Tag: FDA guidance

Six Sigma Belts and levels | Certification types in Six Sigma

“Explore the comprehensive guide to Six Sigma methodologies, including DMAIC, CTQ Tree, and Root Cause Analysis. Learn about the various Six Sigma certification levels – White Belt, Yellow Belt, Green Belt, Black Belt, Master Black Belt, and Champion. Discover the integration of Lean principles and Design for Six Sigma (DFSS). Gain insights into the certification process offered by ASQ and IASSC. Elevate your understanding of quality management, process improvement, and data-driven decision-making in the world of Six Sigma.”

Indian Pharmacopoeia | Pharmacopoeia India (IP 2018)| For Download

The Indian Pharmacopoeia (IP) 2018 stands as a cornerstone in the regulation and standardization of pharmaceuticals in India. Published by the Indian Pharmacopoeia Commission (IPC), an autonomous body under the Ministry of Health and Family Welfare, Government of India, the IP serves as an authoritative reference for the quality, safety, and efficacy of drugs and

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.

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).