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LOGFILE

Cleaning Validation Update - Part 1

LOGFILE 10/2018 – March 2018

Contents

Dear Colleague,

Hand on heart, are you in detail familiar with the recent regulatory update of European cleaning validation requirements? Prevention of cross-contamination is one of the topics in the centre of the recent updates of the EU GMP Guide. And - most important - a paradigm shift took place for the setting of acceptance limits: from purely mathematic to health-based exposure limits.

In today’s feature, we outline key changes to cleaning validation guidance, including setting limits and identifying worst-case active residue that should be part of the cleaning life cycle program. Next week you will read about the various responsibilities the qualified person has in the light of the updated requirements.

Wishing you interesting insights.
Regards,
Sabine Paris







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What a Qualified Person must know about the recent cleaning validation update – Part 1

The first part of today’s feature ‘What a Qualified Person must know about the recent cleaning validation update’ covers key changes to cleaning validation guidance, including setting limits and identifying worst-case active residue that should be part of the cleaning life cycle program. The second part will discuss the various QP responsibilities regarding the new set of requirements for cleaning validation.

This article is reproduced from a recent issue of gmp review, a quarterly journal researched and edited by an expert team experienced in all aspects of pharmaceutical manufacturing and control.

gmp review provides in-depth analyses of international pharmaceutical manufacturing regulations.

>>> Read now: What a Qualified Person must know about the recent cleaning validation update – Part 1








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GMP News: FDA & EMA

2018-03-13
FDA Warns OTC Drugmakers in China and Hong Kong, Drug Manufacturer in the US, Sends 483s to Aurobindo and Sun
The US Food and Drug Administration (FDA) released two warning letters sent to over-the-counter (OTC) drugmakers in China and Hong Kong and a third one to a drug manufacturer in the USA. In addition, two Form 483s for India-based Sun Pharmaceutical Industries and Aurobindo Pharma were released.
Read more ...

2018-03-13
Will the UK Be Part of EMA After Brexit? –EC and UK Follow Different Approaches
While Theresa May promoted the benefits of the UK becoming an associate member of the EMA, the EU took quite an opposite position. In a draft guideline published on 7 March 2018 the EU sets out how the EU council sees its future with the UK. A comment by the British newspaper “The Guardian” states that while the British government does Brexit by speeches the EU prefers releasing documents.
Read more ...







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GMP Question of the Week

What is mandatory to render disinfection reproducible?

>>> Click here to read the answer








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gmp review

gmp review provides in-depth analyses of international pharmaceutical manufacturing regulations.

gmp review keeps readers up to date on the latest Directives, Regulations and Guidelines applicable to the pharmaceutical industry from the FDA, EU, CPMP and ICH positions. Each item comes with analysis and comment on its effect on your company. The dry legal jargon is made understandable to you and your colleagues in manufacturing and quality. As such, gmp review is the perfect companion to the GMP Compliance Adviser and will help provide further useful commentary on the new regulations.

If you are involved in any aspect of GMP then gmp review will provide much-needed information and analysis in a convenient quarterly journal format. gmp review subscribers will also receive gmp-review news, a monthly news service to keep you up-to-date on new developments in GMP and associated regulations.

Annual subscription: £ 190, 210 € and US$ 250 (4 issues)

>>> More information: gmp review







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