Annex 13 – Manufacture of Investigational Medicinal Products

Description

PIC/S Annex 13: Manufacture of Investigational Medicinal Products (IMPs) Online GMP Training 

Course Overview

PIC/S Annex 13 guidance outlines the Good Manufacturing Practice (cGMP) requirements for the manufacture of Investigational Medicinal Products (IMPs).

This interactive eLearning module provides a comprehensive understanding of the latest regulatory updates to PIC/S Annex 13 and provides learners with a current GMP Training Certificate for this GMP education topic. Note: recent PIC/S updates to Annex 13 for IMPs went into effect on 1 February 2022.

What is an IMP? Definition of IMPs (FDA):  An investigational medicinal product (IMP) is a drug or placebo that is being tested or used as a reference in a clinical trial. The FDA, similar to other regulatory authorities, regulates the manufacturing and handling of IMPs to ensure their safety and quality.

Many regulators refer to PIC/S Annex 13 when conducting regulatory compliance site inspections of facilities, processes, procedures and training records.

Regulatory Compliance Requirements for IMPs

This GMP eLearning course will help you learn about:
✅ Manufacturing & Distribution – IMPs and comparator products for Clinical Trials
✅ Regulatory Requirements – Compliance with cGMP and PIC/S Annex 13 standards
✅ Batch Certification & Release – Authorised Person (AP) responsibilities for IMPs (Our PIC/S Annex 16 Online GMP Training course has further details for Authorised Persons & Batch Release)
✅ Blinding & Unblinding Mechanisms – Single-blind, double-blind, and emergency unblinding codes
✅ Preparation & Packaging – Repackaging, labelling, and distribution controls
✅ Recordkeeping & Reporting – Documentation and compliance measures

This self-paced online GMP compliance course covering PIC/S Annex 13 is designed for Sponsors, medical personnel, quality teams, clinical researchers, drug development and drug manufacturing professionals who are involved with IMPs and/or Clinical Trials of new medicines under investigation.

Who Should Take This Course?

This PIC/S GMP Training course covering Annex 13 is essential for professionals, clinicians and laboratory personnel who work with Investigational Medicinal Products (IMPs) & GMP compliance roles, including:
✅ Quality & Manufacturing Personnel Responsible for Batch Release
✅ Clinical Trial Sponsors, Managers & Coordinators
✅ Medicinal Product & Placebo Developers & Healthcare Researchers
✅ Pharmacovigilance & Regulatory Affairs Professionals
✅ GMP Compliance Inspectors & Auditors
✅ Drug Developers including Advanced Therapy Medicinal Product (ATMP) Developers
✅ Logistics Managers & Distribution Teams for IMPs
✅ Medical Device & Biopharmaceutical Manufacturing Personnel

Key Learning Topics for PIC/S Annex 13 (IMPs)  

📌 Common Terminology in IMP Manufacturing – Definitions and key concepts
📌 Regulatory Requirements for IMP Manufacturing & Distribution – Compliance with PIC/S Annex 13
📌 Validation & Quality Management – Expectations for IMPs in Clinical Trials
📌 Personnel Responsibilities & Training – GMP compliance for IMP teams
📌 Cross-Contamination Prevention – Best practices for IMP manufacturing
📌 Product Specification File (PSF) Requirements – Essential documentation
📌 Complaints, Recalls & Returns – Regulatory procedures for IMPs

Why This Course is Essential for GMP Compliance

Many regulatory agencies, such as the FDA, EMA, MHRA, and TGA, require strict adherence to PIC/S Annex 13 for the manufacture and handling of IMPs.

This course provides essential training on:
✔️ Regulatory expectations for IMP manufacturing, validation & documentation
✔️ Best practices for blinding, unblinding, and comparator product handling
✔️ Batch certification & release responsibilities of the Authorised Person
✔️ GMP inspections and regulatory oversight for IMP processes

Certificate GMP Course 

• Successful completion of the Final Assessment for this PIC/S Annex 13 course provides you with a downloadable & printable Certificate of Completion.
• This Certificate should be added to your GMP training records.
• You can also attach your GMP training certificate to your CV when applying for job openings or research positions.

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
✔️ Combine online learning with instructor-led training options (virtual or onsite, where available)

This course is ideal for professionals involved in Clinical Trials, IMP manufacturing, and regulatory compliance within the pharmaceutical, biotechnology, and medical device industries.

Additional GMP Compliance Training & Laboratory Personnel Training Courses Resources

• Explore other relevant courses including Good Laboratory Practice (GLP) training, PIC/S Annex 16 (Authorised Person & Batch Release), Deviations and Non-Conformances Management (online GMP training), and more.
• Click the menu item for ‘store’ to browse over 70 GMP eLearning topics!
• Download the original PIC/S Annexes and GMP Guide publications from the PIC/S Publication Pages for Annex 13.