ICH | What is ICH Guidelines in Pharma
What is the ICH (International Conference on Harmonization)?
The International Conference on Harmonization of Technical Requirements for Registration of Pharmaceutical Products for Human Use (or ICH) is a project that brings together drug regulatory authorities in Europe, Japan and the United States of America and pharmaceutical companies to discuss scientific and technical aspects of pharmaceutical product registration.
ICH objective
The objective is to reduce or avoid the need to duplicate the tests carried out during the research and development of new drugs, to recommend ways to achieve greater harmonization in the interpretation and application of the technical guidelines and requirements for obtaining records. Harmonization should lead to:
Economize human, animal and material resources
Encourage the elimination of unnecessary delays in the availability of new drugs
Maintain guarantees of quality, safety and efficacy
Create restrictions to protect public health
The main outcome of the Harmonization Conference was the Good Clinical Practice Guidelines. ICH guidelines have been adopted into law in several countries, but are only used as guidelines by the FDA.
ICH Guidelines List:
Stability: Q1A - Q1F
Photostability: Q1B
Analytical Validation: Q2
Impurities: Q3A - Q3D
Pharmacopoeias: Q4 - Q4B
Quality of biotech 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 pharmaceutical substances: Q11
Q11 – Development and Manufacture of Drug Substances (Chemical Entities Biotechnological/Biological Entities)
Q12 – Life Cycle Management
Who does the ICH guidelines apply to?
The ICH standards are applicable to all laboratories for the manufacture of medicines for human use, but can also be extended or used as a reference in laboratories that manufacture drugs for veterinary use, companies that manufacture food for both human and animal consumption, and companies that manufacture cosmetic products. or hygiene, both for human and animal use.
