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Human Factors Studies and Related Clinical Study Considerations in Combination Product Design and Development FDA Draft Guidance

Ce document Provides guidance to industry and FDA staff on the Underlying principles of human factors (HF) studies During the development of combination products as defined under 21 3 CFR Part. This guidance Describes Agency Recommendations Regarding HF information in a combination product marketing or investigational purposes and Clarifies the different kinds of HF studies; the recommended timing and sequencing of HF studies; HF studies and how are hand of the process to maximize the likelihood que la combination product user interface is safe and effective for use by The Intended users, uses, and environments. In addition, the guidance Describes how HF studies relates to --other clinical studies. The guidance aussi Provides process considerations for HF information in investigational or marketing applications to Promote Timely development and review of safe and effective combination products.

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Quality Metrics Technical Guide Conformance FDA Draft Guidance

This Quality Metrics Conformance Technical Guide (Guide) reserves as the technical reference for implementation of the draft FDA guidance for industry on Request for Quality MetricsSince publication of the Pharmaceutical cGMPs for the 21st Century in 2004,2 CDER HAS continued to Promote ict vision of "a maximally efficient, agile, flexible manufacturing sector reliably That Produces high-quality drug products without extensive Regulatory oversight."

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Guidance on Good data and record management practices- WHO

Medicines regulatory systems worldwide-have always depended upon the knowledge of organisms That develop, manufacture and package, test, distribute and monitor pharmaceutical products. Implicit in the assessment and review process is trust entre les regulator and the regulated que le Information submitted in folders and used in day-to-day decisionmaking is comprehensive, complete and reliable. The data is qui thesis decisions are based shoulds The Therefore be full as well as Attributable Being, legible, contemporaneous, original and accurate, Commonly Referred to as "ALCOA".

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Applying ICH Q8 (R2) Q9, and Q10 Principles to Chemistry, Manufacturing, and Controls Review (FDA)

The International Council on Harmonization (ICH) "Q8 (R2) Pharmaceutical Development," published November 20, 2009, provides information on how to present knowledge Gained When Applying scientific quality and risk management Approaches for Developing and manufacturing a product. The annex in ICH Q8 (R2) further Top Clarifies key concepts Outlined in the original guidance published in June and 2006 Describes the principles of quality by design (QbD). Some of the information Described in ICH Q8 (R2) Represents the minimum amount of information in the application covered shoulds Provide an application. "Enhanced" or QbD Approaches as described in ICH Q8 (R2) are Encouraged.

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Guideline on the sterilization of the medicinal product, active substance, excipient and primary container

This guideline Provides guidance on the documentation expected for sterile products in the quality for file has marketing permission or application changes applying for a medicinal product, (called Expired quality record Throughout The guideline), and the selection of Appropriate methods of sterilization for sterile products.

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The A3P Association is a major player in the pharmaceutical and biotechnology industry.
Created in 1986, it contributes to the good development of the production of medicines and clean and sterile equipment, it runs a network of professionals 21 000, manufacturers and suppliers, as part of International Congress and technical days.

It now has over 1700 members who share their technical experience, scientific and regulatory.

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