The regulatory [1] evolution integrates continuous improvement as an objective of the pharmaceutical quality system. This implies the implementation of processes that support conclusion about product quality and process conformity at any s...

For the pharmaceutical, biotechnology and all other process industry, it becomes increasingly difficult to safely and effectively use equipment while respecting regulations.

In recent years, intense regulatory activity focuses on biosimilars to define the scope and intensity of exercise necessary to demonstrate their equivalence to the reference medicinal product already marketed.

Over the last decade the implementation of so-called rapid (or modern) microbiological methods (RMM) has, as a general subject, been a constant feature at most any congress, or symposium, that includes sterility assurance or analytical mic...

For years now, the Pharmaceutical Quality systems were based on using procedures, checklists, batch records, with multiple checks of operators.

The QbD (Quality by Design) approach is needed today in the pharmaceutical industry.

Regulations which drive the pharmaceutical world are numerous and very drastic.

The manufacturing processes of injectable preparations does not exclude the possible presence of intrinsic or extrinsic particulate matters that must be quantified and assessed.

The objectives of a Quality Management System are to :

"Cloud Computing" awkwardly frenchified in "Informatique dans les nuages" is currently undergoing a major commercial communication; IT managers of pharmaceutical companies are challenged by their top management about this "newness":