Filtration is a common method of sterilizing drug product solutions. An appropriate sterilizing grade filter is one which reproducibly removes all microorganisms from the process stream, producing a sterile effluent. Such filters usually have a rated porosity of 0.2 micron or smaller. Whatever filter or combination of filters is used, validation should include microbiological challenges […]
3. Steps of Validation Validation plans for water and air systems typically include the following steps: 1. Establishing standards for quality attributes of water and air to manufacture pharmaceuticals. 2. Defining systems and subsystems suitable to produce the desired water and air by considering the quality grades of water and air. 3. Designing equipment, controls, […]
B. Validation life cycle 1. Determination of Quality Attributes In performing the validation, defining the quality attributes—that is, gaining a clear understanding of the required quality and intended use—is the most important issue, and should be determined before starting the validation. Without defining required quality attributes we cannot establish validation protocols, which are the basis […]
II. VALIDATION STRATEGY A. Validation Concept To prove the performance, one must demonstrate (document) that the processes or systems consistently produce the specified quantity and quality of water and/or air when operated and maintained according to specific written operating and maintenance procedures. In other words, validation involves proving 1. Engineering design 2. Operating procedures and […]
SMS service for awareness on cheaper drugs: Sep 1, 2012, 12.59PM IST, The writer has posted comments on this article PTI NEW DELHI: The Department of Pharmaceuticals in the Ministry of Chemicals and Fertilisers is planning to launch a SMS service providing information about affordable alternatives to medicines prescribed by doctors.The Short Message Service (SMS) […]
I. PURPOSE OF VALIDATION High-quality water and air are essential for the manufacture of pharmaceuticals. Water is the most commonly used raw material in pharmaceutical manufacturing; it is indirectly used in the manufacture of all dosage forms for cleaning manufacturing equipment, and is also used as a major component which constitutes injectable products. It is […]
Introduction: Heating, ventilation and air-conditioning (HVAC) play an important role the manufacture of quality pharmaceutical products. A well designed HVAC system will also provide comfortable conditions for operators. HVAC system design influences architectural layouts with regard to items such as airlock positions, doorways and lobbies. The architectural components have an effect on room pressure differential […]
About HEPA (High efficiency particulate air) High-Efficiency Particulate Air or HEPA is a type of air filter. It is a type of filter which has high efficiency to filter out about 99.997% that is why they are termed as High efficiency particulate air filter,HEPA filters are made up of a mesh of fiber glass […]
I. INTRODUCTION This article is written to guide and design how to set up validation procedure, one must recognize that for cleaning validation, as with validation of other processes, there may be more than one way to validate a process. In the end, the test of any validation process is whether scientific data shows that […]
The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) is a project that brings together the regulatory authorities of Europe, Japan and the United States and experts from the pharmaceutical industry in the three regions to discuss scientific and technical aspects of pharmaceutical product registration. The purpose of […]
