STABILITY STUDY

November 17, 2016January 24, 2024 Pharmaceutical Guidanace

STABILITY STUDY MANAGEMENT

To lay down the procedure to conduct stability studies of the drug product (dosage forms)/ Drug substances (API). This Document describes the procedure for assigning the stability of drug substances (Active pharma ingredients) and drug products (Packed finished dosage forms).
The purpose of stability studies is to obtain an evidence on how the quality of drug substance and drug product varies with time under the influence of a variety factors such as temperature, humidity and light, and enables establishment of recommended storage conditions retest period (for drug substances and Intermediates) and shelf life for (drug products).

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STABILITY STUDY MANAGEMENT

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