The Drug Manufacturer's Guide to Site Master Files

PDF Edition - The Drug Manufacturer’s Guide to Site Master Files

April 2013
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In 2013, all European inspectors began asking for a site master file that complies with the 2011 PIC/S revisions to GMPs.

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 from FDAnews 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 [Maas & Peither AG - GMP Publishing], 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.

Changes by the Dozen

Key mandatory changes include:

Greater specificity for release procedures of finished products, including detailed description of qualification requirements (education and work experience) of the authorized person responsible for batch certification and releasing procedures and the role of the authorized person in quarantine and release of finished products and in assessment of compliance with the marketing authorization.

Changes by the Dozen

Expanded quality risk management (QRM) requirements, including a brief description of the QRM methodologies used by the manufacturer and a description in the scope and focus of the QRM of any activities performed at the corporate and local level.

New requirement for product quality review (PQR) standards mandating descriptions of methodologies used.

New requirements that companies outline the controls and compliance mechanisms they have in place for suppliers and service providers; including management of suppliers and contractors.

New mandatory compliance with Transmitting Animal Spongiform Encephalopathy (TSE) guidelines.

New mandatory use of modern control strategies such as Process Analytical Technologies (PAT) or parametric release.

New mandatory requirements for incorporating traceability of batches in the supply chain.

New mandatory requirements for plans and procedures to protect against counterfeiting and falsification.

Cornelia 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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