Annex 13 – Manufacture of Investigational Medicinal Products

Description

PIC/s Annex 13 – Manufacture of Investigational Medicinal Products

Includes recent updates to Annex 13 – Manufacture of Investigational Medicinal Products (IMPs) in PIC/S GMP Guides and Annexes in PIC/S PE 009-16 (PIC/S Version 16), effective 1 February 2022.

PIC/S Annex 13 relates to the specific GMP requirements for the manufacture of investigational medicinal products.

This interactive eLearning module covers the latest GMP guidelines and updates in PIC/S V16 for Annex 13 (IMP manufacturing). This online GMP training module provides learners with an understanding of the regulatory compliance requirements for:

• manufacturing and distributing IMPs and comparator products used in Clinical Trials  
• recordkeeping and reporting requirements including batch certification and batch release requirements by the Authorised Person (AP)
• personnel training requirements
• purpose of blinding and blinding types (definitions of single-blinding, double-blinding, and unblinding codes)
• preparation and packaging requirements for medical products for clinical trials including:
  • repackaging of comparator products
  • blinding and unblinding mechanisms
  • unblinding codes for use in an emergency
  • other regulations

This eLearning module for manufacturing, production, packaging and blinding controls for Investigational Medicinal Products (IMPs) is suitable for all types of personnel.

Annex 13: Manufacture of IMPs: training course learning objectives

This course is suitable for Quality professionals, clinical researchers, manufacturing/production personnel, contractors, and other clinical laboratory and research personnel involved in the development and/or supply chains for Investigational Medicinal Products being used in Clinical Trials.

The objectives of this Annex 13 IMP training module, based on the latest PIC/S GMP guidance in PIC/S Version 16, and other regulatory compliance requirements for various types of IMPs, are:

• to provide an understanding of the common terminology used when discussing the manufacture of investigational medicinal products
• to provide an understanding of validation expectations
• to provide an understanding of personnel responsibilities and training requirements
• to provide an understanding of methods used to prevent cross-contamination
• to provide an understanding of the requirements for Product Specification File (PSF) contents
• to provide an understanding of Quality Control and Quality Management in relation to these products
• to provide an understanding of the specific requirements for the complaints, recalls, returns and destruction procedures.

This course is suitable for a worldwide audience.

This regulatory compliance training course for IMPs is suitable for a variety of personnel roles, such as:

• Quality Management Personnel responsible for batch release
• Responsible Person or Authorised Person
• Medicinal Product Developers
• Healthcare Researchers
• Clinical Trial Sponsors
• Clinical Trial Managers and Clinical Trial Coordinators
• Quality Team Leaders and associates
• Auditors and GMP Compliance Inspectors
• Pharmaceutical Product Complaints Personnel
• Individuals involved with product recalls of therapeutic goods
• Pharmacovigilance teams or contractors
• Logistics Managers for Investigational Medicinal Products
  • Including Advanced Therapeutic Medicinal Products (ATMPs)
• Medical device manufacturing personnel
• Medical device quality assurance teams and device maintenance or testing managers
• Other personnel working in a GMP/cGMP environment
  • Product managers
  • Laboratory testing personnel
  • Operations Managers/Department Managers
  • Customer service/sales representatives
  • Research Data managers
  • Administrative officers and contact personnel
  • Distribution/logistics personnel

---

 

This newly-released training course for PIC/S Annex 13 GMP requirements is ideal to complete along with other courses including PIC/S Annex 16 (Authorised Person & Batch Release), the Complaints Management course, the Deviations and Non-Conformances management course, the CAPA systems requirements training course.

Course duration: Allow 2 to 4 hours to complete this course.