Skip to main content

Quality by design

 QbD is systematic approach to development and begins with predefined objective and emphasises product, process understanding and process control, based on sound science and quality risk management. 

QbD enhance the assurance of product safety and effective drug supply to customer 

QbD also offer promise to significantly improves manufacturing quality performance 

QbD having below steps-

1. Define Target product profile (use, safety and efficacy of the product)

2. Define Target quality product profile - used by the formulator and process engineer as quantitative surrogate for the aspects of clinical safety during development.

Gather relevant prior knowledge about drug substance, critical raw materials and process operation in to knowledge space. Use risk assessment to prioritise for knowledge gaps for further investigation.

3. Design formulation and identify Critical quality attributes/ Critical material attributes of final product, which required to be controlled to meet Target product quality profile.

4. Develop a manufacturing process by which formulation can be produced with expected Critical material attributes.

Identify Critical process parameters and input (raw) material attributes that must be controlled to achieve these Critical material attributes of final product. Use risk assessment to prioritise process parameters and material attributes for experimental verification.

5. Establish a control strategy for entire process that may include input material controls, process controls and monitors, design space around individual and multiple unit operations and/ or final product tests.

Continually monitor and update the process to assure consistent quality.

QTPP (Quality Target product profile)- describes the design criteria for the product, and should therefore form the basis for development of the CQAs, CPPs and control strategy.







Labels:

Comments

Post a Comment

Popular posts from this blog

Change Management System

US Market (Supplement): Post approval drug manufacturing supplement for NDAs/ ANDA submitted to FDA for Major or Moderate manufacturing change. Major change - If a manufacturing change is considered to be major, an applicant must submit and receive FDA approval of a prior-approval supplement (PAS) before the drug product made with the change is distributed. Moderate change- If a manufacturing change is considered to be moderate, an applicant must submit a supplement at least 30 days before the drug product is distributed (a CBE-30 supplement) or, in some cases, submit a supplement at the time of distribution (a CBE-0 supplement).  “CBE” means “changes-being-effected”. Post manufacturing supplement - 1. CBE 0 (Change being effected before 00 days): 2. CBE 30 (Change being effected before 30 days): 3. PAS (Prior approval supplement): EUROPE Market (Variation): A variation to the terms of a marketing authorization is an amendment to the contents of the docume...
Post a Comment
Read more

NVPC

NVPC Online NVPC: Make= Beckman; Model= Met one 6015P; Capacity= 1CFM SOFTWARE= EnVigil Critical alarm: Critical alarms are those alarms when generated indicate excursion which may impact the product quality. Alarm generated in location where the NVPC probe is in close proximity to the product/ sterile container closure/ product contact path. Location for critical alarms includes grade A location - Filling station, Bunging station, Bunging Hopper station, Portable cart, IOS station, AGV station, Near lyophilizer door open, between lyophilizers (near Lyo) and Lyo LAF (rigid barrier transfer conveyor). Critical alarms include the following- 1.     Particle count excursion beyond the acceptance criteria at a particular location. 2.     Sensor Failure, Counter Flow Failure, ERROR or SKIPPED message. Ensure and verify the status of counter flow to meet the below set limit- Target Counter flow – 1.0 CFM. Minimum counter flow: ...
Post a Comment
Read more

Air velocity measurement and correlation to smoke study

Air velocity measurement As part of risk assessment this evaluation should also consider the selection of locations for the critical control points for monitoring air velocity as well as viable and non-viable particles. 1. Problem Statement- Where should airflow velocity measurements be taken with respect to a filling line or other aseptic processing areas? Recommendation Airflow velocity measurements should be taken at locations where meaningful and reproducible results can be obtained. This is typically at a distance of 6 inches from the filter face . Rationale for Recommendation The primary reason for airflow velocity measurements in unidirectional airflow areas (e.g., areas where product, product contact packaging components, and product contact surfaces are exposed) is to assure there is adequate airflow to protect the materials from external airborne contamination . Accurate measurements can be taken and changes over time detected when airflow velocities are e...
Post a Comment
Read more