Application of GLS in R&D Quality Management

Regarding the quality management of drug research and development, in fact, from the national regulatory level, the regulations do not make a clear requirement for the quality management of the research and development stage

With the emergence of our industrialized production and industrialized research and development, in fact, we still need to have a good quality specification to be restrained in the research and development stage

In fact, for quality, it is not a regulation.

Quality is not an end point.

The quality elements of R&D are active, absolute movement and relatively static.

The role of quality in drug development

When we want to do something or when we want to develop a product, we definitely don’t just start doing it with a beat of our heads.

Quality tools in drug development

From the development of a drug to the final commercial product, there are many links, and there are many different regulations, such as GLP, GCP, GMP, etc.

Each department of the R&D laboratory must have a quality management role, and every employee must implement the standards of a good laboratory.

So what are the main elements included in GLS? There are three main elements:

01

The first is the organizational structure and personnel.

02

The second is closely related to everyone's working environment, the safety of occupational health and safety facilities, as well as information security, intellectual property rights and regulatory requirements, equipment and computerized systems

In terms of information security, intellectual property and regulatory requirements, before starting R&D activities with external parties, it is necessary to discuss with the competent authority in advance any intellectual property related and all issues that may occur during the cooperation period, and any disclosure outside the R&D institution originates from the R&D institution Work or the concept or research results of external cooperation with R&D institutions need to be formally approved.

Information security, intellectual property rights and regulations require adequate and recorded tests to ensure applicability and accuracy.

03

The third is the execution and report of the project or experimental design, and the preservation of information related to the quality control project experiment

At the end of the research and development, an inspection data or test report must be given.

The details of the project and experiment must be recorded in time.

GLS is the basic principle for building a quality system in our R&D process, helping to ensure the success of R&D