Design Of Experiments In Pharmaceutical Development Ppt – 2 Design quality This is a systematic approach to the design and development of products and processes. Product quality and performance can be guaranteed by efficient mfg process design. QBD is a comprehensive understanding of the process of obtaining quality products for patient safety. Quality must be built into products and services through proper planning to avoid future failures. Final product analysis alone will not do that, but quality must be designed into the product. Quality issues occur because quality was not planned from the beginning.
3 FDA Perspective The FDA requests the CMC to demonstrate QBD implementation as part of the NDA. QBD involves a broad understanding of the process, goals or objectives are set before the process actually begins. ICH provides strict requirements for product quality in Q8 (R2) drug development, Q9 quality risk management, Q10 drug quality system. The FDA’s approach to QBD is a systematic approach to product design and development and processing.
Design Of Experiments In Pharmaceutical Development Ppt
The advantages of QBD focus on patient safety and product effectiveness. Key quality characteristics are identified and their impact on the quality of the final product is analyzed. Risk assessment is carried out on a scientific basis, a scientific understanding of the processes and methods of medicine is applied, it includes the design and development of products, proposing methods or processes.
Flow Chemistry: Recent Developments In The Synthesis Of Pharmaceutical Products
Elements of QBD 1. Objective definition, i.e. Quality Product Profiles (QTPP) 2. Identification of key quality attributes (CQAs) 4. Development of experimental design. 5. Design and implementation of management strategies. 3. Implement risk assessment. 6. Manage product life cycle, including continuous improvement.
What is QTPP? Set of elements defining a pharmaceutical product A predetermined goal or objective Guidelines for drug product development What is the basis of a QTPP? RLD and its label Applicable regulatory guidelines When determining the QTPP? At the beginning of development, the knowledge gained in development can change some elements.
8 Components of QTPP components related to safety, efficacy, identity, purity and potential, important and non-critical components, e.g. Important: Equality analysis of unusual content: Constant element shape and constant element variables must be present, e.g. Variable element force dosage forms can have an acceptable range of values, e.g. Tablet weight, analysis. Specific requirements for QTPP grade tablets Weight change between two halves Half-dissolved tablets Oral dispersion Hardness Breakdown time Closure of QTPP composites for IR tablets Dosage form Pharmacological weight control Appearance, personality analysis, stool, uniform content.
CQA is a physical, chemical, biological or microbiological characteristic or condition that must be within limits to ensure the desired product quality. CQAs are subset of QTPPs that include key parameters that are likely to change based on raw materials and process changes – Identification testing for dosage forms – Non-CQA – Uniform analysis of content – CQAs are controlled Review the entire DP development. CQA ensures that DP remains at a safe and effective level. For example. Digestion is important for CR tablets, but not for IR tablets if the drug is BCS class I.
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QTPP and CQAs QTPP Components QTPP Dosage Form Strength Weight Pharmacokinetics Appearance Personality Analysis Impurities Uniformity of Dissolution Dissolution Residual Solvents CQAs Analysis (Efficacy) Survival (Safety) K.U. (Effectiveness) Dispersion (Effectiveness)
It is the combination of the probability of the occurrence of the damage and the severity of the damage that improves the quality of the method or process. For example. In the development of analytical methods, minor changes in methods such as reagents, laboratory analyzers, days, temperature, humidity were included in the risk assessment. If the primary method fails, a backup method is used where the risk is assessed. Why risk assessment in product development? To determine the relative risk level at the beginning of product development, to prioritize limited development resources, to assess the need for further research for scaling and technology transfer, to determine the appropriate technical specifications, key process parameters, and production management to cut Minimize variations of key quality attributes.
Formula – Basic properties, level of components, production process, steps for risk assessment, list of all components / processes, create flow chart, process, determine all possible failures for each item with risk inquiry (what Wrong?) Risk analysis, formal risk assessment, available methods for risk assessment, impact of failure mode, analysis and failure mode, impact and criticism, risk analysis and feasibility, statistical analysis tools
QBD Risk Assessment for ANDAs: Examples of Immediate Dosage Forms Common Product Development for Acetriptan Tablets, 20 mg. Acetriptan is a BCS Class II compound and exhibits poor water solubility (less than mg / ml) over physiological pH range. It has three different polymer forms that can affect digestion. Polymorph III is the most stable polymer. Pharmaceutical products are prepared by roller compression process.
Quality By Design (qbd) Based Process Optimisation To Develop Functionalised Particles With Modified Release Properties Using Novel Dry Particle Coating Technique
Risk Assessment for Ingredient Production Process Risk Assessment DP Product Formula CQA Variable Drugs PSD MCC / Lactose Ratio CCS Talc Level Analysis Magnesium Stearate Level MEDIUM LOW High Dispersion Uniformity Drug Degradation Products CQAs * Steps B.P.R.A. Lubricate the mill medium low.
It is useful to investigate variables that have a significant impact on DP CQAs. The traditional method uses OFAT (one factor at a time), a limited number of informational experiments. “DOE” helps to study the interaction of different factors at the same time. Used in optimization studies, it allows the creation of “design space”. “Design space” created at the pilot or pilot level may be submitted for commercial scale but must be tested at the production scale for scale-dependent parameters.
Branches of applied statistics related to planning, directing, analyzing, and interpreting controlled experiments to evaluate the factors that govern the values of a parameter or group of parameters. Strategically planned and executed experiments can provide a wealth of information about the influence of response variables of one or more factors. Many experiments involve keeping certain factors constant and changing the level of other variables. This one-time method (or OFAT) for knowledge processing is ineffective compared to simultaneous factor level variation. It is useful to investigate variables that have a significant impact on DP CQAs. A limited number of informational experiments are limited. DOE helps to study the interaction of different factors simultaneously.
“Design space” The combination and multidimensional interaction of input variables (e.g., material attributes) and specified process parameters to ensure quality. Working in a design space is not considered a change. Moving out of the design space is considered a change and usually begins the transition process after the configuration is approved. The design space is submitted by the applicant and is subject to evaluation and regulatory approval.
Structural Similarity, Characterization Of Poly Ethylene Glycol Linkage And Identification Of Product Related Variants In Biosimilar Pegfilgrastim
“Control Space” The control space is inside the design space. It is the upper and lower limits of the raw material or process in which the parameters and materials are regularly controlled to ensure the quality of the product. If the control size is smaller than the design size, it is considered stable.
Independent Variables: Independent variables are under the control of the creator. These can include compressive strength or filling of mold cavities or mixing time. Dependent variables: Dependent variables are responses or characteristics produced by independent variables. The more variables in the system, the more complexity is involved in the optimization.
The first and second parameters are factors of granulation operation that affect the solubility rate of the tablet (i.e., excipient properties, water volume, size of granules.) The relationship in Figure 1 allows the maximum range of operations to achieve the solubility rate. Wanted. In Figure 1, the design size is defined as a smaller range based on a linear combination of parameters. Parameter 1 has ranges 44 and 53 Parameters 2 have ranges 0 and 1.1. Figure 1: Spatial design for granulation parameters defined by a linear combination of their ranges that provide satisfactory dissolution (e.g.> 80%).
Management Strategy A management strategy is “a set of controls designed based on an existing understanding of a product and process that ensures the operation, process and quality of the product. Management strategy refers to the continuous production of a product that contains The required quality. It is important that the developed method works as intended and produces the right results. For control over this method is necessary. The identified risk factors should be controlled. Attention to high risk factors. System compliance can be monitored and confirmed from time to time by monitoring it. Management strategies include the following elements that contribute to the final quality of the product. Characteristics of inlet materials (eg, pharmaceuticals, additives, container closure), operating conditions of equipment (process parameters), inspections during processing, specifications of finished products, inspections for each unit operation, method and frequency of inspections. And inspection.
Ocular Drug Delivery: Present Innovations And Future Challenges
Throughout the product life cycle, the production process is monitored to ensure that it works as intended to deliver the desired product.
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