Development of Quality Standards

Quality standards are quality attributes and testing methods used to make sure that the generic drug products are well controlled. In general, most of the generic drug have public quality standards as reliable reference for the re-development and consistency assessment. The establishment of quality standards plays an important role in the pharmaceutical equivalence evaluation, and Alfa Chemistry provides reliable service of developing quality standards by selecting suitable research subjects and determining the testing methods. With our experts' knowledge of public standards of many Reference Listed Drugs (RLDs), Alfa Chemistry are able to establish quality standards for your proposed products.

Figure 1. FDA's new pharmaceutical quality initiative. (Lawrence X, Y.; et al. 2019)

Our Services

Analytical method development & optimization

We develop analytical methods for critical materials, intermediates, finished products, related substances, isomers, residual solvents, etc.

Research and establishment of quality standards

• Our expert teams conduct research on multiple batches of critical materials, intermediates, finished products, and transfer and removal of impurities
• Determine the limits of each quality index in the quality standards

Analysis of related dosage forms and reference preparations

Quality analysis and comparison of API and the Reference Listed Drugs (RLDs)

Comparative study with Pharmacopoeia

Workflow of the Establishment of Quality Standards

Establish quality standards with reference to the existing standards

Most of the generic drugs have public standards for reference, so we establish quality standards of your generic products with reference to these existing standards. We determine and provide the quality standard of your product according to the pharmacopoeia's requirements for specific dosage forms. For the addition of antioxidants, bacteriostats, stabilizers, and enhancers (co)solvents in the prescriptions of intravenous injections, and the addition of preservatives in the prescriptions of ophthalmic preparations, we conduct quantitative research on the corresponding excipients.

Establish quality standards that differ from the existing standards

When there is no standard for reference or the self-established method is more applicable, our experts combine the characteristics of your product to establish a quality standard that is different from the existing standard for quality control. The purpose is to be able to detect the specific impurities of the product, or to better reflect the dissolution characteristics of the product.

• We provide verification of self-established methods and comparative studies with pharmacopoeia methods to fully support the rationality and reliability of the methods
• According to the characteristics of different products, we carry out specific characteristic testing items when developing the quality standards

Determination of detection methods

If there are multiple detection methods for the analysis of related substances, we use comparative studies to establish the detection methods. If there is an impurity reference substance, the impurity reference substance is used to confirm the feasibility of the method; if there is no impurity reference substance, our experts conduct a series of forced degradation tests (the degradation degree is generally controlled at about 5%~10%) to initially determine the feasibility of our detection method.

Evaluation criteria

• System applicability, resolution, effective detection, precision and reproducibility when there is an impurity reference substance
• System applicability, effective detection of degraded impurities, and material balance when there is no impurity reference substance

Alfa Chemistry's Advantages

• An interdisciplinary team is well-trained to comprehensively evaluate the quality consistency of product
• Enable to complete the derivation of testing method and qualification limit through product attributes
• Support the application of multivariate techniques such as multidimensional scaling and cluster analysis