The document discusses analytical quality by design (AQbD) and its implementation. It compares traditional analytical methods to AQbD methods. AQbD uses a systematic approach including risk assessment, design of experiments, and establishing a method operable design region. A case study demonstrates developing an HPLC method for assay using an AQbD approach including target measurement, design of experiment, method validation, and establishing a method operable design region. The conclusion states AQbD requires defining the right analytical target profile and using appropriate tools to ensure the right analytics are performed at the right time.
Role of quality system and audits in pharmamaceuticalganpat420
Introduction
cGMP Regulations
Quality Assurance Function
Quality Systems Approach
Management Responsibilities
Resources
Manufacturing Operations
Evaluation Activities
Transitioning to Quality Systems Approach
Audit Checklist for Drug Industry
Role of quality system and audits in pharmamaceuticalganpat420
Introduction
cGMP Regulations
Quality Assurance Function
Quality Systems Approach
Management Responsibilities
Resources
Manufacturing Operations
Evaluation Activities
Transitioning to Quality Systems Approach
Audit Checklist for Drug Industry
FDA’s emphasis on quality by design began with the recognition that increased testing does not improve product quality (this has long been recognized in other industries).In order for quality to increase, it must be built into the product. To do this requires understanding how formulation and manufacturing process variables influence product quality.Quality by Design (QbD) is a systematic approach to pharmaceutical development that begins with predefined objectives and emphasizes product and process understanding and process control, based on sound science and quality risk management. A presentation compiled from material freely available on the WEB to introduce the concepts of QbD for beginners.
NEW ERA OF DRUG PRODUCT: OPPORTUNITIES AND CHALLENGESganpat420
Abstract
Introduction
Global pharmaceutical industry
Indian pharmaceutical industry
Indian Pharmaceutical Market
Opportunities
Challenges
Conclusion
References
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
QUALIFICATION OF MANUFACTURING EQUIPMENTSANKUSH JADHAV
it gives the information about qualification of various manufacturing equipment which is used into the pharmaceutical labs. (only for information purpose)
Speaker at seminar "The Pharmaceutical quality system: ICH Q8/ICH Q9" - University of Parma, 18 May 2012.
Describing steps, tools, and approaches developed for application of QbD to manufacturing processes that have analogous application to the development and use of analytical methods.
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.
Qualification of Friability Test Apparatus.pptxGNIPST
Brief description of qualification of laboratory testing apparatus : Friability Test Apparatus.
share it with your friends also if they faced problem about this topic.
Thank you
FDA’s emphasis on quality by design began with the recognition that increased testing does not improve product quality (this has long been recognized in other industries).In order for quality to increase, it must be built into the product. To do this requires understanding how formulation and manufacturing process variables influence product quality.Quality by Design (QbD) is a systematic approach to pharmaceutical development that begins with predefined objectives and emphasizes product and process understanding and process control, based on sound science and quality risk management. A presentation compiled from material freely available on the WEB to introduce the concepts of QbD for beginners.
NEW ERA OF DRUG PRODUCT: OPPORTUNITIES AND CHALLENGESganpat420
Abstract
Introduction
Global pharmaceutical industry
Indian pharmaceutical industry
Indian Pharmaceutical Market
Opportunities
Challenges
Conclusion
References
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
QUALIFICATION OF MANUFACTURING EQUIPMENTSANKUSH JADHAV
it gives the information about qualification of various manufacturing equipment which is used into the pharmaceutical labs. (only for information purpose)
Speaker at seminar "The Pharmaceutical quality system: ICH Q8/ICH Q9" - University of Parma, 18 May 2012.
Describing steps, tools, and approaches developed for application of QbD to manufacturing processes that have analogous application to the development and use of analytical methods.
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.
Qualification of Friability Test Apparatus.pptxGNIPST
Brief description of qualification of laboratory testing apparatus : Friability Test Apparatus.
share it with your friends also if they faced problem about this topic.
Thank you
Quality by design for Pharmaceutical Industries: An introductionCovello Luca
In this presentation, I have attempted to provide a quick introduction into the main concepts behind Pharmaceutical Quality by Design, an approach that aims to ensure the quality of medicines by employing statistical, analytical and risk-management methodology in the design, development and manufacturing of drugs.
The pharmaceutical Quality by Design (QbD) is a systematic approach to development that begins with predefined objectives and emphasizes product and process understanding and process control, based sound science and quality risk management.
Generic product development and technology transfer : At a glanceDr. Girish S Sonar
It’s honor to get invited as a speaker and to address “Pharma Formulation and Regulatory Symposium” organized by Merck Malaysia on 6th Sept, 2018 at Pullman Bangsar, Kuala Lumpur, Malaysia. The topic I presented was “Generic Product Development and Technology Transfer: At a Glance”. Scientists and industry experts from 31 Malaysia Pharma companies and Universities attended this symposium. The presentation covered challenges and remedies come across from product development to approval from regulatory agencies.
Pleasured to share desk with Dr. Torsten Schadendorf, Marketing Manager Merck Germany, Dr. Gudrun Birk, Head of Controlled Release, Merck Germany and Professor Tin Wui Wong, Universiti Teknologi MARA, Malaysia.
It is a graded seminar presentation of Mohammad Abuzar Shaikh Umer on the topic of quality by design (QbD) with case study on naproxen enteric coated pallets model for QbD study.by using plackette burman boxe behnken design and statistical analysis by using ANOVA.
5-Scientific Approach to Validation.pptxAllanThomas30
Validation is a Science and even the most mundane tasks in healthcare environments, like hand washing, must be validated (to ensure correct method and other factors like correct hand wash agent) and also verified - to create an acceptable baseline for post handwash counts.
The Art Pastor's Guide to Sabbath | Steve ThomasonSteve Thomason
What is the purpose of the Sabbath Law in the Torah. It is interesting to compare how the context of the law shifts from Exodus to Deuteronomy. Who gets to rest, and why?
How to Split Bills in the Odoo 17 POS ModuleCeline George
Bills have a main role in point of sale procedure. It will help to track sales, handling payments and giving receipts to customers. Bill splitting also has an important role in POS. For example, If some friends come together for dinner and if they want to divide the bill then it is possible by POS bill splitting. This slide will show how to split bills in odoo 17 POS.
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.
We all have good and bad thoughts from time to time and situation to situation. We are bombarded daily with spiraling thoughts(both negative and positive) creating all-consuming feel , making us difficult to manage with associated suffering. Good thoughts are like our Mob Signal (Positive thought) amidst noise(negative thought) in the atmosphere. Negative thoughts like noise outweigh positive thoughts. These thoughts often create unwanted confusion, trouble, stress and frustration in our mind as well as chaos in our physical world. Negative thoughts are also known as “distorted thinking”.
The Indian economy is classified into different sectors to simplify the analysis and understanding of economic activities. For Class 10, it's essential to grasp the sectors of the Indian economy, understand their characteristics, and recognize their importance. This guide will provide detailed notes on the Sectors of the Indian Economy Class 10, using specific long-tail keywords to enhance comprehension.
For more information, visit-www.vavaclasses.com
Ethnobotany and Ethnopharmacology:
Ethnobotany in herbal drug evaluation,
Impact of Ethnobotany in traditional medicine,
New development in herbals,
Bio-prospecting tools for drug discovery,
Role of Ethnopharmacology in drug evaluation,
Reverse Pharmacology.
How to Create Map Views in the Odoo 17 ERPCeline George
The map views are useful for providing a geographical representation of data. They allow users to visualize and analyze the data in a more intuitive manner.
5. Role of analytical methods in drug developmentRole of analytical methods in drug development
processprocess
5Dept. of Quality Assurance, DLHHCOP
AQbD- Drug Development Process
8. Steps Synthetic development (QbD) Analytical development (AQbD)
1 QTPP identification ATP (Analytical Target
Profile) identification
2 CQA/CMA identification,
Risk Assessment
CQA identification, Initial
Risk Assessment
3 Define product design space
with DoE
Method Optimization and
development with DOE
4 Refine product design space MODR (Method Operable
Design Region)
5 Control Strategy with Risk
Assessment
Control Strategy with Risk
Assessment
6 Process validation AQbD Method Validation
7 Continuous process Monitoring Continuous process Monitoring
QbD tools for synthetic development and analytical development.
8Dept. of Quality Assurance, DLHHCOP
Traditional versus AQbD
10. Analytical Target Profile (ATP)
Analytical Method Performance Characteristics
S. No. Method performance
characteristics
Defined by ICH and
USP
1 Accuracy, specificity, and
linearity
Systematic variability
2 Precision, detection limit, and
quantification limit
Inherent random variability
3 Range and robustness Not applicable
10Dept. of Quality Assurance, DLHHCOP
AQbD Practical Aspects
11. Selection of Analytical Techniques
Risk Assessment
Design of Experiments (DoE)
› Screening
› Optimization
› Selection of DOE Tools
› Method Operable Design Region (MODR) and Surface Plots
› Model Validation
Risk factor = Severity × Occurrence × Detestability
11Dept. of Quality Assurance, DLHHCOP
AQbD Practical Aspects
12. Design of Experiments (DoE)
› Screening, Optimization and Selection of DoE tools
Design Number of variables
and usage
Advantage Disadvantage
Full factorial
design
Optimization/2–5 variables Identifying the main and
interaction effect without
any confounding
Experimental runs
increase with increase in
number of variables
Fractional factorial
design or Taguchi
methods
Optimization/and screening
variables
Requiring lower number
of experimental runs
Resolving confounding
effects of interactions is a
difficult job
Plackett-Burman
method
Screening/or identifying vital
few factors from large number
of variables
Requiring very few runs
for large number of
variables
It does not reveal
interaction effect
Pseudo-Monte Carlo
sampling
(pseudorandom
sampling) method
Quantitative risk
analysis/optimization
Behaviour and changes to
the model can be
investigated with great
ease and speed. This is
preferred where exact
calculation is possible
For nonconvex design
spaces, this method of
sampling can be more
difficult to employ.
Random numbers that
can be produced from a
random number
generating algorithm
Full factorial
design
Optimization/ 2–5 variables Identifying the main and
interaction effect without
any confounding
Experimental runs
increase with increase in
number of variables
12Dept. of Quality Assurance, DLHHCOP
AQbD Practical Aspects
13. › Method Operable Design Region (MODR) and Surface Plot
› Model Validation
Contour plot for MODR
Systematic simulation graph for
retention time (X2-axis) as method
response at constant X3 (0.8
mL/min as flow rate) with change
in pH (X1--axis).
(Graph shows significant
correlation between the
predicted retention time and
actual (experimental)
retention time with good
correlation coefficient.
13Dept. of Quality Assurance, DLHHCOP
Method Operable Design Region (MODR) and Surface Plot Model Validation
AQbD Practical Aspects
14. Method Verification/Validation
Control Strategy- Continuous Method Monitoring
14Dept. of Quality Assurance, DLHHCOP
AQbD Practical Aspects
S.
No.
Pharmaceutic
al testing
Control strategy
1 Raw material
testing
Specification based on product QTPP and CQA
Effects of variability, including supplier variations,
on process and method development are
understood
2 In-process
testing
Real time (at-, on-, or in-line) measurements
Active control of process to minimize product
variation Criteria based on multivariate process
understanding
3 Release
testing
Quality attributes predictable from process inputs
(design space)Specification is only part of the
quality control strategy
Specification based on patient needs (quality,
safety, efficacy, and performance)
4 Stability
testing
Predictive models at release minimize stability
failures
Specification set on desired product performance
with time
16. Analytical Quality by Design Approach in RP-HPLC Method
Development for the Assay of Etofenamate in Dosage
Forms
Step 1: Target measurement
16Dept. of Quality Assurance, DLHHCOP
AQbD- Case Study
17. Step 2: DoE:Design of Experiment
(Method Optimization and Development)
17Dept. of Quality Assurance, DLHHCOP
Experimental Design
AQbD- Case Study
18. Step 3: Method Operable Design Region
pH of aqueous phase versus % of aqueous phase contour at
1.2ml/min flow rate of mobile phase
18Dept. of Quality Assurance, DLHHCOP
AQbD- Case Study
19. Quadratic model was obtained on application of
SigmaTech software with the polynomial equation:
Y=5.8778-0.0025X1+2.9925X2–0.8088X3–0.4925X1X2
0.075X1X3-0.125X2X3+0.1178X12 +1.1803X22+0.2768X32
19Dept. of Quality Assurance, DLHHCOP
Step 4: DoE: Model validation using regression analysis
Developed
Chromatogram
AQbD- Case Study
20. 20Dept. of Quality Assurance, DLHHCOP
Step 5: : Method validation
AQbD- Case Study
21. In a nutshell……
Parameter Traditional Product QbD AQbD
Approach Based on empirical
approach
Based on systematic approach Based on systematic
approach
Quality Quality is assured by end
product testing
Quality is built in the product
and process by design and
scientific approach
Robustness and
reproducibility of the
method built in method
development stage
FDA submission Including only data for
submission
Submission with product
knowledge and process
understanding
Submission with product
knowledge and assuring
by analytical target
profile
Specifications Specifications are based
on batch history
Specifications are based on
product performance
requirements
Based on method
performance to ATP
criteria
Process Process is frozen and
discourages changes
Flexible process with design
space allows continuous
improvement
Method flexibility with
MODR and allowing
continuous improvement
Targeted response Focusing on
reproducibility, ignoring
variation
Focusing on robustness which
understands control variation
Focus on robust and cost
effective method
Advantage Limited and simple It is expended process
analytical technology (PAT)
tool that replaces the need for
end product testing
Replacing the need of
revalidation and
minimizing OOT and OOS
21Dept. of Quality Assurance, DLHHCOP
AQbD- Summary
22. Dept. of Quality Assurance, DLHHCOP 22
%ofresearch
AQbD- Summary
23. AQbD requires the right ATP and Risk
Assessment and usage of right tools and
performing the appropriate quantity of
work within proper timelines.
‘RIGHT ANALYTICS AT THE RIGHT TIME’
23Dept. of Quality Assurance, DLHHCOP
AQbD- Conclusion
24. Raman, N. V. V. S. S.; Mallu, U. R.; Bapatu, H. R. J. Chem.2014, 2015 (1), 8.
Torbeck L. D.J. Pharm.Tech.35 (10), 2011,46–47
ICH Harmon. Tripart. Guidel. 2009, 8 (August), 1–28.
Jackson, P. 2013, Technical note,
http://www.gmpcompliance.org/daten/training/ECA_QbD_in_Analysis_2013 (accessed
Oct 23, 2016).
Warf S. F. 2013, Conference note; http:// www.ISPE.org/2013QbDConference (accessed
Oct 23, 2016).
Jadhav, M. L.; Tambe, S. R. Chromatogr. Res. Int. 2013, 2013 (2), 1–9.
Borman, P.; Roberts, J.; Jones, C.; Hanna-Brown, M.; Szucs, R.; Bale, nd S. 2010, 2 (7), 2–4.
Hanna-brown, M.; Borman, P.; Bale, S.; Szucs, R. Sep. Sci. 2010, 2, 12–20.
Nethercote P.; Borman P.; Bennett T.; Martin G.; McGregor P. 2010, 1–9.
Vogt, F. G.; Kord, A. S. Pharm. Sci. 2011, 100 (3), 797–812.
Bhatt, D. A.; Rane, S. I. Int. J. Pharm. Pharm. Sci. 2011, 3 (1), 179–187.
Swartz, M.; Lukulay, P. H.; Krull, I.; Joseph, T. LCGC North Am. 2008, 26 (12), 1190–1197.
Meyer, C.; Soldo,T.; Kettenring, U. Chim. Int. J. Chem. 2010, 64 (11), 825–825.
McBrien, M. A.; Ling, S.. The Column 2011, 7 (5), 16–20.
Molnár, I.; Rieger, H. J.; Monks, K. E. J. Chromatogr. A 2010, 1217 (19), 3193–3200.
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Dept. of Quality Assurance, DLHHCOP 24
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Dept. of Quality Assurance, DLHHCOP 25
References