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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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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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ECA / QGP Working Group FINALIZED GDP Interpretation Guide

The last three chapters of an interpretation of the EU Good Distribution Practice Manual (PEM) Jointly-have-been published by the ECA Foundation Working Group on GDP and the Pharmaceutical Quality Group (QGP). Both organizations joined Forces to Develop a Guide Intended to help colleagues in industry with the implementation of the EU GDP Guideline.

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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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Data Integrity and Compliance With CGMP Guidance for Industry

The purpose of this guidance is to Clarify the role of data integrity in current good manufacturing practice (CGMP) for drugs, as required in 21 210 CFR parts, 211, and 212. Part 210 covers Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding of Drugs; General; 211 hand covers Current Good Manufacturing Practice for Finished Pharmaceuticals; and part 212 covers Current Good Manufacturing Practice for Positron Emission Tomography Drugs. This guidance Provides the Agency's current thinking on the establishment and handling of data in according with CGMP requirements.

Data Integrity and Compliance With CGMP Guidance for Industry - Draft Guidance

 

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Transmit and progress together
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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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