Background

Our client is a major pharmaceutical enterprise that has multiple sites in Hungary. The number of employees in Hungary is over 3,000. The products are sold both on the domestic market and in several regions of the world.
The main field of activities of the company includes the production of generic pharmaceuticals, the production of basic pharmaceutical products and R&D. The product range covers over 500 different products. The most important of these are the pharmaceuticals produced using sterile manufacturing technology – from tablets to different parenteral infusions, injections and eye drops.

The most important solutions Com-Forth Kft. implemented in the plants of the pharmaceutical company

• Installation of a SCADA Central Management System (entire site)
• Monitoring of autoclave machines (in the Infusion, Eye drops, Injection and Lyophilization Plants)
• Monitoring of hot air sterilizers (in the Injection Unit and the Biological Control Department)
• Monitoring of isolator machines (in the Sampling Laboratory and the Biological Control Department)
• Reporting for filling machines (Eye drops Unit)
• SCADA system for the solution production system (in the Infusion Unit)
• Machine and system validation (besides proprietary systems HVAC, island mode production machines, etc.)

The solution of Com-Forth Kft – Machine and system validation

We provided validation services for the client both for the solutions supplied by Com-Forth and for the existing elements (legacy software and machines). Validation was performed in line with the legal requirements, GAMP5 recommendations and client requirements based on the lifecycle model (SDLC, Software Development Lifecycle) including the following items:

• compile User Requirement Specification (URS)
  - survey and record current status
  - survey actual use (interviews, consultations)
  - categorize and record user requirements (priority: compliance with professional, technological and legal requirements)
  - review existing documents (SOPs, maintenance instructions, etc.)
  - documentation activities
• compile Risk Assessment (RA)
   -active participation in the work of the Risk Assessment team (assistance to the definition of technology-related risk factors; identify, analyze and categorize professional risks)
  - documentation activities
• compile Validation Plan (VP)
  - participation in the definition of the validation strategy in line with the current general and site regulations (definition of custom validation strategy if necessary)
  - documentation activities
• compile Installation Qualifications (IQ) / Operation Qualifications (OQ) / Performance Qualifications (PQ) classifications
  - define and compile test strategies and protocols
  - execution, record keeping and documentation independently or in cooperation
  - compile Tracking Matrix (TM)
• compile Validation Report (VR)