What is the Requirement For Conducting Stability Study in pharma?
Stability is an important study to conduct on the pharmaceutical product to determine the shelf-life of the product. The requirement for conducting stability study in pharmaceuticals is mandatory.
Stability studies are conducted on pharmaceutical dosage forms with the primary objective of determining their shelf life under recommended storage conditions.
The quality, safety, and efficacy of the dosage form should be ensured throughout its shelf life under prescribed storage conditions.
It is essential to decide the shelf life of a product based on the climate zone where it will be sold.
What are the factors to contribute the stability study?
The stability of pharmaceutical formulations is determined by a number of factors:
- Environmental factors
- Ingradients
- Manufacturing processes
- Packaging material
Environmental Factors:
The environmental factors that contribute to conducting stability studies are 1. Temperature, 2. Humidity, and 3. Exposure of light
These are three environmental factors that affect the drug product on the variation of changes.
Ingradients:
The chemical properties and physical properties of the drug substance, as well as excipients, are also factors that contribute to conducting a stability study.
Manufacturing Processes:
A formulation’s stability can be affected significantly by the conditions under which the components are exposed during manufacture.
Packaging Material:
Packaging material is also a factor that has direct contact with drug substances. Packaging materials and closures of containers have different properties.
It is also required to check the packaging materials and container closure systems and their compatibility.
Investigation of the possibility of interaction between packaging materials used for delivery, storage, and transit of drugs throughout shelf life is necessary.
What is the Methodology of Stability Study?
The characteristics of physical, chemical, biological, and microbiological stability are evaluated using validated methods of analysis.
Parameters commonly evaluated for stability study are, assay or potency, decomposition product concentration, hardness, disintegration, and dissolution.
To ensure there will be no loss over the shelf life period, the effectiveness of additives and antimicrobial agents is also checked.
What are the types of stability Studies?
In the manufacture and release of pharmaceutical products, stability tests are required at various stages.
- Development Phase
- Dossier registration
- Post-registration period
Development Phase:
The purpose of an accelerated stability test is to accelerate the physicochemical degradation of the pharmaceutical formulation. They can be used to evaluate formulations, packaging materials, and manufacturing processes.
Shelf life can also be predicted with these studies. In addition to accelerated studies, real-time studies and simulations should be conducted simultaneously.
Dossier Registration:
The manufacturers of drugs are required to provide information on the stability of the product in its container and packaging to the regulatory authorities. The data should be obtained from both real-time and accelerated studies.
If published data are available on the product or its ingredients, the submitted data should also be accompanied by that information.
Post-Registration Period:
Manufacturers must submit data on the expiration date of registration to the registration body that can be substantiated by real-time stability studies. Monitoring of stability studies occurs when the GMP inspection process takes place.
When there are major changes made to the manufacturing or packaging process of the formulation post-registration, the regulating authorities require additional data to be submitted.
In recent years, the quality and stability of pharmaceutical formulations have been revealed as an important concern for the well-being of the population as a whole.
These are the basic requirement for conducting stability study in pharmaceuticals is mandatory.
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