ISPE

OCTOBER 28, 2022

Before the COVID-19 pandemic, it was unthinkable for a system integrator to suggest remotely conducting an acceptance test for an automation project. In the pharmaceutical sector, the ISPE Good Automated Manufacturing Practice (GAMP) 1. Another two clients are pharmaceutical manufacturers, also in Ireland. Tom O'Kane.

Communication 52

Communication Documentation FDA 52

ISPE

JULY 19, 2023

has taken on significantly increasing momentum in the pharmaceutical industry. Drug shortages are the consequence, seen in all regions of the world and possible for practically all pharmaceuticals. The cross-functional frame conditions are quality and regulatory, cybersecurity, end-to-end data management, and standards.

Documentation 98

Documentation FDA Labelling Communication 98

ISPE

JANUARY 9, 2023

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. It was time for ISPE to update this key guidance document to reflect technological progress.

Documentation 52

Documentation FDA Communication 52

ISPE

JULY 10, 2023

ChatGPT : “Yes, ChatGPT can be useful in regulated areas of the pharmaceutical industry, such as providing information on drug products, their uses, dos-ages, side effects, and interactions with other medications. Specific aspects of pharmaceutical roles (e.g., quality assurance) are not mentioned here.

Labelling 52

Labelling Documentation Pharmaceutical Companies Pharmaceutical Companies 52

ISPE

MAY 11, 2023

™ Roadmap Emmie Heeren AREND JAN WASSINK Venkateshwar Rao Nalluri, PhD Sebastian NIEDERHAUSER 1 May 2023 In the context of data integrity, data flows are essential. The FDA, PIC/S, and WHO have all emphasized the importance and benefits of data flows in their guidance on data integrity.

Packaging 52

Packaging Documentation Communication Data Entry 52