Cosmetics product registration and submission in Israel
Guidelines for the process of cosmetics registration/submission in Israel The Department that is responsible to assure the safety and [...]
Dietary & Food supplement product registration In Israel
Guidelines for the process of food or food supplement registration in Israel If you are planning to market your [...]
Surface Finish and Biocompatible Materials for Pharmaceutical and Medical Devices
Medical device surface treatment Surface roughness level is a parameter of the surface quality commonly measured as the average deviation [...]
OTC drugs and cosmetics regulations and good practices
Background and history In 1938, the Federal Food, Drug and Cosmetic Act (FFDCA) granted FDA authorization for regulation of [...]
Validation- What is it?
What is Validation? Validation is documented evidence that demonstrates a process/equipment/system/software/procedure which complies with specifications, criteria and requirements defined in [...]
OTC Cosmetics Drugs regulation and Good Practices
Background and history In 1938, the FFDCA (Federal Food, Drug and Cosmetic Act) granted FDA cosmetic products and ingredients regulation [...]
Good Storage and Distribution Practice, cold chain Safety and Validation
Background Good Storage and Distribution Practice (GSP/GDP) describes human, veterinary and investigational drug substance and drug products supply chain procedures [...]
Good Weighing Practice for lab and production balance
[vc_row][vc_column][vc_column_text] 1. Introduction Weighing raw materials, product, reagents, excipients and other product related materials is a risk procedure in the [...]
CE/FDA Annex 11/21CFR part 11 Computerized System and Software Validation
What is software validation? Software Validation is part of the computerized system validation (CSV) process. Computerized system validation defined as [...]
Cleaning Validation for Bio-pharmaceutical & Medical Device
Background The definition of "clean" is free from dirt, soil or impurities (chemical/microbial). The cleaning process intend to remove dirt, [...]