New mRNA-based drugs platforms for cancer treatment The successful development of mRNA (messenger ribonucleic acid) based on anti-COVID 19 vaccines happened in a relatively short time through many [...]
חשיבות ה- Data integrity בחברות תרופות אמינות ושלמות הנתונים, או במונח הלועזי Data integrity מאפשרת הן לחברה והן לגופי הרגולציה אשר מבצעים ביקורות איכות ו-GMP תקופתיות, להבין שהנתונים [...]
What is a GMP audit in Israel and abroad? A GMP audit in israel is an audit that covers the Good Manufacturing Practices in the facility. GMP audit [...]
What is MRI? MRI is a non-invasive medical device that combines medical software for imaging techniques that produce three-dimensional anatomically accurate images. It is usually used for infection [...]
Guidelines for the process of food or food supplement registration in IsraelIf you are planning to distribute your dietary food supplements in Israel – you will need to undertake [...]
Guidelines for the process of cosmetics registration/submission in Israel The Department that is responsible to assure the safety and quality of cosmetics products for the Israeli market is [...]
Medical device registration and submissions in Israel In Israel, the regulatory body that is responsible for medical device registration, submissions, supervision and control over the manufacture, assembly, sterilization, import, [...]
Background The definition of "clean" is free from dirt, soil or impurities (chemical/microbial). Cleaning processes are intended to remove dirt, impurities and soil in addition to decontaminating equipment. [...]
Introduction "Nonconformity" investigation is a very common term used in production and product quality improvement areas in the pharmaceutical and medical devices industries. It is mandatory and a [...]
What is software validation? Software validation is part of the computerized systems validation (CSV) process. Computerized systems validation is defined as documented evidence with a high degree of [...]
