Background

On behalf of German development cooperation, PTB supports African countries in the quality assurance and control of pharmaceutical products.

Aseptic manufacturing of sterile products, such as vaccines, injectabilia and ophthalmics, plays an outstanding role for the development of an independent and sustainable healthcare system. Therefore, a training is offered for African pharmaceutical manufacturers and regulatory authorities on sterile production under current Good Manufacturing Practices (cGMP).

PTB has developed a modular training series covering specific aspects of sterile production under cGMP. 

To date, the following 4 training modules of the modular training series have already been conducted both virtually and on-site in Ghana:

Module 1: Current GMP and general aspects of aseptic manufacturing of pharmaceutical products

Module 2: Inspection/Audit Management & Documentation / Risk Management 

Module 3: Insights into Quality Control  

Module 4: EU GMP Annex 1 & CCS

!!! The presentations can be viewed by clicking on the module.

Building on this training series, a new module (Module 5) focusing on the core elements of the Quality Management System (QMS) and the release process has been developed and was presented in 2 virtual training sessions on 12-13 May 2025.

Module 5:  Core elements of the Quality Management System and the Release Process

!!! Please click on the module for the full presentation.

The quality of pharmaceutical products is paramount to ensure patient safety. A critical part of this is an effective Quality Management System (QMS), which comprises key elements such as deviation and change management, document control, and continuous improvement. 

These components collectively oversee all processes from production to release, ensuring consistency and compliance

The Release Process is a pivotal aspect of QMS, ensuring that only products meeting required standards are released to the market. This process involves stringent incoming material testing, inspection protocols, comprehensive documentation management, and strict adherence to regulatory requirements, guaranteeing product safety, efficacy, and quality.

Through this Virtual Training, we will explore the core components of QMS and the Release Process, focusing on ensuring high-quality standards in pharmaceutical manufacturing. This includes an in-depth look at how QMS tools such as deviation management, change control, and APR/PQR support robust decision-making and maintain product integrity throughout the lifecycle. 

Goal & course objectives

Module 5 aims to provide participants with comprehensive knowledge on Quality Management Systems and the Release Process. By the end of the training, participants will be able to:

→ Understand the key aspects and requirements of a QMS.

→ Become familiar with the essential steps in the Release Process for pharmaceutical products.

→ Learn how to handle non-conforming results and deviations.

Who are the targeted participants?

Participants should come from one of the following countries: Ghana, Rwanda, Senegal or South Africa. 

They should be 

(a) personnel of manufacturers of pharmaceutical products, especially quality assurance and manufacturing departments, and management level or

(b) personnel of regulatory authorities (e.g. inspectors, auditors, licensing etc.)

!!! Participants need to be proficient in English, as the course will be conducted exclusively in English. 

Teaching and learning strategy

This virtual training course combines lectures with interactive sessions and group works. Participants will take part in discussions, exchange ideas with fellow participants and participate in case studies which form a vital part of the learning experience. Therefore, the participant must have internet access and facilities to enable audio and video participation. 

After completion of the course, you will receive a certificate.

Course duration

Duration: 2 days – Monday, 12th May and Tuesday, 13th May 2025

The course was held online in 4 x 2,5 hours sessions over 2 days (10 hours in total).

Trainer

Dr. Dirk Feldmann: Head Quality Release and Documentation & Qualified Person, Bausch+ Lomb, Berlin, Germany

Dr. Daniel Meißner: Head QA Operations & Qualified Person, GSK Vaccines GmbH, Marburg, Germany

PTB Contact

Anna Reinhardt, Project Coordinator, anna.reinhardt@ptb.de

Lisa Köhler, Project Assistant, lisa.koehler@ptb.de