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Clara Fargo
EBMT Clinical Research Quality Assurance Coordinator
I have finalised the demo for the ICH-GCP E6 R3 refresher course. Overall, I liked the content and the interface. I also want to thank Whitehall Train...
Good Manufacturing Practice: Annex 13 (English) Course & Certification
Intermediate
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3 hours
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Good Manufacturing Practice: Annex 13 (English)
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About
Good Manufacturing Practice (GMP) Annex 13 defines the specific requirements for the manufacture, handling, and control of Investigational Medicinal Products (IMPs) used in clinical trials. It ensures that IMPs are consistently produced, properly managed, and safely supplied to clinical trial sites in compliance with regulatory standards.
This Good Manufacturing Practice: Annex 13 (English) Course & Certification provides a structured understanding of the complete IMP lifecycle in clinical trials. The course covers key concepts including IMP definition, regulatory expectations, roles and responsibilities of stakeholders, manufacturing and packaging controls, shipping and receipt processes, storage and dispensing procedures, and handling of complaints and recalls. Upon completion, learners receive a certification demonstrating their knowledge of GMP Annex 13 requirements and clinical trial supply chain compliance.
Who Should Enrol ?:
- Pharmaceutical Manufacturing and Production Staff
- Quality Assurance (QA) and Quality Control (QC) Professionals
- Qualified Persons (QPs) and Regulatory Affairs Personnel
- Clinical Trial Supply Chain and Logistics Teams
- Clinical Research and CRO Professionals
- Packaging, Labelling, and Distribution Personnel
- Pharmacists and Life Science Graduates
- Anyone involved in investigational medicinal product management or clinical trial supply
What you will learn
Understand Investigational Medicinal Products (IMPs), Annex 13 requirements, and the roles of sponsors, manufacturers, and qualified persons in clinical trials.
Learn procedures for shipping, receiving, storage, dispensing, and handling IMPs at clinical trial sites.
Develop knowledge of subject handling, study completion procedures, and maintaining compliance with clinical trial regulations.
Gain understanding of complaint handling, recall procedures, and quality practices related to IMP management in clinical research.
Course Syllabus
- Definition of an IMP
- How does Annex 13 affect me?
- Why do we need Annex 13 when we already have GMP?
- Application of Annex 13
- The Sponsor
- The Manufacturer and Packager
- The Qualified Person
- Shipping
- Receipt of the IMP at the clinical trial site (Step 1 – Check the packaging)
- Receipt of the IMP at the clinical trial site (Step 2 – Check the labelling)
- Receipt of the IMP at the clinical trial site (Step 3 – Check the study or trial number)
- Receipt of the IMP at the clinical trial site (Step 4 – Check the expiry/use-by date)
- Receipt of the IMP at the clinical trial site (Step 5 – Check the patient ID and dosage)
- Receipt of the IMP at the clinical trial site (Step 6 – Check the storage conditions)
- Receipt of the IMP at the clinical trial site (Step 7 – Check the batch certification, temperature, and humidity results)
- Receipt of the IMP at the clinical trial site (Step 8 – Quarantine if not assured)
- Storage of the IMP
- Dispensing
- Handling the subject in a clinical trial
- End of the study
- Handling Complaints
- Recalls
- Final Conclusion
Course Benefits
Fully compliant
This course follows the guidance of Annex 13 of the European Commission's GMP guidelines
Certified
All learners who pass the final exam receive a uniquely numbered, personal certificate to demonstrate their subject knowledge. Since the questions are picked randomly from a database, re-sitting the exam doesn’t mean taking the same questions again and again.
Affordable
Our cost-effective prices represent excellent value. You can easily pay up to ten-times more for face-to-face training. We can also offer generous group discounts on larger purchases.
Time-saving
Our new administration system makes it incredibly quick and simple to allocate licences to multiple learners. Learners save time too by choosing when and where they complete the training. Our reporting tools make it easy for administrators to check the progress of learners and identify areas for future training.
Reliable and trustworthy
This course was written by McCarthy Consultant Services Inc (Canadian specialists in regulatory work to support the global pharmaceutical, biotechnology, medical device, food, natural health products and cosmetic industries). You will also stay up to date with any legislative changes in GMP relating to IMPs as our training courses are constantly monitored, reviewed and updated.
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