Conformity tests according to ICH guidelines: stability, bioavailability and content studies
Quality, safety and efficacy are important concepts in drug manufacturing. To ensure that these processes are carried out in accordance with international standards, the guidelines of the ICH (International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use) serve as the basis.
What are the ICH guidelines?
The ICH guidelines set international common standards for drug development and approval. Their main objective is to ensure the quality, safety and efficacy of medicines. Their other goals include harmonizing the standards of regulators in Europe, the US, Japan, and other countries, as well as saving time and costs by avoiding repeated testing of the same drug in different countries. In addition, they facilitate the faster approval of drugs on the global market.
What are the main categories of the ICH Guidelines?
Q – Quality: This category covers topics such as drug manufacturing, stability, impurities, and validation of analytical methods.
- Example: ICH Q1 (stability tests), ICH Q2 (validation of analytical methods).
S – Safety: This category includes safety tests such as toxicology, genotoxicity, and carcinogenicity.
E – Efficacy: This category includes clinical trial design, bioavailability, bioequivalence, and pharmacovigilance standards.
M – Multidisciplinary: This category includes guides on various areas such as the electronic application format (eCTD) and medical terminology (MedDRA).
We support you in conducting stability tests, bioavailability tests, content and quantity analysis in accordance with the ICH guidelines recognized by the regulatory authorities (EMA, FDA, TİTCK). Let's get to know the scope of these tests.
Stability tests (ICH Q1A – Q1F)
The main purpose of this test is to determine the shelf life and storage conditions of the drug. Real-time and accelerated testing is designed to determine the effects of factors such as temperature, humidity, and light. The test results are used to obtain scientific data on durability.
Bioavailability tests (ICH M9, E6)
This test, which is performed to determine how much of the drug is absorbed in the body and how effective it is, is supported by preclinical and clinical studies. Bioequivalence tests are carried out for generics.
Content and Quantity Analysis (ICH Q2 – Validation Guide)
The aim of the test is to prove the correctness and quantity of active ingredients and excipients contained in the drug using methods such as HPLC, GC and spectrophotometry. Accuracy, precision and repeatability must be verified by validation of the analytical method.