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: Tygolar Grole
Country: Botswana
Language: English (Spanish)
Genre: Software
Published (Last): 6 May 2012
Pages: 469
PDF File Size: 1.1 Mb
ePub File Size: 8.94 Mb
ISBN: 543-7-92328-124-5
Downloads: 47342
Price: Free* [*Free Regsitration Required]
Uploader: Faurn

GMP and compliance Americas. 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. It is important that they are clearly defined.

This phase is critical to ensuring the system design meets needs. 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. Similarly, some tests may be delegated to suppliers as they are experts in their own systems.

Subject Matter Expert T to M: All of these tests, collectively referred to astk “Verification”, can now be organized more freely and rationally in order to be more efficient and adapt to each context.

Subject Matter Experts and suppliers. Meet Henriette Asgm, our global expert in process architecture, laboratories, biocontainment and GMP facility design. Read more here including how to disable cookies. 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 collaboration was a great success and will help Pfizer implement the new verification approach system in its manufacturing facilities around asttm world. 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. Henriette Schubert Meet Henriette Schubert, our global expert in process architecture, laboratories, biocontainment and GMP facility design.

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

ASTM E is an approach that goes well beyond verification. It covers the entire project and involves all players from the very start of the project, from the needs definition phase. Requirements The “requirements” are the basis of the Verification, the whole documentary pyramid relating to the verifications is built on these foundations. Linkedin Send by mail.

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

The more detailed the documentation, the more companies felt they were in compliance. Ensure that your manufacturing facility and processes are GMP compliant. TechTalk Personalised drugs transform the way authorities handle GMP With an increase of personalised medicine, regulatory authorities must approve products faster.

Consequently, this activity should be repeated whenever there is a design change. The risk management approach focused on product quality and patient safety enables tailoring of requirements xstm efforts and streamlined verifications. In particular, it validates all verification acceptance criteria related to critical aspects. The principle The ASTM E wstm 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.


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

The steps Step 1: 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. QA controls and focuses its efforts on critical aspects of the processes and systems that may have an impact on product quality.

Input data is knowledge of the product, knowledge of the manufacturing process, regulatory requirements and internal company requirements. Accordingly, it has to be approached on a step by step basis as supplier design documents are published.

Validation transformation from C&Q to ASTM E

The application of these two principles allows the execution of a “right first” test. Supported by the FDA, this widespread approach in the US is starting to be rolled out in Europe, especially to industrialists.

In fact, sometimes the verification step is needed to finalize it. Learn more about our GMP consulting and e25000 services. Test duplication will be avoided provided change is managed, tests that may be conducted at the supplier’s site, even if only partially.

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

This organization is reflected in different resources being mobilized throughout the project. Accordingly, some tests may be conducted at the supplier’s site, either totally or partially. Home Projects Supporting validation transformation What else have personalised drugs changed in GMP?