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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Such an approach makes it possible to take full advantage of the expertise of each individual player, and thus better safeguard projects.

The collaboration was a great success and will help Pfizer implement the new verification approach system in its manufacturing facilities around the e2500.

Validation transformation from C&Q to ASTM E

Accordingly, ast 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. GMP and compliance Americas. The application of these two principles allows the execution of a “right first” test.

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

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.

ASTM E is a standard relating to the specification, design and verification of Pharmaceutical and Biotechnological manufacturing systems and equipment. Linkedin Send by mail. Verification The verification phase is based on two major principles: In particular, it validates all verification acceptance criteria related to critical aspects.


Henriette Schubert Meet Henriette Schubert, our global expert in process architecture, laboratories, biocontainment and GMP facility design. Share Article Linkedin Send by mail. Tests are only repeated if necessary or in the event of a change.

Ensure that your manufacturing facility and processes are GMP compliant.

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

In general, the pharmaceutical industry has r2500 spending on documenting validation activities over the past 20 years. It is important that they are clearly defined.

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. This phase is critical to ensuring the system design meets needs. Cross-functional processes Process 1: Learn more about our GMP consulting and engineering services. The system concerned can then be transferred to the following step.

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

Good Manufacturing Practices IQ: Asstm E 1 has many similarities to the classic “V” cycle process from the definition of requirements to the maintenance of the validated state. Should reservations remain at the point of transfer, they should only concern non-critical aspects and resolution dates must be defined.

Read more here including how to disable cookies. Requirements The “requirements” are the basis of the Verification, the whole documentary pyramid relating to the verifications is built on these foundations.

Conversely, since modifications are identified at an early stage via a well-prepared design, they should be easier to resolve as a result. Similarly, some tests may be delegated to suppliers as they are experts in their own systems.


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

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.

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. Consequently, this activity should be repeated whenever there is a design change. It is an iterative step; regular meetings are held to adjust solutions proposed by suppliers and ensure they are clearly understood.

They also carry the approach by the Quality Risk Analysis. A3P Association Who are we? Where a prototype is concerned, it is evident that the design can only be partially defined. This organization is reflected in different resources being mobilized throughout the project.

Poorly defined or undefined organizational problems e5200 the start of a project will inevitably contaminate technical problems that will certainly arise. 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.