Site Master File Flashcards
What is a site Master file
the company description prepared by the manufacturer whihc covers all GMP aspects
why is a Site Master File needed?
Necessary for the communication with authorities, communication with suppliers and service providers, for project and comany audits
when is SMF requested?
in preparation for an audit
the SMF is part of?
the quality assurance system fo a company
where is the SMF regulated?
Eudralex volume 4, PIC/S, EMA Guide and national legaol basis
what is the PIC/S
pharmaceutical inspection Convention/ Co-operation Scheme
why are the PIC/S important?
they are non-binding informal co-operative arrangment between regulatory Authorities in the filed of GMP for medicinal products for human or veterinary use
the SMS is prepared by who?
the pharmaceutical manufacturer
what is the contain of the SMS
Quality managment policies and activites o the site
the production and/ or quality control of pharmaceutical manufacturing operations
any closely integrated operations at adjacent and bearby buildings
to which part does the SMF belongs
to the quality managment system of the manufacturer
what is the DUNS number?
Data-Universal Numbering system
what is the EudraGM(D) P?
A Database of the European Community of manufacturing, import and whole-sale distribution authorisations and of certificates of GMP and GDP
Which members are part of the interdisciplinary team for the SMF and why it is important to have them
the members are from the Packaging, production, quality control and quality management. it is important to avoide contradiction of the actual processes and procedures of the SMF and that of the other site’s documents such as the SOPs
how is the SMF prepared?
it is prepared in accordance with the explanations for the preparation of an SMF of the PIC/S, which is included in part III of the EU GMP Guide
what does the SMF represents?
it represent the business card of a company. The customer is this case is the authority or increasingly an external intereasted party
