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

The International Council on Harmonisation (ICH) “Q8(R2) Pharmaceutical Development,” published November 20, 2009, provides information on how to present knowledge gained when applying scientific approaches and quality risk management for developing and manufacturing a product. The annex in ICH Q8(R2) further clarifies key concepts outlined in the original guidance published in June 2006 and describes the principles of quality by design (QbD). Some of the information described in ICH Q8(R2) represents the minimum amount of information the applicant should provide in 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 organizations that develop, manufacture and package, test, distribute and monitor pharmaceutical products. Implicit in the assessment and review process is trust between the regulator and the regulated that the information submitted in dossiers and used in day-to-day decisionmaking is comprehensive, complete and reliable. The data on which these decisions are based should therefore be complete as well as being attributable, legible, contemporaneous, original and accurate, commonly referred to as “ALCOA”.

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ECA/PQG Working Group finalises GDP Interpretation Guide

The last three chapters of an interpretation of the EU Good Distribution Practice Guide (GDP) have been published jointly by the ECA Foundation Working Group on GDP and the Pharmaceutical Quality Group (PQG). Both organisations 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 sterilisation of the medicinal product, active substance, excipient and primary container

This guideline provides guidance on the documentation expected for sterile products in the quality dossier for a marketing authorisation application or a variation application for a medicinal product, (called quality dossier throughout the guideline), and the selection of appropriate methods of sterilisation 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 CFR parts 210, 211, and 212. Part 210 covers Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding of Drugs; General; part 211 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 creation and handling of data in accordance with CGMP requirements.

→ Data Integrity and Compliance With CGMP Guidance for Industry - Draft Guidance


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