Site master file

Figure 12.1 The contents of a Site Master File. Extract from PIC/S Explanatory Notes For Industryon the Preparation ofa Site Master File (PE008) PIC/S September 2007.

The detail in the narrative of this section of the report may be reduced where a Site Master File acceptable to the reporting authority has been submitted to the Competent Authority. 

Submit Site Master File in accordance with the current Guidelines for Preparation of a Site Master file. 

Data required as evidence of efficacy in Annexure 13 13/95 Submission of applicant and site master files... 

Are the following included or have they been submitted previously (State date if previously submitted) a) Site Master File of Manufacturing Site/ Packaging Site/Laboratory/Distributor (Quote number ) j i ... 

Manufacturers should be informed of tentative inspection dates, and should be requested to submit information about each manufacturing site to be inspected. This information should normally be provided in a site master file (SMF). An example of a technical questionnaire for pharmaceutical manufacturers is attached as Appendix 8. This information will be used during the preparation for the inspection and during the inspection itself to verify information supplied by the manufacturer to the procurement agency. 

Submit a site master file for each manufacturing site as listed in the product dossier, in the recommended format, also available by electronic mail and on the web page http //mednet3.who.int/prequal/ to... 

Write a letter to the company informing them of the tentative date allocated for the site inspection. Request the company to indicate whether the dates are suitable to them, and also request them to submit a site master file. 

If a site master file (SMF) exists and is available, study the SMF and make notes to be followed up during the inspection (e.g. available equipment, SOPs and records)... 

Part III - GMP related documents - contains documents such as Site Master File (Sect. 35.5.8) and ICH QIO (Sect. 35.5.9). The aim of Part EU is to clarify regulatory expectations and it should be viewed as a source of information on current best practices. ... 

A Site Master File (SMF) gives a concise overview of the current manufacturer s situation and is required as a public document for the Inspectorate to give to other Agencies, when requested. It is mentioned in Part HI of EU-GMP (see Sect. 35.5.7). It includes some identical elements as the Quality manual (Sect. 35.6.1). Table 35.2 shows the abbreviated contents. 

The site master file describes both practical aspects, such as the address and the location of buildings, and quality aspects. For elaborate contents reference is made to the relevant PIC/S inspection guide [21]. The sequence of aspects is the same as in the GMP and also matches the form that a manufacturer should fill to obtain a manufacturing licence. 

Table 35.1 Contents of c-GMP in force at July 2014 Table 35.2 Abbreviated Site Master File Structure...

Premises, equipment and systems most often are described in a Validation Master Plan (VMP, see Sect. 34.11) part of the PQS and are consequently subject to change control. The VMP has to include a summary of the facilities, systems, equipment, processes on site and the current validation status. A Site Master File (see Sect. 35.5.8) includes more detailed description of facilities, equipment and systems. If a Site Master File is available the VMP may simply refer hereto and only add policy and instructions related to the validation activities. 

Explanatory notes for industry on the preparation of a site master file (PE008-3). nC/S inspection guide, http //www.picscheme.org... 

The EU-GMP comprises 3 parts. Part 1 encompasses 9 basic chapters on medicines Pharmaceutical Quality System, Personnel, Premises and Equipment, Documentation, Production, Quality Control, Outsourced activities. Complaints and Product Recall, Self Inspection. Part 2 is about the production of active substances. Part 3 contains about 20 related documents such as a site master file and several annexes (see also Sect. 35.5.7). 

Health Sciences Authority (Singapore). Guidance Notes on Preparation of a Site Master File, May 1999. 

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