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The Drug Manufacturer‘s Guide to Site Master Files
€ 279.00
net
€ 332.01
  19% VAT included
PDF-Download
US$
397.00
Instructions for preparing a Site Master File according to
PIC/S PE 008-4
NEW ++ NEW ++ NEW
Edition: 1st edition 2013
66 Pages
ISBN: 978-3-943267-69-3
Excerpt from the GMP MANUAL

Beginning in January of this year, all European inspectors began asking for a site master file that complies with the 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 all-new 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 MANUAL, 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.

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.

Technical Requirements

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Ms. Wawretschek is a pharmaceutical technical assistant with GxP Services in Germany and a freelance consultant for quality assurance. Previously she worked for Schering AG Berlin in pharmaceuticals analysis, chemical development and quality assurance, where she was responsible for GMP optimization, SOP systems, manufacturing documentation, preparation and execution of audits and inspections by authorities, training programs, qualification and validation.
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