European Pharmaceutical Review

JANUARY 25, 2024

These standardised documents provide meticulously curated and scientifically approved information. Proposal for a Directive of the European Parliament and of the Council on the Union code relating to medicinal products for human use, and repealing Directive 2001/83/EC and Directive 2009/35/EC.” Article 63 EMA (29 January 2020).

Packaging 98

Packaging Documentation Pharmaceutical Companies Pharmaceutical Companies 98

pharmaphorum

NOVEMBER 27, 2020

The two companies agreed to settle the dispute but as part of the settlement Teva received a package of commercial side-deals and cash payments. Teva said in a statement: “The Commission started investigating this agreement in December 2009. However Cephalon did not see a need for, or decide to ever use, the licence.

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Packaging Documentation 52

ISPE

MARCH 7, 2023

As such there’s a growing question of how the industry will improve the sustainability profile of its existing medicines and ensure that sustainability is designed into new medicines, such as products, with a reduced environmental risk, greener manufacturing technologies, and recyclable delivery systems and packaging. 9 December 2021.

Packaging 52

Packaging Pharmaceutical Companies Pharmaceutical Companies Hospitals 52

ISPE

MARCH 29, 2023

Concept Paper: M4Q(R2) Common Technical Document on Quality Guideline.” If elements such as these are adopted during the revision of ICH M4Q, this could influence global regulatory agencies to eliminate the requirement for custom Module 2 commitment documents. 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.” If elements such as these are adopted during the revision of ICH M4Q, this could influence global regulatory agencies to eliminate the requirement for custom Module 2 commitment documents. The authors propose using Module 2.3 Published 15 November 2021.

Documentation 52

Documentation Dosage Packaging Communication 52

ISPE

JANUARY 11, 2023

For example, the equipment for blending and packaging large-volume, high-viscosity formulations is complex, and the residues can be challenging to remove. Bethesda, MD: PDA and River Grove, IL: DHI Publishing, 2009. Bethesda, MD: PDA and River Grove, IL: DHI Publishing, 2009. link] 4 Pluta, P. Process Validation Basics.”

Method Validation 52

Method Validation Documentation Packaging Compounding 52

The People's Pharmacy

MAY 8, 2023

“The FDA said Global Pharma failed to use adequate, tamper-evident packaging and distributed the drugs without proper preservatives.” There have been problems with records in the past: deceit, falsification of documents and even outright fraud. Here’s the kicker.

FDA 72

FDA Pharmaceutical Companies Pharmaceutical Companies Medical Schools 72