A Review on Stability Guidelines by ICH and USFDA Guidelines for New Formulation and Dosage form
Abstract
Stability guidelines for new drug substance and new pharmaceutical formulations as per ICH and USP for the evaluation and consistency for new drug and pharmaceutical dosage form. The brief understanding of these guidelines can be easily recognized by this article. Stability testing Provide a evidence on how the quality of a drug substance or drug product varies with time under the influence of a variety of environmental factors such as temperature, humidity, and light. To establish a re-test period for the drug substance or a shelf life for the drug product and recommended storage conditions. Because physical, chemical or microbiological changes might impact the efficiency and security of the final product. To minimize the Adverse Effects Of Instability In Drug Products Loss of potency of drug such as Change in concentration of active drug, Alteration of bioavailability, Loss of content uniformity, Loss of pharmaceutical elegance and patient acceptability, Formation of toxic degradation products.
References
2. ich.org
3.ICH Harmonised Tripartite Guidelines – Stability Testing of New drug Substances and Products Q1A (R2).
4.ICH Harmonised Tripartite Guidelines- Stability Testing: Photo stability testing Of New Drug Substances and Products Q1B.
5.ICH Harmonised Tripartite Guidelines- Stability Testing for New Dosage Forms Q1C.
6.ICH Harmonised Tripartite Guidelines- Bracketing And Matrixing Designs For Stability Testing of New Drug Substances And Products Q1D.
7.ICH Harmonised Tripartite Guidelines- Evaluation For Stability Data Q1E.
8.ICH Harmonised Tripartite Guidelines – Stability Data Package For Registration Applications In Climatic Zones III And IV Q1F.
9.Guidance For Industry ANDA’s: Stability testing of Drug Substances And Products.
10.International Conference On Harmonization (ICH), Guidance For Industry, Q1A(R2) :Stability Testing of New Drug Substances And Products, “November 2003”
