SEMINAR ON QUALITY BY DESIGN (QbD)

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SEMINAR ON QUALITY BY DESIGN (QbD):

SEMINAR ON QUALITY BY DESIGN (QbD) Presented by-: Presented to-: Lakshay Sharma Mrs. Bharti M.Pharm (QA) Assitant Professor 1418722

CONTENTS:

CONTENTS INTRODUCTION CMA CQA CPP DESIGN SPACE DESIGN OF EXPERIMENTS RISK ASSESSMENT AND MITIGATION/MINIMIZATION

INTRODUCTION:

INTRODUCTION Quality by design (QbD) is a systematic approach to product development that begins with predefined objectives and emphasizes product and process understanding and controls based on sound science and quality risk management (ICH Q8). The regulatory agencies encourage risk-based approaches and the adoption of QbD principles in drug product development and manufacturing.

PRINCIPLES:

PRINCIPLES Designing product and its manufacturing process to meet patient needs with respect to safety and efficacy. Designing manufacturing process to consistently produce product meeting pre-defined quality criteria. Understanding impact of input parameters on product quality to adequately build the controls at the critical points in the process.

OBJECTIVES:

OBJECTIVES The main objectives of QbD is to ensure the quality products, for that product & process characteristics important to desired performance must be resulting from a combination of prior knowledge & new estimation during development. From this knowledge & data process measurement & desired attributes may be constructed. Experimental study would be viewed as positive performance testing of the model ability through Design space. Ensures combination of product & process knowledge gained during development.

Elements involved in QbD based product development:

Elements involved in QbD based product development

CRITICAL QUALITY ATTRIBUTES:

CRITICAL QUALITY ATTRIBUTES A CQA has been defined as “a physical, chemical, biological or microbiological property or characteristics that should be within an appropriate limit, range, or distribution to ensure the desired product quality.” Identification of CQAs is done through risk assessment as per the ICHQ9. Critical Quality Attributes are generally associated with the drug substance, excipients, intermediates and drug product. Critical Quality attributes includes the properties that impart the desired quality, safety, and efficacy.

CONT.:

CONT. CQAs for biotechnological products are typically those aspects affecting product purity, stability. Drug product CQAs can be identified from the Target product profile. Use of strong risk estimation methods for identification of CQAs is new to the QbD standard.

RISK ASSESSMENT:

RISK ASSESSMENT Risk assessment is the linkages between material attributes & process parameters. It is performed during the lifecycle of the product to identify the critical material attributes & critical process parameters. It is impractical for the formulation scientist to investigate all the identified material attributes and process parameters during the formulation optimization studies. Various cause associated with single effect like man, machine, material, method, system, and environment need to be considered to identify root cause.

CONT.:

CONT. It can be better understand with the help, of Fish-Bone Diagram.

CONT.:

CONT . The risk assessment is performed through linking raw material attributes and process parameters to CQAs to arrive at the severity of risk using tools like Basic risk management methods (flowcharts, check sheets, etc.), Failure Mode Effects Analysis (FMEA), Risk ranking and filtering etc. Considering 3 different levels (high, medium, and low), decision on action/investigation required to mitigate that risk will be considered.

FIGURE-Categorizing Risk levels depending upon Likelihood and impact.:

FIGURE-Categorizing Risk levels depending upon Likelihood and impact.

CRITICAL MATERIAL ATTRIBUTES:

CRITICAL MATERIAL ATTRIBUTES A CMA of a drug substance, excipient, and in-process materials is a physical, chemical, biological, or microbiological characteristic of an input material that should be consistently within an appropriate limit to ensure the desired quality of that drug substance, excipient, or in-process material. The CMA is likely to have an impact on CQA of the drug product.

Risk Assessment of the drug substance attributes:

Drug Product CQAs Drug Substance Attributes Solid State Form Hygroscopicity Particle Size Residual Solvents Process Impurities Chemical Stability Physical Attributes (size and splitability) LOW LOW LOW LOW LOW LOW Assay LOW LOW LOW LOW LOW LOW Content Uniformity LOW LOW LOW LOW LOW LOW Drug Release HIGH LOW HIGH LOW LOW LOW Risk Assessment of the drug substance attributes *Solid state form and particle size of DS are CMAs

CRITICAL PROCESS PARAMETER:

CRITICAL PROCESS PARAMETER Critical process parameters (CPPs) are defined as “parameters whose variability have an impact on a CQA and therefore should be monitored or controlled to ensure the process produces the desired quality”. Process robustness is defined as the ability of a process to demonstrate acceptable quality and performance and tolerate variability in inputs at the same time. Process capability is a statistical measure of the inherent process variability for a given characteristics.

Cont.:

Cont. Process capability index is the value of the tolerance specified for a particular characteristic divided by the process capability, which is defined as follows:

DESIGN SPACE:

DESIGN SPACE The ICH Q8(R2) States that the design space is multidimensional combination and interaction of input variables (e.g., material attributes) and process parameters that have been demonstrated to provide assurance of quality.

Cont.:

Cont. Working within the design space is not considered as a change. Movement out of the design space is considered to be a change and would normally initiate a regulatory post approval change process. Design space is potentially scale and equipment dependent, the design space determined on the laboratory scale may not be relevant to the process at the commercial scale. Therefore, design-space verification at the commercial scale becomes essential unless it is confirmed that the design space is scale-independent.

DESIGN OF EXPERIMENTS:

DESIGN OF EXPERIMENTS Design of experiments (DOE) is a structured and organized method to determine the relationship among factors that influence outputs of a process. Application of DOE in QbD helps in gaining maximum information from a minimum number of experiments. When DOE is applied to a pharmaceutical process, factors are the raw material attributes (e.g., particle size) and process parameters (e.g., speed and time), while outputs are the critical quality attributes such as blend uniformity, tablet hardness, thickness, and friability

REFERNECE:

REFERNECE Jadhav Jyotsna Balasaheb, Girawale Nitin Namdeo , and Ashok Rakesh; Quality by Design (QBD) Approach used in Development of Pharmaceuticals; INTERNATIONAL JJOURNAL OF PURE & APPLIIED BIOSCIENCE; 2014. QUALITY BY DESIGN IN PHARMACEUTICAL DEVELOPMENT; Piramal Pharma Solutions. Dr. Nitin Dharmadhikari ; Quality by Design (QbD) in Product Development; Sun Pharma Advanced Research Company Ltd., Mumbai

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