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LOGFILE

Pharma Guide to Cleaning Validation

LOGFILE 26/2018 – July 2018

Contents

Dear Colleague,

Does your cleaning validation meet the current requirements of Annex 15 to the EU GMP Guidelines? And are you already familiar with the new requirements for establishing limits in cleaning validation?

Help is at hand: The new pdf download A Pharma Guide to Cleaning Validation gives you a comprehensive overview on agency expectations. You learn how to set up a risk-based cleaning validation and to fulfill the lifecycle approach for products and processes. Moreover, it explains the new PDE approach and points out its implications for cleaning validation step-by-step.

This pdf download is taken from the gold standard of GMP knowledge databases, the GMP Compliance Adviser.

Enjoy your exclusive chance to read an excerpt from the guide today.

Regards,

Sabine Paris








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Guide to Cleaning Validation

The Pharma Guide to Cleaning Validation shows you what 'done correctly' is. It explains:
  • Regulatory aspects
  • Cleaning process requirements
  • Risk management
  • Design phase
  • Validation phase
  • Ongoing verification/revalidation
  • Documentation
  • PDE Guideline of the EMA
  • Calculating the maximum allowable carryover
  • Visually clean
  • Microbiological state

Every page offers practical strategies to implement an up-to-date cleaning validation and meeting regulatory requirements.

The pdf download is an excerpt from the unparalleled GMP Compliance Adviser.

>>> Read now: Principles of Cleaning Process Requirements - Excerpt from the download

>>> More information and order








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GMP Compliance Adviser

Meeting GMP requirements is a team approach of numerous departments. Consistent practice of processes and background knowledge is crucial. Does your facility meet every current GMP requirement? Here’s a way to make sure you do:

The GMP Compliance Adviser helps you across the full spectrum of questions, challenges and thorny problems you’re likely to face:

  • Keeping your procedures and facilities ready for inspections at any time
  • Reviewing and updating SOPs & procedures fast and easy
  • Benchmarking your processes with proven practices
  • Planning of technical projects with state-of-the-art descriptions
  • Developing new SOPs with field-tested templates
  • Diving deep into new topics and learning from experts
  • Having critical EU, FDA, WHO, PIC/S, ICH and HC requirements at your fingertips
Achieve GMP compliance with the ever-changing demands in the pharmaceutical industry – for as little as the equivalent of an one-hour consulting fee: 99 €/month!

10 000 professionals in over 70 countries use the GMP Compliance Adviser successfully.

Get your access to the largest GMP knowledge database worldwide now!

+++ Also available as a monthly subscription +++

>>> Click here for more information

>>> Click here to order







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GMP News: ICH & FDA

2018-07-05

ICH Prepares for Future Topics

The ICH (International Council for Harmonisation) met in Kobe, Japan, from June 2 – 7, 2018. The corresponding press release provides insight on the topics discussed.

Read more ...

 

2018-07-05

FDA: Two Voluntary Programs on Quality Metrics

The US FDA initiated two new programs on a voluntary basis to gather industry feedback regarding the use of quality metrics. Namely these are a

  • Quality Metrics Feedback Program and a
  • Quality Metrics Site Visit Program.

Read more ...








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GMP Question of the Week

When is it imperative to monitor transport temperatures for finished drug products?

>>> Click here to read the answer








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NEW: Data Integrity in the EU

Nowadays all regulatory authorities focus on data integrity and have their own data integrity guidelines - however, their regulations don’t always agree.

You’ll understand all the requirements with Data Integrity in the EU: Requirements for Quality Management Systems. This report details the ins and outs of all three documents of EMA, MHRA and WHO and explains how the FDA regulations fit in.

You will learn:

  • The five principles of data integrity
  • Differences between EU and UK definitions of data integrity and raw data
  • The differences between raw data and metadata
  • Ensuring the integrity of original paper-based records vs. electronic records
  • Systems to monitor data integrity
  • Laboratory handling and testing of samples
  • Storage and archiving of records
  • Data integrity during process development and validation

The report also includes the texts for:

  • EMA’s question-and-answer document on data integrity
  • MHRA’s GXP data integrity guidance
  • WHO’s Annex 5: Guidance on Good Data and Record Management Practices.

Excerpt from the GMP Compliance Adviser.

Order your copy of Data Integrity in the EU and avoid data problems and breaches that can damage your drug’s success.

>>> Click here to order








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