Preparing equipment and facilities for regulatory audits
In the highly regulated environment of the pharmaceutical industry, audits and regulatory inspections are a constant. The adequate […]
Normative
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.