Analytical Development and Quality Control

With decades of experiences in the pharmaceutical industry, our experts have a depth perception for the importance...

Home / Formulation Services / Analytical Development and Quality Control

Analytical Development and Quality Control

Analytical quality control, commonly referred to as AQC, refers to all processes and procedures designed to ensure consistency, comparability, accuracy and accuracy of laboratory analysis results within a specified range of accuracy. The composition submitted to the analytical laboratory must be accurately described in order to avoid misinterpretation, approximation, qualitative and quantitative data generated by the laboratory can be used for decision-making. In the chemical sense, quantitative analysis refers to the measurement of the number or concentration of elements or compounds in a matrix different from elements or compounds. Analytical method development services and quality control testing support all stages of product and process development, from raw materials to commercial batch release, is the key to the success of the final product.

Application of analytical development and quality control

CMC is involved in all stages of the drug development life cycle after drug discovery. During preclinical drug development, correct analytical methods are validated to monitor the product. The stability test can be carried out, the physical and chemical properties of the product can be determined, the raw materials can be selected and tested. When the drug development process enters the clinical stage, further analytical methods need to be verified, and additional characterization of drug products is needed. At the end of the clinical trial, the amplification process must ensure that the larger batches of products are the same as the drugs tested in the clinical trial and comply with the same specifications. After the manufacturing process is up to standard, batch releases and WIP testing will continue.

Below is a list of our analytical development and quality control services (include but not limited to the following):

An essential component of any biopharmaceutical development plan is analysis. In order to be able to manufacture, release, and demonstrate stability, biopharmaceuticals require a range of appropriate analytical techniques that are reliable, repeatable, and capable of operating in a GMP environment. BOC Sciences CMC services, with our extensive experience in GMP release and stability testing, can meet all your analytical development needs, whether physical, chemical or biological. The significant support and trouble-shooting capabilities of the analytical sector including: Method Development and Validation, Analytical Testing and Release, Stability Study, Stability Study and Regulatory CMC Documentation.

Quality control is a set of methods to maintain standards in a production line or process. Quality control can be applied to methods, equipment, processes or products, usually involving on-site testing or products or procedures to ensure that standards are maintained. According to ICH guidelines, drug quality controlled release and stability testing are supported through analytical method development and cGMP drug stability testing. Drug quality control teams can help determine the shelf life and specifications of drugs and develop drug control strategies for IND/IMPD or BLA/MAA, as well as the design of “by design quality” and “breakthrough treatment programs”.

Why Choose BOC Sciences?

BOC Sciences’ end-to-end services are characterized by high quality and fast turnaround time. In addition to the cost effective solutions, the one-stop services are also available to meet all the needs including analytical & stability, quality control and regulatory CMC documentation. Importantly, the provided package services are qualified for all over the world.

References

  1. Swartz, M. E., & Krull, I. S. (1997). Analytical method development and validation. CRC Press.
  2. Vogt, F. G., & Kord, A. S. (2011). Development of quality-by-design analytical methods. Journal of pharmaceutical sciences100(3), 797-812.
Quote Request
Verification code