Room B Seminars

Integrating multiple sources of data from ERP, instruments and other systems to drive quality across the organisation is becoming ever more important. Whether you are a contract research organization, a contract manufacturer or a vertically integrated pharmaceutical company gathering, manipulating and disseminating data is central to your operation. Moving the ‘Internet of Things’ and the concepts of Industry 4.0 and Laboratory 4.0 from marketing hype to reality means that successful Laboratory Management Information Systems (LIMS) solutions need to be highly flexible. In this presentation we will discuss the continued importance of LIMS in today’s laboratory and show how LIMS fits within your laboratory informatics environment, no matter what that looks like. Of value to all pharmaceutical professionals (CxO, QA/QC, Laboratory) this presentation provides an insight into how LIMS continues to evolve as the glue that links the disparate elements of pharmaceutical manufacturing data and information together to ensure the safe release of final products in the pharmaceutical industry.

Investing in better is what drives us. Imagine a vinyl-free blister which is designed to be fully recyclable and compatible on all standard equipment, serving optimal performance in health protection and environmental safety.

Safe, effective product, consistent with specification, must be our expectation.

The CMO sector has been severely impacted by Covid 19 pandemic and this has resulted in lasting changes to global supply chains. 

This presentation covers the wider implications for Pharmaceutical/Healthcare manufacturing and supply in the UK, now and in the future.  

Key topics: 

· Key supply challenges to manage during the pandemic in 2020

· Problems and opportunities created by the pandemic

· Case study learnings: GMP Manufacturing 

· CMO activities designed for the future  

· Technology Transfer, Data analysis and AI for contract manufacturing 

A staggering one in three of all MHRA listed medicine defects/recalls are based on artwork errors.
During this presentation, there will be an overview of the types of errors and a brief exploration on how to prevent these by applying GMP principles appropriate to artwork origination.

With an ever-increasing competitor market for the production of tablet based pharmaceuticals, businesses are looking to find improvements in productivity. In this presentation we will explore how improvements can be made through washing automation which is now becoming a critical aspect within manufacturing processes. The presentation will focus on the transition from the historical methods of manual cleaning and decontamination of Change Control Parts to semi and fully Automated solutions. We will also review a typical high production installation that relies completely on manual washing capabilities and uncover all the benefits which can be gained from making steps towards a truly controlled and automated washing solution.

Overpressure protection on bioprocessing and pharmaceutical equipment needs to be considered to protect life and investments. In cases where unacceptable pressure levels can be reached safe and reliable pressure protection devices are required. Regulatory standards such as EN13311 specify the requirements for general biotechnology equipment whilst some specific processing equipment is listed with recommended solutions.
One of the often-underestimated health risks is related to the unintended leakage of pressure relief devices such as conventional pressure relief valves, leading to either ingress of microorganisms affecting the quality of processed media or exposure of public or workers to potentially hazardous media. Choosing a suitable leak-tight pressure relief solution such as bespoke rupture or bursting disc devices can mitigate such risks whilst avoiding potential cross contaminations between individual production batches by their smooth and cleanable surface configuration.

Aseptic manufacturing in Grade A environments has traditionally been controlled microbiologically using interval type sampling. Rather than just sampling 1 cubic metre of air by active air sampling, new methods allow for continuous microbial monitoring throughout an entire production cycle, with minimum human intervention, both by the use of traditional TSA agar plates employed over longer periods and by real time microbial monitoring. These methods meet the current thoughts as outlined in the proposed Annex 1 revisions.

Aseptic manufacturing in Grade A environments has traditionally been controlled microbiologically using interval type sampling. Rather than just sampling 1 cubic metre of air by active air sampling, new methods allow for continuous microbial monitoring throughout an entire production cycle, with minimum human intervention, both by the use of traditional TSA agar plates employed over longer periods and by real time microbial monitoring. These methods meet the current thoughts as outlined in the proposed Annex 1 revisions.

TOC analysis is a common and proven tool for the verification of CIP processes in the pharmaceutical industry. While the technology itself delivers fast measurement results, time necessary for grab sampling, transport to laboratory, analysis, data evaluation and finally release has a negative impact on the availability of CIP and production equipment. The use of process analyzer technology (PAT) has the potential to accelerate release processes. To realize major time savings in the verification of CIP processes, Shimadzu has therefor developed concepts with partners from the pharmaceutical industry, taking a novel approach to the use of catalytic combustion Online TOC in this field.

The "Big Three" super-disintegrants (CCS, cPVP, SSG) exhibit very distinct disintegration mechanisms. Understanding these mechnisms in the context of tablet matrix properties, such as solubility and hydrophilicity, is essential for the successful formulation of tablets.

The session will be led by a former MHRA inspector and include tips for preparation and the inspection itself. The inspector or auditor will ask you questions in different ways to help them build up a picture of your compliance level. You will hear questions you might be asked and the right way to answer to demonstrate your compliance.

The different types of audits in the pharmaceutical industry. First, second and third party audits. Why we do these and their focus and priority. Training for auditors. Too basic?

A former MHRA inspector's experience showing different expectations of the UK Pharmaceutical industry. On the one hand, the licence holder has a desire to respond to humanitarian need. On the other hand, they meet many challenges and must still achieve compliance and exercise due diligence. Can we resolve this dilemma?

The European Union's Guide to GMP. The legal status of GMP. How GMP is worded and structured. How GMP is regulated and inforced.