When facilities for manufacturing GMP-regulated products are constructed or converted, their qualification requires a multidisciplinary approach. Many separate technical disciplines and trades, the future operator and its quality assurance department need to be involved. Partial qualifications performed by the trades are increasingly being utilised here. However, all documents must be complete, in compliance with the rules and also uniform in structure and layout. This is a challenge in projects due to time pressure and budgets!
Quafication management is a service for precisely this situation. It controls processes, ensures the desired efficiency of third-party qualification by suppliers and reliably guarantees compliance with rules and regulations. Reliable target achievement – inspection-ready compliance.
Integrated 3C – Construction, Commissioning, Compliance
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.
Project Management in Qualification – Qualification Management
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:
- clarification of the GMP/ validation strategy in an early phase
- coordination of workflows, especially document circulation
- introduction of GMP-compliant technical change management
- preparation and monitoring of schedules for GMP activities
- review of GMP/ qualification services offered by suppliers
- support in GMP negotiations with suppliers
- ensuring execution of the individual qualification steps in compliance with rules and regulations
- coordinating the involvement of all required units in document verification
- ensuring good documentation practices/ data integrity
- compiling all documents relevant for qualification with guaranteed traceability
- and much more
Inspection-ready Integration of External Qualification Procedures
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. Has models at hand for the best possible integration while maintaining an overview during subsequent official inspections.
- controlling function that focuses exclusively on compliance matters during dynamic project work
- confidence that GMP/qualification are being covered in parallel according to rules and regulations
- support in assessing GMP services offered by third parties
- ensuring the timely involvement of all technical disciplines, especially the quality unit
- significant relief for the quality unit by handling the tracking and administration of qualification documents
- meeting project deadlines thanks to flawless qualification processes