We describe the challenges inherent in good engineering practices GEPs that lead to what to consider in evaluating risk. By comparing the organizational structures based on the classic validation V-model and contrasting those with the framework for risk-based validation, it is possible to evaluate the pitfalls that would impede the successful implementation of ASTM E Finally, we will outline the business considerations for streamlining project execution in line with cGMPs. Risk Management And Validation Depending on where your organization is on the pendulum of risk tolerance, there are many benefits to adopting risk-based validation RBV and ASTM E within an overall validation strategy, as long as the organization is structured appropriately.

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Ready or not? Supported by the FDA, this approach, which is widespread in the USA, is starting to be deployed in Europe, especially with industrialists. The principle The ASTM E method is employed to control the implementation of a manufacturing system and secure projects by focusing on critical aspects from a GMP point of view at each step of the process.

The risk management approach focusing on product quality and patient safety makes it possible to adapt needs specification efforts and rationalize verifications. It is important that they are clearly defined.

The input data are product knowledge, knowledge of the manufacturing process, regulatory requirements as well as internal company requirements. The involvement of users and SME in this step is then essential, they will identify the different user needs and facilitate the identification of critical aspects. It is an iterative step; regular meetings are held to adjust solutions proposed by suppliers and ensure they are clearly understood.

Where a prototype is concerned, it is evident that the design can only be partially defined. In fact, sometimes the verification step is needed to finalize it. Executed too early the validity of its results risks being called into question by modifications, dismantling or transport; executed too late it penalizes the planning of the project. In addition, the Verification process consists in limiting test redundancies, repetitions are only carried out if there is a need or a change.

In this logic certain tests could be carried out at the supplier, totally or partially. Similarly, certain tests may be delegated to the supplier who is an expert on his system. During this step, it is important to draw up a summary document listing all tests carried out, the dates they were carried out and their status. The system concerned can then be transferred to the following step.

Should reservations remain at the point of transfer, they should only concern non-critical aspects and resolution dates must be defined. Cross-functional processes Process 1: Good Engineering Practicess Good Engineering Practices are a matter of common sense: good, well-defined and shared organization from the start of a project facilitates its implementation.

Poorly defined or undefined organizational problems at the start of a project will inevitably contaminate technical problems that will certainly arise. Process 3: Design Review The design review is an iterative process. Accordingly, it has to be approached on a step by step basis as supplier design documents are published. This phase is critical to ensuring the system design meets needs. It is aimed at reducing the need for any modifications following handover of the system to end users, as well as avoiding repeat tests following a modification that can have a considerable impact on the launch of production.

Consequently, this activity should be repeated whenever there is a design change. Conversely, since modifications are identified at an early stage via a well-prepared design, they should be easier to resolve as a result. Indispensable from the beginning of the project, they participate in the definition of needs, the identification of critical aspects, the system design review, the development of the verification strategy and the choice of acceptability criteria.

They also carry the approach by the Quality Risk Analysis. They must know the principles of ASTM E and be trained in regulatory requirements, in particular good documentary practices. QA controls and focuses its efforts on critical aspects of the processes and systems that may have an impact on product quality. In particular, it validates all verification acceptance criteria related to critical aspects. This organization is reflected in different resources being mobilized throughout the project.

Such an approach makes it possible to take full advantage of the expertise of each individual player, and thus better safeguard projects. It covers the entire project and involves all players from the very start of the project, from the needs definition phase. Driven by solid anticipation of the design step and the appropriate blend, the approach enables efficient verification via the execution of the right tests at the right time.

After his intervention on several local projects, he covers the CQV activities on all corporate projects realized in Europe. He then participates in a global program consisting of 4 similar projects located in Italy, the United States, France and China, the object being to replicate to be more effective.


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