Annex 12 – Use of Ionising Radiation in Medicinal Products

Description

PIC/S Annex 12: Use of Ionising Radiation in the Manufacture of Medicinal Products

Course Overview

PIC/S Annex 12 outlines the Good Manufacturing Practice (GMP) requirements for the use of ionising radiation in the manufacture of medicinal products. This interactive eLearning module provides a detailed understanding of regulatory expectations for irradiation techniques used in pharmaceutical manufacturing.

This course will help you understand PIC/S Annex 12 guidance including the following topics:
✅ Principles of Ionising Radiation – Techniques, applications, and limitations
✅ Regulatory Requirements – Compliance with PIC/S Annex 12 and GMP standards
✅ Manufacturer & Contract Facility Responsibilities – Key obligations
✅ Validation & Commissioning Requirements – Ensuring GMP compliance
✅ Dosimetry & Processing Controls – Best practices for irradiation procedures

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 This self-paced online GMP training course is designed for quality teams, manufacturing & operations personnel and regulatory affairs professionals involved in radiation processing of medicinal products.

Other suggested courses include GMP01 and GMP02, PIC/S Annex 1 (Sterile Manufacturing), PIC/S Annex 16 (Authorised Persons & Batch Release), Annex 13 (Investigational Medicinal Products or ‘IMPs’), and more.

We offer over 70 GMP/GxP industry courses for compliance with industry regulations and standards including from PIC/S, FDA, TGA, EU EMA, UK MHRA, other regulators, and ISPE & ISO standards! For course details, click on the ‘store’ menu item.

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Who Should Take This PIC/S Annex 12 GMP Course (online)?

This online GMP training course is essential for individuals working with ionising radiation in GMP-regulated environments, including:
✅ Pharmaceutical & Biotech Manufacturers Using Radiation for Sterilisation
✅ Contract Irradiation Facilities & Service Providers
✅ Quality Assurance (QA) & Regulatory Affairs (RA) Professionals
✅ Validation, Process & Equipment Engineers
✅ Operations & Manufacturing Teams
✅ Radiation Safety & Compliance Officers
✅ GMP Inspectors & Auditors Reviewing Annex 12 Compliance

Key Learning Topics

📌 Principles of Irradiation Techniques – Methods, applications, and limitations
📌 Regulatory Requirements for Ionising Radiation in GMP – PIC/S Annex 12 compliance
📌 Manufacturer & Contract Facility Responsibilities – Key compliance obligations
📌 Validation & Qualification – Process validation, equipment commissioning, and facility requirements
📌 Dosimetry & Processing Controls – Understanding dose mapping and process parameters
📌 Product Safety & Quality Assurance – Ensuring compliance with GMP and regulatory expectations

Why This Course is Essential for GMP Compliance

Regulatory agencies such as the FDA, EMA, MHRA, and TGA require strict adherence to PIC/S Annex 12 for the use of ionising radiation.

This GMP eLearning course provides essential training on:

• Regulatory expectations for irradiation techniques and process validation
• Best practices for dosimetry, processing controls, and radiation safety
• Manufacturer and contract facility responsibilities in GMP compliance
• GMP inspections and regulatory oversight for irradiation processes

In addition to Annex 12 guidance for use of ionising radiation during manufacturing, additional radiation-use regulations & environmental safety laws may apply. Consult with your local authority for further details.

Flexible Online Learning Format

This self-paced eLearning course allows participants to:
✔️ Access course materials 24/7 after purchase (valid for 12 months)
✔️ Complete the training at their own pace with practical case studies (the average course completion timeframe is listed below)
✔️ Combine online learning with instructor-led training options (virtual or onsite, where available)

This PIC/S Annex 12 cGMP eLearning course (GMP online) is ideal for professionals responsible for radiation-based sterilisation, validation, and regulatory compliance in the pharmaceutical, biotechnology, and medical device industries.

Certificate GMP Course for PIC/S Annex 12 Compliance Training

• Successful completion of the Final Assessment awards a downloadable/printable Certificate of Completion.
• This Certificate should be added to your GMP training records and attach it to your CV when you apply for job openings in the pharmaceutical sector.

PIC/S Annex 12 GMP Training Program Resources:

In addition to completing this GMP eLearning module on PIC/S Annex 12 (Use of Ionising Radiation during Manufacture of Medicinal Products), you should download the original Annex 12 compliance guidance from the Pharmaceutical Inspection Co-Operation Scheme (PIC/S). Visit the PIC/S publications pages for the latest GMP Guides and Annexes: https://picscheme.org/en/publications.

For GMP Compliance and Manufacturing assistance for the manufacture of medicinal products including products that require the use of Ionising Radiation,  search your browser for “PharmOut GMP Consultants”.

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