ISPE

OCTOBER 26, 2022

Reintroducing the liaison role of International Board members with individual Chapters and Affiliates has given us direct lines of communication to the mutual benefit of the International Board and the local groups. Most Board members were able to attend in person, and we had very productive Board and Executive Committee sessions.

Packaging 52

Packaging Compounding Communication Vaccines 52

pharmaphorum

FEBRUARY 18, 2021

Eli Lilly’s Humalog compound and formulation patents expired in 2013 and 2014, respectively. They employed hundreds of new salespeople to detail doctors and hospitals, spent millions on TV and magazine ads and handed out masses of free samples. 13 They launched a huge effort to transition PRILOSEC patients their newer product NEXIUM.

Prescription Filling 52

Prescription Filling Compounding FDA Communication 52

ISPE

OCTOBER 26, 2022

From a regulatory perspective, the only products that are to be excluded are sensitizing agents, including penicillins and cephalosporins (beta-lactams); potentially genotoxic compounds; and potentially OEB 5 compounds where the risk assessment indicates the compound cannot be adequately controlled. 2 European Commission.

Vaccines 97

Vaccines Compounding Documentation FDA 97

ISPE

OCTOBER 27, 2022

Broad pipelines require facilities to be designed with a large degree of flexibility to support anything from mild reaction conditions to the use of potent or highly biologically active compounds. You may unsubscribe from these ISPE communications at any time. Cell & Gene Therapy. Unlock Access to Member-Only Content. Company Name.

Process Improvement 98

Process Improvement Packaging Dosage Compounding 98

ISPE

MARCH 29, 2023

Challenges with the Current Module 2 Structure The US FDA published a white paper in 2018 calling for a revision to Module 2 because, “there can be a disconnect between applicants and regulators regarding the communication of quality data and its impact on the assessment. Currently, it takes time and/or communications (e.g.,

Documentation 52

Documentation Dosage Packaging Communication 52

ISPE

MARCH 29, 2023

Challenges with the Current Module 2 Structure The US FDA published a white paper in 2018 calling for a revision to Module 2 because, “there can be a disconnect between applicants and regulators regarding the communication of quality data and its impact on the assessment. Currently, it takes time and/or communications (e.g.,

Documentation 52

Documentation Dosage Packaging Communication 52

ISPE

MAY 9, 2023

Additionally, quality control testing of these compounds is conducted using standard testing following applicable pharmacopeia—such as United States Pharmacopeia (USP), European Pharmacopeia (EP), and Japanese Pharmacopeia (JP)—that was current at the time of testing. You may unsubscribe from these ISPE communications at any time.

Documentation 52

Documentation Packaging Pharmaceutical Companies Pharmaceutical Companies 52