The document provides an overview of current good manufacturing practices (cGMP) and discusses their importance for ensuring quality and safety in drug production. It reviews cGMP requirements for different departments at the Blood Bank of Delmarva (BBD), including facilities, purchasing, donor services, quality control, IT, and more. Key points include establishing quality systems and procedures, controlling manufacturing processes, maintaining reliable testing, and generating detailed records to provide a complete history of work performed. Adhering to cGMP regulations helps assure the safety, purity and potency of blood products by building quality in at every stage of production.
Delayed blood transfusion reaction is a reaction too blood transfusion occurring after 24 hours. Can be divided to immune mediated and non-immune mediated. Share about the cause, symptoms, investigations and management.
Two Case Reports of Rare Weak ‘B’ Subgroup Detected During Routine TestingApollo Hospitals
Apart from the usual A, B, AB and O groups, there also exist many variant phenotypes. Variants of Type B blood, with weak expression of the B antigen, have been previously described and are known to be rare. These usually require advanced techniques like ‘Adsorption and Elution’ for their detection. We present 2 similar cases of rare B subgroups identified at our department.
Validation of lab instruments and quantitative test methods Mostafa Mahmoud
This lecture shows the procedures applied when going to validate your laboratory instruments and quantitative test methods also either FDA approved or laboratory developed tests.
Troubleshooting Poor EQA/QC Performance in the Laboratory Randox
Step by step guide for clinical laboratories wishing to troubleshoot poor QC or EQA performance. Tips on how to distinguish between random error and systematic error. Suggested corrective actions are also provided.
Common Transfusion Reactions by Randal Covin, MD, FCAPbloodbankhawaii
Lorem ipsum dolor sit amet, voluptaria percipitur has eu. Nibh iriure nostrud ei mea. Vel dicta voluptua convenire ei, id pro libris viderer. Pri et legendos atomorum, vel eu noster probatus menandri. Omnes possim ut eam, sed ea labore maiorum.
Delayed blood transfusion reaction is a reaction too blood transfusion occurring after 24 hours. Can be divided to immune mediated and non-immune mediated. Share about the cause, symptoms, investigations and management.
Two Case Reports of Rare Weak ‘B’ Subgroup Detected During Routine TestingApollo Hospitals
Apart from the usual A, B, AB and O groups, there also exist many variant phenotypes. Variants of Type B blood, with weak expression of the B antigen, have been previously described and are known to be rare. These usually require advanced techniques like ‘Adsorption and Elution’ for their detection. We present 2 similar cases of rare B subgroups identified at our department.
Validation of lab instruments and quantitative test methods Mostafa Mahmoud
This lecture shows the procedures applied when going to validate your laboratory instruments and quantitative test methods also either FDA approved or laboratory developed tests.
Troubleshooting Poor EQA/QC Performance in the Laboratory Randox
Step by step guide for clinical laboratories wishing to troubleshoot poor QC or EQA performance. Tips on how to distinguish between random error and systematic error. Suggested corrective actions are also provided.
Common Transfusion Reactions by Randal Covin, MD, FCAPbloodbankhawaii
Lorem ipsum dolor sit amet, voluptaria percipitur has eu. Nibh iriure nostrud ei mea. Vel dicta voluptua convenire ei, id pro libris viderer. Pri et legendos atomorum, vel eu noster probatus menandri. Omnes possim ut eam, sed ea labore maiorum.
Good Manufacturing Practice, or GMP, is a set of practices and systems that are aimed at making sure that pharmaceutical products are manufactured in conformance with set requirements and standards. The aim of GMP also referred to sometimes as cGMP or Current Good Manufacturing Practice, is to ensure that there is control and consistency in the pharmaceutical products, so that the processes used for controlling quality and consistency of the product can be traced back in the event of a problem.
An introductory overview of drug regulation in the biotch industry. Provides and intro to cGMP, FDA Inspections and Logistics and Drug Regulation History in the U.S.
A phase 1 clinical trial includes the initial introduction of an investigational new drug product, including biological drug products, into humans. Such studies are conducted to establish the basic safety of the drug, and are designed to determine the metabolism and pharmacologic actions of the drug in humans. The total number of subjects in a phase 1 clinical trial is limited generally to no more than 80 subjects.
This presentation covers the CGMP’s for Investigation New Drugs for Phase I. The presentation has been compiled from publicly available material on the world wide web by “ Drug Regulations” a not for profit organization.
This is a presentation that I developed and gave to the GMP constituency of a medium-sized biopharmaceutical company to satisfy one of the requirements for ongoing cGMP training. I feel that it very well epitomizes one of my central philosophies surrounding GXP and regulatory topic training -- STORYTELLING.
the all the content in this profile is completed by the teachers, students as well as other health care peoples.
thank you, all the respected peoples, for giving the information to complete this presentation.
this information is free to use by anyone.
Instant GMP Compliance Series - Improving DocumentationInstantGMP™
The FDA enforces the Dietary Supplement Health and Education Act (DSHEA) law by inspecting dietary supplement manufacturers, packagers, labelers and holders for Current Good Manufacturing Practices (cGMPs) compliance. One of the main issues they found was the lack of proper documentation. This presentation provides an overview of the documentation that is needed for cGMP compliance.
Ian brings 16 years of experience in the Biotech/Pharmaceutical Industry in Quality Assurance and Quality Control. He has extensive knowledge of all of the applicable regulatory requirements.
My last projects as an independent contractor were with SHIRE, LONZA and NOVARTIS. I conducted Product Investigations from Inoculations of Media to Manufacturing projects which included from line clearance issues to inclusions of foreign material. Also, Inspection of all product packaging to determine a non-negative product impact.
Good Laboratory Practices (GLP) and USP 1058 Validation.pdfConference Panel
This webinar will define what is the US FDA's expectations for proper laboratory practices, systems, equipment usage, and documentation / record-keeping. It will evaluate the requirements for how basic Quality Management System (QMS) expectations/requirements are addressed in the lab environment. The webinar with evaluate pharma GMPs and 21 CFR 58 and associated regulations to see how the GLPs can be implemented in the real world to achieve FDA requirements and ensure the accuracy and repeatability/reproducibility of lab results.
This webinar is intended to provide guidance regarding Good Laboratory Practices (GMP) and lab equipment and analytical methods validation for use in pharmaceutical manufacturing and clinical trials and for use by contract laboratories that support the regulated medical products industries.
Register,
https://conferencepanel.com/conference/good-laboratory-practices-glp-and-usp-1058-validation
Master of Good Manufacturing Practice - Course Detailsutspharmacy
Staff who hold postgraduate degrees in Good Manufacturing Practice (GMP) are essential for many pharmaceutical, biologic, medical device and food manufacturing companies.
This presentation provides an overview of the Master of Good Manufacturing Practice offered at the University of Technology, Sydney (UTS) in Australia. For more information visit www.gmp.uts.edu.au
Pharmaceutical Good Manufacturing PracticesPharmaceutical
When you are in healthcare, Then GMP is must. Regulatory philosophy for product Quality have been changed from "Quality by Testing QbT" to "Quality by Design QbD". Quality is to be built in product and that only can be done by GMP.
WHO Good Manufacturing Practice Requirements
Good Manufacturing Practice is the part of quality assurance that ensures that products are consistently manufactured and controlled to the quality standards appropriate to their intended use.
- Video recording of this lecture in English language: https://youtu.be/lK81BzxMqdo
- Video recording of this lecture in Arabic language: https://youtu.be/Ve4P0COk9OI
- Link to download the book free: https://nephrotube.blogspot.com/p/nephrotube-nephrology-books.html
- Link to NephroTube website: www.NephroTube.com
- Link to NephroTube social media accounts: https://nephrotube.blogspot.com/p/join-nephrotube-on-social-media.html
Flu Vaccine Alert in Bangalore Karnatakaaddon Scans
As flu season approaches, health officials in Bangalore, Karnataka, are urging residents to get their flu vaccinations. The seasonal flu, while common, can lead to severe health complications, particularly for vulnerable populations such as young children, the elderly, and those with underlying health conditions.
Dr. Vidisha Kumari, a leading epidemiologist in Bangalore, emphasizes the importance of getting vaccinated. "The flu vaccine is our best defense against the influenza virus. It not only protects individuals but also helps prevent the spread of the virus in our communities," he says.
This year, the flu season is expected to coincide with a potential increase in other respiratory illnesses. The Karnataka Health Department has launched an awareness campaign highlighting the significance of flu vaccinations. They have set up multiple vaccination centers across Bangalore, making it convenient for residents to receive their shots.
To encourage widespread vaccination, the government is also collaborating with local schools, workplaces, and community centers to facilitate vaccination drives. Special attention is being given to ensuring that the vaccine is accessible to all, including marginalized communities who may have limited access to healthcare.
Residents are reminded that the flu vaccine is safe and effective. Common side effects are mild and may include soreness at the injection site, mild fever, or muscle aches. These side effects are generally short-lived and far less severe than the flu itself.
Healthcare providers are also stressing the importance of continuing COVID-19 precautions. Wearing masks, practicing good hand hygiene, and maintaining social distancing are still crucial, especially in crowded places.
Protect yourself and your loved ones by getting vaccinated. Together, we can help keep Bangalore healthy and safe this flu season. For more information on vaccination centers and schedules, residents can visit the Karnataka Health Department’s official website or follow their social media pages.
Stay informed, stay safe, and get your flu shot today!
These simplified slides by Dr. Sidra Arshad present an overview of the non-respiratory functions of the respiratory tract.
Learning objectives:
1. Enlist the non-respiratory functions of the respiratory tract
2. Briefly explain how these functions are carried out
3. Discuss the significance of dead space
4. Differentiate between minute ventilation and alveolar ventilation
5. Describe the cough and sneeze reflexes
Study Resources:
1. Chapter 39, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 34, Ganong’s Review of Medical Physiology, 26th edition
3. Chapter 17, Human Physiology by Lauralee Sherwood, 9th edition
4. Non-respiratory functions of the lungs https://academic.oup.com/bjaed/article/13/3/98/278874
Title: Sense of Smell
Presenter: Dr. Faiza, Assistant Professor of Physiology
Qualifications:
MBBS (Best Graduate, AIMC Lahore)
FCPS Physiology
ICMT, CHPE, DHPE (STMU)
MPH (GC University, Faisalabad)
MBA (Virtual University of Pakistan)
Learning Objectives:
Describe the primary categories of smells and the concept of odor blindness.
Explain the structure and location of the olfactory membrane and mucosa, including the types and roles of cells involved in olfaction.
Describe the pathway and mechanisms of olfactory signal transmission from the olfactory receptors to the brain.
Illustrate the biochemical cascade triggered by odorant binding to olfactory receptors, including the role of G-proteins and second messengers in generating an action potential.
Identify different types of olfactory disorders such as anosmia, hyposmia, hyperosmia, and dysosmia, including their potential causes.
Key Topics:
Olfactory Genes:
3% of the human genome accounts for olfactory genes.
400 genes for odorant receptors.
Olfactory Membrane:
Located in the superior part of the nasal cavity.
Medially: Folds downward along the superior septum.
Laterally: Folds over the superior turbinate and upper surface of the middle turbinate.
Total surface area: 5-10 square centimeters.
Olfactory Mucosa:
Olfactory Cells: Bipolar nerve cells derived from the CNS (100 million), with 4-25 olfactory cilia per cell.
Sustentacular Cells: Produce mucus and maintain ionic and molecular environment.
Basal Cells: Replace worn-out olfactory cells with an average lifespan of 1-2 months.
Bowman’s Gland: Secretes mucus.
Stimulation of Olfactory Cells:
Odorant dissolves in mucus and attaches to receptors on olfactory cilia.
Involves a cascade effect through G-proteins and second messengers, leading to depolarization and action potential generation in the olfactory nerve.
Quality of a Good Odorant:
Small (3-20 Carbon atoms), volatile, water-soluble, and lipid-soluble.
Facilitated by odorant-binding proteins in mucus.
Membrane Potential and Action Potential:
Resting membrane potential: -55mV.
Action potential frequency in the olfactory nerve increases with odorant strength.
Adaptation Towards the Sense of Smell:
Rapid adaptation within the first second, with further slow adaptation.
Psychological adaptation greater than receptor adaptation, involving feedback inhibition from the central nervous system.
Primary Sensations of Smell:
Camphoraceous, Musky, Floral, Pepperminty, Ethereal, Pungent, Putrid.
Odor Detection Threshold:
Examples: Hydrogen sulfide (0.0005 ppm), Methyl-mercaptan (0.002 ppm).
Some toxic substances are odorless at lethal concentrations.
Characteristics of Smell:
Odor blindness for single substances due to lack of appropriate receptor protein.
Behavioral and emotional influences of smell.
Transmission of Olfactory Signals:
From olfactory cells to glomeruli in the olfactory bulb, involving lateral inhibition.
Primitive, less old, and new olfactory systems with different path
New Directions in Targeted Therapeutic Approaches for Older Adults With Mantl...i3 Health
i3 Health is pleased to make the speaker slides from this activity available for use as a non-accredited self-study or teaching resource.
This slide deck presented by Dr. Kami Maddocks, Professor-Clinical in the Division of Hematology and
Associate Division Director for Ambulatory Operations
The Ohio State University Comprehensive Cancer Center, will provide insight into new directions in targeted therapeutic approaches for older adults with mantle cell lymphoma.
STATEMENT OF NEED
Mantle cell lymphoma (MCL) is a rare, aggressive B-cell non-Hodgkin lymphoma (NHL) accounting for 5% to 7% of all lymphomas. Its prognosis ranges from indolent disease that does not require treatment for years to very aggressive disease, which is associated with poor survival (Silkenstedt et al, 2021). Typically, MCL is diagnosed at advanced stage and in older patients who cannot tolerate intensive therapy (NCCN, 2022). Although recent advances have slightly increased remission rates, recurrence and relapse remain very common, leading to a median overall survival between 3 and 6 years (LLS, 2021). Though there are several effective options, progress is still needed towards establishing an accepted frontline approach for MCL (Castellino et al, 2022). Treatment selection and management of MCL are complicated by the heterogeneity of prognosis, advanced age and comorbidities of patients, and lack of an established standard approach for treatment, making it vital that clinicians be familiar with the latest research and advances in this area. In this activity chaired by Michael Wang, MD, Professor in the Department of Lymphoma & Myeloma at MD Anderson Cancer Center, expert faculty will discuss prognostic factors informing treatment, the promising results of recent trials in new therapeutic approaches, and the implications of treatment resistance in therapeutic selection for MCL.
Target Audience
Hematology/oncology fellows, attending faculty, and other health care professionals involved in the treatment of patients with mantle cell lymphoma (MCL).
Learning Objectives
1.) Identify clinical and biological prognostic factors that can guide treatment decision making for older adults with MCL
2.) Evaluate emerging data on targeted therapeutic approaches for treatment-naive and relapsed/refractory MCL and their applicability to older adults
3.) Assess mechanisms of resistance to targeted therapies for MCL and their implications for treatment selection
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Ve...kevinkariuki227
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Verified Chapters 1 - 19, Complete Newest Version.pdf
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Verified Chapters 1 - 19, Complete Newest Version.pdf
ARTIFICIAL INTELLIGENCE IN HEALTHCARE.pdfAnujkumaranit
Artificial intelligence (AI) refers to the simulation of human intelligence processes by machines, especially computer systems. It encompasses tasks such as learning, reasoning, problem-solving, perception, and language understanding. AI technologies are revolutionizing various fields, from healthcare to finance, by enabling machines to perform tasks that typically require human intelligence.
Explore natural remedies for syphilis treatment in Singapore. Discover alternative therapies, herbal remedies, and lifestyle changes that may complement conventional treatments. Learn about holistic approaches to managing syphilis symptoms and supporting overall health.
The POPPY STUDY (Preconception to post-partum cardiovascular function in prim...
cGMP Training 2013
1. Puzzled by Your Role in cGMP?
2013 Annual GMP Training
Kevin Aquino, Nancy Cary, & Kelly Danyow
2. Purpose
• Provide a general review of current good
manufacturing practices (cGMP).
•Discuss the importance of following cGMPs.
•Provide specific information related to cGMP for each
department at BBD.
•Review requirements for records.
2
3. cGMP Review
So, what are cGMPs?
•cGMP refers to current Good Manufacturing Practice regulations enforced
by the FDA.
•cGMPs provide for systems to assure proper design, monitoring, and
control of manufacturing processes and facilities- establish the foundation
for drug quality
• adherence to cGMP regulations assures the SPPI of products by requiring
manufacturers to control operations
•Includes establishing quality management systems, establishing robust
procedures, detecting and investigating product quality deviations, and
maintaining reliable testing laboratories
•cGMP is sameness and consistency across processes, to ensure the
mitigation of variability that can lead to lack of consistency in the quality of
the product
•“current” in cGMP requires companies to use up-to-date technologies and
systems
•cGMPs are minimum requirements- may exceed but must meet
3
4. cGMP Review
Why are cGMPs important?
•A consumer cannot easily detect that a drug product is safe or will work
•Testing alone is not enough to ensure adequate quality
•It is important that drugs are manufactured following cGMP regulations to
ensure quality is built into the product at every step
•Blood is a drug! The Food, Drug, and Cosmetic Act defines drugs in part
as “articles intended for use in the diagnosis, cure, mitigation, treatment, or
prevention of disease" and "articles (other than food) intended to affect the
structure or any function of the body of man or other animals”
•If manufacturers do not follow cGMP regulations, the drugs it makes are
considered “adulterated” (rendered poorer in quality).
•cGMP violations can lead to seizure or injunction cases even if the drugs
produced are not defective. This can involve destruction of “adulterated”
drugs in a seizure case or forced hiring of outside experts, writing new
procedures, or extensive training of staff in the case of an injunction. The
FDA can also bring criminal cases because of cGMP violations.
4
5. cGMP at BBD
Each Department at
BBD plays an
important part in
maintaining cGMPs
throughout our
organization.
• 21 CFR Parts 210, 211 and
606 contain current Good
Manufacturing Practice for
Drugs/Biologics.
•Addressed in Subparts
5
6. cGMP at BBD
HR
Organization and Personnel
• Each person involved in the collection,
manufacture, testing, storage and distribution of
blood must have the education, training, and
experience (or combination) to perform
assigned functions and provide assurance that
SPPI of product is maintained
•Personnel must be adequate in number
•Supervisors must have adequate education,
training, experience (or combination) to perform
assigned functions and provide assurance that
SPPI of product is maintained
• Personnel responsibilities- good hygiene and sanitation, appropriate PPE,
free of illness that may adversely affect products
•Consultants must have adequate education, training, experience (or
combination)
•Appropriate records must be maintained (Records and Reports)
6
7. cGMP at BBD
Buildings and Facilities
•Buildings must be maintained in a clean and orderly
manner and be of adequate size, construction, and
location
•Operations performed in defined areas to prevent mix-ups
•Adequate lighting, plumbing, ventilation, sanitation
Facilities
& Purchasing
Control of Components and Drug Product Containers
and Closures
•Procedures for receipt, inspection, handling, testing, and approval or rejection of
drug product components and containers
•Handled and stored to prevent contamination
• Distinctive lots and disposition (quarantined, accepted, etc.)
•Rotated so that oldest is used first (FIFO)
Records and Reports
7
8. cGMP at BBD
Holding and Distribution
•Must have warehousing procedures, including quarantined products
•Products must be stored to ensure SPPI
•Must have distribution procedures which include inventory rotation
•System to easily determine distribution of products in case of recall
Returned and Salvaged Products
•Returned products must be identified and held until determined
SPPI maintained
•If not, products are destroyed
•Maintain records of returns (Records and Reports)
Distribution
Packaging and Label Control
• Examination of labeling and packing material (rejected if
deemed unsuitable)
•Strict labeling control to prevent mix-ups
•Visual inspection of product and labels
•Expiration dating to ensure product meets SPPI
Production and Process Control
8
9. cGMP at BBD
Equipment
•Appropriate in design, size, and location
•Cleaned/maintained at appropriate intervals
•Automated/mechanical/electronic equipment routinely calibrated
Production and Process Controls
•Yield shall be calculated
•All equipment must be identified
•Sampling of each batch must be performed (QC)
•Production time limits
•Written procedures for component preparation methods
•Storage temperatures and methods for controlling temp
Lab
(Component &
Processing)
Laboratory Controls
•Determine strength prior to release
•Test to ensure free from microorganisms
•Sampling plans
•Identification/handling of test samples
Packaging and Label Control
Control of Components and Drug Product Containers and Closures
Records and Reports
9
10. cGMP at BBD
Donor Services
Equipment
Production and Process Controls
•Written SOPS shall be maintained and
followed, including:
•Donor suitability criteria
•Methods to prepare phlebotomy site to
ensure a sterile product
•Method to relate product to donor
•Blood collection procedure
•Procedures for automated collections
(plateletpheresis)
•Donor deferral
•QC for supplies used in collection process
Records and Reports
•Donor records- medical interview and phlebotomy, deferrals, therapeutic
requests for phlebotomy, reactions, quarantine records…
10
11. cGMP at BBD
Production and Process Controls
•Deviations from procedure shall be
recorded and justified
•Procedures for investigating adverse
donor and recipient reactions
•Consignee notification of unsuitable blood
products
•Identify previous donations of units that
test positive for infectious diseases (look
back)
QCT
Organization and Personnel
•Must have a quality control unit with responsibility to approve or rejects
components, containers, products, and production records
•Made up of members from multiple departments
Reports and Records
11
12. cGMP at BBD
Equipment
Automatic, mechanical and electrical equipment
•A back up file of data entered into the computer or related system shall be
maintained
IT
Records
•A donor number shall be assigned to each accepted
donor, which relates the unit of blood collected to that
donor, to his medical record, to any component or blood
product from that donor’s unit of blood, and to all records
describing the history and ultimate disposition of these
products
12
13. cGMP at BBD
Production and Process Controls
•SOP’s shall include:
*Criteria used to determine donor suitability,
including acceptable medical history criteria
*Procedures for investigating adverse donor
and recipient reactions
*Procedures for donor deferrals
Scheduling &
Membership
Records and Reports
13
14. cGMP at BBD
Facilities
•First step to assuring cGMP requirement
606.40 is met
•When an interest is expressed in hosting a
corporate on-site blood drive, Marketing
provides a checklist to ensure an adequate
space can be provided
MCR
Organization and Personnel
•Responsible for providing and documenting
proper training to volunteers
14
15. cGMP at BBD
Finance
Supports departments in meeting cGMPs
throughout the organization by providing
resources:
•Buildings and Facilities
•Equipment
•Organization and Personnel
Executive
Supports the organization in ensuring
adherence to cGMPs
15
16. cGMP at BBD
HR
A record is a document stating results achieved or
providing evidence of activities performed.
• Each dept at BBD generates records.
“If it is not documented, it did not happen.”
•Records prove we are compliant to GMP and are
operating in a “State of control”.
Finance
16
17. Records
“ Records shall be maintained concurrently with the performance of each step in the
collection, processing, compatibility testing, storage and distribution of each unit of
blood and blood components so that all steps can be clearly traced. All records
shall be legible and indelible, and shall identify the person performing the
work, include dates of the various entries, show test results as well as
interpretation of the results….. And be detailed as necessary to provide a
complete history of the work performed”.
Records include but are not limited to:
•Donor records
•Processing records- results and interpretation of all tests, component
preparation, labeling…
•Storage and distribution records- visual inspection records, disposition
records, temperature records…
•Compatibility testing records- antibody screening…
•Quality control records- calibration, performance checks of
equipment, proficiency test results…
• Transfusion reaction reports and complaints
•General records- biological product deviations, maintenance records, supply
and reagent records, rejected supply records…
17
18. Things to Remember…
•If documentation does not occur at the same time a step is performed, this leads to
omissions on our records.
To omit = to fail to do
•We can’t assume that undocumented work has been done!
•Must also identify the person performing the work and the date that the work is
performed.
•provides traceability
•If documentation is not required, the space should be filled in with N/A or as
indicated in form key/legend (if applicable)
• Legible is defined as understandable- clear to any potential reviewer.
•Error corrections must be made appropriately- otherwise, we lose traceability.
18
19. Things to Remember…
•When you overwrite or use white-out material, you obliterate original data,
which is unacceptable. Examiner needs to see original data to determine why it
was changed/modified.
When in doubt- cross it out!
•Proper error correction= single line through/ initial and date
•indelible is defined as impossible to remove or permanent.
•We cannot use felt tip pens which may wash away, as well as pencil
which is erasable- these are not indelible.
19
