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 […]
Normative
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
Annex 11 of the GMP enters public consultation: key changes to adapt to the digital era
Annex 11 of the GMP details the requirements for the use of computer systems in manufacturing and
Annex 11 GMP and the quality guarantee in computerized systems: a pillar of pharmaceutical regulation
The pharmaceutical industry, due to its intrinsic relationship with public health, is subject to a rigorous regulatory framework that guarantees
International Comparison in the qualification of pharmaceutical facilities: GMP, ICH and FDA
The qualification of pharmaceutical facilities is an essential requirement to guarantee the quality, safety and regulatory compliance in production
GMP Regulations in the Pharmaceutical Environment: An Essential Guide
The pharmaceutical industry is among the most regulated in the world, and for good reason: health and safety.