Risk Assessment and Risk Management in the Medical and Pharmaceutical Industries

June 17th, 2020|

The medical and pharmaceutical industries are involved in new product development and manufacturing of medicines, medicinal products, biological products, medical devices and combination products. Risk management is a regulatory [...]

Surface finish and biocompatible materials for pharmaceuticals and medical devices

June 18th, 2020|

Medical device surface treatment Surface roughness level is a parameter of surface quality, commonly measured as the average deviation of the surface profile from the mean line (Ra). Surface [...]

Medical device cleaning techniques and validation

June 18th, 2020|

The purpose of medical device cleaning validation is to assure that the medical device cleaning procedure consistently controls potential carryover, contaminants, cleaning agents and extraneous material into the device [...]

Medical device registration and submissions in Israel

March 25th, 2019|

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, and [...]

Pharmaceutical and drug product registration and submissions in Israel

March 18th, 2019|

The process of pharmaceutical and drug product registration in Israel The main regulatory body for pharmaceutical administration in Israel is the Registration Department of the Ministry of Health of [...]

New drug development and regulation from clinical trials to marketing approval

June 18th, 2020|

Background After a new investigational drug pre-clinical stage 1 is completed, and a US IND (Investigational New Drug application) or EU CTA (Clinical Trial Application) submission to the FDA [...]

OTC drugs and cosmetics regulations and good practices

December 15th, 2016|

Background and history In 1938, the Federal Food, Drug and Cosmetic Act (FFDCA) granted FDA authorization for regulation of cosmetic products and ingredients. The statutory provisions of the FFDCA [...]

Good Storage and Distribution Practice (GSP/GDP), cold chain safety and validation

July 7th, 2020|

Background Good Storage Practice (GSP) and Good Distribution Practice (GDP) describe human, veterinary and investigational drug substance and drug product supply chain procedures and standards for assurance of the [...]

Good weighing practice (GWP) for laboratory and production balances

July 7th, 2020|

Introduction Weighing of raw materials, products, reagents, excipients and other product related materials is an area which has risks in the biotechnology and pharmaceutical industries. Any weighing mistake which [...]

CE Annex 11, FDA 21 CFR Part 11: Computerized systems and software validation

July 7th, 2020|

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 assurance [...]

Cleaning Validation for Bio-pharmaceutical & Medical Device

July 7th, 2020|

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. If [...]

Tips for choosing the right cleaning agent for production equipment in the pharmaceutical and medical industries

April 12th, 2020|

Cleaning processes in the pharma and medical fields Cleaning processes that are developed and used in the pharmaceutical, medical, cosmetic, and food industries must be both effective and proven, while [...]

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