Quality Guidelines. /ICH Guidelines; /Work Products; / Home. Harmonisation achievements in the Quality area include pivotal Q6A- Q6B Specifications. With this guideline on specifications and testing methods of new active substances and medicinal products ICH intends to make possible the compilation of a. ICH Q6A specifications: Test procedures and acceptance criteria for new drug The former guideline identifies the limits that are placed on Class 1, 2 or 3.

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Technical issues with regard to GMP of APIs — also in context with new ICH Guidelines – are addressed in this Question and Guidelkne document in order to harmonise expectations during inspections, to remove ambiguities and uncertainties and also to harmonise the inspections of both small molecules and biotech APIs.

The scope of this part is initially limited to well-characterised biotechnological products, although the concepts may be applicable to other biologicals as appropriate. Furthermore, it provides examples of statistical approaches to stability data analysis. Share this page using your social media account.

Quality Guidelines

In addition, guidance is provided in Q3D on how to develop an acceptable level for EIs for drug products administered by other routes of administration. Q3C Concept Paper March Consequently, the ICH SC considered guiddeline the development of a comprehensive training programme and supporting documentation sponsored by ICH was necessary to ensure the proper interpretation and effective utilisation by industry and regulators alike to enable a harmonised and smooth implementation of Q3D on a global basis.

The three organisations conduct their harmonisation efforts q6 a tripartite pharmacopeial harmonisation program known as the Pharmacopoeial Discussion Group PDG. Q2 R1 Validation of Analytical Procedures: Throughout the development of the Q3D Guideline, external audiences, constituents and interested parties have clearly communicated the complexity of the implementation approaches for this guideline.


ICH Q3D Elemental Impurities is a quality guideline for the control of elemental impurities in new drug products medicinal productsand it establishes Permitted Daily Exposures PDEs for 24 Elemental Impurities EIs for drug products administered by the oral, parenteral and inhalation routes of administration.

Q11 IWG – slide deck training material. Q6A activity provided the framework on how to set specifications for drug substances to address how regulators and manufacturers might avoid setting or agreeing to conflicting standards for the same product, as part of the registration in different regions.

This is concerned with testing and evaluation of the viral safety of biotechnology products derived from characterised cell lines of human or animal origin.

Guideline for Residual Solvents. It complements the Guideline on impurities in new drug substances and provides advice in regard to impurities idh products containing new, chemically synthesized drug substances. Quality Risk Managementlinked to an appropriate pharmaceutical quality system, then opportunities arise to enhance science- and risk-based regulatory approaches see Q This Guideline provides recommendations on stability testing protocols including temperature, humidity and trial duration for climatic Zone I and II.

This guideline might also be appropriate for other types of products. This new Guideline is proposed to: The Attachment 2 of this guideline has been revised under Step 4 without further public consultation on 25 October Q3A R2.

Quality Guidelines : ICH

Q4B Annex 1 R1. The new guideline is proposed to harmonise the scientific approaches of Analytical Procedure Development, and to provide the principles relating to the description of Analytical Procedure Development process.


In view of the nature of the products, the topic of specifications include in-process controls, bulk drug, final product and stability specifications and give guidance for a harmonised approach to determining appropriate specifications based on safety, process consistency, purity, analytical methodology, product administration and clinical data considerations.

Experience gained with the implementation of the ICH Q7 Guideline since its finalisation in shows that uncertainties related to the interpretation of some sections exist. Those Products can be found under the Mulidisciplinary Section.

Threshold values for reporting and control of impurities are guide,ine, based on the maximum daily dose of the drug substance administered in the product. It extends the main stability Guideline for new formulations of already approved medicines and defines the circumstances under which reduced stability data can be accepted. Q4B Annex 9 R1. In addition, this annex describes the principles of quality by icn QbD.

While the Q11 Guideline provides the framework, it cannot provide the detailed examples covering the breadth of potential case studies qq6a products within scope of the guideline.

Account has been taken of the considerable guidance and background information which are present in existing regional documents. Q4B Annex 10 R1. Q4B Annex 4B R1. A corrigendum to calculation formula for NMP was subsequently approved on 28 October The main emphasis of the document is on quality aspects.