CategoryPharma & Biotech General

Equipment qualification

E

The qualification of equipment is a GMP requirement. Qualification is the documented evidence of the verification that a pharmaceutical machine meets the pre-determined requirements. The definition varies per guideline. For more information you can check the following documents; Annex 15 of Eudralex Volume 4 – LIFE CYCLE APPROACHEMA Process Validation Guideline for Finished Products ...

The Most important aspect of the gxp’s

T

People often ask me what the most important GMP or GDP aspect is. I used to answer these questions with: Risk Management is key and must be incorporated throughout the whole Quality Management System. Or, I would answer that they should never forget to add and implement effectiveness checks within CAPA management. During the years, as a manager, I realized that how good your Quality Management...

Biosimilars: A New Trend In Indian Pharma

B

Biosimilar development is a consequence of the financial success of biologic therapies and their eventual patent expiration. The pharmaceutical industry must now develop complex biosimilars that resemble FDA-approved biologic agents and invent analytical tools and end points to demonstrate similarity to regulatory authorities. Already in development is a new wave of "biobetter" or "biosuperior"...