MP-C Seminars

The presentation will outline how to build and quality the facility, how to prepare for the licence application. How to obtain the licence. How to ramp up to routine production. Differences between sterile and non-sterile manufacture. Team requirements for a new facility.

How to scope and budget the project and communicate to senior management. Common pitfalls and errors. How long do projects typically take. What you can get out of participating in a new build.

How to create checklists as part of the preparation for internal and external GMP audits. This presentation looks at how an auditor should refer to the standard first, in the planning stage of an audit, to establish exactly what the requirements of GMP are in the first instance. The checklist can then form the basis of questions to ask, when on-site, and as an aid to making notes.

The RESILIENCE Medicines Manufacturing Skills Centre of Excellence creates and delivers training courses for the UK medicines manufacturing community, including industry, NHS and education providers. The Centre is engaging with end users to ensure training adapts to keep pace with evolving technology and sector priorities, such as digital technology, artificial intelligence, data analysis and environmental sustainability. Benefits for educators include access to high quality, readily scalable core materials for training and outreach. Industrialists can accelerate skills development in the business, access industry-ready new graduates, and transfer talent to address any skills gaps in the organisation. This presentation will provide an overview of how the Centre is building approaches to develop and nurture the UK talent pipeline through education, mentoring and outreach, and steps towards scaling-up talent growth across the UK through an affiliate membership network, giving widespread access to educational and outreach materials. 

Quality and cost are the two big drivers of the modern oral solid production. Mega batch and the continuous mini batch approach are two different ways to reach this goal. At first glance it seems that both solutions are completely the opposite of each other. With a closer look both solutions have a lot in common to improve quality and to reduce cost in the life cycle of the product. In this presentation both solutions will be highlighted, case studies will be given and solutions for both possibilities will be shown.
Mega batch and continuous production are both possible ways into a highly automized oral solid dosage production.

Annex 1 states that continuous viable air monitoring in Grade A should be undertaken for the full duration of critical processing, including setup.

This presentation challenges the suitability of the settle plate method and the most common active air sampling methods. Furthermore it challenges the suitability of the current TSA media for use in this application.

Data will be presented to prove and justify that current methods are ineffective in achieving continuous monitoring and as an industry we should be looking to new TSA media formulations and new sampling techniques (data presented) that are more suited to this application.

Discrete Element Method (DEM) simulations offer a powerful tool for predicting the behaviour of bulk powder systems in pharmaceutical manufacturing. However, these simulations require accurate calibration, which typically relies on substantial material quantities. In the early stages of API development, only limited amounts of powder are available, posing a challenge for effective calibration.

We propose a method to use micro-quantities of API for calibrating DEM simulations, enabling accurate predictions for larger-scale systems. By targeting key particle properties—such as compressibility, cohesion, and shear strength—we demonstrate how small samples can be leveraged to align DEM outputs with the performance of full-scale pharmaceutical processes. This approach not only facilitates early-stage development but also supports sustainable practices by reducing material waste and expediting the design of equipment like tablet presses and blenders, setting a new standard for efficiency in pharmaceutical development.