Các hướng dẫn BS EN ISO 13408 & 11138

 

 

Pharmaceutical Quality by Design Using JMP: Solving Product Development and Manufacturing Problems

 

 

Solve your pharmaceutical product development and manufacturing problems using JMP®. Pharmaceutical Quality by Design Using JMP®: Solving Product Development and Manufacturing Problems provides broad-based techniques available in JMP to visualize data and run statistical analyses for areas common in healthcare product manufacturing. As international regulatory agencies push the concept of Quality by Design (QbD), there is a growing emphasis to optimize the processing of products. This book uses practical examples from the pharmaceutical and medical device industries

ISPE Good Practice Guide: Knowledge Management in the Pharmaceutical Industry

 

 

ICH Q10 outlines three objectives: achieve product realization, establish and maintain a state of control, and facilitate continual improvement. Embracing these objectives can be best achieved using the dual enablers, Knowledge Management (KM) and Quality Risk Management (QRM). The first reference to KM in the field of pharmaceutical quality was in ICH Q8 in 2005 as a tool used with QRM for a more systematic Quality by Design (QbD) approach to development throughout the product lifecycle. Three years later, ICH Q10 identified KM and QRM as the enablers of an effective Pharmaceutical Quality System (PQS).

Handbook of Pharmaceutical Granulation Technology (4th edition)

 

This fully revised edition of Handbook of Pharmaceutical Granulation Technology covers the rapid advances in the science of agglomeration,  process control, process modelling, scale-up, emerging particle engineering technologies, along with current regulatory changes presented by some of the prominent scientist and subject matter experts around the globe. Learn from more than 50 global subject matter experts who share their years of experience in areas ranging from drug delivery and pharmaceutical technology to advances in nanotechnology. Every pharmaceutical scientist should own a copy of this fourth edition resource.

ISPE Good Practice Guide: HVAC & Process Equipment Air Filters

 

The goal of the ISPE Good Practice Guide: HVAC and Process Equipment Air Filters is to to be a valuable reference on the selection, application, specification, testing, operation, and maintenance of filters in the pharmaceutical industry. This Guide is intended to be used as supplement to the ISPE Good Practice Guide: Heating, Ventilation, and Air Conditioning (HVAC), providing detailed