Quality guidelines –ICH

Quality guidelines –ICH.

Short for International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use; the ICH is a collaborative project whose objective is to discuss scientific and technical aspects of pharmaceutical product registration. The regulatory authorities of Europe, Japan and the United States, as well as experts from the pharmaceutical industry across these three blocs have come together to form the ICH and carry out its stated objectives.

Aim of avoiding double work

The ICH essentially seeks to bring down, and wherever possible, eliminate the need to replicate the work done during the testing carried out for medicines. It seeks to harmonise and homogenise all the steps needed for research and development of new medicines in these three regions, so that costs come down and more effective ways of testing for and producing medicines can be brought about.

Quality guidelines

ICH has guidelines on Quality, as it has on other aspects such as safety, efficacy and multidisciplinary aspects. It has been issuing Final Guidance Documents for nearly two decades now. The ones pertaining to Quality come under guidelines whose names start from “Q”, symbolising Quality. Depending on their order, these guidelines bear titles that start from “Q”. So, Quality Guidelines start from Q1A and go on adding alphabets for additions into the guidelines.

From November 2005, the ICH Steering Committee has been implementing a new codification system for ICH Guidelines that it adopted that month. This is done to ensure that there is greater logic, consistency and clarity in the numbering/coding of ICH Guidelines.

As of now, this is how the codified guidelines for Quality, as laid out by the ICH, look:

• Stability Q1A – Q1F

• Analytical Validation Q2

• Impurities Q3A – Q3D

• Pharmacopoeias Q4 – Q4B

• Quality of Biotechnological Products Q5A – Q5E

• Specifications Q6A- Q6B

• Good Manufacturing Practice Q7

• Pharmaceutical Development Q8

• Quality Risk Management Q9

• Pharmaceutical Quality System Q10

• Development and Manufacture of Drug Substances Q11

• Cross-cutting Topics






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