General aspects
Validation of parenterals
Validation of tablets
component of validation,function of different departments,reasons for validation,shivajirao s jondhle college of pharmacy asangaon,validation of parenterals,validation of tablets,validation priority,vilegave kailash
Aseptic / sterile- “ A state of control attained by using an aseptic work area and performing activities in a manner that precludes microbiological contamination of the exposed sterile product”
Aseptic / sterile- “ A state of control attained by using an aseptic work area and performing activities in a manner that precludes microbiological contamination of the exposed sterile product”
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
According to U.S.Food and Drug Administration
Process validation is establishing documented evidence which provides a high degree of assurance that a specific process will consistently produce a product meeting its predetermined specifications and quality characteristics.
Technology Transfer and Scale-up in Pharmaceutical IndustryPranjalWagh1
Transfer of technology is defined as “a logical procedure that controls the transfer of any process together with its documentation and professional expertise between development and manufacture or between manufacture sites”.
In Pharmaceutical Industry, technology transfer refers to the processes that are needed for successful progress from drug discovery to product development to clinical trials to full scale commercialization.
It is basically divided into three phases - Research Phase, Development Phase and Production Phase. The presentation elaborates on the technology transfer taking place in production phase. Production phase mainly concerns with validation studies and scale-up.
Validation studies such as performance qualification, cleaning validation and process validation is carried out by R&D department.
Scale-up involves the use of results obtained from lab studies for designing prototype of a product and pilot plant process, constructing pilot plant and further using pilot plant data for full-scale commercialization.
Aseptic / sterile - “ A state of control attained by using an aseptic work area and performing activities in a manner that precludes microbiological contamination of the exposed sterile product”
Validation of aseptic process should be designed to provide assurance through appropriate testing that all phases and activities of the process remain sterile and it is controlled within the predetermined parameters.
Drug product, container, and closure are subject to sterilization separately, and then brought together.
QUADRO Comil technology converts motor energy more efficiently into size reduction forces, leading industry milling performance standards in powder grinding and pulverizing.
Patented and proprietary screen and impeller designs ensure consistent energy transference providing previously unattainable narrow PSD spans for sub 400 micron target range. Furthermore, the H20 unmatched controllability to shift PSD targets, guarantees higher on-spec returns.
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
According to U.S.Food and Drug Administration
Process validation is establishing documented evidence which provides a high degree of assurance that a specific process will consistently produce a product meeting its predetermined specifications and quality characteristics.
Technology Transfer and Scale-up in Pharmaceutical IndustryPranjalWagh1
Transfer of technology is defined as “a logical procedure that controls the transfer of any process together with its documentation and professional expertise between development and manufacture or between manufacture sites”.
In Pharmaceutical Industry, technology transfer refers to the processes that are needed for successful progress from drug discovery to product development to clinical trials to full scale commercialization.
It is basically divided into three phases - Research Phase, Development Phase and Production Phase. The presentation elaborates on the technology transfer taking place in production phase. Production phase mainly concerns with validation studies and scale-up.
Validation studies such as performance qualification, cleaning validation and process validation is carried out by R&D department.
Scale-up involves the use of results obtained from lab studies for designing prototype of a product and pilot plant process, constructing pilot plant and further using pilot plant data for full-scale commercialization.
Aseptic / sterile - “ A state of control attained by using an aseptic work area and performing activities in a manner that precludes microbiological contamination of the exposed sterile product”
Validation of aseptic process should be designed to provide assurance through appropriate testing that all phases and activities of the process remain sterile and it is controlled within the predetermined parameters.
Drug product, container, and closure are subject to sterilization separately, and then brought together.
QUADRO Comil technology converts motor energy more efficiently into size reduction forces, leading industry milling performance standards in powder grinding and pulverizing.
Patented and proprietary screen and impeller designs ensure consistent energy transference providing previously unattainable narrow PSD spans for sub 400 micron target range. Furthermore, the H20 unmatched controllability to shift PSD targets, guarantees higher on-spec returns.
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.
MILLING – Cutting parameters, machine time calculation
Milling operation – Plain milling, side & face milling, form milling, gang milling, end milling, face milling, T slot milling, slitting
GEAR CUTTING – Gear cutting on milling machine – dividing head and indexing method, gear hobbing, principle of operation, advantages & limitation, hobbing tech, gear shaping, gear finishing process
The basic principles of particle size reduction. Presentation includes a comparison of gravity and pneumatic discharge hammer mills, how finished particle size is determined, and an explanation of particle size distribution.
An Over view on Bioassay, structure & principles, types & methods of bioassay. Also mention of other assay's like biotechnology, microbio assay, immunoassay etc.
Pharmaceutical Validation: Role in Phamaceutical Industrykaunainfathema1
This is a brief presentation on various concepts under Pharamaceutical Validation including its importance, scope, history, authorities, types of validation, VMP; along with the ICH and WHO Guidelines to be followed for Calibration of Equipments.
Introduction, Regulatory requirements for validation, Role of FDA, Code of Federal regulation, Validation life cycle, Significance of validation, Types of validation, Process valiadation, Phases of process validation, Process capability design, Process Qualification, Validation maintainance phase
Types of Process validation, Examples
PHARMACEUTICAL QUALITY ASSURANCE SIXTH SEMSTER B PHARM
Introduction, definition and general principles of calibration, qualification
and validation, importance and scope of validation, types of validation, validation master plan. Calibration of pH meter, Qualification of UV-Visible spectrophotometer, General principles of Analytical
method Validation.
U.S.F.D.A. was the pioneer in the concept of process validation.
Validation had proven to be an important tool for quality management of pharmaceutical according to ISO 9000:2000.
U.S.F.D.A. was the pioneer in the concept of process validation.
Validation had proven to be an important tool for quality management of pharmaceutical according to ISO 9000:2000.
Process Validation is Key important factor for the Pharmaceutical Industry to maintain Consistent Quality in product which claimed by the manufacturer.
Validation of Tangential Flow Filtration in Biotech ProcessesMerck Life Sciences
Watch the presentation of this webinar here: https://bit.ly/3hUKfd7
The objective of validation of a unit operation is to demonstrate with a high degree of confidence that the process performs consistently. The present seminar will focus on the validation of the unit operation of TFF and will provide an overview of the regulatory landscape, the validation master plan, approaches to membrane re-use, cleaning validation, and best practices.
In this webinar, you will learn:
• Validation of TFF
• Validation master plan
• Membrane reuse and cleaning
• TFF scale down models
Speaker: Dr. Subhasis Banerjee,
Principal Technical Application Expert, Bioprocessing APAC
UNIT – V : HUMAN PHYSIOLOGY
CHAPTER 20: LOCOMOTION AND MOVEMENT
Types of movement- ciliary, fiagellar, muscular; Skeletal muscle- contractile proteins and musclecontraction; Skeletal system and its functions (To be dealt with the relevant practical of Practical syllabus); Joints; Disorders of muscular and skeletal system-Myasthenia gravis, Tetany, Muscular dystrophy, Arthritis, Osteoporosis, Gout.
UNIT – V : HUMAN PHYSIOLOGY
CHAPTER 17 : BREATHING AND EXCHANGE OF GASES part 1
Human Respiratory System The Mechanism of Breathing Transport of Oxygen,
Regulation of Respiration
Chapter 17 breathing & exchange of gases (repaired) (2)Kailash Vilegave
UNIT – V : HUMAN PHYSIOLOGYCHAPTER 17 : BREATHING AND EXCHANGE OF GASES
Respiratory organs in animals (recall only); Respiratory system in humans; Mechanism of breathingand its regulation in humans-Exchange of gases, transport of gases and regulation of respiration Respiratory volumes; Disorders related to respiration-Asthma, Emphysema, Occupational respiratory disorders.
UNIT – IV : PLANT PHYSIOLOGY
CHAPTER 14 : RESPIRATION IN PLANTS.
Exchange gases; Cellular respiration-glycolysis, fermentation (anaerobic), TCA cycle and electron transport system (aerobic); Energy relations-Number of ATP molecules generated; Amphibolic pathways; Respiratory quotient.
Introduction
History
Why parenteral?
Necessary condition of parenteral
advantages/ disadvantages
Methods of preparation
Quality control
Packaging
Types of parenteral products
Routes of administration
advantages/ disadvantages
conclusion
Kailash vilegave
Kingdom Plantae presented by Vrushali Gharat to Mr. Kailash vilegaveKailash Vilegave
Classification Of Kingdom Plantae, Classification Of Kingdom Plantae, Economic importance Algae.
Ulothrix
Reproduction
Mosses and Liverwort
life cycle of all plants.
Osmotic drug delivery system by Mr. kailash vilegaveKailash Vilegave
INTRODUCTION
ADVANTAGES OF OSMOTIC DRUG DELIVERY SYSTEM
DISADVANTAGES OF OSMOTIC DRUG DELIVERY SYSTEM
REPORTED CASES REGARDING LIMITATIONS AND ADVERSE EFFECTS OF OSMOTIC DRUG DELIVERY SYSTEM
PRINCIPLE OF OSMOSIS
BASIC COMPONENTS OF OSMOTIC PUMP
Welcome to TechSoup New Member Orientation and Q&A (May 2024).pdfTechSoup
In this webinar you will learn how your organization can access TechSoup's wide variety of product discount and donation programs. From hardware to software, we'll give you a tour of the tools available to help your nonprofit with productivity, collaboration, financial management, donor tracking, security, and more.
Unit 8 - Information and Communication Technology (Paper I).pdfThiyagu K
This slides describes the basic concepts of ICT, basics of Email, Emerging Technology and Digital Initiatives in Education. This presentations aligns with the UGC Paper I syllabus.
2024.06.01 Introducing a competency framework for languag learning materials ...Sandy Millin
http://sandymillin.wordpress.com/iateflwebinar2024
Published classroom materials form the basis of syllabuses, drive teacher professional development, and have a potentially huge influence on learners, teachers and education systems. All teachers also create their own materials, whether a few sentences on a blackboard, a highly-structured fully-realised online course, or anything in between. Despite this, the knowledge and skills needed to create effective language learning materials are rarely part of teacher training, and are mostly learnt by trial and error.
Knowledge and skills frameworks, generally called competency frameworks, for ELT teachers, trainers and managers have existed for a few years now. However, until I created one for my MA dissertation, there wasn’t one drawing together what we need to know and do to be able to effectively produce language learning materials.
This webinar will introduce you to my framework, highlighting the key competencies I identified from my research. It will also show how anybody involved in language teaching (any language, not just English!), teacher training, managing schools or developing language learning materials can benefit from using the framework.
Students, digital devices and success - Andreas Schleicher - 27 May 2024..pptxEduSkills OECD
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Synthetic Fiber Construction in lab .pptxPavel ( NSTU)
Synthetic fiber production is a fascinating and complex field that blends chemistry, engineering, and environmental science. By understanding these aspects, students can gain a comprehensive view of synthetic fiber production, its impact on society and the environment, and the potential for future innovations. Synthetic fibers play a crucial role in modern society, impacting various aspects of daily life, industry, and the environment. ynthetic fibers are integral to modern life, offering a range of benefits from cost-effectiveness and versatility to innovative applications and performance characteristics. While they pose environmental challenges, ongoing research and development aim to create more sustainable and eco-friendly alternatives. Understanding the importance of synthetic fibers helps in appreciating their role in the economy, industry, and daily life, while also emphasizing the need for sustainable practices and innovation.
The Art Pastor's Guide to Sabbath | Steve ThomasonSteve Thomason
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How to Create Map Views in the Odoo 17 ERPCeline George
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3. DEFINITION
Validation is attaining & documentation of sufficient
evidence to give reasonable assurance, stating that
equipment or process does & will do what it purports to
do.
According to US FDA
“validation is establishing documented evidence which
provides a higher degree of assurance that a specific
process , equipment or facility meets its pre determined
specifications & quality characteristics & will consistently
produce a product of standard quality”
3
4. Objective :to manufacture product of requisite
quality with low cost
Govt regulation
Assurance of quality
Cost reduction
4
5. WHEN VALIDATION BEGINS
Validation should begin in the designing stage for new
facility & pre formulation stage for a new dosage form.
WHO DOES
In order to have a valid & qualified system it must be
designed by qualified individuals only.
As it is complex process, it is performed by individuals
with necessary training & experience & who are
themselves previously qualified.
5
6. Validation team
Q.A
ENGINERING Q.C
TASK FORCE
LEADER
MAINTENANCE R&D
MFG
6
7. Install, qualify & certify plant facility,
Engineering equipment &support systems.
Design, optimize, qualify
R&D manufacturing process with limits &
specifications.
Operate & maintain plant facilities,
Manufacturing equipments ,support systems, process
and strictly follow SOP.
Follow the validation protocol develop
Q.C by Q.A & validate the incoming stock
,in process critical system &final
product.
Establish approvable validation
Q.A protocols &conduct process validation
by monitoring ,sampling ,challenging
the process & equipment.
7
8. 1. Large volume parenteral.
2. Small volume parenteral.
3. Ophthalmic, other sterile products & medical devices.
8
9. Analytical test procedures
Instrument calibration
Critical support system
Operators
Raw materials
Packaging materials
Equipment
validation
Facilities
Manufacturing process
Product design
Utilities & services
Records & reports
9
10. 1. Prospective validation.
2. Retrospective validation.
3. Concurrent validation.
4. revalidation.
Prospective validation
This is validation program executed before
commercialization of a new drug/ formulation,
to make sure that there are no potential
hazards in full scale manufacture of product.
10
11. It is a program chosen for established products whose
manufacturing process are considered stable (i.e. long
history of state control operation).
This method involves statistical analysis of numerical
data obtained from different batches & then justify
whether the system is qualified or not.
The data includes
a) MFR,BFR.
b) b) assay values.
c) End product test results.
d) In process data.
11
12. Different parameters checked in parenteral.
pH value.
Viscosity.
Density.
Color & clarity.
Potency.
Sterilization parameters.
Different statistical methods are
Basic statistics (mean , standard deviation, tolerance limit ) .
Analysis of variance (ANOVA) .
Regression analysis.
Cumulative sum analysis.
Control charting – most advance & useful.
12
13. This method includes in process monitoring of critical process
steps & end product testing of current production along with
documentation .
This shows that the manufacturing is in state of control
The same parameter of retrospective validation are evaluated with
more stress on critical parameters affecting the process .
Revalidation
This method involves validation of facility which is previously
validated when
1 Change in critical component .
2 Change in critical piece of equipment.
3 Change in facility / plant (design / location ).
4 Significant increased / decease in batch size.
5 Sequential batches fail to meet product / process specifications
13
14. Design & validation of facility
There are four basic steps in validation of
facility
1. Planning
2. Documentation
3. Construction
4. Testing
14
15. 1. Planning
Site selection
Design staff
Material flow path
Room layout
15
17. Typical room layout:
Salient feature
Double door with interlock system
Positive pressure in sterile area.
Separate entry for material &personal.
Clean room or class-100 room in the filling area.
Entry is done only after gowning
17
19. Its done for
1. Sensitivity
2. Accuracy
3. precision
19
20. Air system
Validation is performed mainly in four phases
1. Pre construction phase - - design &engineer air system
2. Construction phase - - all steps of planning are in
place
3. Post Construction phase - - rest phase
4. Post Construction phase - -same test are performed
with machines
HVAC system
Purpose-To provide a specific set of environmental
conditions required for manufacturing process.
20
21. HVAC
AIR FILTRATION CONTROL SYSTEM
AIR HANDLING AIR DISTRIBUTION
21
22. Class-100 room: particle count limit 100/cubic foot of 0.5 µm
or larger in size.
Class- 10,000 room : particle count limit 10,0000/cubic foot
of 0.5 µm or larger in size
Area Absolute Intermediate Pre-filter
preparation optional recommended recommended
washing optional recommended recommended
filling required optional recommended
packaging not required not recommended
recommended
22
23. Hepa filter leak test .
Temperature control test.
Humidity control test.
Air flow uniformity test.
Pressure control test.
Particle count test.
Induction leak test.
Airborne microbial sampling.
23
24. Different classes of water
CLASS MINERAL MICROBE T.M.REM PYROGE QUALITY
S OVAL N
WELL + + - + I
WATER
POTABLE + CONTRO - + II
L
PURIFIE - CONTRO - + III
D L
W.F.RINS - CONTRO + NIL IV
E L
W.F.I - NIL + NIL V
24
25. SAMPLE POINT TEST FREQUENCY
RAW WATER MICROBIAL, cl DAILY
RESIDUAL, TDS,PH
FILTERS MICROBIAL, cl DAILY
RESIDUAL
DISTILLATION /R.O MICROBIAL ,pH CONTINUOUS
EQUIPEMENT
STORAGE TANK MICROBIAL, p H, MULTIPLE TIME IN
PYROGEN, CYCLE
CHEMICALS USP.
DISTRIBUTION MICROBIAL DAIILY
/USAGE POINT PYROGEN , pH
25
26. 1.VALIDATION OF GASES : nitrogen, carbon
dioxide, compressed air.
VALIDATION OF GASES INCLUDES 3 STEPS
Supply of gas (adequate purity & quality)
Storage conditions
Distribution network
26
27. 2. Validation of steam system
validation of steam generator
Efficiency.
Pressure.
Analysis of condensate.
Distribution network.
3. Validation of electrical system
main objective is to meet :
Qualitative specifications. (frequency, voltage,
stability ).
Quantitative specifications ( load demand).
Back up system are validated .
27
28. VALIDATION OF FILLING
Parenterals are checked for
1. Fill volume
2. Syringe able volume
3. Sterile filling
Monitoring of viable &non viable particles:
Particle counter
Strip test
Reuter centrifugal sample (RCS)
28
29. D-value: time required to reduce the microbial content by
90%i.e.one logarithmic reduction
F-value: time required to destroyed all spores of suspension when
using a suspension at 121 c
Z-value: the no of degree required for 1 log reduction in D-value
N0 –value: No of living organism / defined unit of surface
Log reduction value: ability of filter in terms of log reduction of
microbial population.
29
30. Biological indicator
E.g. for steam sterilization-Bacillus stearothermophillus
for dry heat sterilization- Bacillus subtilis var. niger
for ethylene oxide- Bacillus subtilis var. globigli
for ionizing radiation- bacillus pumilis
30
31. Operation condition are 121ºc, 15Psig, for
20 min
1. Qualification & calibration:
Checking, upgrading the unit
2. Selection & calibration of thermocouples
3. Selection & calibration of B.I
4. Heat distribution studies
1. cool spot is find out
2. temp dif should not be more than + 2.5ºc
5. Heat penetration studies
By container mapping studies- in which
thermocouples are introduced at different heights in
the container.
31
32. Its done for
Batch oven & tunnel oven
validation mainly includes
1. Qualification & calibration
2. Selection & calibration of thermocouples
3. Selection & calibration of B.I
4. Air balance determination
5. Heat distribution studies
1. cool spot is find out
2. temp dif should not be more than + 2.5ºc
6. Heat penetration studies
32
33. Validation of radiation sterilization
Major source are cobalt 60, ceasium136 .
Determine D-values using biological indicator.
First calculation of dose based on bio –burden.
Calibration of equipment so that same amount of
radiation is released every time.
Normal dose for over kill approach is 2.5 Mrad.
33
34. Sources for contamination are
Skin &hair fragments.
Droplets from mucous membrane.
Material deposition due to personal.
Fibers released from person &equipment.
Packaging material.
so to maintain aseptic conditions we need something
other thsn hepa filters i.e. SANITIZER
Def- it is defined as a chemical agent that kills microbial
contamination in the vegetative form only.
E.g.; Hypochlorite , phenol ,surfactant etc.
34
35. Membrane filters are cartridges & plates
Physical integrity of filter media is checked by
1. Bubble point test.
2. Bacterial challenge test.
3. Flow rate.
4. Longevity of filter.
35
36. a) INTEGRITY OF RUBBER :
1. Quality
2. Penetratability
3. Fragmentation
4. Water extractive
5. Self-seal ability
b) INTEGRITY OF GLASS :
There are mainly 4 types of glass
TYPE I (borosilicate glass ). For (parenterals)
TYPE II ( treated soda lime glass). (for dry powders)
TYPE III (soda lime glass).
TYPE IV (non parenteral glass)
36
37. 1. Chemical composition
2. Leaching
3. Powder glass test
4. Water attack test
C) Leaking tests:
There are mainly two types of leak test:
1. Vacuum dye leak test.
2. Autoclave dye test.
37
38. Validationis a systematic approach to
identifying, measuring, evaluating
,documenting,& reevaluating a series of critical
steps in manufacturing process that require
control to ensure are producible final product.
38
39. Key elements that form the basis of a
prospective process validation program
1.Definition of the desirable attributes of drug product or
components thereof as well as those characteristics that
are not desired
2. Establishment of limitation or constraints for these
attributes
3. Determination of the controls or testing parameters that
will be measured or tested.
4. Initiation of studies to establish control or boundary limits
for those attributes that influence the product, process
,quality & performance.
39
40. It includes validation of both active ingredients& excipients.
Characteristics
particle size, surface area, color, density.
Chemical characteristics- water content residue on ignition &
heavy metals.
Variables:
Flow, blend uniformity, granulation solution/binder uptake
compressibility ,lubricant efficiency
eg;1) Mg sterate (lubricant). Its action depends on particle
size.
2) dyes (color)
variation in material occur depending up on ….
a) Method of transportation chosen,
b) Exposure of material to undesirable conditions (heat and
humidity)
40
41. Steps involved in validation of raw
materials
1. Each raw material should be validated by performing checks
on several batches, preferably 3,from the primary supplier as
well as the alternate supplier .the batches chosen should be
selected to represent the range of acceptable specifications
both high and low
2. Depending on susceptibility of the raw material to ageing
,either physical , chemical or microbial stability assessed .
41
42. Once the samples of raw materials have been selected it should
be used to manufacture a batch of final dosage form it may be
appropriate to manufacture to several lots of final product with
raw material at the low &high ends of the specifications limit .
The final step of raw material should involve an on –site
inspection of the supplier to review the vendors manufacturing
operations and control procedures
42
43. Analytical criteria must be assessed ……….
1. Accuracy of method
2. Precision of method
3. In –day /out –of-day variation
4. Operator variation.
5. Instrument variation
6. Laboratory variation
43
44. process validation can be defined as means of challenging a
process during development to determine which variables must
be controlled to ensure consistent production of a product or
intermediate.
Steps in development of validation program :
1. Obtaining test data to determine the numerical range of each
parameter
E.g.: assess the tablet hardness over a series of batches .
2. Establishing specification limits from the test data derived for a
given parameter.
3. Determining how well the specification limit indicates that the
process is under control
4. Certify the equipment operating conditions
Eg: rpm , temp, are within specification limits.
44
45. General tests in process validation are
1. Moisture content
2. Content uniformity
3. Hardness
4. Disintegration & dissolution
5. Friability
6. Weight variation
7. Granulation particle size distribution
45
46. A. Tablet composition:
Normal properties
Density
Particle size distribution
Surface area
Flow properties
Moisture content
solubility
46
47. B. Process evaluation & selection:
Blending operation
Determine time of un mixing
Characteristics of blend
bulk density
Particle size distribution
Color uniformity
C. Wet granulation
1.Evaluation of binder
Binder concentration
Solubility in granulating solution
2.Evalution of mixed granulation
3.Evalution of drying
47
48. 4. Tablet compression
Appearance
Color quality
Power flow
Speed of tablet machine
5.Tablet coating
Evaluate coating procedure in different size pans
Coating speed
Amount of material required / application
48