Description

Annex 12 – Use of Ionising Radiation in the Manufacture of Medicinal Products

Annex 12 – Use of Ionising Radiation in the Manufacture of Medicinal Products

PIC/S Annex 12 relates to the specific GMP requirements for the use of ionising radiation in the manufacture of medicinal products.

This interactive e-Learn module provides an understanding of the GMP regulations relating to the use of ionising radiation in the manufacture if medicinal products.

The objectives of this training module are:

• to understand the principles of irradiation techniques
• to understand the applications and limitations of irradiation techniques
• to understand the responsibilities of manufacturers and contract irradiation facilities
• to understand particular validation requirements
• to understand the specific commissioning and premise requirement
• to understand dosimetry and processing requirements

Certification

After successful completion of each course, the trainee will have the option of printing or saving a personalised training certificate that meets regulatory GMP requirements.

Course duration: Allow 1 to 1.5 hours to complete this course.