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Bridging the healthcare digital divide: a gradual approach to adopting ePI

European Pharmaceutical Review

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).

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EU fines Teva and Cephalon €60.5m for ‘pay for delay’ scheme

pharmaphorum

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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Life-Cycle Approach to Cleaning Topical Drug Products

ISPE

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.”

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Why Are FDA Inspections So Ineffective and Disappointing?

The People's Pharmacy

“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
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A Proposal for a Comprehensive Quality Overall Summary

ISPE

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.

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A Proposal for a Comprehensive Quality Overall Summary

ISPE

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.

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Air Quality and Hashimoto’s – Is the Air You’re Breathing Making You Sick?

The Thyroid Pharmacist

Feel free to use my own health timeline as a guideline to document your health journey. Most filter manufacturers have pictures on their filter packaging that indicate what they will and will not filter, along with the MERV rating. 2009 Oct-Nov;25(9-10):577-81. 2009 Oct;16(5):385-91. 2010;20(7):755-761. doi:10.1089/thy.2010.1636.