GAMP® 5: The Quality Strategy for Computerized Systems
In the era of Industry 4.0, digital transformation in the regulated sector is no longer an advantage […]
Normative
Impact of the Annex 15 revision on manufacturers
In the previous article we analyzed what changes Annex 15 brings and what key message the inspectors are sending, as well
GMP Annex 15 is currently under review
Annex 15 – Qualification and Validation is one of the classic pillars of European GMP and, precisely because
The new EMA GMP inspection plan until 2028: when supervision becomes a strategy
In January 2026, the new GMP/GDP Inspectors Working Group (GMDP IWG) work plan came into effect.
Risk Management in Aseptic Manufacturing: Practical Application of ICH Q9
Aseptic manufacturing represents one of the most critical environments within the pharmaceutical industry. The absence of a
Data Integrity according to FDA, EMA and MHRA
Data Integrity is a central pillar in the pharmaceutical industry and in any regulated environment.
Technical guide for the design, construction, validation and maintenance of pharmaceutical clean rooms
Regulatory compliance and contamination control strategies 1. Introduction to the modern pharmaceutical engineering paradigm The pharmaceutical industry
Keys for the design of pharmaceutical facilities in compliance with GMP (2nd part)
In the first part of this article we explore the foundations of the design of facilities under GMP, focusing on flows, control
Keys for the design of pharmaceutical facilities in compliance with GMP (1st part)
The design of pharmaceutical facilities is much more than an architectural exercise: it constitutes the basis for guaranteeing the quality of the
Preparing equipment and facilities for regulatory audits
In the highly regulated environment of the pharmaceutical industry, audits and regulatory inspections are a constant. The right one