What should be in a site master file?
1.1 The site master file (SMF) is prepared by the pharmaceutical manufacturer and should contain specific information about the quality management policies and activities of the site, the production and/or quality control of pharmaceutical manufacturing operations carried out at the named site and any closely …
How do I create a website master file?
Guidelines for Preparation of Site Master File (SMF)
- Prepare a Site Master File containing about 25 to 30 A4 size pages as per contents are given in Annexure.
- Each page of SMF shall have the following header.
- Document No.: Effective Date:
- Each page of SMF shall have the following footer.
- Prepared by: Approved by:
Is a site master file required?
► The principle audience for the SMF is the regulator, who highly recommend including the SMF as part of the application to manufacture medicinal products. This allows to plan GMP inspections before getting to site. However, the SMF is not currently a mandatory requirement.
What is FDA site master file?
2.1 The Site Master File is prepared by the cosmetic and/or Household Hazardous Substance manufacturer and contains specific information about the quality assurance, the production and/or quality control of HHS manufacturing operations carried out at the named site and any closely integrated operations at adjacent and …
What is the function of site master file?
Provide layouts and flow charts of the manufacturing areas showing the room classification and pressure differentials between adjoining areas and indicating the production activities (i.e. compounding, filling, storage, packaging, etc.)
Who is TRS 961?
WHO Heating, ventilation and air-conditioning systems for non-sterile pharmaceutical dosage forms (Annex5, TRS 961) Content: These guideline focuses primarily on the design and good manufacturing practices (GMP) requirements for HVAC systems for facilities for the manufacture of solid dosage forms.
What is the purpose of site master file?
What is the difference between Site Master File and quality manual?
A Site Master File (SMF) is a GMP document that describes the site, major activities, key personnel, site layout, etc. A Quality Manual (QM) is an ISO 9001 document that described the whole Quality Management System.
What is site master file in pharmaceutical industry?
What are master files?
A collection of records pertaining to one of the main subjects of an information system, such as customers, employees, products and vendors. Master files contain descriptive data, such as name and address, as well as summary information, such as amount due and year-to-date sales.
What is site master file in clinical research?
Study Site Master File (ISF): The file held by the site Principal Investigator containing the essential documents that demonstrate that the trial has been conducted in accordance with regulatory requirements and ICH GCP, enabling both the conduct of a clinical trial and the quality of the data produced to be evaluated.
What is TRS in WHO guidelines?
The WHO Technical Report Series (TRS) makes available the findings of various international groups of experts that provide WHO with the latest scientific and technical advice on a broad range of medical and public health subjects.
What is the site master file?
1.1 The Site Master File is prepared by the pharmaceutical manufacturer and should contain specific information about the quality management policies and activities of the site, the production and/or quality control of pharmaceutical manufacturing operations carried out at the named site and any closely
What is an EMEA site master file?
As examples the United Kingdom, Germany, the United States and Taiwan were selected. The EMEA considered a Site Master File as “helpful” for preparing and carrying out the inspection. The same applies for competent regulatory authorities in Germany, the MHRA in the United Kingdom and the regulatory authority of Taiwan.
What is SMF (site master file)?
SMF (Site Master File) as the name indicates is a document that provides authentic information regarding the site of a pharmaceutical manufacturing plant.
When were the guidelines for preparing a site master file changed?
On 5 November 2002, the guidelines for the preparation of a SITE MASTER FILE (first edition, April 2000) were replaced by the PIC/S explanatory notes for industry on the preparation of a site master file, 1 November 2002.