When pharmaceutical companies evaluate the quality consistency of their generic drugs, they should focus not only on the test consistency, but also on how to ensure this consistency. QbD (quality-by-design) emphasizes the employment of risk management tools to identify and control of critical product attributes and processes parameters to maintain product quality within an acceptable range. The concept of QbD is not only widely used in the R&D and management of pharmaceutical drug, but more and more companies are also applying it to the consistency evaluation of products. Based on a thorough study of the quality attributes of products, researchers employ a variety of risk management tools and identification strategies to control the product quality within the acceptable range of regulation, to ensure that the quality of generic drugs are consistent with the the Reference Listed Drugs (RLDs) in both R&D and subsequent production. At Alfa Chemistry, our QbD's team offers industrial knowledge & tailored solutions in providing the comprehensive research of critical materials and process to ensure the consistency of intra-batch and inter-batch products. Moreover, our experts have extensive experience in applying QbD to the consistency evaluation and the writing of application materials.
Figure 1. Application of QbD in pharmaceuticals. (Lalit, S.; Vijay, S. 2015)
Application of QbD Strategy
- Enhance the consistency in drug quality
- Ensure the efficacy of generic drugs
- Reduce the frequency of supervision
- Provide deep process understanding which can facilitate process improvement over time, increase yield and reduce costs
What We Offer?
In the writing and declaration of consistency evaluation materials for generic drugs, critical quality attributes (CQAs) and critical material attributes (CMAs) need to be included in the regulatory documents of generic drug products. Our experts help you clarify the CQAs and CMAs of the RLDs, and control these two key elements to ensure the consistency between your generic drug and the reference preparations.
Our QbD-based consistency evaluation process to improve the chances of your proposed product's acceptance
- Determine critical elements in the drug development and manufacturing
- Perform risk assessment
- Determine and create optimal design space
- Deliver quality control strategy
As an indispensable parameter in the consistency evaluation, CQAs are commonly used to evaluate the quality of products because they determine product effectiveness or safety. If the quality attributes of generic drugs deviate too much from those of the RLDs, it will affect the efficacy of the drug and even threaten patient safety. Alfa Chemistry supports a series of multivariate tools to identify potential CQAs based on a comprehensive research on the clinical characteristics, product labeling, and in vitro drug release and physicochemical properties of the RLDs.
Figure 2. Determining a list of CQAs to ensure product quality, safety, purity, and efficacy. (Michael, F. 2015)
In order to ensure that the quality of raw and excipients for generic drugs is consistent with that of the RLDs, pharmaceutical manufacturers should control CMAs within a certain range as much as possible. Therefore, identifying the CMAs of the product can effectively avoid the variation that occurs during the production process. By identifying the CMAs of raw materials (such as purity, solubility, crystal form, etc.), our experts help you correctly select raw materials that comply with the RLDs during the production of generic drugs, so as to ensure the stability of formulations and products.
Our Support Services
- Product development
- Regulatory approval
- Market launch
- Life cycle management
References
- Lalit, S.; Vijay, S. Quality by Design (QbD) Approach in Pharmaceuticals: Status, Challenges and Next Steps. Drug Delivery Letters. 2015. 5(1): 2-8.
- Michael, F. Quality by Design (QbD) Approach to Generic Transdermal or Topical Product Development. American pharmaceutical review. 2015.
