薬学および生命科学における研究開発の国際ジャーナル

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The Role of Validations and Quality Management systems Related Regulatory observations in the Global Pharmaceutical sector

Dr. Sagaram Sudhakar

It is very essential to reflect upon the fact that validation activities play a very important and critical role in the Pharmaceutical manufacturing sector. During the project execution the organization should pay a close attention for these activities. And there must be a Risk assessment and risk mitigation program. The Documentation of these activities must be Designed and executed properly. The review of the recent regulatory observations shows that there is a big gap in this regard which leads to the issue of the 483 observations.

Once again it is very interesting to reflect upon the fact that the number. In the GMP warning letters were increased In this presentation we are going to focus on the trends of the warning letters issued in 2018-19 and the trend of the 483 issued by the regulatory authorities.

It is very essential to reflect upon the fact that Documentation activities play a very important and play critical role in the Global Pharmaceutical manufacturing sector. Designee and execution of procedure is possible only thorough Good documentation Practice only During the Regulatory audits the presentation of Documentation roll is very critical and the organization should pay a close attention for these activities. And there must be a Risk assessment and risk mitigation program. The Documentation of these activities must be designed and executed properly.