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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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. The document does not prescribe any particular analytical, nonclinical or clinical strategy.

Q2 R1 Revision The scope of the revision of ICH Q2 R1 will include validation principles that cover analytical use of spectroscopic or spectrometry data e. 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.

It contains the Interchangeability Statement from Health Canada. 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.

Given the nature of this topic, no Concept Paper was developed for Q4B. The Guideline specifically deals with those impurities which might arise as degradation products of the drug substance or arising from interactions between drug substance and excipients or components of primary packaging materials. This Guideline is intended to provide guidance on the contents of Section 3. A corrigendum to calculation formula for NMP was subsequently approved on 28 October Q4B Annex 4B R1.


This topic was endorsed by the Assembly in June Guideline withdrawn on 8 June EC, Europe – Deadline for comments by 16 August Harmonisation achievements in the Quality area include pivotal milestones such as the conduct of stability studies, defining relevant thresholds for impurities testing and a more flexible approach to pharmaceutical quality based on Good Manufacturing Practice GMP risk management.

Step 4 – Audio presentation.

Quality Guidelines : ICH

The main emphasis of the document is on quality aspects. W6a gained with the implementation of the ICH Q7 Guideline since its finalisation in shows that uncertainties related to the interpretation of some sections exist.

Q14 Analytical Procedure Development. Q14 Analytical Procedure Development Guideline The new guideline is proposed to harmonise the scientific approaches of Analytical Procedure Development, qa to provide the principles relating to the description of Analytical Procedure Development process. Implementation of the Q4B annexes is intended to avoid redundant testing by industry.

This is concerned with testing and evaluation of the viral safety of biotechnology products derived from characterised cell lines of human or animal origin. For each regulatory q6s this pharmacopoeial text is non-mandatory and is provided for informational purposes only.

The correction was integrated in the Guideline that was then renamed Q5A R1. Where a company chooses to apply quality by design and quality risk management Q9: Therefore, this guideline is intended to assist in the collection of relevant technical information guideliine serves as evidence that the manufacturing process changes will not have an adverse impact on the quality, safety and efficacy of the drug product.


Swissmedic, Switzerland – Refer to the press release on Swissmedic, Switzerland’s website. Products administered on skin and its appendages e.

Q11 Development and Manufacture of Drug Substances. Guideline for Residual Solvents. Tests for Specified Micro-organisms General Chapter.

Quality Guidelines

Share this page using your social media account. While the Q11 Guideline provides the framework, it cannot provide the detailed examples covering the breadth of potential case studies for products within scope of the guideline. 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.

The document with the first and second set of Points to Consider Document was finalised in June q6q Novemberrespectively.