cGMP-Qualification and Validation

Successful realization of plant qualification by experienced engineers with special expert knowledge

The production of pharmaceuticals is a particularly demanding task. In order to be able to guarantee the necessary quality of the drugs, it is essential to place consistently high demands on the production processes in the manufacture of drugs and active ingredients. The engineers at UTEK are aware of the high cGMP (Current Good Manufacturing Practice) requirements in the production of pharmaceuticals. We implement the requirements for documentation and testing of manufacturing processes for you at all levels in plant qualification – in plant design, in documentation and in the inventory of computer-aided systems.

Implementation of cGMP requirements in plant design (basic and detail engineering)

• Analyzing the variables influencing the product quality
• Preparation of technical specifications, data sheets and inquiry drawings of all equipment for inquiries and orders
• Preparation of RI flow diagrams (with MicroStation SE or AutoCAD) taking into account GMP aspects, if necessary on-site survey of existing equipment
• Clarification of technical details with suppliers

Qualification documents according to Standard Operating Procedures (SOPs)

• Validation planning
• Requirements specifications/user requirements
• Qualification plans
• Requirements specifications
• Test plans and test protocols for Design Qualification, Installation Qualification, Operational Qualification and Performance Qualification
• Verification of compliance with cGMP requirements per equipment class
• Quality inspection (FAT), incoming goods inspection, installation acceptance, calibration
• Functional test (SAT)
• Qualification reports/validation final report

More services to implement cGMP guidelines in documentation:

• Qualification testing
• Performing as-built recordings
• Performing system-specific tests (e.g., volume measurements, leak tests)
• Measuring temperature distributions (e. g. in steam autoclaves, hot air sterilizers, freeze dryers, pasteurization vessels) using Kaye Validator 2000

Technical documentation (according to customer specifications)

• Creation of technical documentation according to SOP
• Checking technical documentation for completeness (compiling checklists to record the current status)
• Creation of plant and operating descriptions
• Creation of maintenance plans

Deadline monitoring and coordination of plant qualification (with the departments involved)

• Creation of qualification checklists for recording the processing status
• Creation of schedules

Qualification (computer validation) with the departments involved

Inventory of computerized systems taking into account the life cycle model

Classify computerized systems

• Analyze the impact on product quality and regulatory data
• Evaluate the results

Implement user requirements and cGMP requirements

Qualification documents according to Standard Operating Procedures (SOPs) taking into account the V-model

• Validation Master Plans
• Qualification plans
• Specifications
• Requirements specifications
• Risk assessments (classification of GMP-critical functions)
• Test plans and test protocols for Design Qualification, Installation Qualification, Operational Qualification and Performance Qualification
• Writing of the qualification reports

Qualification tests (according to specifications)

Checking the installation of all components, documentation of the system configuration
Execution of system specific tests (e. g. I/O checks, alarm tests, …)

More services to implement cGMP guidelines in the computerized systems inventory:

• Checking hardware and software documentation for completeness (Creation of checklists to record the current status, e.g. ordering documents, operating instructions, manuals, circuit diagrams, function sequence diagrams, calibration records, spare parts lists, …)
• Creation of SOP test plans (test objects: operation, access protection, data security/archiving, failure and restart plan, change management, training courses)

Monitoring of deadlines and coordination of qualification with the departments involved

• Creating qualification checklists to record processing status
• Writing schedules

UTEK realizes customer-specific measures for plant qualification. Please contact us. We will be happy to advise you!