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.

Author: Garamar Kigarn
Country: Mayotte
Language: English (Spanish)
Genre: Environment
Published (Last): 3 July 2004
Pages: 270
PDF File Size: 4.97 Mb
ePub File Size: 12.13 Mb
ISBN: 715-7-93643-317-9
Downloads: 37121
Price: Free* [*Free Regsitration Required]
Uploader: Nesar

ASTM E is a standard relating to the specification, design and verification of Pharmaceutical and Biotechnological manufacturing systems and equipment. Supported by the FDA, this widespread approach in the US is starting to be rolled out in Europe, especially to industrialists.

ASTM E 1 has many similarities to the classic “V” cycle process from the definition of requirements to the maintenance of the validated state. All of these tests, collectively referred to as “Verification”, can now be organized more 2e500 and rationally in order to be xstm efficient and adapt to each context.

Subject Matter Experts and suppliers. The principle The ASTM E method makes it adtm 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.

The risk management approach focused on product quality and patient safety enables tailoring of requirements specification efforts and streamlined verifications. The steps Step 1: Requirements The “requirements” are the basis of the Verification, the whole documentary pyramid relating to the verifications is built on these foundations.

It is important that they are clearly defined. 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. It is an iterative step; regular meetings e25500 held to adjust solutions proposed by suppliers and ensure they are clearly understood.


Where a prototype is concerned, it is evident that the design can only be partially defined. In fact, sometimes the verification step is needed to finalize it. Verification The verification phase is based on two major principles: The application of these two principles allows the execution of a “right first” test.

Performed f2500 early the validity of its results may be challenged by modifications, disassembly or transport; executed too late it penalizes the planning of the project.

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

Moreover, the Verification process consists in limiting test duplication. Tests are only repeated if necessary or in the event of a change.

Accordingly, some tests may be conducted at the supplier’s site, either totally or partially. Similarly, some tests may be delegated to suppliers as they are experts in their own systems. 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 system concerned can then be transferred to the following step.

Should reservations remain at the point of transfer, they should only concern non-critical aspects and resolution dates must be defined. Cross-functional processes Process 1: Poorly defined or undefined organizational problems at the start of a project will inevitably contaminate technical problems that will certainly arise.

Design Review The design review is an iterative process. Accordingly, it has to be approached on a step by step basis as supplier design documents are published.

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

This phase is critical to ensuring the system design meets needs. It is aimed at reducing the need for any modifications following handover of the system to end users, as well as avoiding repeat tests following a modification that can have a considerable impact on the launch of production. Consequently, this activity should be repeated whenever there is a design change. Test duplication will be avoided provided change is managed, tests that may be conducted at the supplier’s site, even if only partially.


Conversely, since modifications are identified at an early stage via a well-prepared design, they should be easier to resolve as a result.

This organization is reflected in different resources being mobilized throughout the project. Such an f2500 makes it possible to take full advantage of the expertise of each individual player, and thus better safeguard projects. ASTM E is an approach that goes well beyond verification. It covers the entire project and involves all players from e25000 very start of the project, from the needs definition phase. 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.

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

Validation transformation from C&Q to ASTM E

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.

Linkedin Send by mail. Good Manufacturing Practices IQ: Subject Matter Expert T to M: A3P Association Who are we? 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.

They also carry the astk by the Quality Risk Analysis. They must know the principles of ASTM E and be trained in regulatory requirements, especially good documentary practices. QA controls and focuses its efforts on critical aspects of the processes and systems that may have an impact on product quality. In particular, it validates all verification asgm criteria related to critical aspects. Share Article Linkedin Send by mail.