Compliance Testing according to ICH Guidelines: Stability, Bioavailability, and Assay Studies
Quality, safety, and efficacy are crucial concepts in pharmaceutical manufacturing. To ensure these processes are conducted 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 foundation.
What are the ICH Guidelines?
The ICH Guidelines establish international common standards for pharmaceutical development and registration. Their primary objective is to ensure the quality, safety, and efficacy of medicinal products. Additional goals include harmonizing regulatory standards across Europe, the USA, Japan, and other countries, as well as saving time and costs by avoiding redundant testing of the same drug in different regions. Furthermore, they facilitate the expedited approval of pharmaceuticals in the global market.
What are the main categories of the ICH Guidelines?
Q – Quality: This category covers topics such as pharmaceutical manufacturing, stability, impurities, and the validation of analytical methods.
- Example: ICH Q1 (Stability studies), ICH Q2 (Validation of analytical methods).
S – Safety: This category encompasses safety assessments such as toxicology, genotoxicity, and carcinogenicity.
E – Efficacy: This category covers clinical study design, bioavailability, bioequivalence, and pharmacovigilance standards.
M – Multidisciplinary: This category includes guidelines on various areas such as the electronic Common Technical Document (eCTD) format and medical terminology (MedDRA).
We assist you in conducting stability tests, bioavailability tests, and content and quantitative analyses in accordance with ICH guidelines recognized by regulatory authorities (EMA, FDA, TİTCK). Let us define the scope of these tests.
Stability studies (ICH Q1A – Q1F)
The primary purpose of this test is to determine the shelf life and storage conditions of the drug product. Real-time and accelerated tests are conducted to assess the effects of factors such as temperature, humidity, and light. The test results provide scientific data regarding shelf life.
Bioavailability tests (ICH M9, E6)
This test, conducted 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 performed for generic drugs.
Content and Quantitative Analyses (ICH Q2 – Validation Guideline)
The objective of the test is to demonstrate the accuracy and quantity of the active pharmaceutical ingredients (APIs) and excipients contained in the drug product, using methods such as HPLC, GC, and spectrophotometry. Accuracy, precision, and repeatability must be verified through analytical method validation.