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LOGFILE

2017 - The Regulations Report

LOGFILE 19/2018 – May 2018

Contents

Dear Colleague,

Your task as a quality manager is inter alia to be aware of all current GMP regulations at all times. This is quite a tough job. With our summary review of the important GMP documents published in 2017, you'll save time and nerves and get the precise overview you need for your daily business.

Thus, you will be comprehensively informed and at the same time provided with a compact overview that you can also use as a GMP checklist. Hand on heart: Have you already considered all these new regulations?

Regards,
Sabine Paris







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24 Documents You Should Know About: 2017 - The Regulations Report

Do you still have last years new regulatory developments in mind?
Are you sure you didn’t miss out on one or the other?
Do you need to review some of the changes?

Our editor Sabine Rabus has compiled for you an overview of 24 important GMP documents published in 2017. This report of 2017 GMP documents helps you to maintain an overview of developments in the most important international regulations.

In the report you will find a brief description of the individual documents, a link to our detailed news on each issue, and a link to the original document.

>>> 2017 - The Regulations Report







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GMP Fundamentals

A Step-by-Step Guide from Beginner to Advanced Level and Beyond

This handbook is a practical and easy-to-read guideline, giving you a quick and comprehensive overview of the complex world of Good Manufacturing Practice (GMP) without the need of previously acquired knowledge.

Some topics are:

  • GMP: Purpose and basic pharmaceutical terms
  • Laws, licenses and inspections
  • Personnel: Responsibility and hygiene
  • Standard Operating Procedures (SOP) and documentation
  • and many more.

Using practical examples and comparisons to everyday life, this book helps to easily understand GMP regulations.

GMP Fundamentals is available as a book and as pdf download.

>>> Click & View: GMP Fundamentals

>>> More information and order: GMP Fundamentals









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GMP News: PIC/S & FDA

2018-05-14
PIC/S Meeting in April 2018
From 16 to 18 April 2018 the PIC/S Committee and PIC/S Executive Bureau meetings took place in Geneva, Switzerland.
Read more ...

2018-05-14
Danish-Japanese collaboration – FDA Confidentiality Commitment
The Danish Medicines Agency recently met with representatives from the Japanese Ministry of Health, Labour and Welfare (MHLW), and the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) in Copenhagen.
Read more ...







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GMP Question of the Week

What is the dew point temperature?

>>> Click here to read the answer








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Approved Pharmaceutical Water Qualities

What are the different types of pharmaceutical water? What are they used for in the pharmaceutical industry? What microbiological and physicochemical requirements are described in the pharmacopoeias?

Approved Pharmaceutical Water Qualities provides you with the answers. The report will walk you in detail through the requirements for the four water types that are of particular importance for pharmaceutical manufacturing:

  • Drinking water as source water
  • Purified Water (PW)
  • Highly Purified Water (HPW)
  • Water for Injection (WFI)

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

>>> More information and order








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