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Challenging Conventional Limits

LOGFILE 37/2018 – October 2018


Dear Colleague,

Do you also store your standard medicinal products at "normal temperatures", i.e. at 15–25 °C? But is it really necessary to stick to these temperatures? Does it make sense to warm up the storage facilities during the cold season, spending lots of money and polluting the environment?

The new chapter 24.F of our GMP Compliance Adviser presents a challenging case study in order to find answers to these questions – and comes to a trend-setting result.

Read today in an exclusive excerpt from this chapter that a broadening of the temperature range to 9–25 °C would not negatively affect the quality and safety of standard medicinal products and medical devices and would at the same time save energy and money.

Wishing you interesting insights,
Sabine Paris


What is the point of "heating" medicinal products to 15–25 °C?

Whether international guidelines that deal with the storage of medicinal products, nor the European Pharmacopoeia do prescribe a mandatory temperature range of 15–25 °C for the storage and transportation of standard medicinal products.

Nevertheless, storage at "room temperature" or at "15–25 °C" is widely understood to be necessary. To maintain this temperature range, however, energy must be used for heating; budgets and the environment are needlessly burdened.

Read in today's feature about the results of a case study that challenges conventional limits.

It is an excerpt from our just updated GMP Compliance Adviser, the gold standard of GMP online knowledge.

>>> Read now: What is the point of "heating" medicinal products to 15–25 °C?


GDP Audit Questionnaire: 700+ Question Checklist Ensures You're Meeting GDP Requirements

Are you facing a GDP audit? Or simply want to benchmark to make sure you're doing everything right?

With time and resources at a premium, you need a set of simple SOPs to get your staff up to speed.

The GDP Audit Questionnaire includes more than 700 questions — with references to GMP/GDP regulations and EN ISO 13485 — to prepare you for the implementation of GDP audits.

The pdf download is an excerpt from the unparalleled GMP Compliance Adviser - the unique GMP knowledge source for the drug industry.

Order the GDP Audit Checklist — your step-by-step SOP for making sure your distribution practices pass muster.

>>> Click here for more information and order


GMP Question of the Week

Which are the 4 basic maintenance strategies?

>>> Click here to read the answer



CDRH publishes proposed Medical Device Guidance Development 2019

On 3 October 2018, the US FDA’s Center for Devices and Radiological Health (CDRH) has published three lists of guidance documents that may be published in 2019:

  • Prioritized medical device guidance documents that the Agency intends to publish in FY 2019 ("A-list")
  • Device guidance documents that the Agency intends to publish, as the Agency's guidance-development resources permit, in FY 2019 ("B-list")
  • Previously-issued final guidances for which CDRH is interested in receiving feedback whether these final guidances should be revised or withdrawn (retrospective review list). This list includes documents which were issued in 1989, in 1999 and in 2009.

Read more ...


GMP Compliance Adviser

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