First, let me address a few points. 820.181 does not forbid including things in the DMR. It has the minimum requirements, not the maximum. Secondly, the DMR works with the Quality System Record (QSR) described in 820.186. The DMR contains device specific information, but the QSR can include information that is not device specific. For example, if many devices are processed in the same clean room, then the clean room procedures, i.e., production environment specifications, could appear once in the QSR instead of being repeated in each DMR.
I generally advise against using the terms verification and validation without a qualifying adjective. For example, design validation and process validation have very different requirements. To refer to both as only “validation” runs the risk of confusion and lack of clarity.
Process validation, see 820.75, has two elements relevant to this discussion. 820.75(a), calls for process validation and would typically include protocols and reports. I would not expect to see them in the DMR. In contrast, 820.75(b) requires running the process, collecting data, making adjustments, etc. I would expect to these procedures in the DMR.
820.80 requires product verification. In particular, 820.80(b), (c), and (d) refer to aspects of product verification. I would expect to see them in DMR, but they might be included in 820.181(c).
Production software validation falls under 820.70(i). I would not expect to see the protocols and reports in the DMR. However the use of the software would certainly be covered by a procedure in 820.181(b) or (c) depending on the intended purpose of the software.
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Dan O'Leary
Swanzey NH
United States
Original Message:
Sent: 12-08-2015 11:08
From: Lorenzo Muratori
Subject: Interpeting 21 CFR 820.181 DMR
Dear all,
Reading 21 CFR 820.181 (b) "Production process specifications including the appropriate equipment specifications, production methods, production procedures, and production environment specifications;" it seems to me that the documentation pertaining to the Verification and/or Validation of the manufacturing process is NOT to be included in the DMR. It is the description of the process, equipment, tools, methods, procedures, etc, which are to be included in the DMR, regardless on how the company verified and validated it.
Similarly, the Validation of the SW tools used in the manufacturing process doesn't need to be addressed in the DMR. But the following must be part of the DMR: the SW tools themselves needs to be identified, described, where the location of the source files repository is, how to build the executable program, what kind of HW is needed to run it.
I would be grateful if you could correct or integrate my statement, please?
Kindest regards
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Lorenzo Muratori
Elekta
West Sussex
United Kingdom
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