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The Inspectors View on PV

LOGFILE 41/2018 – November 2018


Dear Colleague,

The importance of process validation has increased continuously in recent years. This is particularly evident in the numerous regulations that have been revised in Europe and the USA (e.g. Annex 15, EMA and FDA guidances).

The German GMP inspectorates also set out their expectations in the Aide Mémoire for the inspection of process validation published at the beginning of this year. The Aide Mémoire is a well-structured guide to planning and implementing process validation, which is worth reading.

Due to its importance for the pharmaceutical industry, we translated the directive document into English. With this volume, you receive a bilingual comparison with excellent practical applicability, also in an international context.

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

Sabine Paris


NEW: Inspection of Process Validation

Do your validation processes meet their specified requirements?

The new regulatory guide "Inspection of Process Validation" written by German GMP inspectors is brilliant. It offers an excellent up-to-date approach on process validation and facilitates the planning and execution of all necessary steps to be compliant.

  • What should validation documentation contain?
  • How does one implement continued process verification?
  • What is the role of risk management?
  • What receives particular attention during an inspection?

In this bilingual (English/German) PDF you will be given specific answers to these and other frequently asked questions.

This Aide-Mémoire is a structured guide for the planning and execution of process validation. New concepts for modern process validation are introduced and known facts are summarised.

>>> Read now: GMP Requirements for Process Validation – Excerpt from the pdf download Inspection of Process Validation

>>> More information and order


GMP Compliance Adviser

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  • Save search time: All important GMP regulations in one search engine (EU, U.S., ICH, WHO, Canada, …).
  • Save consulting budget: 3000+ pages GMP interpretation from experts for technology, procedures, quality systems, trainings, etc. - in one single online source 24/7.

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

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The GMP Compliance Adviser is also available as a monthly subscription.

>>> Click here for more information & order: Monthly subscription



PIC/S Meeting 2018 in Chicago
The PIC/S Committee met on 24-25 September 2018, in Chicago. The meeting was attended by 38 Participating Authorities as well as by a number of Applicants, Pre-Applicants and Associated Partner Organisations. The event was hosted by the US FDA which symbolised the effort to strengthen inspectional approaches and assessments worldwide and to further share and discuss respective regulatory decisions and information. The keyword “harmonisation” and the impact of PIC/S on this matter had been especially highlighted by the FDA.
Read more ...


GMP Question of the Week

What is the objective of a quality policy?

>>> Click here to read the answer


Questionnaire for preparing GMP-inspections

Would you like to make your next regulatory inspection less stressful?
This comprehensive checklist of questions investigators typically ask helps you to make it happen!

The GMP Audit Questionnaire contains more than 650 questions related to audits and inspections. Each question has a reference to the current EU GMP Guide Part I/II and the 21 CFRs 210/211/11.

The GMP Audit Questionnaire works great for both sides - the auditor and the inspected company. It facilitates your efficient preparation for
  • an audit or an inspection to come
  • self-inspections
  • your own GMP audit of suppliers and subcontractors.

The book is an excerpt from the GMP Compliance Adviser.

This perfect working tool comes in a compact format and offers plenty of space for your own notes.

>>> Click here for more information and order

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