QCE is accomplished by determining whether the prescription of the proposed product is consistent with that of the Reference Listed Drugs (RLDs) after determining the quality standard. Therefore, QCE puts forward higher requirements on the research and development, technical knowledge of generic companies. Focusing on drug quality research and management for many years, Alfa Chemistry provides you with reliable QCE services in accordance with FDA guidelines.
Purpose of QCE
- Improve the overall quality of drug product
- Realize the substitution of generic drugs for the RLDs in clinical practice
- Verification of the compliance of the production process
Our Services
To ensure that your products are well controlled, we select the quality attributes and methods to be analyzed based on the published quality standards and pharmacopoeia's requirements for specific dosage forms.
What we offer:
- Establishment of analytical methods for key raw materials and product
- Determination of detection methods for related substances
For some generic drugs that are different from the RLDs in terms of production process, preparation ingredients, analysis methods, etc., pharmaceutical companies are required to verify the quality standards. At Alfa Chemistry, once the quality standard is determined, we provide method validation services to help you determine whether the established method is suitable for product analysis. Our comprehensive services include: analytical method feasibility study, complete method validation test, etc.
We offer a wide range of verification programs:
- Related substance identification, microbial detection, dissolution rate; content determination, etc
- Validation characteristics: specificity, limits of detection (LOD) and limits of quantitation (LOQ), linear range, precision, accuracy
Research and control of impurities is an effective means to control the risks of drug products, and it is also an important part of drug quality consistency research. The FDA requires comparative studies of the impurity profiles of proposed products and the RLDs to ensure that the impurity levels of the products are consistent with those of the RLDs. In conjunction with the published guidelines for impurity analysis, our experts employ a variety of chromatography and spectroscopy technologies including HPLC, UPLC, mass spectrometry and IR for the identification and quantification of differences in impurity profiles between your generic products and the RLDs.
Permeability refers to the rate at which drug molecules pass through these biofilm barriers, is a critical factor affecting the bioavailability of orally administered drugs. Alfa Chemistry can accurately and efficiently evaluate the permeability of generic drugs, and further analyze the rate and extent of drug uptake into the body, as well as the bioavailability of the drug.
We offer a variety of models to predict the permeability of generic drugs in vitro and in vivo:
- In Vivo Intestinal Perfusion Modeling in Animals
- Isolated Intestinal Capsule Model
- Cell Model
- Parallel Artificial Membrane (PAMPA) Permeation Model
Figure 1. Strategy for consistency evaluation of dosage forms. (Wei, X. C; et al. 2020)
Why Choose Alfa Chemistry?
- Help you fully understand the critical attributes of products
- With our years of experience in generic drug R&D, Alfa Chemistry has successfully completed a number of QCE projects
- Completion of analysis based on different requirements with the rapid delivery of accurate and compliant documents
- Multidisciplinary team of experts from various fields (Quality Unit, Business Development, Regulatory Affairs, Manufacturing Operations)
Reference
- Wei, X. C.; et al. Recent advances of novel technologies for quality consistency assessment of natural herbal medicines and preparations. Chinese Medicine. 2020. 15(1).
