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 astj review is an iterative process. With an increase of personalised medicine, regulatory authorities must approve products faster. The principle The ASTM E method asstm 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.

Henriette Schubert Meet Henriette Schubert, our global expert in process architecture, laboratories, biocontainment and GMP facility design.

Moreover, the Verification process consists in limiting test duplication. 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.

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

This phase is critical to ensuring the system design meets needs. TechTalk Personalised drugs transform the way authorities handle GMP With an increase of personalised medicine, regulatory authorities must approve products faster. Where a prototype is concerned, it is evident that the design can only be partially defined. Good Manufacturing Practices IQ: Ensure s2500 your manufacturing facility and processes are GMP compliant.

It is important that they are clearly defined. QA controls and focuses its efforts on critical aspects of the processes and systems that may have an impact on product quality. 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. This organization is reflected in different resources being mobilized throughout the project. Indispensable from the beginning of the project, they participate in the definition of needs, the identification of critical aspects, the system astj review, the development of the verification strategy and the choice of acceptability criteria.

Read more here including how to disable cookies. During this step, it is important to draw up a summary document listing all tests carried out, the wstm they were carried out and their status.

Consequently, this activity should be repeated whenever there is a design change. GMP and compliance Americas. Input data is knowledge of the product, knowledge of the manufacturing process, regulatory requirements and internal company requirements. In general, the pharmaceutical industry has increased spending on documenting validation s2500 over the past 20 years. ASTM E is an approach that goes well beyond verification.

Subject Matter Experts and suppliers. The application of these two principles allows the execution of a “right first” test. In particular, it validates all verification acceptance criteria related to critical aspects.

Verification The verification phase is based on two major principles: Conversely, since modifications are identified at asgm early stage via a well-prepared design, they should astj easier to resolve as a result.

Should reservations remain at the point of transfer, they should only concern non-critical aspects and resolution dates must be defined.

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

ASTM E is a standard relating to the specification, design and verification of Pharmaceutical and Biotechnological manufacturing systems and equipment. In fact, s2500 the verification step is needed to finalize it. Share Article Linkedin Send by mail. 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.

Test duplication will be avoided provided change is managed, tests that may be conducted at the supplier’s site, even if only partially. Accordingly, it has to be approached on a step by step basis as supplier design documents are published. The risk management approach focused on product quality and patient safety enables tailoring of requirements specification efforts and streamlined verifications.


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

It is an iterative step; regular meetings are held to adjust solutions proposed by suppliers and ensure they are clearly understood. Meet Henriette Schubert, our global expert in process architecture, laboratories, biocontainment and GMP facility design. By continuing astmm use our website you accept the use of cookies. Such an approach makes it possible to take full advantage of the expertise of each individual player, and thus better safeguard projects. The ASTM E standard focuses on the critical aspects of pharmaceutical manufacturing with regard to the patient.

Validation transformation from C&Q to ASTM E

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. They also carry the approach by the Quality Risk Analysis.

What else have personalised drugs changed in GMP? Cross-functional processes Process 1: The more detailed the documentation, the more companies felt they were in compliance. Learn more about our GMP consulting and engineering services. 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. A3P Association Who are we?

Requirements The “requirements” are the basis of the Verification, the whole documentary pyramid relating to the verifications is built on these foundations. Supported by the FDA, this widespread approach in the US is starting to be rolled ast, in Europe, especially to industrialists. The system concerned can then be transferred to the following step.