Monitoring: “A Step towards Quality Control and Improvement”
The regulatory  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...
Digital process analytics reduces maintenance and simplifies records
For the pharmaceutical, biotechnology and all other process industry, it becomes increasingly difficult to safely and effectively use equipment while respecting regulations.
Biosimilars comparability: challenge and impact on comparability of innovator products
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.
Current United States Pharmacopeia (USP) Efforts Regarding Rapid (“Modern”) Microbiological Methods
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...
QA and Human factor
For years now, the Pharmaceutical Quality systems were based on using procedures, checklists, batch records, with multiple checks of operators.
QbD and Design Space : Who, When, How, and Why ?
The QbD (Quality by Design) approach is needed today in the pharmaceutical industry.
ISO9001 certification of a pharmaceutical industry : example of Lilly France
Regulations which drive the pharmaceutical world are numerous and very drastic.
Visual inspection of injectable preparations: from detection to characterisation of particulate matters
The manufacturing processes of injectable preparations does not exclude the possible presence of intrinsic or extrinsic particulate matters that must be quantified and assessed.
Quality Management System
The objectives of a Quality Management System are to :
Does Pharmaceutical regulation apply in the cloud
"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":
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