MP-D Seminars

Guardtech Group Commercial Director Mark Wheeler will outline the most critical elements of any new cleanroom construction project, beginning with key documentation, performance specification and process flow before moving on to thoughts on personnel, product considerations and regulatory compliance. The focus will then shift on to the host building, health & safety concerns, future proofing and project prioritisation, as well as touching on some of the Guardtech Group's best Pharmaceutical cleanroom builds in the past 5 years.

Choosing the Most Suitable Sample Points for Particle and Microbial Monitoring – A Risk Based Analysis

This paper will start by explaining the difference between cleanroom classification and monitoring. It then considers EU GMP Annex 1 and looks at ways to select the correct viable and non-viable sample point locations when considering the installation of a Facility / Environmental Monitoring System in an aseptic manufacturing facility. Looking at what is reviewed in risk assessments, it then follows a journey through the process to illustrate a methodology of how sample points are defined and finishes with some practical examples.

Classical Microbiology methods for Environmental Monitoring of air, or for looking at CFU’s from Water takes time (5 days or more) and has a very low recovery rate. Real time and rapid microbiological methods (RMM) are now encouraged by Annex 1 and can give an immediate response to the presence of bioburden. So you can “see now and react now” to excursion events as they happen or you can trend bioburden and be sure you are in control continuously.

Unplanned downtime in pharmaceutical manufacturing conceals hidden costs that significantly impact profitability. This educational presentation will illuminate how traditional spare part management contributes to these losses and provide a framework for quantifying them. Attendees will learn how digitised assets can strategically mitigate downtime-related expenses, ultimately improving operational efficiency and revealing significant cost-saving opportunities.

In this presentation, the MTC will showcase a range of advanced automation and digital capabilities that have been developed to support the sector, with a particular focus on customisation. To further advance the use of technology in the pharmaceutical industry, we will also discuss an exciting new collaborative Laboratory Automation programme, which is currently in development and offers opportunities for input and collaboration.

Advancement's in CCIT to semi-automate/fully automate integrity testing and it's results. Removing non-deterministic methods and replacing with valid, data backed, deterministic test methods that meet Annex 1, FDA, PDA , 21 CFR compliance and ASTM standards.
Sharing understanding on statistical sampling and requirements to 100% inspect.

Digitalisation of processes is inevitable to remain competitive and improve performance. However, without a proper strategy to implement digital Quality processes, the benefits of the transformation could be limited and the adoption slow and sometime counterproductive.

This presentation will provide some guidance for companies on how to step back and be more strategic about how they look at Quality System digitalisation, starting with the digital maturity assessment.

This interactive session will provide an overview of the key regulatory changes, recently implemented, relating to the manufacture, importation, supply and control of medicines, within the UK, from a GxP and compliance perspective. The impact of future key changes, driven by the MHRA, EU, US FDA, ICH etc, currently awaiting implementation or under discussion, will also be assessed.

An ideal session for those wishing to recap on the implementation of the ‘Windsor Framework’ and check they haven’t missed any upcoming regulatory changes.

The role of the QP in pharmaceutical supply is often seen as an expensive necessity. A ‘hired pen’. It is regularly referred to as a ‘releasing QP’ role, which is miles from the truth under current legislation.

I’ll be talking about the breadth of the QP role, and why it is essential that QPs are not just sitting at a desk releasing batches. I’ll also explain what companies should expect to get when they hire a QP- regardless of whether they are permanent or a consultant.

The Pharmaceutical Quality System (PQS) is always a focus of regulatory inspections, whether that be documentation, deviations, changes or CAPA effectiveness yet it is consistently an area of non-compliance observations. Why? The PQS should be seen as a holistic function with all individuals and teams operating in harmony to identify, impact assess and resolve deficiencies quickly, thereby mitigating future risks. The goal of senior leadership should be to establish a mature quality culture across their organisation. This will achieve lower levels of non-RFT, higher levels of continuous improvement, improved efficiencies and morale, ultimately leading to lower attrition and a better understanding of GMP and risk.

In an ever-evolving pharmaceutical market and a highly competitive employment landscape, it is crucial for individuals and organizations to stand out from the competition. Without a harmonized workforce, the core of these organizations, the “making” and “distributing” of pharmaceuticals can be affected.

The purpose of this talk aims to provide valuable insights for attendees, offering guidance from a recruiter's perspective on how individuals can enhance their chances of securing the best roles, whether contract or permanent, and how employers can attract top talent. Recognising the networking opportunities provided by the conference, this session will particularly benefit those in attendance.

During the presentation, three key areas will be explored:

1. Understanding the recruitment landscape: Exploring the shift towards consultancy roles, the long-term implications for the industry, available training and development opportunities for individuals, as well as changes in hiring and onboarding processes for companies.
2. Thriving culture for employers: Strategies for creating an environment that fosters growth, challenges employees appropriately, and maximises staff retention.
3. Empowering employees: Unveiling ways to optimise current employment situations, maximise chances when applying for roles, and differentiate oneself from other applicants.

Through real-life examples, this talk will showcase successful companies that have implemented strategies to harmonise their cultures, providing attendees with valuable insights and actionable steps for personal and professional improvement.

Hydrogen peroxide (H2O2) is widely used in pharmaceutical manufacturing but presents significant safety challenges due to its reactive and hazardous nature. This presentation will focus on best practices for detecting and managing H2O2 exposure, ensuring worker safety and compliance. We will explore effective H2O2 detection methods, critical factors in selecting personal protective equipment (PPE), and common pitfalls that compromise safety. Additionally, attendees will learn how to develop an integrated, end-to-end prevention strategy, combining real-time monitoring, risk assessment, and protective measures to mitigate hazards and ensure a safer pharmaceutical manufacturing environment.

The presentation will aim to illustrate the regulatory evolutions related to NAs, moving from general ones to nitroso APIs. The crucial point will be the analytical approach to the different matrices in function of the MDD of the drugs and the different limits foreseen for each impurity. The presentation will also include different case studies.

The Pharmaceuticals sector is, by its nature, highly regulated and CAPEX-friendly. These conditions are powerful drivers of quality and long-term progress but have the potential to suffocate daily operational improvement and stifle true manufacturing excellence. An antidote for this is having a truly effective Improvement Cycle embedded at the heart of operations.

The Improvement cycle is simple in its concept – 4 key stages driving daily improvement: Getting the Right Facts, Understanding & Prioritising, Getting People Working Effectively, Using the right Improvement tools & actions – and yet fiendishly difficult to implement in a world-class manner.

Chartwell are operational improvement specialists, working across all manufacturing industries but with a particular focus in pharmaceuticals. We help achieve capacity & productivity improvements in this sector of 20-50% within 3-6 months with little or no CAPEX. How? An industry-leading approach to the improvement cycle, coupled with rigorous application of structured methodologies.

In this presentation, I’d like to use the opportunity to share with the conference attendees some key principles they can take back to their companies to help rapidly strengthen their Improvement Cycle and benefit from a step-change improvement of their current assets.

Excipients are inert in terms of therapeutic benefit to the patient, but they play an increasingly critical role in delivery of the therapy to the patient. With therapies also broadening from traditional chemical-based agents into biologics, as well as combination products and even medical devices, what then is an excipient? And for the new technologies, how can existing excipient guidelines and approaches be applied? 

Nick Carter has worked in the international trade of raw materials for the pharmaceutical industry for over 35 years. Any new product development or change control for an alternative source of an API comes with huge costs and he is keen to share his experience of mitigating the many risks associated with the API supply process.

Freeze drying, also known as lyophilization, which is the removal of water, is widely used in pharmaceutical formulation for several key reasons:
1. it can enhance the stability of active ingredients that are sensitive to heat and moisture.
2. it can extend the shelf life of pharmaceuticals and enable easier storage and transport.
3. it can maintain the structural integrity of complex molecules, and
4. freeze-dried products can be effectively reconsituted by adding moisture.
This study presents differential scanning calorimetry, X-ray powder diffraction, Fourier transform infrared spectroscopy and Raman spectroscopy data for isomalt, which demonstrate its suitability as an excipient in freeze-dried formulations.
In addition the crystallization tendency of the freeze-dried isomalt samples by storing them in three different relative humidity (RH) conditions (2, 9 and 16%) at room temperature in open vials is explained.

Established in the 1980s, the primary goal of the Global Responsible Care Programme was to improve health, safety, security, and environmental performance across the chemical sector. Initially focusing on areas such as risk management and product safety, new developments to the scope of Responsible Care now incorporate responsible material sourcing, communication of sustainability metrics, as well social responsibility. The programme’s KPIs measure essential factors like health and safety performance, as well as introducing member companies to new sustainability initiatives and legislation. This talk covers new developments to the CBA’s Responsible Care Programme, outlining how embracing the Eight Guiding Principles of Responsible Care can contribute to a more sustainable and responsible future in the chemical supply chain industry.