Pharmaceutical Stability Study Guideline

Guidelines for conducting stability studies for new products are as follows: 1. Formal stability studies should include accelerated and long-term stability testing in at least two primary production batches for stable drug products and at least three primary production batches in the case of sensitive ...

SOP for Operation and cleaning of Stability Chamber

Objective: To set up a procedure for the operation and cleaning of Stability Chamber-III (Instrument ID: QC/040). Scope: This SOP is applicable for the operation and cleaning of Stability Chamber-III (Instrument ID: QC/040). Responsibility: 1. Operating personnel is responsible for carrying out the procedure. 2. ...

On-going stability programme

1. After marketing, the stability of the medicinal product should be monitored according to a continuous appropriate programme that will permit the detection of any stability issue (e.g. changes in levels of impurities or dissolution profile) associated with the formulation in the marketed package. 2. ...

Stability

In pharmaceutical industry, stability testing is a process that is used to determine the quality of a drug substance or drug product over a period of specified time under specific environmental conditions. With stability testing, pharmaceutical industry inspects the quality of drug substances and drug ...
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