Validation for ERP Priority and SAP systems at Pharma and Medical companies

מהי ולידציה למערכות ERP פריוריטי? מערכת ERP היא מערכת ממוחשבת לתכנון משאבי הארגון והיא נמצאת בשימוש כמעט בכל העסקים והארגונים הבינוניים והגדולים בעולם, אך גם בשימוש של חברות קטנות Read More >>>

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 Read More >>>

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 Read More >>>

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 Read More >>>

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 Read More >>>

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 Read More >>>

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 Read More >>>

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 Read More >>>

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 Read More >>>

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 Read More >>>

Medical devices Cleaning Validation

GA 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 have Read More >>>

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 Read More >>>

Validation – What is it?

What is Validation? Validation is documented evidence that a process/equipment/system/software/procedure complies with specifications, criteria and requirements which are defined in a pre-approved protocol and detailed in: Specifications Definitions Quality Read More >>>

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, Read More >>>

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 Read More >>>

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