The purpose of my presentation is to look at industry expectations for GMP projects in light of the ASTM E guidance. I will also look at the. standard: ASTM E, Standard Guide for Specifica- tion, Design, and Verification of Pharmaceutical and Bio- pharmaceutical Manufacturing Systems and. When Pfizer wanted to change its traditional approach to validation, NNE’s in- depth knowledge of the new ASTM E “Standard Guide for Specification.

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Performed too early the validity of its results may be challenged by modifications, disassembly or transport; executed too late it penalizes the planning of the project. The collaboration was a great success and will help Pfizer implement the new verification approach system in its manufacturing facilities around the world.

Conversely, since modifications are identified at an early stage via a well-prepared design, they should be easier to resolve as a result. Good Manufacturing Practices IQ: Accordingly, some tests may be conducted at the supplier’s site, either totally or partially. Where a prototype is concerned, it is evident that the design can only be partially defined. Consequently, this activity should be repeated whenever there is a design change.

What else have personalised drugs changed in GMP?

The more detailed the documentation, the more companies felt they were in compliance. Read more here including how to disable cookies. In general, the pharmaceutical industry has increased spending on documenting validation activities over the past 20 years. Should reservations remain at the point of transfer, they should only concern non-critical aspects and resolution dates must be defined.

Accordingly, it has to be approached on a step by step basis as supplier design documents are published.


After his intervention on several local projects, he covers the CQV activities on all corporate projects realized in Europe.

Meet Henriette Schubert, our global expert in process architecture, laboratories, biocontainment and GMP facility design. 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 implication of the users and EMS in this step is then essential, they will identify the different user needs and will facilitate the identification of the critical aspects. We use cookies for the purpose of improving your site experience, site traffic analytics, statistics, and marketing from us and certain third parties — click here to see who.

Supporting validation transformation from C&Q to risk-based approach

In fact, sometimes the verification step is needed to finalize it. In particular, it validates all verification acceptance criteria related to critical aspects.

ASTM E is a standard relating to the specification, design and verification of Pharmaceutical and Biotechnological manufacturing systems and equipment. All of these tests, collectively referred to as “Verification”, can now be organized more freely and rationally in order to be more efficient and adapt to each context.

ASTM E 1 has many similarities to the classic “V” cycle process from the definition of requirements to the maintenance of the validated state.

Requirements The “requirements” axtm the basis of the Verification, the whole documentary pyramid relating to the verifications is built on these foundations. 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.

Validation transformation from C&Q to ASTM E

It covers the entire project and involves all players from the very start of the project, from the needs definition phase. Tests are only repeated if necessary or in the event of a change.


Verification The verification phase is based on two major principles: The principle The ASTM E method makes it possible to control the implementation of a system in production and to secure the projects by focusing on the critical aspects from a GMP point of view, at each stage of the process. They must know the principles of ASTM E and be trained in regulatory requirements, especially good documentary practices. Henriette Schubert Meet Henriette Schubert, our global expert in process architecture, laboratories, biocontainment and GMP facility design.

They also carry the approach by the Quality Risk Analysis.

ASTM E let’s cross the Bridge! – A3P – Pharmaceutical Industry & Biotechnology

Subject Matter Expert T to M: Focus on what is critical to the patient In general, the pharmaceutical industry has increased spending on documenting validation activities over the past 20 years. Input data is knowledge of the product, knowledge of the manufacturing process, regulatory requirements and internal company requirements.

The system concerned can then be transferred to the following step. The ASTM E standard focuses on the critical aspects of pharmaceutical manufacturing with regard to the patient. Moreover, the Verification process consists in limiting test duplication. Similarly, some tests may be delegated to suppliers as they are experts in their own systems. Design Review The design review is an iterative process. It is an iterative step; regular meetings are held to adjust solutions proposed by suppliers and ensure they are clearly understood.