ISPE

MARCH 29, 2023

Concept Paper: M4Q(R2) Common Technical Document on Quality Guideline.” 9 Among other things, the M4Q(R2) EWG is working toward “organizing product and manufacturing information in a suitable format for easy access, analysis, and knowledge management.” The authors propose using Module 2.3 Published 15 November 2021.

Documentation 52

Documentation Dosage Packaging Communication 52

ISPE

MARCH 29, 2023

Concept Paper: M4Q(R2) Common Technical Document on Quality Guideline.” 9 Among other things, the M4Q(R2) EWG is working toward “organizing product and manufacturing information in a suitable format for easy access, analysis, and knowledge management.” The authors propose using Module 2.3 Published 15 November 2021.

Documentation 52

Documentation Dosage Packaging Communication 52

ISPE

SEPTEMBER 11, 2023

POD is suitable for a wide range of products, including oral solid dosage forms, mAbs, and cell therapy. Developing the Biofacility of the Future Based on Continuous Processing and Single-Use Technology.” Review: Continuous Manufacturing of Small Molecule Solid Oral Dosage Forms.” Journal of Biotechnology 213 (2015):120–30.

Health and Personal Care Stores 52

Health and Personal Care Stores Vaccines Packaging Documentation 52

ISPE

AUGUST 30, 2022

The International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines contain information regarding regulatory requirements for raw materials. The name of each material, where it is used in the process, and information on the quality and control should be provided.

Documentation 52

Documentation FDA Packaging Communication 52