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:
โ Principles of Ionising Radiation โ Techniques, applications, and limitations
โ Regulatory Requirements โ Compliance with PIC/S Annex 12 and GMP standards
โ Manufacturer & Contract Facility Responsibilities โ Key obligations
โ Validation & Commissioning Requirements โ Ensuring GMP compliance
โ Dosimetry & Processing Controls โ Best practices for irradiation procedures
ย 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.
Who Should Take Thisย 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:
โ Pharmaceutical & Biotech Manufacturers Using Radiation for Sterilisation
โ Contract Irradiation Facilities & Service Providers
โ Quality Assurance (QA) & Regulatory Affairs (RA) Professionals
โ Validation, Process & Equipment Engineers
โ Operations & Manufacturing Teams
โ Radiation Safety & Compliance Officers
โ GMP Inspectors & Auditors Reviewing Annex 12 Compliance
Key Learning Topics
๐ Principles of Irradiation Techniques โ Methods, applications, and limitations
๐ Regulatory Requirements for Ionising Radiation in GMP โ PIC/S Annex 12 compliance
๐ Manufacturer & Contract Facility Responsibilities โ Key compliance obligations
๐ Validation & Qualification โ Process validation, equipment commissioning, and facility requirements
๐ Dosimetry & Processing Controls โ Understanding dose mapping and process parameters
๐ Product Safety & Quality Assurance โ 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
Thisย self-paced eLearning courseย allows participants to:
โ๏ธย Access course materials 24/7ย after purchase (valid for 12 months)
โ๏ธย Complete the training at their own pace with practical case studies (the average course completion timeframe is listed below)
โ๏ธย Combine online learning with instructor-led training optionsย (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 theย Final Assessmentย awards a downloadable/printableย Certificate of Completion.
This Certificate should be added to your GMP training records and attach it to yourย 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).ย 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,ย search your browser for “PharmOut GMP Consultants”.
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