What is IPQC & IPQC Test
Appearance
Drug content determination
pH
Sensitivity test
Spreadability
Rate of absorption
Extrudability
Consistency Test
Rheology & Viscosity
Auditing of Granulation Operation in Dry Production AreaPritam Kolge
Auditing of Granulation Operation in Dry Production Area.....
This topic comes under Audits and Regulatory Compliance....
This is useful for M.Pharm (Pharaceutical Quality Assurance) Students who studying in First year sem II....
This Presentation Contain following...
#Objectives
#Fundamentals of Granulation
#Reasons for Granulation
#Methods of Granulation
#Agglomeration
#Fundamentals and Audit of Dry Granulation
#Steps in Dry Granulation
#Fundamentals and Audit of Fluid Bed Granulation
#Scale-Up of Fluid bed Granulation
#High share granulation-Fundamentals, Audit and Scale-Up
#Overview and Comparison of Different Granulating Techniques
#Audit of Mixing and Blending, Wet granulation, Wet milling, Drying, Milling
#Conclusion
#References
Thanks For Help and Guidance of Mr. D.P.Mali Sir
What is IPQC & IPQC Test
Appearance
Drug content determination
pH
Sensitivity test
Spreadability
Rate of absorption
Extrudability
Consistency Test
Rheology & Viscosity
Auditing of Granulation Operation in Dry Production AreaPritam Kolge
Auditing of Granulation Operation in Dry Production Area.....
This topic comes under Audits and Regulatory Compliance....
This is useful for M.Pharm (Pharaceutical Quality Assurance) Students who studying in First year sem II....
This Presentation Contain following...
#Objectives
#Fundamentals of Granulation
#Reasons for Granulation
#Methods of Granulation
#Agglomeration
#Fundamentals and Audit of Dry Granulation
#Steps in Dry Granulation
#Fundamentals and Audit of Fluid Bed Granulation
#Scale-Up of Fluid bed Granulation
#High share granulation-Fundamentals, Audit and Scale-Up
#Overview and Comparison of Different Granulating Techniques
#Audit of Mixing and Blending, Wet granulation, Wet milling, Drying, Milling
#Conclusion
#References
Thanks For Help and Guidance of Mr. D.P.Mali Sir
Expiry date , calculation of yields, production record review, change controlSantosh kumar
The responsibility of the pharmaceutical manufacturer is that the drug product should have the stated potency and therapeutic effectiveness till the end of the shelf life of the product This shelf life should be based on t
IPQC?
Its Need
In-Process Quality Control tests for Tablets
Hardness
Friability
Thickness
Disintegration Time
Weight variation
Content uniformity
Dissolution test
Leakage testing for strip and blister packaging
ICH STABILITY TESTING GUIDELINES (ICH Q1A-Q1F).pptxDurgadevi Ganesan
ICH Stability Testing Guidelines: ICH Q1A-Q1F (Q1 series)
Q1A(R2): STABILITY TESTING OF NEW DRUG SUBSTANCES AND PRODUCTS
Q1B: PHOTOSTABILITY TESTING OF NEW DRUG SUBSTANCES AND PRODUCTS
Q1C: STABILITY TESTING FOR NEW DOSAGE FORMS
Q1D: BRACKETING AND MATRIXING DESIGNS FOR STABILITY TESTING OF NEW DRUG SUBSTANCES AND PRODUCTS
Q1E: EVALUATION OF STABILITY DATA
Q1F: STABILITY DATA PACKAGE FOR REGISTRATION APPLICATIONS IN CLIMATIC ZONES III & IV
Expiry date , calculation of yields, production record review, change controlSantosh kumar
The responsibility of the pharmaceutical manufacturer is that the drug product should have the stated potency and therapeutic effectiveness till the end of the shelf life of the product This shelf life should be based on t
IPQC?
Its Need
In-Process Quality Control tests for Tablets
Hardness
Friability
Thickness
Disintegration Time
Weight variation
Content uniformity
Dissolution test
Leakage testing for strip and blister packaging
ICH STABILITY TESTING GUIDELINES (ICH Q1A-Q1F).pptxDurgadevi Ganesan
ICH Stability Testing Guidelines: ICH Q1A-Q1F (Q1 series)
Q1A(R2): STABILITY TESTING OF NEW DRUG SUBSTANCES AND PRODUCTS
Q1B: PHOTOSTABILITY TESTING OF NEW DRUG SUBSTANCES AND PRODUCTS
Q1C: STABILITY TESTING FOR NEW DOSAGE FORMS
Q1D: BRACKETING AND MATRIXING DESIGNS FOR STABILITY TESTING OF NEW DRUG SUBSTANCES AND PRODUCTS
Q1E: EVALUATION OF STABILITY DATA
Q1F: STABILITY DATA PACKAGE FOR REGISTRATION APPLICATIONS IN CLIMATIC ZONES III & IV
ICH Stability testing of new drug substances and products QA (R2) - 2015
Almudena Camacho
Mohammad Koosha
Rocio Monroy
Professor Peivand Pirouzi Inc. -
Copyright 2015 - Professor Peivand Pirouzi Inc., International Corporate Training, Canada
All rights reserved
Stability testing protocol for herbal products in a detailed review.It’s the ability of formulation to retain its physical, chemical, microbiological and toxicological parameter same as that time of manufacture .
Drug product remains within specifications established to ensure its identity, strength, quality and purity.
Stability – Chemical and Physical integrity of herbal medicinal products.
Over a given time period and under the influence of environmental factors including temperature, humidity and light.
To provide evidence on how the quality of active substance varies with time and environmental factors
To establish re- test period for active substance
To establish shelf life of finished products.
To recommend storage conditions.
To evaluate the efficacy of drug.
To develop suitable packing information for drug product
To submit stability information for regulatory agencies.
1.Physical stability study:-
The original physical properties namely appearance, uniformity, palatability, dissolution, and suspend ability are maintained.
Chemical stability study:-
Each and every active ingredient retains its chemical integrity as well as potency specified on label, within the specified limits.
It involves drug assay and determination of drug degradation.
ICH Guideline Stability Testing of New Drug Substances and Product Q1A(R2).pptxTrishala Bhatt
This presentation outlines the ICH Guideline for Stability Testing of New Drug Substances and Products, Q1A(R2). It serves as a comprehensive framework for ensuring the stability of new pharmaceuticals, with a focus on the requirements for registration applications within the EC, Japan, and the United States. The guideline emphasizes a balance between a standardized approach and the flexibility to adapt to specific scientific considerations and characteristics of the materials under evaluation.
ICH guidelines for stability studies of different formulation and active pharmaceuticals.
physical, chemical, microbial, toxicological therapeutic stability studies.
accelerated and intermediate, long term stability studies
by following the stability studies we can predict the expiry period and half life of product and avoid the toxic effect of the unstable product
WHO Guideline & Stability Protocols for Liquid Dosage FormsAnindya Jana
These guidelines seek to exemplify the core stability data package required for registration of active pharmaceutical ingredient (APIs) & finished pharmaceutical protocols (FPPs), replacing the previous WHO guidelines in this area. However, alternative approaches can be used when they are scientifically justified. Further guidelines can be found in International Conference on Harmonisation (ICH) guidelines and in the who guidelines on the active pharmaceutical ingredient master file procedure.
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.
Operation “Blue Star” is the only event in the history of Independent India where the state went into war with its own people. Even after about 40 years it is not clear if it was culmination of states anger over people of the region, a political game of power or start of dictatorial chapter in the democratic setup.
The people of Punjab felt alienated from main stream due to denial of their just demands during a long democratic struggle since independence. As it happen all over the word, it led to militant struggle with great loss of lives of military, police and civilian personnel. Killing of Indira Gandhi and massacre of innocent Sikhs in Delhi and other India cities was also associated with this movement.
The French Revolution, which began in 1789, was a period of radical social and political upheaval in France. It marked the decline of absolute monarchies, the rise of secular and democratic republics, and the eventual rise of Napoleon Bonaparte. This revolutionary period is crucial in understanding the transition from feudalism to modernity in Europe.
For more information, visit-www.vavaclasses.com
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The Roman Empire A Historical Colossus.pdfkaushalkr1407
The Roman Empire, a vast and enduring power, stands as one of history's most remarkable civilizations, leaving an indelible imprint on the world. It emerged from the Roman Republic, transitioning into an imperial powerhouse under the leadership of Augustus Caesar in 27 BCE. This transformation marked the beginning of an era defined by unprecedented territorial expansion, architectural marvels, and profound cultural influence.
The empire's roots lie in the city of Rome, founded, according to legend, by Romulus in 753 BCE. Over centuries, Rome evolved from a small settlement to a formidable republic, characterized by a complex political system with elected officials and checks on power. However, internal strife, class conflicts, and military ambitions paved the way for the end of the Republic. Julius Caesar’s dictatorship and subsequent assassination in 44 BCE created a power vacuum, leading to a civil war. Octavian, later Augustus, emerged victorious, heralding the Roman Empire’s birth.
Under Augustus, the empire experienced the Pax Romana, a 200-year period of relative peace and stability. Augustus reformed the military, established efficient administrative systems, and initiated grand construction projects. The empire's borders expanded, encompassing territories from Britain to Egypt and from Spain to the Euphrates. Roman legions, renowned for their discipline and engineering prowess, secured and maintained these vast territories, building roads, fortifications, and cities that facilitated control and integration.
The Roman Empire’s society was hierarchical, with a rigid class system. At the top were the patricians, wealthy elites who held significant political power. Below them were the plebeians, free citizens with limited political influence, and the vast numbers of slaves who formed the backbone of the economy. The family unit was central, governed by the paterfamilias, the male head who held absolute authority.
Culturally, the Romans were eclectic, absorbing and adapting elements from the civilizations they encountered, particularly the Greeks. Roman art, literature, and philosophy reflected this synthesis, creating a rich cultural tapestry. Latin, the Roman language, became the lingua franca of the Western world, influencing numerous modern languages.
Roman architecture and engineering achievements were monumental. They perfected the arch, vault, and dome, constructing enduring structures like the Colosseum, Pantheon, and aqueducts. These engineering marvels not only showcased Roman ingenuity but also served practical purposes, from public entertainment to water supply.
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Macroeconomics- Movie Location
This will be used as part of your Personal Professional Portfolio once graded.
Objective:
Prepare a presentation or a paper using research, basic comparative analysis, data organization and application of economic information. You will make an informed assessment of an economic climate outside of the United States to accomplish an entertainment industry objective.
1. M. Pharm Sem-I Presentations
Title- ICH Stability Testing Of New Drug Substance And Drug Product.
SUBMITTED TO
SAVITRIBAI PHULE, PUNE UNIVERSITY , PUNE
FOR
PARTIAL FULFILMENT OF REQUIREMENTS FOR THE AWARD OF
MASTER OF PHARMACY
IN THE SUBJECT
Pharmaceutical Quality Assurance
IN THE FACULTY OF SCIENCE AND TECHNOLOGY
Bhujbal Knowledge City,
MET’s Institute of Pharmacy,
Adgaon, Nashik, 422003.
Maharashtra, India
Academic Year-2021-22 1
Presented By- Mandlik Amruta
and
Thorat Prajakta.
Guided By- Dr. Sapna
Ahirrao.
3. Objective:-
• This guidelines defines the stability data package for new
medicine substance (API) or medicine product ( final product)
that’s necessary for a enrollment operation within the three
region of the Japan, European Commission, and the United
States
• . The guideline seeks to explain core stability data package for
new medicine substance and product but leaves sufficient
inflexibility to encompass variety of different partial situation
that may encounter due to specific scientific consideration and
characteristics of material being estimated
3
4. Scope:-
• The guideline addresses the information to be submitted in
enrollment operation for new molecular realities and associate
the medicine product.
• This guideline doesn't presently seek to cover information to
be submitted for abbreviated operations, variation, clinical
trials operation,etc.
• Specific details of the slice and testing not covered in this
guideline.
4
5. General principal:-
• The purpose of stability testing is to provide evidence on how
the quality of drug substance or drug product varies with time
under the influence of variety of environmental factor such as
temperature, humidity and light.
• These information help us to established a re-test period for
drug substance (API) or shelf life for final product and
recommended storage conditions.
5
6. Guidelines for stability testing
Drug substance:-
1. General
2. Stress testing
3. Selection of batches
4. Container closure system
5. Specification
6. Testing frequency
7. Storage condition
6
7. Generalities:-
• Stability of the drug substance is an integral part of the
systematic approach in stability evaluation.
Stress testing:-
• The stress testing may be carried out on a single batch of the
drug substance. It should include the effect of temperature,
humidity, oxidation and photo stability.
– Eg. The effect of temperature in 10 degrees increment
above that for accelerated testing (eg. 50°C to 60°C)
7
8. • The testing should also estimate the vulnerability of the
medicine substance to hydrolysis across wide range of pH
values when in result or suspense.
• Helps to identify the declination product thus the declination
pathway and natural stability of patch, and validate the
stability indicating power of the logical procedure used.
•
8
9. Selection of batches:-
• Data from formal stability studies should be handed on at lest
three primary batches of medicine substance.
• The batches should be manufactured to a minimum of airman
scale batches by the same system of manufacture and
procedure which is used for final product.
• Container check system-
• The stability study should be conducted on medicine substance
packed in vessel check system that’s same as packaging
proposed for storehouse and distribution
9
10. Specifications:-
• Stability studies should include testing of those attributes of
the medicine substance that are susceptible to change during
storehouse and likely to impact quality, safety, and/ or
efficacity.
• The testing should cover the physical, chemical, natural and
microbiological attributes.
• Validated logical should be applied.
10
11. Testing frequency:-
11
Testing frequency
Long term studies
Accelerated storage
conditions
Intermediate storage
condition
Should be sufficient to
establish the stability
profile of the drug
substance.
Retest period of at least 12 months
Test every 3 months for 1st year
Every 6 month for 2nd year and
annually thereafter through the
proposed retest period
Minimum of 3 time points,
including the initial and final
time points.( Eg. 0,3 and 6
months)
Is needed as result of
significant change at
the accelerated
storage condition
minimum of 4 time
points of 0,6,9,12
month, from 12
month study is
recomanded
12. Testing frequency and storage condition:-
General case study Storage condition Minimum time
period covered by
data at submission.
Long term 25°c ± 2°c/ 60% RH
± 5% RH or
30°c ± 2°c or 65%
RH ± 5% RH
0, 3, 6, 9,12 months
18, 24 months
36 months and
annually.
12 months
Intermediate 30°c ± 2°c or 65%
RH ± 5% RH
0, 6, 9, 12 months 6 months
Accelerated 40°c ± 2°c or 75%
RH ± 5% RH
0,3,6 months 6 months
12
13. Drug substance / Drug product:-
Stability commitment
When available long term stability data on primary batches don’t
cover the proposedre-test or shelf life granted at time of blessing
from at least three product batches, a commitment should made to
continue the stability study post blessing in order to forcefully
establish the stability
13
14. Statement / labelling:-
• Storage statement should be established for labelling based on
stability study of the drug substance or product according to
national or regional requirements.
• Re test date or expiration date should be display on container
labels.
14
15. Drug product:-
1. General
2. Selection of batches
3. Container closure system
4. Specification
5. Testing frequency
6. Storage condition
15
16. Drug product:-
Generalities:-
Stability studies grounded on the conclusion of medicine
substance stability.
Attributes to test are those susceptible to change during
storehouse and likely to impact on quality, safety or efficacity.
Physical, chemical, natural and microbiological
. Preservative content fore.g. Antioxidant, antimicrobial.
Functionality teste.g. Dissolution rate for lozenge form.
Antimicrobial preservative effectiveness on primary batch at
proposed shelf life.
16
17. Selection of batch:-
• At lest 3 primary batches (pilot scale)
• Same formulation
• Same container closer system as proposed for marketing
including secondary package and container label.
• The manufacturing process used for primary and production
batch should be similar
• It should provide same quality and meeting the specification as
that intended for marketing.
• 2 of the 3 batch should be pilot scale and 3rd one can be
smaller.
17
18. • If possible batches of drug product should be manufactured by
using different batches of drug substances.
• Stability studies should be performed on each individual
strength and container size of drug product unless bracketing
or matrixing is applied.
18
19. Container closure system:-
• Stability testing should be conducted on dosage form packed
in container closer system proposed for marketing.
• Any available studies carried out on drug product out side its
immediate container or other packaging material can form a
useful part of stress testing of dosage form.
19
20. Specification:-
• Stability study should include those attributes of drug product
that are susceptible to change during storage and are likely to
influence quality, safety, and efficacy.
• The test should cover the physical, chemical, biological,
microbiological attributes, preservative content and
functionality test.
20
21. Testing frequency and storage conditions:-
21
General case study storage condition Minimum time
period covered by
data at submission.
Long term 25°c ± 2°c/ 60% RH
± 5% RH or
30°c ± 2°c or 65%
RH ± 5% RH
0, 3, 6, 9,12 months
18, 24 months
36 months and
annually.
12 months
Intermediate 30°c ± 2°c or 65%
RH ± 5% RH
0, 6, 9, 12 months 6 months
Accelerated 40°c ± 2°c or 75%
RH ± 5% RH
0,3,6 months 6 months
22. Significant change:-
• The significant change for drug product is defined as
1. A 5% change in assay from its initial value or failure to meet
acceptance criteria for potency when using biological or
immunological procedure.
2. Any degradation product exceeding its acceptance criteria.
3. Failure to meet acceptance criteria for appearance, physical
attributes and functionality test.
22
23. Types of container
• Impermeable container
– No sensitivity to moisture or potential solvent loss
– Stability study under any control or ambient humidity.
• Semipermeable container
– Determine the water loss at low RH condition
– 5% water loss after 3 months at accelerated condition is
significant change
– Small container (1ml or less), 5% or more of water loss
may be appropriate.
23
24. Testing frequency storage conditions for semipermeable
container :-
General case study Storage condition Minimum time period
covered by data at
submission
Long term 25°C ± 2°C / 40% RH ± 5%
RH
30°C ± 2°C / 35% RH ± 5%
RH
12 months
Intermediate 30°C ± 2°C / 35% RH ± 5%
RH
6 months
accelerated 40°C ± 2°C / NMT 25%RH 6 months
24
25. Approach for determining water loss
The ratio of water loss is calculated by following formula
25
100 – reference % RH
100 – alternative % RH
Ratio of water loss =
Alternative relative
humidity
Reference relative
humidity
Ratio of water loss at
given temperature
65% RH 35% RH 1.9
75% RH 25% RH 3.0
26. Testing frequency storage conditions:-
• Storage in refrigerator
26
General case study Storage condition Minimum time period
covered by data at
sumission
Long term 5°C ± 3°C 12 months
accelerated 25°C ± 2°C or 60% RH ±
5% RH
6 months
• Storage in freezer
General case study Storage condition Minimum time period
covered by data at
sumission
Long term -20°C ± 5°C 12 months
27. Conclusion
• Stability studies of pharmaceutical substance helps in
developing the pharmaceutical dosage form and new
Formulation.
• From these studies it is easy to predict the shelf life of the
drug including effect of environmental factors for the
degradation of the product.
27
28. Case study:-
• the medicine substance stability data were used to support medicine
in capsule (DiC) product. The compass of the design gauged across
5 small motes with medicine in capsule phrasings. The FDA
Guidance for Industry, cGMP for Phase l Medicines (U.S. Food and
Drug Administration, 2008) allows representative samples of phase
1 investigational medicines to be used to cover stability and quality.
In the case of DiC phrasings it was determined that the medicine
substance stability data was representative of the DiC stability. The
defense in the Clinical Trial Operation (CTA) included representing
the Common Technical Document (CTD) SectionS. 7 in SectionP. 8.
The CTA also included reference to accelerated stability data on the
medicine substance as part of the defense.
28
29. Case study:-
Regulatory cessions were performed in the US, France and Spain.
Challenges were entered in two cases (US and Spain) and the
agencies requested that the DiC be placed on long- term stability
concurrent with the clinical study. Due to timing considerations,
further specialized discussion wasn’t pursued, and the DiC was
placed on long- term stability. The primary benefit was still
realized by this approach; time savings in not staying for the one-
month medicine product stability data previous to IND or CTA
form.
29
30. Conclusion
The case studies presented here described how the combination
of scientific rationale and product knowledge have been hold
successfully to develop stability strategies that were robust and
efficient. It is evident that there are a multiple of opportunities
for scientifically sound lean stability approaches to be adopted.
30
31. Reference:-
1. Stability Testing of New Drug Substances And Products
Q1A(R2). ICH Harmonised Tripartite Guideline. Step 4
version. 6 February 2003 18
2. https://www.researchgate.net › fulltextLean Stability Case
Studies—Leveraging Science
3. https://www.ich.org
4. https://www.researchgate.net/publication/333236574_STABI
LITY_STUDIES_OF_PHARMACEUTICAL_PRODUCTS
31