October 3, 2020

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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Quality Guidelines : ICH

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

Q1A – Q1F Stability. However the principles in this guideline are important to consider during these stages. The scope of the revision of ICH Q2 R1 will include validation principles that cover analytical use of spectroscopic or spectrometry data e.

It advises on the types of information that are considered valuable in assessing the structure of the expression construct used to produce recombinant DNA derived proteins.

The main emphasis of the document is on quality aspects.

The annex is not intended to establish new standards: Validation of Analytical Procedures: With respect to the latter representatives from China, India and Australia have been invited to participate. The correction was integrated in the Guideline that was then renamed Q5A R1.


This Guideline provides recommendations on stability testing protocols including temperature, humidity and trial duration for climatic Zone I and II. The scope of this part is initially limited to well-characterised biotechnological products, although the concepts may be applicable to other biologicals as appropriate. Following favourable evaluations, ICH will issue topic-specific annexes with information about these texts and their implementation.

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.

Q1E Evaluation of Stability Data. Technical issues with regard to GMP of APIs — also in context with new ICH Guidelines – are addressed in this Question and Answer 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.

Q10 Pharmaceutical Quality System. The elements of Q10 should be applied in a manner that is appropriate and proportionate to each of the product lifecycle stages, recognising the differences among, and the different goals of each stage.

This topic was endorsed by the Assembly in June 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.

Quality Guidelines

Products administered on skin and its appendages e. Q3D R1 draft Guideline. In addition, this annex describes the principles of quality by design QbD. Q2 R1 Validation of Analytical Procedures: The guideline does not apply to contents of submissions for drug products during the clinical research stages of drug development.


This new guidance is proposed for Active Pharmaceutical Ingredients APIs harmonising the scientific and technical principles relating guidleine the description and justification of the development and manufacturing process CTD sections S 2. The document with the first and second set of Points to Consider Document was finalised in June and Novemberrespectively.

Q4B Annex 9 R1. This new guideline is intended to improve regulatory communication between industry and regulators and facilitate more efficient, sound scientific and risk-based approval as well as post-approval change management of analytical procedures.

Contribute to Q3D R1. Q4B Annex 7 R2.

To determine the applicability of this guideline gujdeline a particular type of product, applicants should consult with the appropriate regulatory authorities. Q4B Annex 10 R1. Share this page using your social media account. Furthermore, the revised document takes into account the requirements for stability testing in Climatic Zones III and IV in order to minimise the different storage conditions for submission of a global dossier.