Stability studies of pharmaceutical products ensuring the maintenance of product quality, safety and efficacy throughout the shelf life are considered as prerequisite for the acceptance and approval of any pharmaceutical product. Stability of a pharmaceutical product may be defined as the capability of a particular formulation in a specific container/closure system to remain within its physical, chemical, microbiological, toxicological, protective and informational specifications. Stability studies are required to be conducted in a planned way following the guidelines issued by ICH, who and or other agencies. Importance of various methods followed for stability testing of pharmaceutical products, guidelines issued for stability testing and other aspects related to stability of pharmaceutical products have been included in the present review
The pharmaceutical industry is a vital component of health-care systems all over the world engaged in discovery, development, manufacture, and marketing of medicines for human as well as animal health. Pharmaceutical industries also have many environmental problems, like the other chemical industries. The pharmaceutical industry is based primarily on the scientific formulation, research, and development of drugs, that is, helpful in the prevention or treatment of diseases and disorders. The manufacturing of APIs and formulation processes involves the use of various chemicals which includes various corrosive and irritant agents such as acids, bases, oxidizing and reducing agents, solvents, and many more which can be found sometimes at very high concentrations and are hazardous to health of persons performing the various processes during manufacturing and formulation of API and medicines. The effective management of the chemical risks linked to the handling of these agents is mandatory for the safety of the workers in the industry, ethically and also legally as per the rules and guidelines of various acts regulating the functioning of the pharma industry. This article provides a comprehensive review of various chemical hazards generally encountered by the pharmaceutical industry, its management and regulation in India.
The goal of the validation is to assure that quality is built into the system at every step, and not just tested for at the end. The validation activities will commonly include training on production material and operating procedures, training of people involved, and monitoring of the system while in production. Each and every doses form needs to be validated to reduce the chances of batch failures and market recalls. In case of metered-dose inhalers (MDIs) also it becomes mandatory. US Food and Drug Administration defines process validation as "establishing documented evidence which provides a high degree of assurance that a specific process will consistently produce a product meeting its predetermined specifications and quality characteristics." MDIs are known as device that is made to deliver a specific amount of aerosolized medication in the form of short burst directly to the lungs when inhaled by the patient. Furthermore, the inhalational drug delivery causes less pain and is convenient for administration. The patients of asthma, emphysema, and chronic obstructive pulmonary disease are prescribed for quicker relief. The present paper is a summary of process involved in the manufacturing of MDIs and focuses on the regulatory requirements along with their process validation.
Nanotechnology is the emerging field in medicine that is expected to induce exceptional therapeutic benefits. Nanoparticles have been improving the therapeutic effect of drugs and are prepared by using varioustechniques. Silver Nanoparticles are attracting interest for the clinical application because of its potential biological properties such as antibacterial properties; antifungal properties etc. Due to its highly efficient properties Silver Nanoparticles are invasively used in the field of medical and health care. Against a large number of micro-organisms, Silver Nanoparticles are proven to be exceptionally productive for their antibacterial effects. Its mechanism of action is still unknown but the method of synthesis is highly economical, affordable and reliable. Desired properties can be achieved by changing the shapes and Sizes of Silver Nanoparticles. The main aim of this work is to provide an outline and general review on Silver Nanoparticles, with special reference to their mechanism of action and antimicrobial activity.
Process validation is an essential part for the safety and quality of the drug products. Validation act as guidance that is intended to assist manufacturers in understanding quality management system requirements concerning process validation. It is a fundamental component for assuring the quality system used by pharmaceutical industries. Process validation is the key element to ensure the identity, purity, safety, and efficacy of drug products. The process validation of Prasugrel Hydrochloride Tablet USP precisely focused on the aim and method of analysis. The emphasis will be on the practical inspectional requirement, rather than on a theoretical approach that does not reflect the practicalities encountered when validating actual production operations. The Process validation reduces product recalls and troubleshooting assignments which results in more economical manufacturing process and quality products. In this paper an overview is given on process validation with special reference to solid dosage form of Prasugrel Hydrochloride Tablet USP containing dose of 10 mg.
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