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.
HPLC is one of the most powerful techniques for separation and quantitative determination of the constituents in a mixture. It works on the principle of Affinity chromatography having two phases viz: stationary and mobile phase. The constituent with lower affinity for stationary phase travels faster and vice-versa. A detector in HPLC is placed at the end of the system. Its work is to analyse the solution which is eluting from the column. Detectors are broadly classified into two groups: Bulk property detectors and solute property detectors. Bulk property detectors (Nonselective detectors) are those that measure the changes in solute and mobile phase in combination. Such detectors show fluctuation in readings even with slight change in mobile phase combination. Solute property detectors are also called as selective detectors because they give response for a particular physical or chemical property of the analyte, being ideally independent of the mobile phase. Other than that there are numerous newer developments made in detectors for more accurate determination. The present paper is meant on to focus on different detectors used in HPLC, there area of utilisation and the advancement made in recent time.
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