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Ask Our Experts Part 2

LOGFILE 01/2018 – January 2018


Dear Colleague,

In 2017 we introduced for the first time the “Ask our Experts”-button in our GMP Compliance Adviser. Up to now, our publisher team and our authors have received a lot of questions, which are not only relevant to the questioner – but also to the GMP community.

Would you know ad-hoc the answer to:

  • Is it sufficient to label incoming material containers externally or in addition internally?
  • What are the normal operating ranges in a non-sterile plant (ISO 8)?
  • Do HEPA filters have an expiry date, so the filter has to be replaced even if it passes a filter integrity test?

My colleague Sabine Rabus has summarised the most relevant questions. We believe that they are of interest to all of us. Be well informed within a seven minute reading time!

Sabine Paris


Ask Our Experts – Four GMP Questions and Answers

The subscribers of our GMP Compliance Adviser, the world’s most comprehensive GMP online knowledge base, have the unique opportunity to get answers to those GMP questions that cannot be resolved within their company or that need additional expert advice. Our service is not only well received but also extensively used by our customers.

For our LOGFILE readers, we have compiled ten questions that reached us through the Ask Our Experts-button. We already published the first six questions and answers (LOGFILE 47/2017). Today's feature presents another four questions and answers. Check them out!

>>> Read now: Ask Our Experts – Part 2, Four GMP-Questions Which Might be of Interest to You


GMP Question of the Week

Which are the key aspects of personnel hygiene?

>>> Click here to read the answer


GMP News: Annex 1 & Chinese Manufacturers

Draft to Annex 1 on Sterile Manufacturing Published
On 20 December 2017 the European Commission has published the long awaited draft of Annex 1 “Manufacture of Sterile Medicinal Products”. The public consultation period is open from 20 December until 20 March 2018.
Read more ...

India reports quality shortcomings of Chinese pharma companies
The Economic Times of India has published an article saying that the Indian government has issued showcause notices to eight Chinese pharmaceutical companies. Those companies were inspected by a special Indian inspection team and were found to supply poor quality APIs to drug manufacturers in India.
Read more ...


New: Principles of Equipment Qualification

The FDA and EMA both stress the importance of equipment qualification. If you can't prove that your equipment, operations and processes all work the way they're supposed to, you can't reliably produce a quality product and pass regulatory muster.

This report lays out the basics of building a four-phase qualification plan - design qualification, installation qualification, operational qualification and performance qualification - that satisfies US and EU requirements. It covers:

  • Building a qualification team
  • Formulating a qualification plan
  • Documenting qualification results
  • Using risk analysis methods to evaluate equipment's impact on the manufacturing process
The following bonus materials are included in the report: 
  • Instructive diagrams
  • Checklists for carrying out a qualification plan
  • FDA guidance Principles of Process Validation and
  • EU GMP guideline Annex 15, Qualification and Validation.

Order your copy of Principles of Equipment Qualification and understand the four phases of qualification.

>>> More information and order: Principles of Equipment Qualification

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