Pharmaceutical manufacturing quality: A combination of Quality by Design (QbD) & cGMP

Pharmaceutical manufacturing quality: A combination of Quality by Design (QbD) & cGMP

The following is the summary of a noteworthy discussion from the 2019 GMP Academy Master Course – Particle Measuring Systems, Rome, Italy

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 of regulatory requirements and practical applications pertaining to contamination monitoring and control systems for aseptic processes and clean environments. The three-day course focused on designing an effective monitoring strategy for aseptic/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 an 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, by definition, all physical, chemical and 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 centered on the steps for managing a contamination control strategy for an aseptic process and the tools to be used. All agreed that the first step is to perform a process overview, and then a cause and effect analysis should be performed. Fishbone1 diagrams are a reliable tool for this analysis. A deeper and more detailed risk analysis of each event should then be assessed using Failure Mode, Effects & Criticality Analysis (FMECA)2. Finally, based on the findings from the previous steps, effective Corrective and Preventative Actions (CAPA) should be implemented and managed.

Personnel training and qualification was evaluated with a specific focus on its interaction with aseptic procedures. Interesting debates focused on the root cause analysis for contamination caused from personnel handling, with a clear distinction between incorrect handling of materials and incorrect interventions made inside the critical filling areas. These debates confirmed the importance of personnel training and procedural understanding. Incidentally, this is also a hot topic with Pharma Sterility Assurance experts.

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

Contact our experts for questions about Contamination Control and to learn more about our Advisory Services.


1The fishbone diagram is a cause-and-effect diagram that helps managers to track down the reasons for imperfections, variations, defects or failures. The diagram looks just like a fish’s skeleton with the problem at its head and the causes for the problem feeding into the spine.

2Failure Mode, Effects & Criticality Analysis (FMECA) is a method which involves quantitative failure analysis. The FMECA involves creating a series of linkages between potential failures (Failure Modes), the impact on the mission (Effects) and the causes of the failure (Causes and Mechanisms).



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