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1MP from Comecer

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Learn about 1MP, the new business unit from Comecer that can help you build a GMP radiopharmaceutical facility.

Learn about 1MP, the new business unit from Comecer that can help you build a GMP radiopharmaceutical facility.

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  • 1. is a turn-key solution that allows the customer to create and customize a new GMP production center using only one contact/reference for all equipment, in order to minimize the timeline of the project and to provide innovative technologies.
  • 2. DESIGN QUALIFICATION COMMISSIONING QUALIFICATION ACTIVITIES SITE PLANNING GMP QUALITY SYSTEM TRAINING VALIDATION ACTIVITIES
  • 3. One purpose of is to customize and optimize facility layout including:
  • 4. One purpose of is to customize and optimize facility layout including: Architecture
  • 5. One purpose of is to customize and optimize facility layout including: Architecture Classification areas
  • 6. One purpose of is to customize and optimize facility layout including: Architecture Classification areas Ventilation and HVAC
  • 7. One purpose of is to customize and optimize facility layout including: Architecture Classification areas Ventilation and HVAC Personnel & Material flow
  • 8. One purpose of is to customize and optimize facility layout including: Architecture Classification areas Ventilation and HVAC Personnel & Material flow Radiomonitoring
  • 9. One purpose of is to customize and optimize facility layout including: Architecture Classification areas Ventilation and HVAC Personnel & Material flow Radiomonitoring Air Compressing Station
  • 10. One purpose of is to customize and optimize facility layout including: Architecture Classification areas Ventilation and HVAC Personnel & Material flow Radiomonitoring Air Compressing Station Design Qualification
  • 11. Supply of production and quality control equipment compliant with pharmacopeia SOFTWARE MANAGEMENT SYSTEM RADIOMONITORING SYSTEM DISPENSING UNIT HOT CELLS AND HOODS QUALITY CONTROL EQUIPMENT SYNTHESIS PLATFORMS
  • 12. The customer is supported during the Construction and Commissioning phase, when suppliers have to assure that all the installations, systems and equipment have been properly projected and installed and operate according to customer requirements. The following activities are performed in this phase: • Technical support during critical construction phases, according to Design Qualification • Technical meetings • Revision of the as-built project • Supervision of Site Acceptance Test Protocol for critical equipment
  • 13. The qualification activities are performed to properly guarantee the reliability of equipment, systems and process prior to the start of the process validation activities Ready for Process validation
  • 14. helps you to elaborate a proper quality system • The Validation Master Plan outlines the principles involved in the qualification of a facility, defining the areas and systems to be validated, and provides a written program for achieving and maintaining a qualified facility. • The Site Master File should contain specific information about the quality management policies and activities of the site, the production and/or quality control of pharmaceutical manufacturing operations • The Organization chart and job descriptions of the Key Personnel of a GMP Facility are defined according to GMP Chapter 2 • The Technical Specifications define quality specifications for each raw material and finished product considering Pharmacopoeia requirements. • Each department should have SOP’s for the correct management of environment, equipment, and materials, describing flows and responsibilities.
  • 15. Before starting the validation activities, theoretical and practical training focused on Radiopharmaceutical GMP production and quality control is provided to Customer personnel. The training is performed in the authorized radiopharmaceutical facility where it is possible to verify the practical and theoretical applications. Duration Number of participants Language Validation master Plan Analytical Methods Quality Agreements Batch Record 10 working days Maximum 4 English Synthesis Modules Site Master File Change Control Training Management Self Inspection Dispensing Modules Hot Cells Autoclave CAPA Deviation and OOS Complaints and recall Product Quality Review QUALITY ASSURANCE Batch Record Raw materials GC Radio-HPLC Radio-TLC Dose Calibrator Gamma spectrometer Master Formula Processing and Packaging Calibration and maintenance PRODUCTION Scale and pH-meter Endosafe PTS Analytical worksheets Maintenance Management Standard Operating Procedures HVAC Analytical methods QUALITY CONTROL Cyclotron technical functioning CYCLOTRON
  • 16. Validation of analytical methods Method validation is the process used to confirm that the analytical procedure employed for a specific test is suitable for its intended use. Results from method validation can be used to establish the quality and reliability of analytical results. Bioburden The scope of this validation is to demonstrate that the process, prior to the sterile filtration, does not contain bioburden in excess. This will be done by testing bioburden on a total of three batches simulating a real production. Mediafill (in case of aseptic dispensing) According to guidelines the process simulation with media fill is the validation of an aseptic manufacturing process. This is to demonstrate that rooms, equipment and personnel are able to manufacture a product with a very low contamination rate Cleaning validation The objective of this validation is to demonstrate that the cleaning procedure used is effective in removing residual product and solvents.
  • 17. Process Validation Objective The objective of the Process Validation protocol is to demonstrate that [18F] FDG, using a pre qualified equipment and materials, can be consistently manufactured to the required product specification. Scope The PV protocol demonstrates that all aspects of [18F] FDG product quality are consistently met when manufactured in accordance with the designated SOPs. Furthermore during the PV these activities will be verified: • Equipment/System qualification • Product specifications • Batch size and master formula • Acceptance criteria • Analytical method validation verification • Stability test • SOP’S verification • Expiry testing • Training Verification
  • 18. After completion of the whole project will provide an extended service to preserve the quality and capacity of the customer production center in terms of: • • • • • • Calibration and validation program Preventive maintenance Audit Continuous education and training Development and production of new tracers Facility improvement