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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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.

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. It covers the entire project and involves all players from the very start of the project, from the needs definition phase.


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. 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 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 important that they are clearly defined. Design Review The design review is an iterative process.

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

With an increase of personalised medicine, regulatory authorities must approve products faster. Linkedin Send by mail.


Moreover, the Verification process consists in limiting test duplication. Read more here including how to disable cookies. Learn more about our GMP consulting and engineering services. 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. Accordingly, some tests may be conducted at the supplier’s site, either totally or partially.

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.

The steps Step 1: 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.

Good Manufacturing Practices IQ: Subject Matter Expert T to M: The more detailed the documentation, the more asttm felt they were in compliance. Ensure that your manufacturing facility and processes are GMP compliant.

Verification The verification phase is based on two major principles: Share Article Linkedin Send by mail.

Validation transformation from C&Q to ASTM E

In particular, it validates all verification acceptance criteria related to critical aspects. Tests are only repeated if necessary or in the event of a change.

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

Consequently, this activity should be repeated whenever there is a design change. Conversely, since modifications are identified at an early stage via a well-prepared design, they should be easier to resolve as a result. GMP and compliance Americas. In fact, sometimes the verification step is needed to finalize it. The collaboration was a great success and will help Pfizer implement the new verification approach system in its manufacturing facilities around the world. Similarly, some tests may be delegated to suppliers as they are experts in their own systems.


The risk management approach focused on product quality and patient safety enables tailoring of requirements specification efforts and streamlined verifications. This phase is critical to ensuring the system design meets needs. It is an iterative step; regular meetings are held to adjust solutions proposed by suppliers and ensure they are clearly understood. Such an approach makes it possible to take full advantage of the expertise of each individual player, and thus better safeguard projects.

Cross-functional processes Process 1: After his intervention on several local projects, he covers the CQV activities on all corporate projects realized in Europe. 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. What else have personalised drugs changed in GMP?

ASTM E is a standard relating to the specification, design and verification of Pharmaceutical and Biotechnological manufacturing systems and equipment.

ASTM E 1 has many similarities to the classic “V” cycle process from the definition of requirements to the maintenance of the validated state. Supported by the FDA, this widespread approach in the US is starting to be rolled out in Europe, especially to industrialists. Subject Matter Experts and suppliers.