Tag: Pharmaceuticals

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.

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).