ASEAN Guideline on Stability Study of Drug Product

Hướng dẫn của Asean về nghiên cứu độ ổn định của thuốc.

1. INTRODUCTION
1.1 The objective of a stability study is to determine the shelf-life, namely the time period of storage at a specified condition within which the drug product still meets its established specifications.
1.2 Stability is an essential factor of quality, safety and efficacy of a drug product. A drug product, which is not of a sufficient stability, can result in changes in
physical (like hardness, dissolution rate, phase separation, etc.) as well as in chemical characteristics (formation of high risk decomposition substances). Microbiological instability of a sterile drug product could also be hazardous.
1.3 The stability study consists of a series of tests in order to obtain an assurance of stability of a drug product, namely maintenance of the specifications of the drug product packed in its specified packaging material and stored in the established storage condition within the determined time period.
2. OBJECTIVES
This guideline is intended to provide recommendations on the core stability study package required for drug products, but leaves sufficient flexibility to encompass the variety of different practical situations that may be encountered due to specific scientific considerations and characteristics of the products being evaluated. This guideline can also be used to propose shelf-life based on the stability data generated from the study package.

Click here to get completed document.

 

 

Bình luận

Bài viết liên quan


  • Hotline : 0906094868

Cpharma.vn © Copyright 2013

phone 0906 094 868