ISPE

JANUARY 9, 2023

The 2nd Edition highlights the use of critical thinking by knowledgeable and experienced subject matter experts (SMEs) to define appropriate approaches. Since the publication of the first edition, GAMP ® 5 has been far and away the leading international guidance on GxP computerized systems validation and compliance.

Documentation 52

Documentation FDA Communication 52

ISPE

JULY 7, 2023

USP/BIOPHORUM Workshop on Continuous Manufacturing of Biologics Trudy Patterson Fri, 07/07/2023 - 08:45 Features July / August 2023 USP/BIOPHORUM Workshop on Continuous Manufacturing of Biologics John F. This article summarizes trends from the workshop and ponders next steps. 1 , 2 , 3 There are also barriers to the adoption of BCM.

FDA 52

FDA Pharmaceutical Companies Pharmaceutical Companies 52

Pharmaceutical Technology

DECEMBER 9, 2022

It is estimated that Brazil’s SUS currently spends around 10% of the country’s GDP on its healthcare, which before the election, was forecast to rise to 12.6% A recent report from GlobalData states that the Brazilian generics market grew by 9.67% year-on-year in 2021 to $5.2bn, accounting for around 29.4%

Pharmaceutical Companies 98

Pharmaceutical Companies Pharmaceutical Companies Communication 98