Month: July 2022

Common Technical Document | CTD Guidance | ICH CTD or ECTD

TD which is also called as Common Technical Document has gained importance in the regulatory review process which led to harmonized E submission which leads to implement the good review practices.

Alert: Monkeypox Spread: Will India be a next Africa

While India has seen it’s 4th Monkeypox case in new Delhi, it has become the great concern for the government to stop the further spread of the monkey pox. 16,000 cases being detected worldwide over last seven months and five people died due it, WHO has confirmed.

Alert: Monkey Pox is the next pandemic- Emergency Declared by WHO | क्या है मंकी पॉक्स

What is Monkey pox                                       The disease which was emerged from rodent and non-primates, monkey pox is a serious threat to the human beings currently. It is similar to small pox but more severe than the former. After the eradication of

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Microbiological Quality Considerations in Non-sterile Drug Manufacturing Guidance for Industry

FDA guideline on Microbiological Aspects of Non sterile dosage forms for the pharmaceutical manufacturing.The recommendations herein apply to solid non sterile dosage forms, as well as semi-solid, and liquid non-sterile dosage forms (e.g., topically applied creams, lotions and swabs, and oral solutions and suspensions).

Quality by Design (QbD)

“Discover the power of Quality by Design (QbD) and International Council for Harmonisation (ICH) Guidelines in shaping exceptional manufacturing standards. QbD, a proactive approach, ensures product quality from the start by integrating scientific principles into development. Explore the significance of ICH guidelines like Q8, Q9, Q10, and Q11 in aligning pharmaceutical development globally. Delve into frequently asked questions about QbD and ICH, unlocking insights into effective implementation. Elevate your understanding of pharmaceutical quality assurance, drug development principles, and global standards for optimized success. Embrace innovation and compliance with this simplified guide to QbD and ICH.”