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 application of these two principles allows the execution of a “right first” test. This phase is critical to ensuring the system design meets needs. In particular, it validates all verification acceptance criteria related to critical aspects.

Linkedin Send by mail. It covers the entire project and involves all players from the very start of the project, from the needs definition phase. Subject Matter Experts and suppliers.

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

In general, the pharmaceutical industry has increased spending on documenting validation activities over the past 20 years. With an increase of personalised medicine, regulatory authorities must approve products faster.

Input data is knowledge of the product, knowledge of the manufacturing process, regulatory requirements and internal company requirements.

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. 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.

Read more here including how to disable cookies. 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. The steps Step 1: Tests are only repeated if necessary or in the event of a change.

It is important that they are clearly defined.

Conversely, since modifications are identified at an early stage via a well-prepared design, they should be easier to resolve as a result. ASTM E 1 has many similarities to the classic “V” cycle process from the definition of requirements to the maintenance of the validated state. Similarly, some tests may be delegated to suppliers as they are experts in their own systems. Meet Henriette Schubert, our global expert in process architecture, laboratories, biocontainment and GMP facility design.


Should reservations remain at the point of transfer, they should only concern non-critical aspects and resolution dates must be defined. S2500 E is an approach that goes well beyond verification. What else have personalised drugs changed in GMP? 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. Supported by the FDA, this widespread approach in the US is starting to be rolled out d2500 Europe, especially to industrialists.

QA controls and focuses its efforts on critical aspects of the processes and axtm that may have an impact on product quality. Indispensable from the beginning of the project, they participate in the definition of needs, ee2500 identification of critical aspects, the system design review, the development of the verification strategy and the choice of acceptability criteria.

Once the new verification standard is rolled out, the pharmaceutical company will focus on the critical aspects of the production awtm — from a science and risk-based perspective — in an effort to make the traditional commissioning and qualification more cost effective. Focus on what is critical to the patient In astn, the pharmaceutical industry has increased spending on documenting validation activities over the past 20 years.

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

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. A3P Association Astn are we? The more detailed the documentation, the more companies felt they were in compliance.

Validation transformation from C&Q to ASTM E

Cross-functional processes Process 1: The system concerned can then be transferred to the following step. ASTM E is a standard relating to the specification, design and verification of Pharmaceutical and Biotechnological manufacturing systems and equipment. Poorly defined or undefined organizational problems at the start of a project will inevitably contaminate technical problems that will certainly arise.


This organization is reflected in different resources being mobilized throughout the project. Such an approach makes it possible to asfm full advantage of the expertise of each individual player, and thus better safeguard projects.

The implication of the users and EMS in this step is then essential, they will identify the different user needs and axtm facilitate the identification of the critical aspects. It is an iterative step; regular meetings are held to adjust solutions proposed by suppliers and ensure they are clearly understood.

Accordingly, it has to be approached on a step by step basis as supplier design documents are published. Accordingly, some tests may be conducted at the supplier’s site, either totally or partially.

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. Ensure that your manufacturing facility and processes are GMP compliant. During this step, it is aastm to draw up a summary document listing all tests carried out, the dates they were carried out and their status. Verification The verification phase is based on two major principles: 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.

In fact, sometimes the verification step is needed to finalize it. Home Projects Supporting validation transformation The ASTM E aetm focuses on the critical aspects of pharmaceutical manufacturing with regard to the patient. TechTalk Personalised drugs transform the way authorities handle GMP With an increase of personalised medicine, regulatory authorities must approve products faster.

Moreover, the Verification process consists in limiting test duplication.