Master files

Record—A. collection of data items (fields) of various types, which may also be records themselves. If EMPl is a record in the master file of employees, EMPl.NAME may be a character field, FiMPl.ZIP an integer field, and EMPl.SAL a real field. 

The sponsor and investigator, as appropriate, must retain all essential documents relating to the trial for at least 5 years after its completion. Documents should be securely archived, with restricted access to maintain subject confidentiality. Collectively, these constitute the Trial Master File, and facilitate any audit and evaluation of... 

Figure 5.5 Essential documentation for a Trial Master File.

LIST NUMBERS OF ALL INVESTIGATIONAL NEW DRUG APPLICATIONS <21 CFR Pan 312), NEW DRUG OR ANTIBIOTIC APPLICATIONS (S CFR Part 3U). DRUG MASTER FILES (2i CFR Pan 314.420A AND PRODUCT LICENSE APPLICATIONS <21 CFR Part 601) REFERRED TO IN THIS APPLICATION. 

Letters of authorization for reference to other applications or drug master files Waiver requests... 

Investigational New Drug Applications (INDs), NDAs, Premarket Approval Applications (PMAs), Premarket Notifications (5 lO(k)s), Investigational Device Exemptions (IDEs), Biological Master Files (BMFs) and DMFs that are referenced in the current application. 

Plasma Master Files and Vaccine Antigen Master Files... 

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. 

Drug Master Files Investigational New Drug Application New Drug Application... 

Information on existing or new excipients can be described and provided to the FDA in an NDA directly. Alternatively, the manufacturers of excipients may prepare and submit type IV Drug Master Files (DMF) to support the use of an excipient in one or more NDAs. The DMFs are discussed in FDA s regulations under 21 CFR Section 314.420 and the FDA-issued Guidance for Drug Master Files (8). When authorized by the DMF submitter (i.e., the excipient manufacturer) and cross-referenced by an NDA submitter, the FDA reviews the DMF to make determinations on the safety, manufacture, and quality of the excipient use in the new drug that is the subject of the then pending NDA. The DMF becomes active when reviewed in conjunction with the review and approval of an NDA. 

The FDA Guideline for Drug Master Files (21 CFR Part 314.420) consists of the following sections ... 

Food and Drug Administration. Cover Form for the Technical Review of Drug Master Files, FDA, Rockville, MD, 1998. 

Drug Master File deoxyribonucleic acid design qualification effective dose... 

Box 7.3 Documents present in master files concerning the study drug(s)... 

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