European Pharmaceutical Review

JUNE 19, 2025

4,5,6 However, these benefits are contingent on the ability to generate comprehensive, high-quality analytical and PK data packages. 10 The package, once adopted, is expected to introduce changes to regulatory exclusivity, market access, and competition rules for medicines, including biosimilars, across the EU. Document 9286/25.

Biosimilars 97

Biosimilars Packaging Documentation Drug Development 97

European Pharmaceutical Review

APRIL 8, 2025

Given that multiple work packages may often start or end together, or else take longer than others ( Figure 1 ), the introduction of new PAT requires assessment and planning by multiple departments. Any documentation, such as validation reports then helps with compliance and later regulatory submissions and requests.

Documentation 52

Documentation Packaging Pharmaceutical Manufacturing 52

pharmaphorum

NOVEMBER 27, 2020

Although Teva and Cephalon are now the same company, the case dates back to June 2005 when the firms were separate entities. 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.

Packaging 52

Packaging Documentation 52

RX Note

JUNE 5, 2023

The Hidden Truth Studies have shown that the antineoplastic residues can be found be on the external packaging of both oral and IV drugs. Change gloves every 30 minutes during compounding or immediately when damaged or contaminated, unless otherwise recommended by the manufacturer's documentation.

Compounding 52

Compounding Packaging Hospitals Chemotherapy 52

GMPSOP

MARCH 17, 2023

ISO 9000:2005 Sec. Additional documents included each month. In a packaging line, a printer was used to imprint manufacturing and expiry dates on a batch of empty cartons which will be used to fill tablet strips. Further to corrective action, the defective packaging (carton) lot was destroyed which was initially quarantined.

Documentation 52

Documentation Packaging Process Improvement Pharmaceutical Manufacturing 52

European Pharmaceutical Review

NOVEMBER 24, 2022

One area in which the problem can be tackled effectively is product packaging. With predictions that the global market for anticounterfeiting packaging is set to reach almost $250 billion by 2026, growth in authentication and anti-tamper devices such as holograms appear to have a healthy future.”

Packaging 111

Packaging Labelling Documentation Dosage 111

European Pharmaceutical Review

APRIL 14, 2025

In the EU, the EU pharmaceutical package of reform 5 includes a proposed new Directive, 6 which will replace the current Medicines Directive (2001/83/EC). Master file the manufacturing dossier in which the main regulatory documents are collected and to which all subordinate sites refer. One file per product. Internet] UK Government.

Hospitals 52

Hospitals Documentation Packaging Communication 52