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Quality Metrics Conformance Technical Guide

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 Metrics. Since publication of the Pharmaceutical cGMPs for the 21st Century in 2004, 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."


Submission of Data Quality Metrics Guidance for Industry

Quality metrics are used Throughout The drugs and biologics NDUSTRY to monitor quality control systems and processes and drive continuous improvement efforts in drug manufacturing. These metrics can be Useful to FDA aussi: to help Develop compliance and inspection policies and practices, Such As risk-based inspection scheduling of drug manufacturers; to Improve the Agency's Ability to predict, and The Therefore, Mitigate Possibly, future drug Shortages; and to encourage the pharmaceutical industry to Implement state-of-the-art, innovative quality management systems for pharmaceutical manufacturing.


Reporting for Medical Device Manufacturers Guidance for Industry

This guidance paper Describes and Explains the Food and Drug Administration's (FDA, we, us) That current regulation addresses reporting and recordkeeping requirements applicable to manufacturers of medical devices for device-related adverse events and some Malfunctions.


Contract Manufacturing Arrangements for Drugs Quality Agreements Guidance for Industry

This guidance Describes FDA's current thinking on Defining, Establishing, and Documenting manufacturing activities of the Parties Involved in contract drug manufacturing subject to current Good Manufacturing Practice (CGMP) requirements. In Particular, we describe how parts Involved in contract drug manufacturing can use quality agreements to delineate Their manufacturing activities to Ensure compliance with CGMP.


Circumstances That Constitute Delaying, Denying, Limiting, gold has Refusing Drug Inspection Guidance for Industry

This guidance covers facilities That are subject to inspection under section 704 of the FD & C Act.2 This guidance olefins the type of action, inaction, and Circumstances que la FDA considers to Constitute Delaying, Denying, or limiting inspections, gold Refusing to permit entry or inspection for the Purposes of 501 section (j).


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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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BROWSER A3P is a tool comprising the majority of links to texts, guides, regulatory documents and websites for the pharmaceutical, biotechnology and biomedical.
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