The document outlines a comprehensive turn-key solution for creating and customizing a GMP production center, emphasizing a single point of contact for equipment to streamline project timelines and incorporate innovative technologies. It details various phases of construction and commissioning, qualification activities, and the establishment of quality systems, alongside training requirements for personnel. Additionally, it addresses process validation and the ongoing support provided to maintain facility quality and capacity after project completion.

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