Quality management is a cornerstone in ensuring the excellence and reliability of products. At FWQRC-Global GxP & Regulatory Consultant, we firmly believe in Marquardt’s 1984 quality management success triad, comprising of:

#Quality Philosophy and Policy: This is the foundation, embodying our core beliefs and guiding principles that steer our approach to quality.

#Quality Management Systems: Our structured processes and procedures are designed to consistently meet quality standards.

#Quality Technology Systems: We leverage cutting-edge technology to enhance and monitor the quality of our products.

Balancing these three facets is crucial. Each element is interdependent, contributing uniquely to the overall quality landscape. We ensure that equal attention and innovation are infused into each facet, fostering a holistic approach that elevates product quality while ensuring compliance with global standards.

Join us in this journey of uncompromised quality. Your support amplifies our commitment to delivering excellence consistently. Let’s together build a world where quality is not just a standard, but a way of life.

Do you need an advisor, compliance expert, technologist, or ongoing support?

Is there a need for a process expert to create SOPs from cGMP?

Are you looking for an eQMS expert for a software implementation or system import?

Will your organization need to meet compliance requirements by a deadline?

FWQRC has a proven track record in facilitating success for numerous life science organizations.

Contact us to learn more and get the conversation started info@fwqrc.com

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WHO along with many international and regional organizations and national authorities recognizes the potential of Artificial Intelligence (AI) in accelerating the digital transformation of health care.

AI has an evident potential to strengthen health service delivery to underserved populations, enhance public health surveillance, advance health research and the development of medicines, support health systems management and enable clinical professionals to improve patient care and perform complex medical diagnoses.

However, existing and emerging AI technologies, including large language models, are being rapidly deployed without a full understanding of how such AI systems may perform potentially either benefitting or harming end users, including health-care professionals and patients.

Consequently, to facilitate the safe and appropriate use of AI technologies for the development of AI systems in health care, the WHO and the International Telecommunication Union (ITU) have established a Focus Group on AI for Health (FG-AI4H)

WHO document (i.e., ISBN 978-92-4-007888-8) provides a listing of key regulatory considerations and as a resource that can be considered by all relevant stakeholders in medical devices ecosystems, including developers who are exploring and developing AI systems, regulators who might be in the process of identifying approaches to manage and facilitate AI systems, manufacturers who design and develop AI-embedded medical devices, health practitioners who deploy and use such medical devices and AI systems, and others working in these areas

Advanced manufacturing can integrate novel technological approaches, use established techniques in an innovative way, or apply production methods in a new domain where there are no defined best practices or experience.

Advanced manufacturing can potentially be used for new or currently marketed small molecule drugs or biological products.

FDA’s Advanced Manufacturing Technologies Designation Program, which is required under section 506L of the Federal Food, Drug, and Cosmetic Act (FD&C Act), offers a framework for persons or organizations (e.g., applicants, contract manufacturers, technology developers) to request designation of a method or combination of methods of manufacturing a drug as an AMT.

The program is intended to facilitate the development of drugs that are manufactured using a designated AMT, submitted in an application under section 505 of the FD&C Act (21 68 U.S.C. 355) or section 351 of the Public Health Service Act (PHS Act, 42 U.S.C. 262), and regulated by the Center for Drug Evaluation and Research (CDER) or the Center for Biologics Evaluation and Research (CBER). The holder of the AMT designation or another authorized party may reference or rely upon data or information about the designated AMT in an application in the same context of use for which the designation was granted.

FDA will expedite development and assessment of an application, including supplements, for drugs that are manufactured using a designated AMT as described in section 506L(d)(1) of the FD&C Act

Takeaway: Use of designated AMTs can provide greater assurance of quality, shorten drug development time, assist stakeholders in more efficiently meeting regulatory requirements for commercial manufacturing, and strengthen regulatory predictability for products that use a designated AMT.

To encourage the adoption of designated AMTs, FDA offers early engagement opportunities, before application submission, with persons or organizations seeking designation of a method of manufacturing as an AMT (hereinafter requestors), designated AMT holders, and applicants to advise on designated AMTs and their implementation in drug manufacturing.

The guidance assists stakeholders with cosmetic product facility registration and product listing submissions to FDA, by describing who is responsible for making the registration and listing submissions, what information to include, how to submit, when to submit, and certain exemptions to the registration and listing requirements.

As described in the guidance, FDA will be using the FDA Establishment Identifier (FEI) as the required facility registration number. To facilitate the registration process, the owner or operator of a facility will need to obtain an FEI number before submitting the facility registration.

Takeaway: The responsible person will need to obtain the relevant facility registration (FEI) number(s) for each facility where their cosmetic products are manufactured or processed, because the facility registration number(s) is required for the product listing submission. If the facility is a small business that is exempt from registration and has no facility registration number, then facility name/address can be provided instead for the product listing