What should be in a site master file?
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 …
What documents are in the trial master file?
Ideally, the documents included in the TMF are: Trial documents (protocol, investigator’s brochure, participant information documents, SOPs, instructions, manuals, guidelines, etc.) Documents related to the Investigational Product (certificates of analysis, shipment records, storage records, etc.)
Is a site master file required?
The Site Master File is a requirement in just about every set of pharmaceutical regulations except the US FDA for GMP operations and would be a fundamental expectation to receive a GMP certificate. You should most certainly have one in place prior to your certification inspection and be prepared to provide it.
What is the purpose of a site master file?
What is the importance of 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 …
How do you write a good document?
Best practices for writing documentation:
- Include A README file that contains.
- Allow issue tracker for others.
- Write an API documentation.
- Document your code.
- Apply coding conventions, such as file organization, comments, naming conventions, programming practices, etc.
- Include information for contributors.
How do I create a validation master plan?
Also describes how the VMP helps to ensure validation activities are carried out following company protocols, which are designed to evaluate whether equipment, systems, processes and methods: Meet design specifications. Are suitable for intended use. Satisfy cGMP regulations.
What is master formula record?
Master formula record (MFR) is a master document for any pharmaceutical product. It contains all information about the manufacturing process for the product. MFR is prepared by the research and development team of the company and all other documents like BMR and BPR are prepared using MFR by the manufacturing units.
What are the current guidelines on the site master file?
The current guidelines on the Site Master File require the following information in this chapter: “Description of the Quality Control ac- tivities carried out on the site in terms of physical, chemical, micro- biological and biological testing.”
What is the drug manufacturer’s Guide to site master files 10?
The Drug Manufacturer’s Guide to Site Master Files 10 • Responsibilities related to the maintaining of quality system including senior management; and • Information of activities for which the site is accredited and certified, including dates and contents of accreditations, names of accrediting bodies.
What is the storage and handling of master documents?
Storage and handling of Master Documents. If documents and records are stored or archived off-site, List of types of documents/records; Name and address of storage site, and an estimate of the time required retrieving documents from the off-site archive. C5.2 – Other Documentation Related to Product Quality – Site Master File (SMF):
What is the procedure for revising the site Master File (SMF)?
Any revision to be done to the Site Master File (SMF) in the existing year shall be in the forms of Amendments. The Obsolete copy of the Site Master File (SMF) shall be stamped as “OBSOLETE”, stored and destroyed as per document control SOP.