ISPE

MARCH 29, 2023

This article summarizes an alternate and more functional way to format the QOS presented in Module 2.3. For purpose of illustration used throughout this article, labels have been assigned to each CQA. The summary included the concepts outlined in this article and aimed to clearly convey the product control strategy.

Documentation 52

Documentation Dosage Packaging Communication 52

ISPE

MARCH 29, 2023

This article summarizes an alternate and more functional way to format the QOS presented in Module 2.3. For purpose of illustration used throughout this article, labels have been assigned to each CQA. The summary included the concepts outlined in this article and aimed to clearly convey the product control strategy.

Documentation 52

Documentation Dosage Packaging Communication 52

ISPE

AUGUST 30, 2022

In this article, the term “raw material” refers to a material used in the manufacturing and packaging of a drug substance (DS) or a drug product (DP). This article highlights the regulatory expectations of raw materials, the challenges of postapproval changes. and the impact on supply resiliency. 11 Ahluwalia, K., Abernathy, J.

Documentation 52

Documentation FDA Packaging Communication 52

ISPE

MARCH 15, 2023

linear) design process is central to successfully attaining such comprehensive sustainability goals and project needs (see Figure 1). query=environment Labeling and Organization There are various ways to group the many types of environmental sustainability challenges and goals. Chemical Engineering and Processing 171 (2022): 108727.

Packaging 52

Packaging Labelling Health Compliance Process Improvement 52