Regulatory Document – Site Master File

Duration: 70 Minutes
This webinar will guide the manufacturer of medicinal products in the preparation of a Site master file (SMF) that is useful to the regulatory authority in planning and conducting GMP inspections.
Site Master File
Instructor: Kenneth F. Miles
Product ID: 501708
The Site Master File is a company description compiled by the drug manufacturer that contains all good manufacturing practice (GMP) aspects. It is also a regulatory requirement. The company description should meet all documentation requirements according to GMP standards. The authorities will examine the Site Master File and all references and appendices for accuracy, completeness and actuality. So the Site Master Files becomes part of the quality assurance system of a company.

Objectives of the Presentation
  • Introduction to Site master File
  • Purpose and scope of Site master File
  • Content of Site Master File
  • General information on the manufacturer
  • Quality management system of the manufacturer
  • Personnel
  • Premises and equipment
  • Documentation
  • Production
  • Quality control (QC)
  • Distribution, complaints, product defects and recalls
  • Self inspections
Why Should you Attend
A Site Master File has two purposes. First, it is intended for submission to the authorities. Second, it is expected to be a part of the management of suppliers and service providers. The Site Master File plays a further important role in project and company audits in connection with purchase and sale of shareholdings (due diligence audits).

Who will Benefit
  • CEOs
  • VPs
  • Compliance Officers
  • Attorneys
  • Regulatory Affairs
  • Quality Assurance
  • R&D
  • Validation Department
  • Manufacturing Engineers
  • Consultants
  • Anyone interested in understanding the regulations requirements
Topic Background
A Site Master File (SMF), also referred to as plant master file or site reference file, is prepared by the manufacturer and contains specific information about the quality management system in place, the production and/or quality control of pharmaceutical manufacturing operations carried out at the named site and any closely integrated operations at adjacent and nearby buildings. If only part of a pharmaceutical operation is carried out on the site, a Site Master File need only describe those operations, e.g. analysis, packaging, etc. Guidance on the preparation and set up is provided in the Pharmaceutical Inspection Co-Operation Scheme (PIC/S) Explanatory Notes for Industry on the preparation of a Site Master File in the current version as of July 2004 (PE 008-2). PIC/S is a cooperative arrangement between health authorities whose purpose includes leading the international development, implementation, and maintenance of harmonized GMP standards and quality systems of world-wide pharmaceutical inspectorates.
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Instructor Profile:
Dr. Kenneth F. Miles is a seasoned professional in Quality, Regulatory and Clinical affairs and development strategy for drugs, biologics, medical devices and combination products. He has worked in senior quality and regulatory roles in the medical products industry for more than 20 years. Dr. Miles has worked for a number of large and small pharmaceutical, biotech and medical device companies. He also interfaced with FDA at Local, District and Centre levels and has dealt with several foreign ministries to bring companies into compliance. He has set up regulatory and quality systems for countries around the world, including the Pacific Rim, Europe and South America. He is the senior member of the American Society for Quality, (Certified Quality Engineer) and member and Fellow of Regulatory Affairs Professional Society (Certified Regulatory Affairs). Dr. Kenneth F. Miles is the recipient of the GMP Institute Hall of Fame Award.


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