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.
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