Herbs are an effective source of Ayurvedic medicine and other traditional medicines as well as modern medicine. Faced with the challenges of modern medicine, the world is shifting toward Ayurvedic theories of health management. In the treatment of the disease, the use of drugs is not limited. This increases the demand for raw materials exponentially. However, production growth is still linear. Rapid depletion of resources creates major problems. To fill the deficit, advances in adulteration and substitution are becoming more prevalent. This adulteration and substitution are a burning problem in an industry that threatens the integrity of Ayurvedic system of medicine. Imprecise knowledge, misidentification, deforestation, and personal gain have led to adulteration. Therefore, an understanding of all ways of adulteration and substitutions is needed to amend this illegal act and maximize consumer safety. This article focuses on adulteration, its types and various methods of adulteration, as well as the concept of substitution, reasoning, and its types. Attempts have also been made to differentiate these two related terms.
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.
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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