חשיבות ה- Data integrity בחברות תרופות

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 שנוצרו [...]

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

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 [...]

Good weighing practice (GWP) for laboratory and production balances

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 [...]

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

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 [...]

Risk Assessment and Risk Management in the Medical and Pharmaceutical Industries

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 [...]

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

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 [...]

Simha Vazana

QA Manager, Phibro “Many thanks to Eran Yona and the Bio-Chem staff. The company was invited on short notice to our new facility to support an FDA inspection. The job [...]

Amitai Itzhakov

Process Technology Specialist, Omrix “Eran and Bio-Chem’s team were instrumental in assisting the group I manage to complete qualification activities prior to, during and after important audits by regulatory [...]

Ofer Sagi

Quality Engineering Manager, Johnson & Johnson "Eran from Bio-Chem supported and counseled Medimor Ltd. during its transformation from an antenna manufacturing company named “Galtronics” to one of the leading [...]

Yaki Sidis

Project Manager, Johnson & Johnson “I've worked with Bio-Chem for the last three years on a biological manufacturing process scale-up; this tech transfer project included commissioning, installation and qualification [...]

Eran Efroni

Operations Manager, Instrumetrics “Eran Yona and the Bio-Chem supported the Neopharm group in challenging projects in the fields of manufacturing process engineering, validation, GMP and quality in the fields [...]

Aharon Lutzky

CEO, Tikun Olam “Bio-Chem accompanied and consulted for Tikum Olam in the fields of medical cannabis growth and product manufacture, quality, validation, training, regulation and purchasing of manufacturing equipment, GAP, [...]

Alice Cohen

Quality Inspection Audits Manager “Bio-Chem consulted for our company for several years on GMP issues, quality audits, QC and validation. The projects run by Bio-Chem supported our routine activities, while [...]

Hovav Amram

GMP Plant Engineering Manager, Sigma-Aldrich “I met Eran Yona and Bio-Chem 8 years ago when I was the GMP plant engineer at Sigma-Aldrich. Bio-Chem supplied GMP and validation consulting [...]

Vladimir Altshul

Quality, Safety and Ecology Manager, Maxima Group “Many thanks to Eran Yona and the Bio-Chem team. You did complex work in a precise and professional manner, while considering our needs [...]

Dr. Moshe White

QA Project Manager, Kamada “Eran Yona of Bio-Chem assisted Kamada with a cross-contamination risk assessment project. Eran led a comprehensive risk assessment in different departments at the plant, brought some [...]

David Anolik

QA Manager, Phoenicia Phoenicia Glass Works Yeruham worked with Bio-Chem on a project to improve quality processes for glass products supplied to company customers. In this framework, Bio-Chem conducted comprehensive [...]

Medical devices Cleaning Validation

[vc_row][vc_column][vc_column_text] A contaminated medical device may lead to serious implications and risk to the patient/user. Medical device manufacturers must ensure they have correctly identified all potential risks and contaminants and [...]

Cleaning medical devices techniques and validation

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

Webinar Simulation

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Fermentation in the Bio-Pharmaceutical industry

[vc_row][vc_column][vc_column_text] 1. Background Many Bio-Pharmaceutical and biological products are based on (different) cell-type fermentation. Bio-Pharmaceutical products can be either intra or extra cellular metabolites that have a pharmacological effect. Fermentation, [...]

Stem cell medicinal products cGMP and cGTP

[vc_row][vc_column][vc_column_text] 1.  Background The usage of stem cells for therapeutic and clinical applications is a fast growing area in Biotech research and development. Stem cells potential to differentiate into specific [...]

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