Archive for category Assurance Research
Managing Science and Research
Posted by admin in Assurance, Assurance Research on October 6, 2011
Managing science and research requires a unique skill set that are not the same as general management skills required for other types of businesses. General management theory is applicable to science and research management, but not sufficient to cater for the specific requirements of science and research management. For that purpose we assume in this article that the reader is already familiar with general management principles and approaches. Our focus here is to look at the specific requirements of science and research management.
An important aspect is understanding what would constitute good science and how to create an environment that would allow the knowledge generation aspect of science and research to flourish. Important aspects that differ from general management principles are:
1. Quality assurance often supersedes the process-focused approach in organization generally. Especially where the problems are not standard and therefore require unique approaches to be solved, it is very difficult to provide consistent quality assurance and performance indicators. Read the rest of this entry »
Quality Assurance in Pharmaceutical Industry
Posted by admin in Assurance Research, Quality Assurance on October 6, 2011
Pharmaceutical quality assurance is a dynamic process, a state of mind or an understanding of the regulations and guidance relating to the development and manufacture of pharmaceutical products.
Quality Assurance is a constituent of quality management riveted to assure, generate precise and reliable results on all lab activities that are undertaken. Drugs that are marketed must be safe and therapeutically active. Performance should be consistent and predictable. Or it can be defined as the sum of all activities and responsibilities required to ensure that the medicine that reaches the patient is safe and effective.
The System of Quality Assurance
This department can be divided into four major areas: Quality control, production, distribution, and inspections.
1. QA ensures the arrangements made for the manufacture, supply and use of the correct starting and packaging materials.
2. Any deviation from the written production and process control procedures which are followed in the execution of various production and process control functions shall be reported investigated and recorded by the quality dept. Read the rest of this entry »