In-process Assay Services

As a leader in the pharmaceutical industry, Creative Biolabs has a very powerful technical level and a wealth of experience in the production and quality control of drugs. We can provide excellent technical services in the process of your Live Biotherapeutics Products (LBPs) development so that your project can be carried out smoothly.

In the pharmaceutical industry, to prevent non-conforming products, it is necessary to ensure the total quality of products and control the errors in the production process. The whole transaction process includes a strict quality control test so that the product is perfect before it is put on the market. GMP requires manufacturers to control key aspects of their specific operations through product and process life cycle validation.

In-process control. Fig.1 In-process control. (Wood, 2011)

The Definition of In-Process Controls

During the production process, materials should be inspected for identity, strength, quality, and purity and approved. Before the completion of the production process, the checks should be put into effect. The function of in-process controls involves monitoring and where necessary, adaptation of the production process to meet the specifications, which may also include the control of equipment and environment.

Objectives of In-Process Controls

In-process controls can be performed periodically during or at the end of the process. The goals of in-process control are both quality and process control. Such as:

  • Check the conformance of the product with the compendial standards.
  • To optimize the production process.
  • Each step of a production process is controlled to assure that the product meets all quality attributes.
  • Quality and process control.

The total quality of the product is assured by both the in-process quality control and product quality control tests. The total dealing process represents rigorous QC tests to make products completely indefectible before they are delivered into the market.

Sampling in Process Controls

Unified sampling is carried out in the whole batch of production. The sampling plan includes:

  • The sampling process.
  • The sampling location.
  • The sampling numbers.
  • Describe the technology that prevents contamination of the product being sampled.
  • State the type and requirement of the sample container to be used.

In-Process Controls and Tests

  • Uniformity of products.
  • Content of active ingredients.
  • Uniformity of weight.
  • Friability.
  • Disintegration test.
  • Dissolution test.
  • Content uniformity and homogeneity.
  • Clarity, Completeness, or pH of solutions.

Monitoring the processes for the formation of an API is the first step to ensuring quality in pharmaceutical manufacturing. Having reliable and reproducible methods will enable the production plant to guarantee the consistency of drugs batch after batch. Creative Biolabs is dedicated to LBP development, offering you one-stop-shop services for the entire process of your project, especially in-process controls. If you need in this aspect, please feel free to contact us for more information.

Reference

  1. Wood C. In-Process Control Testing. Separation Science and Technology. 2011, 10: 397-427.

For Research Use Only. Not intended for use in food manufacturing or medical procedures (diagnostics or therapeutics). Do Not Use in Humans.

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