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The Drug Manufacturer‘s Guide to Site Master Files
€ 345.00
€ 410.55
Der MwSt.-Satz richtet sich nach der Produktart, auf Print-Produkte werden 7% und auf digitale Produkte 19% berechnet. Bei Bundle-Produkten werden beide Steuersätze berücksichtigt. Vor dem endgültigen Auslösen der Bestellung wird die MwSt. bestellspezifisch angezeigt.
pdf download
Instructions for preparing a Site Master File according to
PIC/S PE 008-4
Edition: 1st edition 2013
66 Pages
ISBN: 978-3-943267-69-3
Delivery: immediately after receipt of payment
Excerpt from the GMP Compliance Adviser

All European inspectors ask for a site master file that complies with the "Explanatory Notes on the preparation of a Site Master File" of Part III of the EU GMP Guide als well as with the identical 2011 revision of the PIC/S guidance document PE 008 “Explanatory Notes for Pharmaceutical Manufacturers on the Preparation of a Site Master File”.

If you don’t have an updated site master file – or a site master file at all – you’re out of compliance with dozens of new or changed requirements.

This report will help you perform a comprehensive gap analysis that assures your Site Master File matches your company‘s activities. In addition, readers will review:
  • Up-to-date explanations and analysis of all the new Site Master File changes
  • A sample document illustrating what the newly overhauled Appendix 8 (Equipment and Devices for Production and Quality Control) of a Site Master File should look like
  • A complete sample Site Master File to use as a template
  • A thorough review of the elements every Site Master File must include
  • And much more...
Your guide, Cornelia Wawretschek, is author of a chapter in the GMP Compliance Adviser, Good Manufacturing Practices and Implementation, from which The Drug Manufacturer’s Guide to Site Master Files is adapted.

Remember — Without an up-to-date Site Master File, you are not authorized to market pharmaceuticals to European customers. Don’t risk it.

Reading Sample

The Drug Manufacturers Guide to Site Master Files - Reading Sample

Technical Requirements

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Filesize: 1,4 MB

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Please note the following procedure guidelines:

If you choose payment by bank transfer:

  • You will receive an advance invoice.
  • After payment is received an email with the download information will be sent.

If you choose payment by credit card:

  • Immediately after the credit card payment you will receive an email with the download information.
  • The invoice will be sent by postal mail as soon as possible.
Wawretschek, Cornelia

Cornelia Wawretschek has been working as a freelance QA consultant for 15 years. She has many years of experience in the areas of pharmaceutical processes and analysis with a focus on the development of semi-solid and liquid dosage forms, sterile production as well as investigational medicinal products.

A Process Approach to Pharmaceutical Quality Systems
Quality Agreement