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. Cone-bottom reaction vessels can provide the turndown required to process a variety of scales and handle different reactions.

Process Improvement 98

Process Improvement Packaging Dosage Compounding 98

ISPE

MARCH 29, 2023

The list of potential CQAs can be modified when the formulation and manufacturing process are selected and as product knowledge and process understanding increase.” The initial risk assessment is based on information on the target compound as well as prior knowledge and experience from other products with similar characteristics.

Documentation 52

Documentation Dosage Packaging Communication 52

ISPE

MARCH 29, 2023

The list of potential CQAs can be modified when the formulation and manufacturing process are selected and as product knowledge and process understanding increase.” The initial risk assessment is based on information on the target compound as well as prior knowledge and experience from other products with similar characteristics.

Documentation 52

Documentation Dosage Packaging Communication 52

ISPE

AUGUST 30, 2022

With shortages, regulatory complexity is compounded due to differences in submission and data requirements from various regulatory agencies. 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.

Documentation 52

Documentation FDA Packaging Communication 52