h-header

news

News dal mondo

19

Lug

PIC/S adopts guidance on PQS risk-based change management, COVID-19 risk assessments

The guidance document, “How to Evaluate and Demonstrate the Effectiveness of the Pharmaceutical Quality System with regard to Risk-Based Change Management,” was originally drafted in 2019 and has now been updated in response to input from industry representatives, the organization said.

[PIC/S: COVID-19 Risk Assessment for National Routine On-Site InspectionsHow to Evaluate and Demonstrate the Effectiveness of a Pharmaceutical Quality System in relation to Risk-based Change Management]

17

Set

Governo vara decreto legge su green pass obbligatorio nel luoghi di lavoro pubblici e privati

Dal 15 ottobre e fino al 31 dicembre 2021, termine di cessazione dello stato di emergenza, la Certificazione...

15

Set

Publication of a new general chapter on balances in European Pharmacopoeia Supplement 10.6

At its 168th session (November 2020), the European Pharmacopoeia (Ph. Eur.) Commission adopted...

15

Set

EU - Strategia in materia di sostanze chimiche per la sostenibilità

Risoluzione del Parlamento europeo del 10 luglio 2020 sulla strategia in materia di sostanze chimiche...

10

Set

FDA . Development of Abbreviated New Drug Applications During the COVID-19 Pandemic – Questions and Answers

US FDA's updated Q&A guidance on developing generics for submission via the abbreviated new...

slider-banner

h-footer