23.08.2016 |

LOGFILE No. 31/2016 – Separate Device Specification for the FDA?

Separate Device Specification for the FDA?
Your question - our answer

by Thomas Peither

At the editorial office of GMP-Publishing we receive a steady stream of interesting questions from our readers and customers on GMP regulations and their practical implementation. One recent question focused on the (presumed) requirement by the U.S. FDA for device specifications that are to be generated from the User Requirement Specification (URS).

In today’s feature article I shall present my view of this topic together with excerpts from current GMP guidelines. This will provide you as a LOGFILE subscriber with up-to-date information, at the same time giving you an inside look at the activities of our editorial staff, which encompass far more than simply publishing specialised GMP texts.

Do I need a separate device specification for the FDA?

Documents for qualifying facilities and devices are often designated in many different ways. Various terms are used within this context, such as customer’s requirements, technical specifications, URS or user demands. The specification of a device or facility often contains elements of all these documents together. And this “URS” then forms the reference point for all subsequent activities.

This does not indicate that an additional document is required. I take a pragmatic approach here, and I expect such specifications to be clearly and unambiguously formulated in one document. And in that case it does not matter what the title of the document is. Unfortunately, however, this is not always the case.

When a URS is being created, the performance or levels of precision that the facility or device is ultimately capable of achieving in routine operation are not always known. In such a case would it be necessary to adjust the URS at a later date?

It is not necessary to know precisely what the facility is capable of achieving. However, it is necessary to know what performance is to be expected from it. It is perfectly acceptable for the real performance to be higher; the URS does not have to be modified.

Of course the URS can be adjusted at a later date – but in that case, please do so only by adhering to the appropriate change procedure.

What do the current GMP guidelines require?

Several excerpts from the current GMP guidelines are included below in support of the above-given comments:

EU GMP Guideline Annex 15

User Requirements Specification (URS)

3.2 The specification for equipment, facilities, utilities or systems or should be defined in a URS and/or a functional specification. The essential elements of quality need to be built in at this stage and any GMP risks mitigated to an acceptable level. The URS should be a point of reference throughout the validation life cycle.

U.S. FDA: Guidance for Industry
Process Validation General Principles and Practices

C. Stage 2 – Process Qualification

1. Developing the concept of a facility and qualification of utilities and equipment

[...] Qualification of utilities and equipment generally includes the following activities:

  • Selecting utilities and equipment construction materials, operating principles and performance characteristics based on whether they are appropriate for their specific uses
  • Verifying that utility systems and equipment are built and installed in compliance with the design specifications (e.g., built as designed with proper materials, capacity and functions, and properly connected and calibrated)
  • Verifying that utility systems and equipment operate in accordance with the process requirements in all anticipated operating ranges. This should include challenging the equipment or system functions while under load comparable to that expected during routine production. It should also include the performance of interventions, stoppage and start-up as is expected during routine production. Operating ranges should be shown capable of being held as long as would be necessary during routine production.

U.S. FDA: Pharmaceutical CGMPs for the 21st century – a risk-based approach
Science-Based Regulation of Product Quality

As pharmaceutical manufacturing evolves from an art to a science and engineering based activity, application of this enhanced science and engineering knowledge in regulatory decision-making, establishment of specifications, and evaluation of manufacturing processes should improve the efficiency and effectiveness of both manufacturing and regulatory decision-making. [...]




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Thomas Peither
Executive Director and Editor in Chief
Maas & Peither AG – GMP-Verlag
Schopfheim (Germany)
E-mail: thomas.peither@gmp-verlag.de