ISPE

MARCH 29, 2023

Concept Paper: M4Q(R2) Common Technical Document on Quality Guideline.” Ultimately, the summary was not adopted during the QbD pilot, but was reintroduced in 2014 when a Pharmaceutical Research and Manufacturers of America (PhRMA) team prepared a white paper describing the content and format of an improved Module 2.

Documentation 52

Documentation Dosage Packaging Communication 52

ISPE

MARCH 29, 2023

Concept Paper: M4Q(R2) Common Technical Document on Quality Guideline.” Ultimately, the summary was not adopted during the QbD pilot, but was reintroduced in 2014 when a Pharmaceutical Research and Manufacturers of America (PhRMA) team prepared a white paper describing the content and format of an improved Module 2.

Documentation 52

Documentation Dosage Packaging Communication 52

Pharmaceutical Technology

JANUARY 6, 2023

According to the legal documents , the plaintiffs accused the companies of “violating federal antitrust laws, alleging “per se” and “rule of reason” violations”. At the centre of the case was Gilenya’s ‘405 patent, which details methods for treating relapsing multiple sclerosis with a specific dosage of the drug.

Documentation 97

Documentation FDA Hospitals Dosage 97

ISPE

JULY 5, 2023

13 An FDA-authored paper indicating support for the implementation of CM using science- and risk-based approaches followed soon thereafter. In addition to the FDA, health authorities in Canada, Europe, Australia, Japan, Switzerland, and New Zealand have also approved applications with CM for the production of solid oral dosage forms.

FDA 52

FDA Dosage Documentation Pharmaceutical Companies 52

ISPE

SEPTEMBER 11, 2023

POD is suitable for a wide range of products, including oral solid dosage forms, mAbs, and cell therapy. Review: Continuous Manufacturing of Small Molecule Solid Oral Dosage Forms.” EFPIA White Paper on CMC Development, Manufacture and Supply of Pandemic COVID-19 Therapies and Vaccines.” doi:10.1016/j.jbiotec.2015.06.388

Health and Personal Care Stores 52

Health and Personal Care Stores Vaccines Packaging Documentation 52

ISPE

JULY 6, 2023

For much of the pharmaceutical industry, batch manufacturing (BM) processes that have been relied upon for decades remain the preferred approach for most oral solid dosage (OSD) drug products. This document catalogs and summarizes the various risks to the company. Office of Pharmaceutical Quality (OPQ) White Paper.

Insurance 52

Insurance Documentation Pharmaceutical Companies Pharmaceutical Companies 52