Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

Site Master File, a competent regulatory document ***

Susanne Rathmann (Abschlußjahr: 2007)

Language: English

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 harmonised GMP standards and quality systems of world-wide pharmaceutical inspectorates.

The function of a Site Master File is to give the national regulatory authority inspector

• an introduction to the company and its activities,
• an indication that an appropriate quality system is in place,
• an information about the sites GMP compliance,
• and an indication that the site is “ready for inspection” prior to an inspection taking place.

Depending on national requirements a SMF is not required, can be either voluntary submitted or must be submitted to the competent authority.

The assessment of a SMF, if available, will be part of the inspection report. Therefore, the content should reflect brief, but comprehensive, current practice at the site. Preparation and maintenance of a SMF is a complex and even time consuming task, which requires co-ordination and resources. Based on the structure of a given company input from various departments is required. In this thesis two possible procedures for set up and maintenance of a Site Master File are introduced and a summary of possible advantages and disadvantages of both procedures is provided.
The question under which circumstances it is advisable for companies to prepare a SMF and under which circumstances it is advisable to better not to prepare a SMF is raised. As there are a lot of factors to take into account a decision analysis is performed. It is concluded that for global working companies there are more arguments for set up a SMF than against a SMF provided that a set up and maintenance strategy, laid down in a written procedure, is available.
The United Kingdom, Germany, the United States and Taiwan are selected as examples to illustrate different usage of a SMF in different regions.

Pages: 63, Annexes 6, pages: 12