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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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.

Subject Matter Experts and suppliers. Poorly defined or undefined organizational problems at the start of a project will inevitably contaminate technical problems that will certainly arise. Test duplication will be avoided provided change is managed, tests that may be conducted at the supplier’s site, even if only partially. After his intervention on several local projects, xstm covers the CQV activities on all corporate projects realized in Europe.

The collaboration was a great success and will help Pfizer implement the new verification approach ee2500 in its manufacturing facilities around the world.

Good Manufacturing Practices IQ: Henriette Schubert Meet Henriette Schubert, our global expert in process architecture, laboratories, biocontainment and GMP facility design. Conversely, since modifications are identified at an early stage via a well-prepared design, they should be easier to resolve as a result.

Such an approach makes it possible to take full advantage of the expertise of each individual player, and thus better safeguard projects. Read more here including how to disable cookies. 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.


Ensure that your manufacturing facility and processes are GMP compliant. The more detailed the documentation, the more companies felt they were in compliance. ASTM E is a standard relating to the specification, design and verification of Pharmaceutical and Biotechnological manufacturing systems and equipment.

Linkedin Send by mail. This phase is critical to ensuring the system design meets needs. Verification The verification phase is aztm on two major principles: 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.

Share Article Linkedin Send by mail. Requirements The “requirements” are the basis of the Verification, the whole documentary pyramid relating to the verifications is built on these foundations. 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. A3P Association Who are we?

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

Supported by the FDA, this widespread approach in the US is starting to be rolled out in Europe, especially to industrialists. ASTM E is an approach that goes well beyond verification. During e5200 step, it is important to draw up a summary document listing all tests carried out, the dates they were carried out and their status. In fact, sometimes the verification step is needed to finalize it.

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. Accordingly, some tests may be conducted at the supplier’s site, either totally or partially. 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.


It covers the entire project and involves all players from the very start of the project, from the needs definition phase. Moreover, the Verification process consists in limiting test duplication.

Validation transformation from C&Q to ASTM E

Home Projects Supporting validation transformation 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. 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.

Consequently, this activity should be repeated whenever there is a design change. They also carry the approach by the Quality Risk Analysis. Learn more about our GMP consulting and engineering services. The steps Step 1: The risk management approach focused on product quality and patient safety enables tailoring of requirements specification efforts and streamlined verifications.

The ASTM E standard focuses on the critical aspects of pharmaceutical manufacturing with regard to the patient. Meet Henriette Schubert, our global expert in process architecture, laboratories, biocontainment and GMP facility design.