Presentation on avoiding the GMP errors with some controls and actions which are mentioned in the same which may help the industry on current trends of regulatory inspections.
I am uploading this GMP presentation to make aware who are working in pharma and help to maintain high standards in products manufacturing .
GMP Vs cGMP: It is my understanding that , Ultimately GMP & cGMP both the aim is same, means to prevention of the product from bad quality entering the market to endover peoples's life.
GMP applies to pharmaceutical and healthcare products and help to maintain high standards in these products.
cGMP is to remind accepting countries that all guidelines must be followed with latest and current production processes i.e employ technologies and systems which are up-to-date in order to comply with the regulation.
FDA (Food and Drug Administration) included the word “current” to ensure that regulated firms use the most current Good Manufacturing Practices (I believe that some firms would actually use outdated versions of the GMP’s to manufacture regulated products.
(the FDA have made their standards immediately identifiable i.e cGMP; Other international bodies such as the ICH, WHO use the term GMP, as do Canada, Japan and the EMEA (European authority). In FDA view cGMP means following 21 CFR 210 and 211 and no other.)
Master batch record,batch production record ,Quality Audit Type and plan &Rec...KarishmaFuse
Standard Operating procedure(SOP), Preparation review ,Approval Issuance of master batch Record MBR and Batch Production Record (BPR) and Quality Audit Type, plan and Objectives.
Good Documentation Practice (GDocP) is an essential part of the quality assurance and such, related to all aspects of GMP” this definition is based on WHO. It is a systematic procedure of preparation, reviewing, approving, issuing, recording, storing and archival of document.
Quality Audit in pharmaceutical industryHari Haran
It deals with the understanding and process for auditing
pharmaceutical industries. This covers the methodology involved in auditing process of different in pharmaceutical industries.
In Pharma and Biotech, Weightage of the Documentation is around 70 % because as per FDA "If you do not have Document, You dint have do it."
So Good Documentation Practice is of tremendous importance for the Industry to comply any regulation like FDA, GMP or ISO.
standard operating procedure are the important document for pharmaceutical company & organization which may follow reference copy of the manufacturing batch or lot.
I am uploading this GMP presentation to make aware who are working in pharma and help to maintain high standards in products manufacturing .
GMP Vs cGMP: It is my understanding that , Ultimately GMP & cGMP both the aim is same, means to prevention of the product from bad quality entering the market to endover peoples's life.
GMP applies to pharmaceutical and healthcare products and help to maintain high standards in these products.
cGMP is to remind accepting countries that all guidelines must be followed with latest and current production processes i.e employ technologies and systems which are up-to-date in order to comply with the regulation.
FDA (Food and Drug Administration) included the word “current” to ensure that regulated firms use the most current Good Manufacturing Practices (I believe that some firms would actually use outdated versions of the GMP’s to manufacture regulated products.
(the FDA have made their standards immediately identifiable i.e cGMP; Other international bodies such as the ICH, WHO use the term GMP, as do Canada, Japan and the EMEA (European authority). In FDA view cGMP means following 21 CFR 210 and 211 and no other.)
Master batch record,batch production record ,Quality Audit Type and plan &Rec...KarishmaFuse
Standard Operating procedure(SOP), Preparation review ,Approval Issuance of master batch Record MBR and Batch Production Record (BPR) and Quality Audit Type, plan and Objectives.
Good Documentation Practice (GDocP) is an essential part of the quality assurance and such, related to all aspects of GMP” this definition is based on WHO. It is a systematic procedure of preparation, reviewing, approving, issuing, recording, storing and archival of document.
Quality Audit in pharmaceutical industryHari Haran
It deals with the understanding and process for auditing
pharmaceutical industries. This covers the methodology involved in auditing process of different in pharmaceutical industries.
In Pharma and Biotech, Weightage of the Documentation is around 70 % because as per FDA "If you do not have Document, You dint have do it."
So Good Documentation Practice is of tremendous importance for the Industry to comply any regulation like FDA, GMP or ISO.
standard operating procedure are the important document for pharmaceutical company & organization which may follow reference copy of the manufacturing batch or lot.
Good Manufacturing Practices.
Basic rules of GMP
Various aspects of GMP.
How do GMP change.
Comparison of GMP.
Quality assurance
Principles of QA
Functions of QA department.
Documentation
Importance of documentation of records
Important areas of documentation
Components of documentation
Good Manufacturing Practice is a set of regulations, codes, and guidelines for the manufacture of drug substances and drug products, medical devices, in vivo and in vitro diagnostic products, and foods.
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
Cross-Functional Teams: A Product Manager's NirvanaMovel
Cross-functional teams solve challenging problems faster by employing multi-disciplinary approach and delivering business value early and often. The fact that multi-disciplinary team members work on the same problem at the same time brings a number of advantages, of which speed of delivery and product quality are most important. The ability to listen and consider other viewpoints is a key to understanding tough problems and when applied properly, the results can be spectacular!
In this 60-minute session, we’re going to explore the benefits of cross-functional teams and look at how Product Managers can employ cross-functional teams to drive business value. We will look at key aspects of successful cross-functional teams such as:
How cross-functional teams maximize business value
* Alignment of business goals and return on investment
* How to assemble a cross-functional team
* Technology and the stack – no need to be an expert, but an understanding of the stack can help balance the business with the technical stories
* Driving user experience – here again, the PM is not a UI/UX designer, but someone who has the final say of the overall direction or “feel” of the product
* Diving the work among the x-functional team
* Epic and story definition when working with cross-functional teams
* Tracking progress
* How to prioritize features based on a technology stack
We’re going to look at ways to recruit and retain cross-functional talent and some of the organizational challenges that can arise as a result of this new team structure.
The audience of product managers, product owners, executives, technical managers and recruiting managers will learn what makes cross-functional teams successful, look at industry best practices and apply these strategies in their own organizations.
Basic Training Slides for Food Manufacturing.pptbeijingdaxing510
Food Manufacturing provides processing professionals news on recalls, safety, quality control, capital equipment, operational trends and best maintenance
Employability & Personal Development - Rights & Responsibilities in the Workp...The Pathway Group
Employability & Personal Development - Rights & Responsibilities in the Workplace will give you an understanding of your rights and responsibilities in the work place.
If you would like to know more about pathway group training/pre-employment training please call us on: 0121 707 0550 or e-mail: info@pathwaygroup.co.uk
Handle Potent Compounds? 10 mistakes when using powders weighing hoodsDean Calhoun
If you handle potent compounds (or highly potent active pharmaceutical ingredients) and you're using a powders weighing hood, this presentation is for you. In this presentation, pharmaceutical industry experts from Affygility Solutions discuss 10 common mistakes when using powders weighing hoods (enclosures) to weigh out highly potent compounds. Highly potent compounds usually include category 3, 3A, 4, and 5 compounds such as oncology APIs.
Just providing the information on Impurities in drug substances & Drug products to share my view and the collected information from the web for knowledge purpose.
21CFR regulations & its applicability in the industry and FDA perspective on the same and FDA check points on 21CFR regulations during their inspection.
Please find the an attachment which contains writing an effective 483 response to the regulatory authority. Please feel free to request the copy if interested.
Acute scrotum is a general term referring to an emergency condition affecting the contents or the wall of the scrotum.
There are a number of conditions that present acutely, predominantly with pain and/or swelling
A careful and detailed history and examination, and in some cases, investigations allow differentiation between these diagnoses. A prompt diagnosis is essential as the patient may require urgent surgical intervention
Testicular torsion refers to twisting of the spermatic cord, causing ischaemia of the testicle.
Testicular torsion results from inadequate fixation of the testis to the tunica vaginalis producing ischemia from reduced arterial inflow and venous outflow obstruction.
The prevalence of testicular torsion in adult patients hospitalized with acute scrotal pain is approximately 25 to 50 percent
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
Prix Galien International 2024 Forum ProgramLevi Shapiro
June 20, 2024, Prix Galien International and Jerusalem Ethics Forum in ROME. Detailed agenda including panels:
- ADVANCES IN CARDIOLOGY: A NEW PARADIGM IS COMING
- WOMEN’S HEALTH: FERTILITY PRESERVATION
- WHAT’S NEW IN THE TREATMENT OF INFECTIOUS,
ONCOLOGICAL AND INFLAMMATORY SKIN DISEASES?
- ARTIFICIAL INTELLIGENCE AND ETHICS
- GENE THERAPY
- BEYOND BORDERS: GLOBAL INITIATIVES FOR DEMOCRATIZING LIFE SCIENCE TECHNOLOGIES AND PROMOTING ACCESS TO HEALTHCARE
- ETHICAL CHALLENGES IN LIFE SCIENCES
- Prix Galien International Awards Ceremony
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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
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.
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
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
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Explore natural remedies for syphilis treatment in Singapore. Discover alternative therapies, herbal remedies, and lifestyle changes that may complement conventional treatments. Learn about holistic approaches to managing syphilis symptoms and supporting overall health.
Pulmonary Thromboembolism - etilogy, types, medical- Surgical and nursing man...VarunMahajani
Disruption of blood supply to lung alveoli due to blockage of one or more pulmonary blood vessels is called as Pulmonary thromboembolism. In this presentation we will discuss its causes, types and its management in depth.
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
New Drug Discovery and Development .....NEHA GUPTA
The "New Drug Discovery and Development" process involves the identification, design, testing, and manufacturing of novel pharmaceutical compounds with the aim of introducing new and improved treatments for various medical conditions. This comprehensive endeavor encompasses various stages, including target identification, preclinical studies, clinical trials, regulatory approval, and post-market surveillance. It involves multidisciplinary collaboration among scientists, researchers, clinicians, regulatory experts, and pharmaceutical companies to bring innovative therapies to market and address unmet medical needs.
1. COMMON WAYS TO AVOID THECOMMON WAYS TO AVOID THE
MOST FREQUENT GMP ERRORS
COMMON WAYS TO AVOID THE
2 March 2016
COMMON WAYS TO AVOID THE
MOST FREQUENT GMP ERRORS
Page 1
2. Intro…..
"Most of the 483s and warning
of the common GMP errors.of the common GMP errors.
mistakes (and ways to avoid
based on the historical data
common good manufacturing
pharmaceuticals can be easily
simple rules. "
warning letters are issued because
. I have described common. I have described common
them) in the following slides
data and experience. Many
manufacturing practice errors in
easily avoided by following a few
Page 2
3. Intro…..
“Safety - First, Last, and Always”
"We all must observe safety rules,"We all must observe safety rules,
to protect the product from contamination
ultramodern equipments, in our
that cost millions of dollars, and
nevertheless, some of the products
with are potently bio hazardouswith are potently bio hazardous
through some pieces of equipment
First, Last, and Always”
rules, for our own safety andrules, for our own safety and
contamination. We work with
our laboratories and facilities
and with exciting technology,
products and materials we work
hazardous. Electricity running
Page 3
hazardous. Electricity running
equipment also presents a risk. “
4. Intro…..
"Guards, such as on packaging
reason. Locating eyewashes,
equipment "emergency stop"equipment "emergency stop"
company's evacuation procedures
maintenance on vessels,
lyophilizers, learn the appropriate
follow them thoroughly without
deviations. That includes companydeviations. That includes company
orders and lockout and tag out
the equipment is not in use before
"
packaging equipment, are there for a
eyewashes, fire extinguishers, and
stop" buttons, learn yourstop" buttons, learn your
procedures. If you clean or do
tanks, steam lines, or
appropriate safety precautions and
without any shortcuts and
company policy regarding work
Page 4
company policy regarding work
out procedures to ensure that
before you begin maintenance.
5. Check points:
1. Personal & Product Safety
not wearing your safety glasses.
have to protect them. Always wearhave to protect them. Always wear
shoes, respirators, and other personal
Take the time to think things thoroughly
your instinct. Avoid situations that
and let your supervisors or others
Material Safety Data Sheets (MSDS)Material Safety Data Sheets (MSDS)
you work in your work place.
Safety: One common GMP mistake is
. Your eyes are too precious, we
wear your safety glasses, safetywear your safety glasses, safety
personal protective equipment.
thoroughly. Stay alert, and trust
that look potentially dangerous,
others know about it. Read the
(MSDS) for all the materials that
Page 5
(MSDS) for all the materials that
6. Check points:
2. Labelling Instructions: Identifying
vendor had changed the process
manufacturing due the change
"looked different from our routine
and signs carefully. Check for "released"
material has not expired and
Caution and warning signs in your
local language spoken in the plant
Identifying and suspecting that a
process in a raw material
change in label instructions
routine supplies" Read all the labels
"released" labels. Ensure that the
that it’s the correct material.
your plant should be printed in the
Page 6
plant.
7. Check points:
3. Alertness in Work: Be especially
when you are tired, called away,
safety violations occur most oftensafety violations occur most often
before lunch, before your shift
home, when someone interrupts
thought, and so on. Be especially
The most common injuries in our
back injuries, so use proper liftingback injuries, so use proper lifting
think about what you are about to
or back at risk.
especially careful around breaks,
away, and so on. GMP regulation and
often right before break times,often right before break times,
is over, when it's time to go
interrupts you or breaks your train of
especially vigilant during those times.
our business seem to be hand and
lifting techniques, slow down, and
Page 7
lifting techniques, slow down, and
to do before putting your hands
8. Check points:
4. Gowning Practice: Wear only appropriate clothing.
Supervisors are responsible for providing on
(including training in proper attire, such as sterile
then monitoring employees to make sure that they are wearing
appropriate clothing.
One common GMP error is not wearing your lab coat while you
are in the laboratory (or visitors or contractors not wearing hair
coverings, shoe coverings, lab coats, and so on). Splashes can
be dangerous and can ruin your clothes. While visiting bulk drug
plants, don't wear designer suits or shoes.
Wear only appropriate clothing.
Supervisors are responsible for providing on-the-job training
(including training in proper attire, such as sterile gowning) and
then monitoring employees to make sure that they are wearing
One common GMP error is not wearing your lab coat while you
are in the laboratory (or visitors or contractors not wearing hair
Page 8
coverings, shoe coverings, lab coats, and so on). Splashes can
be dangerous and can ruin your clothes. While visiting bulk drug
plants, don't wear designer suits or shoes.
9. Check points:
4. Gowning Practice:
Another common error is wearing your lab coat or plant uniform
outside the building and also proceeding to wash room with theoutside the building and also proceeding to wash room with the
same. Some 483 observations noted that employees were
smoking outside of buildings while wearing their plant uniforms.
Jewellery is not allowed in certain areas. Check with your
supervisor if you're not sure..
Another common error is wearing your lab coat or plant uniform
outside the building and also proceeding to wash room with theoutside the building and also proceeding to wash room with the
same. Some 483 observations noted that employees were
smoking outside of buildings while wearing their plant uniforms.
is not allowed in certain areas. Check with your
Page 9
10. Check points:
5. Cleanliness: Keep surfaces and equipment clean. Follow
approved cleaning procedures, and use approved cleaning
solutions, People may become sick and in the most serious casesolutions, People may become sick and in the most serious case
due to cleaning was inadequate, and the cleaning process had
never been validated. One of the first things that investigators
or visitors notice while they visit your plant is the facility's
general cleanliness. Ensure that each equipment was cleaned by
checking the "Cleaned Equipment" status tag and equipmentchecking the "Cleaned Equipment" status tag and equipment
logbook. If possible, open the equipment and look inside to
make sure that no rinse solvent was accidentally left behind.
Keep surfaces and equipment clean. Follow
approved cleaning procedures, and use approved cleaning
solutions, People may become sick and in the most serious casesolutions, People may become sick and in the most serious case
due to cleaning was inadequate, and the cleaning process had
never been validated. One of the first things that investigators
or visitors notice while they visit your plant is the facility's
general cleanliness. Ensure that each equipment was cleaned by
checking the "Cleaned Equipment" status tag and equipment
Page
10
checking the "Cleaned Equipment" status tag and equipment
logbook. If possible, open the equipment and look inside to
make sure that no rinse solvent was accidentally left behind.
11. Check points:
6. Health & Hygiene: Wash your hands. Most pharmaceutical
plants have signs in the bathrooms reminding employees to
wash their hands before returning to the plant or work area. Ifwash their hands before returning to the plant or work area. If
you've ever put your hand on a plate and cultured the bacteria
present, you know that bacteria are everywhere, in large
quantities, although omnipresent in life, they are not something
that any one of us wants in our medicines or injectables.
Wash your hands. Most pharmaceutical
plants have signs in the bathrooms reminding employees to
wash their hands before returning to the plant or work area. Ifwash their hands before returning to the plant or work area. If
you've ever put your hand on a plate and cultured the bacteria
present, you know that bacteria are everywhere, in large
quantities, although omnipresent in life, they are not something
that any one of us wants in our medicines or injectables.
Page
11
12. Check points:
7. Report an Illness: Working personnel should notify their
supervisors when they have a cold or any viral infections. It is a
GMP requirement that employees and temporary employees doGMP requirement that employees and temporary employees do
this. On those days when you're not feeling
be assigned to attend GMP classes, revise SOPs, or catch up
your scintillating GMP reading, such has articles like this one.
Working personnel should notify their
supervisors when they have a cold or any viral infections. It is a
GMP requirement that employees and temporary employees doGMP requirement that employees and temporary employees do
this. On those days when you're not feeling up to par, you can
be assigned to attend GMP classes, revise SOPs, or catch up on
your scintillating GMP reading, such has articles like this one.
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13. Check points:
8. Use of Approved Material: Use only Approved & Released
raw materials, packaging components, and labels. Use no
expired materials. Under cGMPs, only released materials can be
used in all clinical and commercial lots of product. A common
error is to store expired materials with current materials. Proper
segregation is required and Remove and/or destroy all expired
materials.
Use only Approved & Released
raw materials, packaging components, and labels. Use no
, only released materials can be
used in all clinical and commercial lots of product. A common
error is to store expired materials with current materials. Proper
segregation is required and Remove and/or destroy all expired
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14. Check points:
9. Committing Mistakes due to shortfall of TIME:
though the pace of our industry is fast, and everyone has more
to do than they can possibly get done, everyone deserves the
time to think things through. Hence, think before plan and plan
before doing the work or committing the time lines...
All the time, everybody will be rushed in their work area, where
there is greatest possibility of committing the critical mistakes in
work area which hampers the GMP status of the product /
activity.
Committing Mistakes due to shortfall of TIME: Even
though the pace of our industry is fast, and everyone has more
to do than they can possibly get done, everyone deserves the
time to think things through. Hence, think before plan and plan
before doing the work or committing the time lines...
All the time, everybody will be rushed in their work area, where
there is greatest possibility of committing the critical mistakes in
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work area which hampers the GMP status of the product /
15. Check points:
9. Committing Mistakes due to shortfall of TIME:
There is no such thing as a dumb question. Better to ask and
get an answer than to assume and risk a batch, It's critical thatget an answer than to assume and risk a batch, It's critical that
supervisors make sure their people feel comfortable asking
those questions and admitting their mistakes.
Committing Mistakes due to shortfall of TIME:
There is no such thing as a dumb question. Better to ask and
get an answer than to assume and risk a batch, It's critical thatget an answer than to assume and risk a batch, It's critical that
supervisors make sure their people feel comfortable asking
those questions and admitting their mistakes.
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16. Check points:
10. Documentation: Always fill in the blanks. Record all
requested information. If it’s truly not applicable, write N/A;
your initials, and the date. If pages or sections of forms are not
applicable, line through them, write N/A, your initials, and the
date. The correct information must be entered on batch records,
equipment logbooks, and test result forms, otherwise, your QA /
Regulatory Inspector will find out with you soon why you didn't
complete the work and sometimes it leads to in complete
documentation for the activity is been done.
Always fill in the blanks. Record all
requested information. If it’s truly not applicable, write N/A;
your initials, and the date. If pages or sections of forms are not
applicable, line through them, write N/A, your initials, and the
date. The correct information must be entered on batch records,
equipment logbooks, and test result forms, otherwise, your QA /
Regulatory Inspector will find out with you soon why you didn't
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complete the work and sometimes it leads to in complete
documentation for the activity is been done.
17. Check points:
11. Online Entries:
Record results as you get them. One common GMP error is to
speed through documents at the end of the day or at the end ofspeed through documents at the end of the day or at the end of
your shift, filling in all the blanks at one time. But we all know
that it is impossible to remember what we did five minutes ago,
much less eight hours ago. You have to train yourself and your
people to record results and information as you get it
records, lab notebooks, and test result forms.records, lab notebooks, and test result forms.
Record results as you get them. One common GMP error is to
speed through documents at the end of the day or at the end ofspeed through documents at the end of the day or at the end of
your shift, filling in all the blanks at one time. But we all know
that it is impossible to remember what we did five minutes ago,
much less eight hours ago. You have to train yourself and your
people to record results and information as you get it - on batch
records, lab notebooks, and test result forms.
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records, lab notebooks, and test result forms.
18. Check points:
11. Online Entries:
Print clearly in logs, and fill them out completely. Fill out all logs
and other documents completely. Your handwriting must beand other documents completely. Your handwriting must be
clear and legible. If your handwriting, like mine, is difficult to
read, then print.
Print clearly in logs, and fill them out completely. Fill out all logs
and other documents completely. Your handwriting must beand other documents completely. Your handwriting must be
clear and legible. If your handwriting, like mine, is difficult to
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19. Check points:
12. Use Indelible Ink:
The industry standard is black / blue indelible ink because it
photocopies well and does not smear. Pencil is unacceptablephotocopies well and does not smear. Pencil is unacceptable
because it smears easily and can be erased and also it releases
graphite particles which cannot be controlled in clean rooms
especially.
The industry standard is black / blue indelible ink because it
photocopies well and does not smear. Pencil is unacceptablephotocopies well and does not smear. Pencil is unacceptable
because it smears easily and can be erased and also it releases
graphite particles which cannot be controlled in clean rooms
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20. Check points:
13. Banish the correction fluid:
prohibited.
14. Line through, Initial, and date all changes:
way to make a change is to line through the error once using
your indelible ink pen, clearly write the correction above or
beside it, and initial and date the correction.
13. Banish the correction fluid: Using correction fluid is
Line through, Initial, and date all changes: The correct
way to make a change is to line through the error once using
your indelible ink pen, clearly write the correction above or
beside it, and initial and date the correction.
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21. Check points:
15. Data Falsification: Never backdate or falsify the records.
Always use today's date when documenting your work. If you do
not, you are falsifying records.not, you are falsifying records.
For example, if One has manufactured a batch of a product
today, and did not fill out a line on a batch record, a QA
employee would stop by as part of his online review and ask the
person whether he had completed that step or not. If the
chemist did remember completing it, He would write in thechemist did remember completing it, He would write in the
Comments section of the document that QA had noticed that he
had failed to document the step and that he had in fact
completed it.
Never backdate or falsify the records.
Always use today's date when documenting your work. If you do
For example, if One has manufactured a batch of a product
today, and did not fill out a line on a batch record, a QA
employee would stop by as part of his online review and ask the
person whether he had completed that step or not. If the
chemist did remember completing it, He would write in the
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chemist did remember completing it, He would write in the
Comments section of the document that QA had noticed that he
had failed to document the step and that he had in fact
22. Check points:
15. Data Falsification:
He would initial and date the comment the day that he was
writing it.writing it.
Preferably, to raise the deviation in those situations and re
the personnel whoever involved in that activity.
He would initial and date the comment the day that he was
Preferably, to raise the deviation in those situations and re-train
the personnel whoever involved in that activity.
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23. Check points:
16. Constructive Thoughts /Actions:
Take action to make things better. we may reach a conclusion
faster than someone else. Have the courage to bring up things
that need to be improved. Be the responsible employee who
picks the piece of paper from the floor rather than steps over it.
As your move up in your career, people are going to trust
you with information that is confidential and sensitive. You
must honour their confidences but also take action.
Constructive Thoughts /Actions:
action to make things better. we may reach a conclusion
faster than someone else. Have the courage to bring up things
that need to be improved. Be the responsible employee who
picks the piece of paper from the floor rather than steps over it.
As your move up in your career, people are going to trust
you with information that is confidential and sensitive. You
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their confidences but also take action.
24. Check points:
17. Calibration Status: Ensure that equipment is calibrated
before using it. Equipment that must be calibrated in a
manufacturing or laboratory environment typically has anmanufacturing or laboratory environment typically has an
equipment calibration tag on it which indicates the date
the equipment was last calibrated, who did the calibration, and
next calibration due date. Check to make sure that your
equipment is within calibration before you use it. Otherwise,
your results or measurements could be inaccurate.your results or measurements could be inaccurate.
Ensure that equipment is calibrated
before using it. Equipment that must be calibrated in a
manufacturing or laboratory environment typically has anmanufacturing or laboratory environment typically has an
equipment calibration tag on it which indicates the date
equipment was last calibrated, who did the calibration, and
next calibration due date. Check to make sure that your
equipment is within calibration before you use it. Otherwise,
your results or measurements could be inaccurate.
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your results or measurements could be inaccurate.
25. Check points:
18. Numbering System: Record ID, part, lot, document,
revision, and other control numbers. When something goes
wrong with a product lot, trying to determine the true source ofwrong with a product lot, trying to determine the true source of
the problem is often like solving a mystery. The GMPs require
that you assign and use unique numbers on each lot of your raw
materials, reagents, documents, and all lots of produced product
to permit traceability should there ever be a problem.
While, filling out a batch record or recording your results, recordWhile, filling out a batch record or recording your results, record
equipment, lot, sample, reference sample, and document and
revision numbers.
Record ID, part, lot, document,
revision, and other control numbers. When something goes
wrong with a product lot, trying to determine the true source ofwrong with a product lot, trying to determine the true source of
the problem is often like solving a mystery. The GMPs require
and use unique numbers on each lot of your raw
materials, reagents, documents, and all lots of produced product
to permit traceability should there ever be a problem.
While, filling out a batch record or recording your results, record
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While, filling out a batch record or recording your results, record
equipment, lot, sample, reference sample, and document and
26. Check points:
19. Eatables are Prohibited in Work area:
food, gum, tobacco, or house plants into production and
laboratory areas. A common GMP error is bringing drinks into a
laboratory. Smoking, eating, and drinking are prohibited in a
GMP facility. You do not want to have food inside a GMP facility
because rodents and other pests will try to enter the area to get
the food. A beetle can bore through 0.125 inch of solid plastic to
get to food or the glucose or sucrose stored on pallets in your
warehouse. Houseplants may have insects on their soil and
leaves.
Eatables are Prohibited in Work area: Do not bring
food, gum, tobacco, or house plants into production and
laboratory areas. A common GMP error is bringing drinks into a
laboratory. Smoking, eating, and drinking are prohibited in a
GMP facility. You do not want to have food inside a GMP facility
because rodents and other pests will try to enter the area to get
the food. A beetle can bore through 0.125 inch of solid plastic to
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get to food or the glucose or sucrose stored on pallets in your
warehouse. Houseplants may have insects on their soil and
27. Check points:
20. Pest & Rodent Control: Check your pest control devices
frequently with the ID no and location of it. If you use an
outside pest control service, test it by placing a plastic mouse inoutside pest control service, test it by placing a plastic mouse in
one of the traps. If the service doesn't find it, it's not doing a
thorough job inspecting and cleaning the traps. Because rats like
to run along walls - they do not see well, and they feel safer
against a wall - rodent traps should be placed along walls.
Antidotes should be available in the site in case of any situationAntidotes should be available in the site in case of any situation
of inhaling or taking it inside.
Check your pest control devices
frequently with the ID no and location of it. If you use an
outside pest control service, test it by placing a plastic mouse inoutside pest control service, test it by placing a plastic mouse in
one of the traps. If the service doesn't find it, it's not doing a
thorough job inspecting and cleaning the traps. Because rats like
they do not see well, and they feel safer
rodent traps should be placed along walls.
Antidotes should be available in the site in case of any situation
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Antidotes should be available in the site in case of any situation
28. Check points:
21. Thorough Review of Document:
document / record, check for data accuracy, for completeness,
and correct calculations. In our industry, a signature is a legal
and an ethical responsibility. If you have signature authority and
are asked to sign on something, you must do to the best of your
ability, review it thoroughly and completely, make sure that
everything that needs to be attached is attached, and make
sure that all calculations are correct. Never sign something
without thoroughly reviewing it first. Never sign something that
you know to be wrong. Get it corrected and then sign it.
21. Thorough Review of Document: Before signing on any
document / record, check for data accuracy, for completeness,
and correct calculations. In our industry, a signature is a legal
and an ethical responsibility. If you have signature authority and
are asked to sign on something, you must do to the best of your
ability, review it thoroughly and completely, make sure that
everything that needs to be attached is attached, and make
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sure that all calculations are correct. Never sign something
without thoroughly reviewing it first. Never sign something that
you know to be wrong. Get it corrected and then sign it.
29. Check points:
22. Duplication of Data is Prohibited:
Record data directly on the appropriate form or notebook. Do
not write original data on scrap paper, napkins, or paper towels
and then transfer the information to the appropriate form or
notebook. If you accidentally record your data on a piece of
scrap paper, staple it to the form or notebook, because it is
original data. Always attach printouts and labels where
indicated. Never throw away original data.
Duplication of Data is Prohibited:
Record data directly on the appropriate form or notebook. Do
not write original data on scrap paper, napkins, or paper towels
and then transfer the information to the appropriate form or
notebook. If you accidentally record your data on a piece of
scrap paper, staple it to the form or notebook, because it is
original data. Always attach printouts and labels where
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indicated. Never throw away original data.
30. Check points:
23. OOS Handling:
Never simply average Out-of-Specification
passing result do not continue testing samples until you get
enough that pass. As a result of the Barr case, there has been a
lot of scrutiny in this area. Every company should have an SOP
that discusses how to handle out
how to handle failure investigations. Encourage your people to
tell you that what went wrong during the analysis / batch
handling when OOS result has obtained.
Specification results to obtain a
passing result do not continue testing samples until you get
enough that pass. As a result of the Barr case, there has been a
lot of scrutiny in this area. Every company should have an SOP
that discusses how to handle out-of- specification results and
how to handle failure investigations. Encourage your people to
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tell you that what went wrong during the analysis / batch
handling when OOS result has obtained.
31. Check points:
24. Secondary Check: Have another person perform double /
secondary check as Indicated in the batch record / Document /
Record. Double checks are mandatory for critical steps, like
weighing and adding raw materials, because people have
discovered that historically those are problematic areas.
Secondary check means that one person performs the work
while another person observes and makes any suggestions or
corrections. Individuals then sign or
where indicated. GMPs require that you have sufficient staff to
do this.
Have another person perform double /
secondary check as Indicated in the batch record / Document /
Record. Double checks are mandatory for critical steps, like
weighing and adding raw materials, because people have
discovered that historically those are problematic areas.
Secondary check means that one person performs the work
while another person observes and makes any suggestions or
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corrections. Individuals then sign or initial the batch record
where indicated. GMPs require that you have sufficient staff to
32. Check points:
25. Proper closing of inter linked
receiving, and other doors closed. A common error is to leave
shipping and receiving doors open after a delivery has arrived
an open invitation for pests of all kinds. Owls, snakes, rats, and
mice have been found in warehouses looking for food, water,
and shelter. A field mouse only needs 0.25 inch to get under a
door, so check the bottom of your outside doors. If there is a
gap, you could be inviting a rodent problem. The
that you have an effective pest control program; keeping your
receiving doors closed will help.
Proper closing of inter linked Doors: Keep shipping,
receiving, and other doors closed. A common error is to leave
shipping and receiving doors open after a delivery has arrived -
an open invitation for pests of all kinds. Owls, snakes, rats, and
mice have been found in warehouses looking for food, water,
and shelter. A field mouse only needs 0.25 inch to get under a
door, so check the bottom of your outside doors. If there is a
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gap, you could be inviting a rodent problem. The cGMPs require
have an effective pest control program; keeping your
33. Check points:
26. Auditee Attitude: During an Inspection, answer all
questions honestly and directly. Do not guess or speculate. Do
not volunteer information. Refer questions that you cannot
answer to your supervisor. FDA and other regulatory agencies
know that this is how employees are trained. Don't be evasive,
and don’t try to hide the truth. Don't guess, and don't state your
opinion. "If you think we're bad, you should see those guys
down the hall!"
During an Inspection, answer all
questions honestly and directly. Do not guess or speculate. Do
not volunteer information. Refer questions that you cannot
answer to your supervisor. FDA and other regulatory agencies
know that this is how employees are trained. Don't be evasive,
and don’t try to hide the truth. Don't guess, and don't state your
opinion. "If you think we're bad, you should see those guys
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34. Check points:
27. Highlighting the Mistakes:
Report mistakes - or suspected mistakes
to your supervisor after the identification of it. Management will
hate making mistakes by employees, rather be perfect. But the
truth is that we're all human, and human beings make mistakes.
As a supervisor, encourage your people to tell you things. Don’t
jump all over them when they do so they never do it again. And
don't go looking for scapegoats.
Highlighting the Mistakes:
or suspected mistakes - as soon as possible
to your supervisor after the identification of it. Management will
hate making mistakes by employees, rather be perfect. But the
truth is that we're all human, and human beings make mistakes.
As a supervisor, encourage your people to tell you things. Don’t
jump all over them when they do so they never do it again. And
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35. Check points:
27. Highlighting the Mistakes:
If something goes wrong in your group, you as a supervisor or
manager must accept responsibility for the mistake see what
you can reconstruct or recover, and figure out how you can
prevent the mistake from happening it again and train your
personnel on such cases not to repeat the same or occur the
same in future.
Highlighting the Mistakes:
If something goes wrong in your group, you as a supervisor or
manager must accept responsibility for the mistake see what
you can reconstruct or recover, and figure out how you can
prevent the mistake from happening it again and train your
personnel on such cases not to repeat the same or occur the
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36. Check points:
28. Continues reading / reviewing of SOP’s:
Read and become familiar with all SOPs and other documents
that relate to your work. You must know your SOP’s. A commonthat relate to your work. You must know your SOP’s. A common
483 observation continues to be "Firm failed to follow its own
SOP." If an SOP needs to be revised, tell your supervisor and
offer to help revise it and get it approved.
Continues reading / reviewing of SOP’s:
Read and become familiar with all SOPs and other documents
that relate to your work. You must know your SOP’s. A commonthat relate to your work. You must know your SOP’s. A common
continues to be "Firm failed to follow its own
SOP." If an SOP needs to be revised, tell your supervisor and
offer to help revise it and get it approved.
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37. Conclusion:
Apart from the above mentioned, following also to be
required to ensure avoiding the
discipline, Attitude in work area, Co
Cordial relations in work area with supervisors and with
sub-ordinates, loyal to the company / position or
designation and finally professional attire in our part.
Apart from the above mentioned, following also to be
required to ensure avoiding the GMP Errors like Self
discipline, Attitude in work area, Co-operation, Team work,
Cordial relations in work area with supervisors and with
ordinates, loyal to the company / position or
designation and finally professional attire in our part.
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38. Thank you very much for the attention and
for your valuable time……!!!!for your valuable time……!!!!
Thank you very much for the attention and
for your valuable time……!!!!for your valuable time……!!!!
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