Qualification of Dissolution Test Apparatus and Validation of Utility System this presentation will help to enhance your knowledge in validation and qualification area.
CONTENTS
1. General areas interest in the building:
Walls and celling's
Floors and drains
Doors ,windows and fittings
Equipment
Pipelines
2. RAW MATERIALS
3. WATER
Microbiological results
Essential document
PQ is divided into 3 phases
Microbiological procedure reviewed
4. PACKAGING MATERIALS
Role of quality systems and audits in pharmaceutical manufacturing environmentMalay Pandya
By regulation, appropriate practice, and common sense, quality assurance (QA) is a critical function in the pharmaceutical manufacturing environment. The need for an independent unit to audit and comment on the appropriate application of standard operating procedures, master batch records, procedures approved in product applications, and the proper functioning of the quality control (QC) unit is paramount.
This helps assure that products are manufactured reliably, with adherence to approved specifications, and that current good manufacturing practices (cGMP) are maintained in conformance to regulation, both in the facility in general and the microenvironment of each product ’s manufacturing sequence.
Qualification of Dissolution Test Apparatus and Validation of Utility System this presentation will help to enhance your knowledge in validation and qualification area.
CONTENTS
1. General areas interest in the building:
Walls and celling's
Floors and drains
Doors ,windows and fittings
Equipment
Pipelines
2. RAW MATERIALS
3. WATER
Microbiological results
Essential document
PQ is divided into 3 phases
Microbiological procedure reviewed
4. PACKAGING MATERIALS
Role of quality systems and audits in pharmaceutical manufacturing environmentMalay Pandya
By regulation, appropriate practice, and common sense, quality assurance (QA) is a critical function in the pharmaceutical manufacturing environment. The need for an independent unit to audit and comment on the appropriate application of standard operating procedures, master batch records, procedures approved in product applications, and the proper functioning of the quality control (QC) unit is paramount.
This helps assure that products are manufactured reliably, with adherence to approved specifications, and that current good manufacturing practices (cGMP) are maintained in conformance to regulation, both in the facility in general and the microenvironment of each product ’s manufacturing sequence.
It is process of “Establishing documentary evidence that provide a high degree of assurance that a specific process will consistently produce a product meeting its predetermined specifications and quality attributes”.
In the pharmaceutical industry, it is very important that in addition to final testing and compliance of products, it is also assured that the process will consistently produce the expected results.
Validation is action of proving in accordance with the principles of good manufacturing practices, that any procedure, process, equipment, material, activity or system actually leads to expected results.
Cleaning validation is documented evidence with a high degree assurance that one can consistently clean a system or a piece of equipment to predetermined and acceptable limits.
The primary regulatory concern driving the need for cleaning validation is cross contamination of the desired drug substance either by other API from previous batch runs or by residues from the cleaning agents used.
The prime purpose of validating a cleaning process is to ensure compliance with federal and other standard regulations
1. Cross contamination with active ingredients
Contamination of one batch of product with significant levels of residual active ingredients from previous batch cannot be tolerated.
In addition to the obvious problems posed by subjecting consumers or patients to unintended contaminants, potential clinically significant synergistic interactions between pharmacologically active chemicals are a real concern.
2. Contamination with unintended materials or compounds
While inert ingredients used in drug products are generally recognized as safe for human consumption, the routine use, maintenance and cleaning of equipment's provide the potential contamination with such items as equipment parts, lubricants and chemical cleaning agents3. Microbiological contamination
Maintenance , cleaning and storage conditions may provide adventitious microorganisms with the opportunity to proliferate within the processing equipment.
This presentation was made to solely for students to make them aware/ understand basics of “Validation”. These slides are part of lectures delivered in M. Pharmacy Curriculum & taken up from various books and websites
Qualification of tablet compression machinePritam Kolge
Qualification of Tablet Compression Machine ...
This topic comes under Quality Control and Quality Assurance....
This is useful for M.Pharm (Pharaceutical Quality Assurance) Students who studying in First year sem II....
This Presentation Contain following...
#Introduction
#Design Qualification
#Installation Qualification
#Operational Qualification
#Performance Qualification
#Case Study
#Conclusion
#References
Thanks For Help and Guidance of Dr. Mrs. N. M. Bhatia Mam
Validation: Validation is a documented program that provides high degree of assurance that a specific process, method or system consistently produces a result meeting pre-determined acceptance criteria.
Process Quality Control
SPC, SQC Defined
Difference between SQC and SPC
Controlling Process Inputs (independent variables)
Process Capability with MINITAB
Monitoring process outputs (dependent variables)
7QC-Tools with MINITAB
It is process of “Establishing documentary evidence that provide a high degree of assurance that a specific process will consistently produce a product meeting its predetermined specifications and quality attributes”.
In the pharmaceutical industry, it is very important that in addition to final testing and compliance of products, it is also assured that the process will consistently produce the expected results.
Validation is action of proving in accordance with the principles of good manufacturing practices, that any procedure, process, equipment, material, activity or system actually leads to expected results.
Cleaning validation is documented evidence with a high degree assurance that one can consistently clean a system or a piece of equipment to predetermined and acceptable limits.
The primary regulatory concern driving the need for cleaning validation is cross contamination of the desired drug substance either by other API from previous batch runs or by residues from the cleaning agents used.
The prime purpose of validating a cleaning process is to ensure compliance with federal and other standard regulations
1. Cross contamination with active ingredients
Contamination of one batch of product with significant levels of residual active ingredients from previous batch cannot be tolerated.
In addition to the obvious problems posed by subjecting consumers or patients to unintended contaminants, potential clinically significant synergistic interactions between pharmacologically active chemicals are a real concern.
2. Contamination with unintended materials or compounds
While inert ingredients used in drug products are generally recognized as safe for human consumption, the routine use, maintenance and cleaning of equipment's provide the potential contamination with such items as equipment parts, lubricants and chemical cleaning agents3. Microbiological contamination
Maintenance , cleaning and storage conditions may provide adventitious microorganisms with the opportunity to proliferate within the processing equipment.
This presentation was made to solely for students to make them aware/ understand basics of “Validation”. These slides are part of lectures delivered in M. Pharmacy Curriculum & taken up from various books and websites
Qualification of tablet compression machinePritam Kolge
Qualification of Tablet Compression Machine ...
This topic comes under Quality Control and Quality Assurance....
This is useful for M.Pharm (Pharaceutical Quality Assurance) Students who studying in First year sem II....
This Presentation Contain following...
#Introduction
#Design Qualification
#Installation Qualification
#Operational Qualification
#Performance Qualification
#Case Study
#Conclusion
#References
Thanks For Help and Guidance of Dr. Mrs. N. M. Bhatia Mam
Validation: Validation is a documented program that provides high degree of assurance that a specific process, method or system consistently produces a result meeting pre-determined acceptance criteria.
Process Quality Control
SPC, SQC Defined
Difference between SQC and SPC
Controlling Process Inputs (independent variables)
Process Capability with MINITAB
Monitoring process outputs (dependent variables)
7QC-Tools with MINITAB
Statistical process control is defined as and use of statistical technique to control a process or production method .It is used in manufacturing or production process to measure how consistently a product perform according to its design specification.
Process Capability in Manufacturing: Achieving Excellence in QualityMileyJames
In the realm of manufacturing, achieving consistent and high-quality products is paramount. Process capability, a fundamental concept in quality management, plays a pivotal role in ensuring that manufacturing processes meet or exceed customer expectations. This essay explores the significance of process capability in the manufacturing field, its methodology, the benefits it offers, and its role in continuous improvement.
Anti ulcer drugs and their Advance pharmacology ||
Anti-ulcer drugs are medications used to prevent and treat ulcers in the stomach and upper part of the small intestine (duodenal ulcers). These ulcers are often caused by an imbalance between stomach acid and the mucosal lining, which protects the stomach lining.
||Scope: Overview of various classes of anti-ulcer drugs, their mechanisms of action, indications, side effects, and clinical considerations.
Report Back from SGO 2024: What’s the Latest in Cervical Cancer?bkling
Are you curious about what’s new in cervical cancer research or unsure what the findings mean? Join Dr. Emily Ko, a gynecologic oncologist at Penn Medicine, to learn about the latest updates from the Society of Gynecologic Oncology (SGO) 2024 Annual Meeting on Women’s Cancer. Dr. Ko will discuss what the research presented at the conference means for you and answer your questions about the new developments.
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
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.
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
- 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
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
Ozempic: Preoperative Management of Patients on GLP-1 Receptor Agonists Saeid Safari
Preoperative Management of Patients on GLP-1 Receptor Agonists like Ozempic and Semiglutide
ASA GUIDELINE
NYSORA Guideline
2 Case Reports of Gastric Ultrasound
2. Introduction :
A pharmaceutical company produces products such as tablets,
capsules as per customer requirements.
Customer requirements are the significant features that the
customers expect to find in a product. Development scientists
translate those requirements into ‘Critical-to- Quality’ (CTQ)
characteristics of the products that they are about to produce.
As example, hardness, thickness, uniformity of weight, assay,
dissolution etc are CTQ characteristics of tablets.
When these CTQ characteristics are assessed and quality
targets are determined, development scientists specify upper
and lower limit within which variables of CTQ characteristics
must fall.
3. To evaluate production process performance, the CTQ
characteristics are monitored when production in progress.
Control chart is one of the tools which used to monitor the
characteristics. We can see whether the data of CTQ
characteristics are within limit or not from control chart.
Even if all the monitored data are within set limit, there is a
possibility to produce defective product. The tool by which
we can say the process is capable to produce product
complying customers’ requirements is process capability
index Cpk.
4. Control Chart and Process
Capability
While the production is in progress, the performance of the
production process is monitored to detect and prevent
possible variations.
The tool frequently used to monitor a process performance
while the production is in progress is the control chart.
It helps to detect assignable causes of variations and facilitate
corrective actions. But a control chart is not the correct tool to
determine if the customer’s requirements are met because it is
only used to monitor the performance of production processes
in progress.
Suppose that we are monitoring a compression process of a
product X and that the thickness of the product is critical to
quality (CTQ).
5. Figure-1: Thickness of product X (capable process)
•Control chart of Figure 1 plot the measurements that were
obtained while monitoring the compression process.
•Remember that control charts are constructed by taking samples
from the production line at present intervals and plotting the
means of the samples on a chart.
6. • From the observation of the compression process that
generated the graph of Figure-1, we can conclude that the
process is acceptably stable and that the variations are within
the control limits that is within UCL & LCL.
The output in this case is within the UCL (4.6) and the LCL
(3.4).
• If the standard specified limits were 4.0 for the lower
specified limit (LSL) and 6.0 for the upper specified limit
(USL), some of the parts produced by the machine would
have met the customers’ expectations and some not.
• In other words, a portion would have been considered as
defective. So a stable and in-control production process does
not necessarily mean that all the output meets customers’
requirements or standard specified limit.
• To understand the process capability, it is required to relate
standard specified limit (voice of the customer) with control
limit (voice of the process).
7. • The control charts do not relate the process performance to
the customers requirements because there is not any statistical
or mathematical relationship between the standard specified
limits and the process control limits.
• The process capability analysis is the bridge between the two;
it compares the variability of an in-control and stable
production process with its standard specified limit and
capability indices are generated to measure the level of the
process performance as it relates to the customers’
requirements.
• A process is said to be capable if the process mean is
centered to the specified target and the range of the specified
limits is wider than the one of the actual production process
variations (Control Limits), as in the graph in Figure-1.
8. Figure-2: Thickness of Product X (incapable process)
If the spread of the natural variations (control limits) is larger
than the one of the standard specified limits, as in the example of
Figure-2.
9. • The process is considered incapable because some of the
parts produced are outside the standards specified limit.
• Though control chart of Figure-2 is showing that all tested
data are within standard specified limit, but there is
possibility to produce product with defective thickness since
control limit is wider than standard specified limit.
• Data plotted in chart are mean value; individual values
possess some variation from mean value. So, individual value
might be out of standard specified limit in case of Figure-2.
11. Calculation of Process Capability
• calculation of process capability is applicable for normal data.
If in a sigma scaled graph, 99.73% observations are
concentrated between ±3σ from the mean, the data
distribution can be considered as normal.
• Process capability indices can be divided into two groups: the
indices that measure the processes potential capabilities, and
the ones that measure their actual capabilities.
• The potential capability indices determine how capable a
process is if certain conditions are met essentially, if the mean
of the process natural variability is centered to the target of
the standard specifications.
12. Potential Capability, Cp:
• A process is said to be capable if the spread of the natural
variations fits in the spread of the specified limits. This is so
when the ratio of the specified range to the control limits is
greater than one.
• In other words, the following ratio should be greater than 1.
• The value of Cp = 1 if the standard specified limit equals the
limit of the natural variations of the process (control limit), in
which case the process is said to be barely capable; it has the
potential to only produce non defective products if the
process mean is centered to the specified target.
Approximately 0.27 percent, or 2700 parts per million, are
defective.
13. • The value of Cp > 1 if the standard specified limit is greater
than control limit, in which case the process is potentially
capable if the process mean is centered to the specified target
and is (probably) producing products that meet or exceed the
customers’ requirements.
• The value of Cp < 1 if the standard specified limit is smaller
than control limit. The process is said to be incapable.
14. Actual Process Capability, Cpk :
• The reason why Cp > 1 does not necessarily mean that the
process is not producing defects, is that, the range of the
control limits might be smaller than the one of the standard
specified limits, but if the process mean is not centered to the
specified target, one side of the control limit might exceed the
specified limits.
• If the process mean is not centered to the specified target, Cp
would not be very informative because it would only tell
which of the two ranges (process control limits and standard
specified limits) is wider, but it would not be able to inform
on whether the process is generating defects or not. In that
case, another capability index is used to determine a process’
ability to respond to customers’ requirements and it is Cpk.
15. •The Cpk measures how much of the production process really conforms to the
standard specifications. The k in Cpk is called the k-factor; it measures the level
of deviation of the process mean from the specified target.
16. Process Capability Analysis
Assumptions
• Process capability analysis assumes whether the production
process is in-control and stable or not.
• Because what are being compared are the specified limits and
the control limits.
• If the process is out of control for a time period, some of the
measurements might be outside the control limits and would
not be taken into account.
• As example, isolated out of specification (OOS) should not
be considered in process capability analysis. Because, that
isolated OOS might be due to specific reason which can not
be considered as general phenomena.
17. • The stability of the process refers to the ability of the process
auditor to predict the process trends based on past experience.
• A process is said to be stable if all the variables used to
measure the process performance have a consistent mean and
a consistent variance over a sufficiently long period of time.
• If the value of Cpk=1, the process can be considered barely
capable. In this case, there is a risk to fall down capability
below 1, hence process may produce defective product.
• If the value of Cpk>1, the process is capable. It means
process is capable to meet or exceed customer’s expectations.
• If the value of Cpk<1, the process is incapable. In this case,
improvement of process or revision of specification is
required.