Monthly Archives: November 2012

Part III: Qualification of Water and Air Handling Systems

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 … Continue reading

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Part II: Qualification of Water and Air Handling Systems

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 … Continue reading

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Recent Facts of Indian Pharma Industry

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 … Continue reading

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Part I: Qualification of Water and Air Handling Systems

 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 … Continue reading

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Brief Idea On HVAC System

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 … Continue reading

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About HEPA filters used in HVAC system

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 … Continue reading

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Guide To Inspections Validation Of Cleaning Processes

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. … Continue reading

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Brief Introduction Of ICH Guidelines

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 … Continue reading

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Cleanroom Classification and Examples for Working Steps According to EU GMP Guide

Cleanroom Classification The current demands in today’s pharmaceutical industry for quality control and quality assurance have been driven by the aspiration to deliver consistently high quality and safe products to the consumer. The standards that are set to meet this … Continue reading

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Major Drug Regulatory Agencies World Wide

 Pharmaceutical companies and regulatory agencies work together to enhance patient safety when a medicine is first being studied (pre-approval) and after it becomes available to patients and their health care providers as a treatment option, following authorization by regulatory agencies … Continue reading

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