Do you want to produce radiopharmaceuticals in accordance with the GMP regulations?

We have a great team to help you

Radiopharmaceutical production is our passion

We offer our skills for complex radopharmaceutical production

Our team will assist you during all stages of the implementation project of your radiopharmaceutical facility (design, commissioning, quality system implementation, qualification and validation, technology transfer and staff training) with great competence and in full compliance with GMP regulations.

Prevent errors, save time, cut costs

The implementation and management of a radiopharmaceutical facility is a complex process and therefore no detail should be overlooked. When we work with you, your challenge is our challenge. This will result in an effective process aimed at preventing errors due to lacking design as well as removing coordination hurdles among the different specialists involved, hence also saving time and costs.

Our skills have no limits

In order to assist you, we have identified 8 key areas:

1

PRELIMINARY AND EXECUTIVE PROJECT DESIGN

2

PROJECT ASSESSMENT ACCORDING TO THE GMP REGULATIONS AND DESIGN QUALIFICATION

3

SUPPORT FOR CONSTRUCTION AND IMPLEMENTATION WORKS

4

QUALITY SYSTEM IMPLEMENTATION

5

QUALIFICATION AND VALIDATION

6

TECHNOLOGY TRANSFER

7

TRAINING

8

REGULATORY ASSISTANCE

Here is an overview of our services:

Design and Implementation

Thanks to our staff’s engineering, pharmaceutical and managing skills, we are able to design a radiopharmaceutical facility, while providing various services such as plans, perspective drawings, rendering and technical reports. We also follow through on all the construction stages, from site set-up to final implementation of the facility.

GMP quality system implementation

We offer our experience and expertise in the radiopharmaceutical sector and provide experts in the field of Quality Assurance for quality system implementation and assessment. Our support activities encompass the management of standard documentation and raw materials, as well as the qualification of suppliers, equipment, staff, changes, deviations, off-specification items and inspections. In addition to the abovementioned activities, we also provide customized solutions according to the customer’s specific needs.

Moreover, our experts carry out a wide range of auditing activities, in order to assess compliance of the site with the GMP regulations. After all these activities are provided, a final report will be issued including the general state of the system, along with any situations of non-compliance and the proposed action plan to achieve fully regulatory compliance.

Qualification and validation

We carry out qualification activities for classified rooms, isolators, hot cells for radiopharmaceutical handling or dispensing, shielded cells for synthesis modules, synthesis modules, autoclaves, pass-through boxes / materials, refrigerators and climatic chambers. Furthermore, we make our analysis laboratories available for the development and validation of analytical methods for chemical, physical and microbiological quality control; we also perform cleaning procedures of classified rooms, as well as cleaning and process validation activities.

All these activities are performed by a specialized division with trained staff who have extensive knowledge in radioprotection measures and certified equipment.

Production start-up

We will assist you during the initial production stage, as well as coordinate the phases of synthesis, formulation, division, packaging and control of the finished products.

Technology transfer

Technology transfer is the opportunity for us to pass on a wide range of skills and technological innovations that we have developed thanks to over 10 years of research on projects and radiopharmaceutical production processes.

Regulatory assistance

We are able to offer regulatory assistance, in order to accelerate and streamline the marketing authorization process for your radiopharmaceutical product.

Management activities

In the case of facilities authorized to operate abroad, our staff also takes care of the site’s management.

Training

We offer technical training for radio pharmacy personnel.

Contact Itelpharma

We will be happy to assist you.

Contact us