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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Design Review The design review is an iterative process. Requirements The “requirements” are the basis of the Verification, the whole documentary pyramid relating to the verifications is built on these foundations.

Ensure that your manufacturing facility and processes are GMP compliant. Meet Henriette Schubert, our global expert in process architecture, laboratories, biocontainment and GMP facility design. Once the new verification standard is rolled out, the pharmaceutical company will focus on the critical aspects of the production processes — from a science and risk-based perspective — in an effort to make the traditional commissioning and qualification more cost effective.

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. The application of these two principles allows the execution of a “right first” test.

Such an approach makes it possible to take full advantage of the expertise of each individual player, and thus better safeguard projects. This organization is reflected in different resources being mobilized throughout the project. It is an iterative step; regular meetings are held to adjust solutions proposed by suppliers and ensure they are clearly understood.

Good Manufacturing Practices IQ: 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. 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.

Supported by the FDA, this widespread approach in the US is starting to be rolled out in Europe, especially to industrialists. Conversely, since modifications are identified at an early stage via a well-prepared design, they should be easier to resolve as a result. In general, the pharmaceutical industry has increased spending on documenting validation activities over the past 20 years. 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 collaboration was a great success and will help Pfizer implement the new verification approach system in its manufacturing facilities around the world. In particular, it validates all verification acceptance criteria related to critical aspects. 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.

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. 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. Tests are only repeated if necessary or in the event of a change. It is important that they are clearly defined.

What else have personalised drugs changed in GMP?

Subject Matter Expert T to M: 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. Accordingly, it has to be approached on a step by step basis as supplier design documents are published. GMP and compliance Americas.

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

asstm It covers the entire project and involves all players from the very start of the project, from the needs definition phase. Home Projects Supporting validation transformation Test duplication will be avoided provided change is managed, tests that may be conducted at the supplier’s site, even if only partially. ASTM E is an approach that goes well beyond verification.

TechTalk Personalised drugs transform the way authorities handle GMP With an increase of personalised medicine, regulatory authorities must approve products faster.


The more detailed the documentation, the more companies felt they were in compliance. Input data is knowledge of the product, knowledge of the manufacturing process, regulatory requirements and internal company requirements.

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Validation transformation from C&Q to ASTM E

A3P Association Who are we? Learn more about our GMP consulting and engineering services. The ASTM E standard focuses on the critical aspects of pharmaceutical e250 with regard to the patient.

Henriette Schubert Meet Henriette Schubert, our global expert in process architecture, laboratories, biocontainment and GMP facility design. ASTM E 1 has many similarities to the classic “V” cycle process from e500 definition of requirements to the maintenance of the validated state. Where a prototype is concerned, it is evident that the design can only be partially defined. Should reservations remain at the point of transfer, they should only concern non-critical aspects and resolution dates must be defined.

The risk management approach focused on product quality and patient safety enables tailoring of requirements specification efforts and streamlined verifications. Asym fact, sometimes the verification step is needed to finalize it.

Poorly defined or undefined organizational problems at the start of a project will inevitably contaminate technical problems that will certainly arise. They also carry the approach by the Quality Risk Analysis.

Consequently, this activity should be repeated whenever there is a design change. QA controls and focuses its efforts on critical aspects of the processes and systems that may have an impact on product quality. 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.

Share Article Linkedin Send by mail. Subject Matter Experts and suppliers. After his intervention on several local projects, he covers the CQV activities on all corporate projects realized in Europe.

Similarly, some tests ast be delegated to suppliers as they are experts in their own systems.