quality by design

WELCOME TO MY PRESENTATION

Quality by Design (QbD) For Formulation And Development

Presented by:-SUHASINI . VM.Pharm 1st year(Pharmaceutics)

Ref.: ICH Q8 (R2)

SIGNIFICANCE OF QbD : Quality by Design means –designing and

developing formulations and manufacturing processes to ensure a predefined quality

Quality by Design requires – understanding how formulation and manufacturing process variables influence product quality .

Quality by Design ensures – Product quality with effective control strategy

BENEFITS OF QBD: QbD is good Business Eliminate batch failures Minimize deviations and costly investigations Avoid regulatory compliance problems Organizational learning is an investment in the

future QbD is good Science Better development decisions Empowerment of technical staff

IMPORTABT OF OBD FOR FORMULATION AND DEVELOPMENT Quality target product profile (QTPP) Critical quality attribute (CQAs)Initial risk assessment for drug substance

attributes Initial risk assessment for drug formulation

attributes 1. Selection of excipients2. Excipients compatibility studies 3. Development of Q& Q formula for initial

formulation development

Design development strategies DOE for optimization of formulationInitial risk assessment for manufacturing

process Pilot bioequivalence studies Well defined control strategyScale up from lab to pilot scale and then

commercial scale Container and closure system Development studies to be supported with

stability studies

Initial risk assessment for drug formulation attributes

“A planned set of controls, derived from current product and process understanding that ensures process performance and product quality…..”

ICH Q8 (R2) & Q10 Control Strategy includes following elements (but not limited to):

Input material attributes (e.g. drug substance, excipients, container closure)

Equipment operating conditions In-process controls Finished product specifications Controls for each unit operations Methods and frequency of monitoring and control.

Control Strategy

Pilot bioequivalence studies A pilot study in a small number of subjects can be carried out before proceeding with a full bioequivalence study.

The study can be used to validate analytical methodology, assess variability, optimize sample collection time intervals, and provide other information.

Example : Pilot bioequivalence studies can help determine the sampling schedule to assess lag time and dose dumping.

Scale up from lab to pilot scale and then commercial scale It is the part of the pharmaceutical

industry where a lab scale formula is transformed into a viable product by development of liable practical procedure of manufacturing.

Evaluating the results of laboratory studies and making product and process corrections and improvements

Container and closure system Suitable container closure system to

achieve the target shelf life and to ensure product integrity during shipping

primary packaging components & secondary packaging components, if the latter are intended to provide additional protection to the drug product.

Packaging aspects must be considered during the development of product. The packaging process parameters may affect the final product quality.

Development studies to be supported with stability studies "…… to provide evidence on how the quality

of a drug substance or drug product varies with time under the influence of a variety of environmental factors such as temperature, humidity & light, & enables recommended storage conditions, re-test periods & shelf lives to be established”

1. Long Term2. Intermediate3. Accelerated

Advantages of QbD Benefits for Industry:

Better understanding of the process. Less batch failure. More efficient and effective control Return on investment / cost savings. Allows for implementation of new technology to improve

manufacturing Improves interaction with FDA –deal on a science level instead of on a

process level Allows for continuous improvements in products and manufacturing

process.

1. Guidance for Industry: Q8(R2) Pharmaceutical Development

2. Guidance for Industry: Q9 Quality Risk Management

3. Guidance for Industry: Q10 Pharmaceutical Quality System

4. http : // www.drug regulation .org

THANK YOU