Q
QE
Dear all coves
Can some one explain by definition what is a difference between a DMR, DHF and DHR. Here is how FDA defines them
DHF :
§ 820.30(j) Design history file.
Each manufacturer shall establish and maintain a DHF for each type of device.
The DHF shall contain or reference the records necessary to demonstrate that the design was developed in accordance with the approved design plan and the requirements of this part.
II. DEFINITIONS
§ 820.3(e) Design history file (DHF) means a compilation of records which describes the design history of a finished device.
DMR :
DEVICE MASTER RECORD
Title 21 CFR 820.3(j) states a “Device master record means a compilation of records containing the procedures and specifications for a finished device.” A Device Master Record (DMR) is a comprehensive record of all of the procedures and instructions required to manufacture each type of glove. A DMR contains or refers to the location of documents for manufacturing and processing activities, such as procurement, processing, labeling, test and inspection, and packaging. The DMR also contains information on the design, formulation, specifications, complete manufacturing procedures, quality assurance requirements, acceptance criteria, packaging, and labeling of a finished glove.
DHR :
Sec. 820.184 Device history record.
Each manufacturer shall maintain device history records (DHR’s). Each manufacturer shall establish and maintain procedures to ensure that DHR’s for each batch, lot, or unit are maintained to demonstrate that the device is manufactured in accordance with the DMR and the requirements of this part. The DHR shall include, or refer to the location of, the following information:
(a) The dates of manufacture;
(b) The quantity manufactured;
(c) The quantity released for distribution;
(d) The acceptance records which demonstrate the device is manufactured in accordance with the DMR;
(e) The primary identification label and labeling used for each production unit; and
(f) Any device identification(s) and control number(s) used.
Can some one explain by definition what is a difference between a DMR, DHF and DHR. Here is how FDA defines them
DHF :
§ 820.30(j) Design history file.
Each manufacturer shall establish and maintain a DHF for each type of device.
The DHF shall contain or reference the records necessary to demonstrate that the design was developed in accordance with the approved design plan and the requirements of this part.
II. DEFINITIONS
§ 820.3(e) Design history file (DHF) means a compilation of records which describes the design history of a finished device.
DMR :
DEVICE MASTER RECORD
Title 21 CFR 820.3(j) states a “Device master record means a compilation of records containing the procedures and specifications for a finished device.” A Device Master Record (DMR) is a comprehensive record of all of the procedures and instructions required to manufacture each type of glove. A DMR contains or refers to the location of documents for manufacturing and processing activities, such as procurement, processing, labeling, test and inspection, and packaging. The DMR also contains information on the design, formulation, specifications, complete manufacturing procedures, quality assurance requirements, acceptance criteria, packaging, and labeling of a finished glove.
DHR :
Sec. 820.184 Device history record.
Each manufacturer shall maintain device history records (DHR’s). Each manufacturer shall establish and maintain procedures to ensure that DHR’s for each batch, lot, or unit are maintained to demonstrate that the device is manufactured in accordance with the DMR and the requirements of this part. The DHR shall include, or refer to the location of, the following information:
(a) The dates of manufacture;
(b) The quantity manufactured;
(c) The quantity released for distribution;
(d) The acceptance records which demonstrate the device is manufactured in accordance with the DMR;
(e) The primary identification label and labeling used for each production unit; and
(f) Any device identification(s) and control number(s) used.