25 April 2023 Seminars

With the growth of computerized systems and automation being used throughout the healthcare manufacturing process, Manufacturing Executions System (MES) Technology has been introduced to the work Process.
The technology has spawned the use of electronic record creation of the production record entries.
"Desired State" - goal as described in FDA risk-based approach guidance.

Timely e-records production and access mitigate the risk.
Continuous "real time" Quality Assurance (24x7).
(CPP) Critical Process Parameter data recorded and correlated to product quality characteristics - how process factors impact performance or product.
Tools such as statistical process control and ad-hoc reporting to facilitate better scientific process understanding and provide the basis for PAT (Process Analytical Tec

Roshan will provide a simplified overview of Pharmacovigilance (PV).  The presentation will cover a

background of PV, relevant laws and regulations, role of a QPPV and ultimately how PV plays an integral role in patient safety.

David will look at the difficulties being faced by manufacturers and auditors in conducting audits in the post pandemic world. Drawing on his extensive experience of auditing facilities around the world and virtually, he will look at how difficulties and challenges can be overcome to bring about a successful audit for both parties.

“Workshop: Making Pharmaceuticals…Sustainably

Led by Adrian LaPorta / Claire Edwards / Adam Hawthorne

Manufacture and distribution of pharmaceuticals causes significant greenhouse gas emissions. Many leading pharmaceutical companies have pledged impressive remissions reductions but the challenges of implementing these, whilst maintaining or improving access to medicines, are complex.  In this workshop, facilitated  by the institutions of chemical and mechanical engineers and the International Society for Pharmaceutical Engineering (UK affiliate), we invite pharmaceutical  professionals to discuss how to  accelerate the transition to sustainability. We invite you to consider how to:

• Take a holistic view of sustainability in the sphere of pharmaceuticals
• Achieve or help others achieve independently measurable improvements in sustainability
• Inject urgency and move away from a business-as-usual approach
• Co-ordinate effectively with other decarbonisation initiatives
• Maintain the pace of innovation in improving human health, whilst achieving sustainability
• Improve access to medicines, whilst achieving sustainability

Format:

Requirements for attendance:

Because of the style and content of the session attendance will be by invitation with a limited number of attendees. To apply for a workshop place, please complete the following questionnaire, by 3rd April.   (Please note: This information will be kept anonymous.) Only individuals that have registered to attend Making Pharmaceuticals or Distributing Pharmaceuticals as well as completing the workshop application form, will be eligible for a place at the workshop.

There will be a presentation to brief! To achieve deep discussions and development the session will be highly interactive and involve group work and problem solving. The session has three key objectives:

• To examine the challenges we face
• To provide direction [to whom?] for pharmaceutical personnel working in this subject area
• To share new thoughts, ideas, and solutions

Session Duration: 1.25 hours*

Many thanks, The Making Pharmaceuticals and Distributing Pharmaceuticals Organising Team

Please register for the workshop  HERE

Many organisations approach Data Integrity auditing with a very narrow focus on audit trail review of laboratory equipment.

While this is an important element there are many other areas which should be audited to ensure the "auditee" organisation has built an holistic data integrity approach into their Data Governance System, that incorporates and internal and external perspective with suppliers.

Aseptic isolators are commonly used in the pharmaceutical and life science industries in many applications, including filling lines, cell therapy processes, and sterility testing. This paper will outline some of the options and requirements that need to be considered when integrating an environmental or facility monitoring system (EMS or FMS) into these areas. It will discuss both viable and non-viable monitoring, and cover many of the aspects that need to be reviewed when producing a URS for such a system.

Flow through cytometry is a widely accepted technology for measurement of microbial contamination in laboratories. But it’s not common for in process control

This technology gives more than just a real number of organisms in a sample. It allows for more insight into the population.

Differentiation between living and dead cells, between high and low nucleic acid organisms and even some information about the population itself makes it a promising technology for water bioburden analysis.

The technology and the primary validation as the first step for the total validation procedure will be presented.

Regardless of technology, there are always considerations for any manufacturing process to get the best from it. This unique presentation, delivered by an internationally recognised 3D print expert with 20 years of experience in 3D printing describes how transformative the power of 3D printing can be when applied correctly and how these same principles are already being adopted by the pharmaceutical industry to drive profitability, productivity, and business risk reduction.

The Annex 1 revision comes into force on August 25th, 2023 (with the exception of section 8.123). With 4 months to go until the implementation date, Phil Rose from NSF will look at the what has changed in the revision and what has not. He will detail what the changes in Annex 1 actually mean for companies and, perhaps most importantly, discuss some of the most frequent questions that he has received from companies on the Annex 1 revision. This expert presentation will provide insights and 'real life' issues impacting the pharma industry as it gets ready for August 25th.

The chemical and pharmaceuticals industry is the United Kingdom’s second largest industry contributing over £50 billion pounds to the UK economy and is the nation’s number one manufacturing exporter. It is therefore important for the future prosperity of the country that the chemical supply chain industry continues to flourish. The Chemical Business Association (CBA) is the leading trade association representing the complete chemical supply chain. An extensive and diverse membership gives the distinct advantage of a 360-degree view and insight of the global chemical supply chain and factors that will affect it going forward.

A sustainable supply chain needs to be maintained and supported over time. Since the turn of the century, globalisation has rapidly increased with massive volumes of freight travelling vast distances around the world. This has been enabled by an integrated global supply chain which has grown and evolved to become highly optimised, and we have become dependent on its efficient and cost-effective operation which today underpins our society and economy. However, in the last two years several factors including the current Russia-Ukraine crisis, Covid-19 and Brexit have broken down and disrupted key links within the global supply chain, exposing our reliance on its efficient operation.

Companies also need to consider the environmental and social impact of their products’ journey through the supply chain, from raw materials sourcing to production, storage, delivery, and every transportation link in between. There is a growing demand and expectation from consumers for integrating sustainability practices into supply chain management.

The CBA has been working with its members and other organisations to help ensure the chemical supply chain is sustainable, both economically and socially, and this presentation will discuss some of these initiatives and look at the catalysts and underlying root causes that led to the current disruptions in this supply chain, and what the future might hold for the chemical supply chain.

ChemoSeed is a cylindrical, biodegradable drug eluting seed for the administration of chemotherapy directly into the resection margin of high-grade gliomas and is designed to deliver the chemotherapy for greater than 7 days.  The release is diffusion controlled, with the biodegradable polymer degrading at between 3- and 6-months post implantation when the chemotherapy is exhausted.  It provided localised delivery of a high local dose avoiding systemic toxicity, reducing side effects with no impact on wound healing.  The diameter of ChemoSeed allows for ease of administration using a 12-gauge biopsy needle or catheter, which adds minimal time (< 40 minutes) to current resection surgery procedures.  Between 15 and 60 seeds could be implanted into the brain parenchyma/ resection margin and a rate of 30 seconds per seed. ChenoSeed has been included onto the Tess Jowell BRAIN MATRIX clinical trial as a Phase II study.  This talk will take you through the development of ChemoSeed, from tissue culture and drug release studies to preclinical testing, demonstrating an accelerated development pathway that will see translation from concept to patient benefit within 5 years.

Drug product development involves various activities such as drug substance characterization, excipient selection, formulation development, process identification, process development, scale up, process robustness, technology transfer, process validation, regulatory submission and commercialization. All these steps involve fundamental science and Process Engineering application. Lot of techniques have been developed for material characterization and recently tools have been developed for process modelling for critical unit operations.

In this presentation, case studies will be presented to highlight the key principles related to formulation development and application of first principles approach for process development. Drug development activities related to late phase product development and some of the troubleshooting for critical process and formulation issues will be discussed.

Recent research shows there is an overwhelming recognition of the need for a more holistic, joined-up approach to pharmaceutical Good Distribution Practice and a pressing need for regulatory compliance to reflect rapidly changing market realities. To fill these gaps a group of leading pharma supply-chain stakeholders has come together to create an independent Good Distribution Practice (GDP) program to champion the improvement of global GDP practices and quality management systems.

The GDP-Universal Compliance Initiative (GDP-UCI) is a cross industry collaborative model that will build on current best practices by applying evidence-based improvements to the control of medicine distribution and the regulatory compliance thereof.  For this to happen the industry needs to come together.

The UK top 10 R&D investing companies (which have some subsidiaries around the world) invested €17.4 billion in pharmaceutical manufacturing, and the top two UK-based firms belong to the pharmaceuticals sector, with GSK and AstraZeneca respectively ranking 29 and 31 worldwide in 2020. In March 2020, the UK government committed to the creation of the Advanced Research and Invention Agency (ARIA) which is an independent research body to fund high-risk, high-reward scientific research. Besides, data analytics, digital tools and digital transformation can help to establish collaborations with external stakeholders (including patients, academia, non-governmental organisations and industry) and with international regulatory authorities on ‘Big Data’ initiatives. Thanks to such digital technologies, data can be managed and analysed within a secure and ethical governance framework. However, it is necessary to understand the latest advancements and problems when utilising enhanced data analytics for pharmaceutical safety and authenticity in order to optimise the system operation and consumer trust. Enhanced data analytics methods and their current applications in the UK pharmaceutical industry should be evaluated to establish an initial approachable framework. There are a variety of international and national regulations about data sharing and collaboration in pharmaceutical sectors, particularly about safety and authenticity. Although many data analyses can be used to support and maintain the interests and trust in UK’s consumers, it is hard to monitor the effective the translation into good practices due to different concerns. Therefore, the project focuses on relevant regulations-standards related to the pharmaceutical supply chain with the support of data analytics, and case studies of opportunities and challenges before offering potential suggestions.

Having a shiny new build is great but what happens when you put a person into it, you need to be ready.  You need to cover the boring (policies & procedures), the incidental (the colour of the tiles in the toilets), the critical (containment strategy) and the important (welfare facilities: parking, rest spaces, restaurant).  Listen to Rob talk about the good, the bad and the ugly of a brand-new, cutting-edge facility build out project!

Having a shiny new build is great but what happens when you put a person into it, you need to be ready.  You need to cover the boring (policies & procedures), the incidental (the colour of the tiles in the toilets), the critical (containment strategy) and the important (welfare facilities: parking, rest spaces, restaurant).  Listen to Rob talk about the good, the bad and the ugly of a brand-new, cutting-edge facility build out project!

3D printing technologies have been recognised as having significant potential for on-demand manufacturing of personalised medicine due to their advantage of accurately controlling the microstructure of solid dosage forms. One of the most researched and published thermal-based 3D printing method is fused deposition modelling (FDM). However, there are significant formulation limitations with FDM as most pharmaceutical grade polymers cannot be directly used to form printable filaments, and the addition of excipients such as plasticisers are necessary to enable printing. These additives used to tune the mechanical properties of the filaments can often have undesired effects on drug release. This talk will discuss the development of the first direct granule fed 3D printing of pharmaceutical solid dosage forms with high precision to print solid and porous structures. The printing used in this study, Arburg Plastic Freeforming (APF), thermally processes granules and extrudes drops of material under high pressure. This fundamental difference with FDM led to the improved ability in printing porous structure with materials that are not possible to process without additives, such as plasticisers that often could have an undesired impact on drug release performance.