MP-D Seminars

The presentation will cover the remediation of a global supply chain and its QMS to restart supply of critical and life saving medicines and the need for senior leadership support to achieve the safe flow of medicine after unfavourable inspections and failures of the local and global quality systems.
This will include overviews of remediating qms systems such as APQRs, deviations, batch back logs, versatility in training new staff and QPS, support and leadership, interactions with competent authorities and how some of the war stories were resolved and could be improved if faced again.

The new Annex 1 is the ‘hottest’ regulatory topic currently. The recently introduced standard for sterile medicinal products significantly raises the regulatory requirements in a number of areas.
This presentation identifies those areas where Industry routinely failed to comply with the previous Annex 1 and looks ahead to predict the potential compliance ‘pitfalls’ within the revised guidance and how to avoid these.

This session offers a chance to consider sterile and cleanroom compliance from the perspective of a former MHRA steriles accredited inspector, before most companies will have been inspected against the new Annex 1.

Often we are given procedures to follow with no involvement in the content, how they are written and even if they make any sense to us. In this lively presentation we will cover the importance of involving the end-user in the design and wording of procedures, so that they are written in a style, language and way that the end-user understands. We will also cover how to check if a new procedure reflects reality, as sometimes they require actions that, in reality, cannot always be done that specific way.

Quality Risk Management or QRM is used for identifying, assessing, and mitigating risks, and it is a critical part of an effective pharmaceutical quality system to effectively control the production and distribution of medicinal products. The industry standard for QRM, ICHQ9, has been around for nearly twenty years now, and the most recent revision, ICHQ9(R1), was just last year reissued to update and correct some deficiencies in the original text.
A good QRM process will list all potential risks associated with the product or manufacturing process under review using science-based decision-making. QRM should be embedded in the QMS with its own procedure to outline how risk assessments are determined, including the level of formality and type of assessment to be used. Risk analysis/assessment tools identify and assess hazards, while risk control is used to minimize or manage risk to acceptable levels. The QRM process itself involves making decisions for each hazard on the severity, probability of occurrence, and detectability.
Pharmaceutical manufacturers and distributors can and often do fall foul of not correctly utilising QRM principles in their competent authority inspections, leading to inspection non-compliance findings. For example, in your change control process, could you put your hand on your heart and say that all risks in all change controls are identified and assessed and appropriate risk mitigation strategies implemented to ensure that the products meet all critical quality attributes? Also, with the revised Annex 1 now effective, can we be certain that cross-contamination risks are all fully addressed to ensure that residues will not contaminate subsequent batches?

In this presentation, I intend to give an overview of effective QRM processes, when risk management should be used, and the pitfalls to avoid. I will also give some examples of really effective QRM tools suitable for various situations where risk assessments should be used and tips and advice on how to use these tools.

- Despite being a payments technology company, Mastercard struggled to improve the efficiency of its supply chain payments operations, and we'd like to understand how this compares with pharma, which will be far more complex
- Mastercard has 30,000+ Purchase requisitions a year across 180 countries
- Payment terms were disparate – we aimed to standardise terms across our supplier base
- We created a tool called Global Treasury Intelligence to become the “air traffic control” for Mastercard’s Sourcing and Supplier team
- It’s given us visualisation across our ERP and Procure to Pay systems unified into a single interface, enabling us to drill into the data (historically has needed to be manually joined)

Auditing is a very important aspect of any Quality Management System, and is a specific requirement of both GMP and GDP. However, often audits are preformed as part of person's very busy schedule, with limited planning and preparation for the audit itself, resulting in the audit not being as effective, efficient and professional as it could be. In this lively presentation we will cover some of the main activities to be performed at the planning stage of any audit, including what to ask for in advance and how to review documentations in advance to get an appreciation of the organisation before you arrive on-site.