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. What else have personalised drugs changed in GMP?

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

With an increase of personalised medicine, regulatory authorities must approve products faster. The system concerned can then be transferred to the following step. 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.

Cross-functional processes Process 1: Consequently, this activity should be repeated whenever there is a design change.

Validation transformation from C&Q to ASTM E

It is important that they are clearly defined. After his intervention on several local projects, he covers the CQV activities on all corporate projects realized in Europe.

Share Article Linkedin Send by mail. Good Manufacturing Practices IQ: Similarly, some tests may be delegated to suppliers as they are experts in their own systems. Driven by solid atm of the design step and the appropriate blend, the approach enables efficient verification via the execution of the right tests at the right time.

A3P Association Who are we? Supported by the FDA, this widespread approach in the US is starting to be rolled out in Europe, especially to industrialists. 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. They must know the principles of ASTM E and be trained in regulatory requirements, especially good documentary practices.


Home Projects Supporting validation transformation QA controls and focuses its efforts on critical aspects of the processes and systems that may have an impact on product quality.

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

TechTalk Personalised drugs transform the way authorities handle GMP With an increase of personalised medicine, regulatory authorities must approve products faster. 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.

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The ASTM E standard focuses on the critical aspects of pharmaceutical manufacturing with regard to the patient. 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.

It is an iterative step; regular meetings are held to adjust solutions proposed by suppliers and ensure they are clearly understood. In fact, sometimes the verification step is needed to finalize it. Design Review The design review is an iterative process. Poorly defined or undefined organizational problems at the start of a project will inevitably contaminate technical problems that will certainly arise.

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


Such an asstm makes it possible to take full advantage of the expertise of each individual player, and thus better safeguard projects. Linkedin Send by mail. ASTM E is a standard relating to the specification, design and verification of Pharmaceutical and Biotechnological manufacturing systems and equipment.

They also carry the approach by the Quality Risk Analysis. Subject Matter Experts and suppliers. Learn more about our GMP consulting and engineering services. 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.

Accordingly, it has to be approached on a step by step basis as supplier design documents are published. This organization is reflected in different resources being mobilized throughout the project.

Input data is knowledge of the product, knowledge of the manufacturing process, regulatory requirements and internal company requirements. Tests are only repeated if necessary or in the event of a change. In general, the pharmaceutical industry has increased spending on documenting validation activities over the past 20 years.

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

Accordingly, some tests may be conducted at the supplier’s site, either totally or partially. ASTM E 1 has many similarities to the classic “V” cycle process from the definition of requirements to the maintenance of the validated state.