New EU GDP Guidelines Published

Quality and integrity of medicinal products are key factors that must be maintained during the entire supply chain from the manufacturer to the patient. The European Commission revised the guidelines that lay down appropriate tools to assist wholesale distributors in conducting their activities and to prevent falsified medicines from entering the legal supply chain.

Wholesale distribution of medicinal products is defined as "all activities consisting of procuring, holding, supplying or exporting medicinal products, apart from supplying medicinal products to the public. Such activities are carried out with manufacturers or their depositories, importers, other wholesale distributors or with pharmacists and persons authorized or entitled to supply medicinal products to the public in the Member State concerned."

The revised EU GDPs, Good Distribution Practices, become effective September 8, 2013.
Guidelines of 7 March 2013 on Good Distribution Practice of Medicinal Products for Human Use (2013/C 68/01)

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ICH Photosafety - FDA EU Draft Guidance

• Respected FDA CGMP online training courses and programs taught by SkillsPlus International Inc.

Updated December 23, 2021

ICH Photosafety Guidance Aims to Bridge FDA, EU Differences:

"The FDA and Health Canada recently opened for industry comment new guidance from the International Conference on Harmonisation  on the photosafety testing of drug compounds.

“The S10 draft guidance document clarifies some points in the current EMA and FDA guidance that are known weaknesses, based on accumulated information and experience since those documents were issued in the mid-2000s,” Doug Learn, director of photobiology at Charles River, told In-Pharmatechnologist.com."

'via Blog this'

Read the guidance (updated link):

PHOTOSAFETY EVALUATION OF PHARMACEUTICALS - S10 (pdf) 

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EU Says Turn Down MP3 Players Or Risk Hearing Loss

I think this makes a lot of sense. I take the bus and train to work, and pass a lot of folks listening to an MP3 player. Guess what, I can hear their tunes only too well, too! Seems to me most of these players are putting out some decibels. So the European Union (EU) in some wisdom has set out to reduce the volume put out by MP3 players. Read the full story in this Boston Globe news article, "EU tells music lovers to turn down MP3 players."

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Free GMP Glossary

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Updated September 25, 2020

The link in the original post broke.

I offer you this alternative link instead:
Terminology & Definitions in Pharmaceuticals - Pharmaceutical Guidelines

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I'm continually amazed at all the fabulous free GMP resources that can be found on the web. Take a look at this GMP Glossary made available by the Maas & Peither GMP Publishing Team. This team's description, "Definitions of GMP terms derived from EU, FDA and ICH guidelines are the base of your GMP communication and documentation."

They're right. Not only can your communication and documentation be made more precise, you can use this glossary for your GMP training efforts and classroom training.

Previous posts on FDA GMP training:

1. The Health, Drug, Prescription, and GMP Supersite: 4 Free Articles on GMP Training
2. The Health, Drug, Prescription, and GMP Supersite: Free GMP Training Tip - Your Homework Is To Sleep Before Class
3. The Health, Drug, Prescription, and GMP Supersite: 2 Free GMP Training Tips - Make It Fun!

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