether CGMP violations
involving data integrity have been remedied.
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83. These expectations mirror those developed for the
Application Integrity Policy.
For more detailed guidance, see the
◦ “Points to Consider for Internal Reviews and Corrective Action
Operating Plans” public document available on the FDA Web site,
accessible at
http://www.fda.gov/ICECI/EnforcementActions/ApplicationIntegrit
yPolicy/ucm1347. htm.
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84. This presentation is compiled from freely
available resources like the websites of FDA,
specifically the draft guidance issued by FDA
titled Data Integrity & compliance with cGMP
“Drug Regulations” is a non profit organization
which provides free online resource to the
Pharmaceutical Professional.
Visit http://www.drugregulations.org for latest
information from the world of Pharmaceuticals.
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