ISPE

MAY 10, 2023

Each issue of Pharmaceutical Engineering magazine features thought-provoking content that is available to Members only, but NOW we're giving you exclusive access to see what you've been missing out on. You may unsubscribe from these ISPE communications at any time. Proceedings of Medical Informatics, Europe, Nice, 2022: 755–59.

Chemotherapy 52

Chemotherapy Documentation Dosage Communication 52

ISPE

JANUARY 8, 2023

Building on these concepts, we provide insights and guidance on how to effectively support the “Human-AI-Team,” a term of the FDA 5 we believe describes very well the target operating model when interacting with AI: in a collaborative manner, complementing the strengths of cognitive as well as AI in GxP-related areas.

Communication 52

Communication Documentation FDA 52

ISPE

SEPTEMBER 11, 2023

m/s recommendation made its way into the US Food and Drug Administration (FDA)’s “Sterile Drug Products Produced by Aseptic Processing—Current Good Manufacturing Practice” 7 and into the EC GMP Annex 1 “Manufacture of Sterile Medicinal Products” in 2003. You may unsubscribe from these ISPE communications at any time. At what velocity?

Documentation 52

Documentation FDA Packaging Communication 52

ISPE

MAY 9, 2023

21 Similarly, the FDA Center for Drug Evaluation and Research (CDER) began issuing electronic CPPs (eCPP) starting December 2021. Modernization of the FDA CDER Export Certificate Program.” You may unsubscribe from these ISPE communications at any time. Published 20 April 2021. Published 3 November 2021. Accessed 6 July 2022.

Documentation 52

Documentation Packaging Pharmaceutical Companies Pharmaceutical Companies 52

Pharmaceutical Technology

JUNE 6, 2023

In a 2022 annual report, the US Food and Drug Administration’s (FDA) Office of Generic Drugs stated it had approved 106 first generics— the introductory generic competitors of branded drugs. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

Vaccines 52

Vaccines FDA Communication 52

ISPE

AUGUST 29, 2022

In May 2021, the US Food and Drug Administration (FDA) published a draft industry guidance, ICH Q12: Implementation Considerations for FDA-Regulated Products. The FDA has also offered both early dialogue and training to share knowledge and experience with the industry, providing an excellent example for other regulators to follow.

Documentation 52

Documentation FDA Communication Packaging 52

Pharma Marketing Network

JUNE 11, 2020

Yeah, I even wanted to wear the shirt to this FDA meeting. You know, in November 2009, the FDA held a public hearing about the promotion of Food and Drug Administrative Related Regulated Medical Products, using the internet and social media tools. And now it’s a common communication channel even for the President.

Pharmaceutical Companies 52

Pharmaceutical Companies Pharmaceutical Companies Communication FDA 52

ISPE

AUGUST 30, 2022

Recent US FDA data show that the lack of raw material availability contributes to 27% of drug shortages (see Appendix ). It is considered a moderate change by the FDA (CBE30) and NMPA. This change ranges from a moderate change (CBE-30) by the FDA to a minor change not requiring prior approval by the WHO.

Documentation 52

Documentation FDA Packaging Communication 52

ISPE

MAY 9, 2023

Its Pharmaceutical Education & Research Center (PERC) is a US Food and Drug Administration (FDA)-registered, cGMP-compliant, single-source CRO equipped with the latest equipment and technologies, for most dosage forms, found in the pharmaceutical industry. You may unsubscribe from these ISPE communications at any time.

Vaccines 94

Vaccines Pharmaceutical Companies Pharmaceutical Companies Medical Schools 94

ISPE

OCTOBER 26, 2022

For example, an assessment for a facility primarily focused on US and EU markets would only consider GMPs and regulations from EudraLex and the FDA. FDA CFR Title 21 Parts 211, 600, and 1271; 8. , FDA Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing–Current Good Manufacturing Practice, 11.

Vaccines 97

Vaccines Compounding Documentation FDA 97

ISPE

JANUARY 10, 2023

5 The FDA has indicated it may “consider available information and approaches to mitigate the risk to product quality associated with the change to support a reporting category for certain supplements that is lower than what otherwise would be most suitable.” This approach is aligned with guidance presented recently by the FDA.

Packaging 52

Packaging FDA Communication Vaccines 52