Proceedings of the 2019 GMP Academy Master Course

The first GMP Academy Master Course took place from November 26 – 28 at Particle Measuring Systems (PMS) in Italy.

International experts met to share their knowledge and expertise on regulatory requirements and practical applications of contamination monitoring and control systems for aseptic processes and clean environments. The three-day course focused on designing an effective monitoring strategy for aseptic or sterile products and processes.

Pharma Industry Experts Gather for GMP Academy

PMS identified the need to facilitate the exchange of scientific information concerning good manufacturing practice (GMP) principles across generations, institutions, and colleagues. The etymology of “academy” underscores that this course focuses on the cultural accumulation of knowledge, and its development and transmission. Sharing of expertise through open and constructive dialogue is the main purpose of GMP Academy.

How to Design a Sterile Contamination Control Strategy

During the final discussion of pharmaceutical control strategies, presented by Anna Campanella, the following question was asked: It is possible for pharmaceutical quality to be the combination of Quality by Design (QbD) and current Good Manufacturing Practices (cGMP)?

The question simplifies a more complex argument. If the process is under control, all physical, chemical or biological risks to product contamination are under control. However, if we are strictly in compliance with cGMP guidelines, what kind of issues might occur?

A very interesting discussion developed that centred on the steps for managing a contamination control strategy for an aseptic process and the tools used. All agreed that a process overview represents the first step, and then a causes and effects analysis should be performed. Fishbone diagrams can be a reliable tool for this analysis. A deeper and more detailed risk analysis of each event should then be assessed by FMECA. Based on the previous steps, effective CAPAs should be managed is this approach.

Personnel training and qualification were evaluated with a specific focus on aseptic procedures. Interesting debates focused on the root cause analysis for contamination caused by personnel handling, with a clear distinction between incorrect handling of materials and incorrect interventions made inside the filling machine. These debates confirmed the importance of training and procedure understanding, which is also considered a hot topic of Pharma Sterility Assurance experts.

Several publications about pharmaceutical quality were mentioned and discussed in consideration of auditor expectations.

Proceeding of Sterility Assurance: Designing Pharmaceutical Processes with the QbD Approach

Limited information was provided by the University concerning basic pharmaceutical processes, highlighting the importance of direct professional experience and knowledge acquisition. Manufacturing design, quality management and process understanding are essential to the multi-factor approach for effectively analyzing pharmaceutical processes. Expertise was shared and discussed during the 3-days GMP Academy with a focus on improvement through continuous learning.

Presentations by Gilberto Dalmaso described the primary phases and related criticalities of aseptic pharmaceutical processes and products. Marco Benvenuti, Andrea Castiglioni, and Anna Campanella emphasized the importance of a risk-based approach, both for qualification and validation of new areas and equipment, in addition to quality risk management of aseptic processes. Dr Ulrich Zuber shared an interesting case study concerning rapid on-line detection methods and an interesting idea about modern air and water monitoring strategies.

A modern risk-based verification model was brought forward as the alternative to the traditional V-model, both referring to the ISPE Guide and ASTM E2500-13. The goal of ISPE is to make the implementation process for GMP systems cost-effective and effective for the lifecycle of the manufacturing system from concept to retirement. All the participants concluded the QRM approach combined with modern critical thinking principles and a science-based approach should be strongly recommended for optimal design and management of pharmaceutical processes. Food for thought was the discussion of vendor documentation and the advantages of early Subject Matter Expert (SME) involvement in project design.

Scientific evidence supports total CFU counts representing a small portion of all microorganisms, and a pharmaceutical manufacturer evaluated the implementation of a modern alternative microbiological method to detect viable contaminants in water loops. Different on-line monitoring devices for Instantaneous Microbial Detection (IMD) were analyzed for both pure water (PW) and water for injection (WFI) loops. Experimental data obtained via IMD was consistent, but there were some difficulties in validation studies. In particular, there was a need to perform additional controlled experiments to establish a sound conversion rate between the standard method and the new technology. WFI loop sanitization and test condition reproducibility for traditional methods and new technologies were the main difficulties drastically lengthening implementation times.

Education and Real Life Examples: A Gap or an Opportunity for Improvement?

The opening presentation of GMP Academy concerned the analysis of the existing partnership between University and Industry. An interesting study was conducted with nearly 3,300 students from three different faculties to evaluate the main aspects of pharmaceutical processes studied at University. This study showed that of five post-degree courses activated in the last five years, few if any included the study of QbD and ICH rules. Sterile process studies are not included in any course, including those within the umbrella of Chemistry and Pharmaceutical Technology.

Professor Tuccinardi of Pisa University reported a general willingness among university students and researchers to attend presentations and training sessions provided by pharmaceutical manufacturers and suppliers. Also, he noted that some of the most important successful innovative drugs are the result of Industry and University collaboration and expertise. Several government bodies encourage and facilitate graduate and undergraduate participation in the pharmaceutical industry, providing the opportunity for the validation and implementation of new technologies.

Past problems related to pharmaceutical products and processes were contrasted with a new and modern approach. Cleanroom and equipment validation, environmental monitoring data, trained and qualified operators have long been considered milestones of an effective contamination control strategy. Pharmaceutical process understanding shows us that achieving zero risk is not possible. Rather, it is risk management that should be used to achieve the most effective way to control contamination in pharmaceuticals.

Our hope is for pharmaceutical experts to maintain their curiosity, enthusiasm, and quest for knowledge and understanding. We need them to be effective teachers with experience in the industry to teach the next generation to become the new experts for critical pharmaceutical processes.

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