The promotion of pharmaceutical policies encourages the pharmaceutical industry fast development. To seize market opportunities, many companies have decided to build new plants or new workshops to improve production capacity or expand production capacity. Compared with other industries, the new pharmaceutical plants require lots of preparatory work to provide sufficient written evidences, to show the authorities that the new plant meets the intended purpose. This indicates insufficient consideration and planning in the early stage could lead project not countable delay or even failure, finally lose the market opportunity.
Therefore, for new projects in the pharmaceutical industry, the most optimal choice is to combine the good engineering standards GEP with the GMP compliance standards. This changes the GMP work, especially qualification and validation, from a burden into an effective tool to promote the project quality because of the rig or of the requirements. The C & Q management, namely Commissioning & Qualification, is an important part and tool of the integrated GEP and GMP method. The core concept is to leverage resources to the greatest extent to serve a project.
gempex has many practical experiences in new plant commissioning & qualification projects. Our experts background cover engineering, pharmaceutical, chemical, biological, and other fields, we can provide our customers professional service and support!
Experienced in commissioning and qualification projects for new plant
Good approach well combining the GEP and GMP
Modern commissioning and qualification concepts, meet customer needs and regulatory requirements
While construction projects as such are complex and demanding, GMP considerations only make them more so. Now the technical disciplines of construction, process control and GMP/ qualification need to be combined. This begins at the start of the project and continues through all phases, especially in the areas of C = construction, C = commissioning and qualification, and C = compliance. gempex through cooperation has developed a process model that shows step by step what needs to be done when in order to take all technical disciplines into account and execute the 3C integrated. Mastering complexity.
Although qualification is not new and has virtually become standard, it continues to frequently cause problems with new construction and conversion projects in particular. Many suppliers offering qualification of their subsections are not aware of the scope and approach to comply with rules and regulations. Not paper but the substance behind it matters: the required level of detail and correct integration of the quality unit. This is where gempex offers qualification management:
Due to scarce resources and rising time pressure, qualification is increasingly being shifted to manufacturers and suppliers today. While experts are available here, their knowledge of qualification is heterogeneous, and the documents often have different structures. gempex reviews integration options within the scope of qualification management. Usability and compliance with rules and regulations are examined.gempex has models at hand for the best possible integration while maintaining an overview during subsequent official inspections.
