Impact Pharmaceutical Services

SEPTEMBER 15, 2023

Structure-based drug design has evolved, facilitating the exploration of novel chemical probes and lead compound potency, and molecular docking utilizes target structures to predict interactions and offers simplicity and speed. Both processes are evolving to enhance product development and output.

Documentation 59

Documentation Process Improvement Compounding 59

ISPE

SEPTEMBER 11, 2023

This article presents relevant insights on the current regulatory and technical landscape for decentralized manufacturing, with select examples of current applications, and discusses perspectives on evolving and adapting the current regulations to meet future capabilities. Accessed March 2023. drug supply.,”

Health and Personal Care Stores 52

Health and Personal Care Stores Vaccines Packaging Documentation 52

ISPE

MARCH 29, 2023

[link] This novel approach to Module 2 uses a structure that shows how enhanced process knowledge, product understanding, and risk assessments are linked to the control strategy. This article summarizes an alternate and more functional way to format the QOS presented in Module 2.3. Currently, it takes time and/or communications (e.g.,

Documentation 52

Documentation Dosage Packaging Communication 52

ISPE

MARCH 29, 2023

[link] This novel approach to Module 2 uses a structure that shows how enhanced process knowledge, product understanding, and risk assessments are linked to the control strategy. This article summarizes an alternate and more functional way to format the QOS presented in Module 2.3. Currently, it takes time and/or communications (e.g.,

Documentation 52

Documentation Dosage Packaging Communication 52

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. Conclusion.

Process Improvement 98

Process Improvement Packaging Dosage Compounding 98

ISPE

AUGUST 30, 2022

With shortages, regulatory complexity is compounded due to differences in submission and data requirements from various regulatory agencies. An excipient is formulated with the active pharmaceutical ingredient and is typically not chemically or physically altered prior to use; therefore, all components are likely present in the DP.

Documentation 52

Documentation FDA Packaging Communication 52