ICH Q10: final guidance for implementing an effective quality management system for the pharmaceutical industry. The FDA has just issued its final guidance on ICH Q10. This internationally harmonized guidance is intended to assist all pharmaceutical manufacturers by describing a model for an effective quality management system called pharmaceutical quality system. Based on International Organization [...]
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Critical New Readability Drug Packaging Guidelines – European Commission
Ahead of the next Pharmapack Conference, the European Commission has revised its guidance on the readability of consumer pharmaceutical labeling. This includes primary and outer packaging labels as well as leaflets / inserts. The main purpose of this document is to provide guidance on how to ensure that the information on the package label and [...]
Don’t Miss Pharmapack 2009 – International Drug And Drug Delivery Packaging Conference
This conference, supported by industry opinion leaders and exhibitors will take place in Paris January 21, 22, 2009. The event provides a unique opportunity to not only update on state of the art scientific developments but also to do business with like minded people in the drug packaging and drug delivery business. The location is [...]
New FDA Publication – Guidance for Industry: Process Validation: General Principles and Practices
The United States FDA has just issued a new Guidance for Industry: Process Validation: General Principles and Practices This is an important new proposed guideline document and the FDA is inviting comments within 60 days of it being published in the register. Our initial observations at Sibaya LifeScience! are: Aligning process validation activities with the [...]
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