GMP-compliant design means complying with the applicable requirements. These requirements are determined by products, processes, product applications and the resulting regulations. For GMP-compliant design to be realised, the user needs to specify the requirements clearly in a user requirement specification (URS). Only when customer needs are clearly described as objectives can they be met in a satisfactory and compliant manner in the end. There is good reason that the URS is listed first in the qualification lifecyle in Annex 15 of the EU GMP Guideline.
Implementing clearly specified GMP requirements through requirement specifications and technical concepts and ensuring compliance is the goal.
Top of the List but not First
In practice however the requirement specification is not the first document to be created. Numerous ideas have already been generated by then and various concepts discussed, often on the basis of initial technical drawings. That is legitimate since every idea first requires a few sketches. But that does not make the requirement specification superfluous or easier to prepare. The key is not getting irritated by too many technical details and preparing the requirement specification, not with solutions but consistently with the customer’s wishes. User requirements clearly define the specification.
More than a Requirement Specification – the Question and Answer Game
VDI 2519 for instance defines the requirement specification as a document that describes the requirements from the user’s perspective – what and what for. The answer is given by the technical specification prepared from a technical perspective. It proposes concrete solutions and realisation proposals – how and with what. This first, fundamental answer from central engineering in turn poses questions for detailed planning. Now system and component suppliers provide answers in detailed functional specifications. Numerous requirement and functional specifications can therefore be prepared in a project. Maintaining an overview at all times is essential.
Maintaining an Overview, Identifying Benefits, Achieving GMP Compliance
Preparing well-structured requirement and functional specifications at all levels is important. And maintaining an overview. Broad practical experience with technology and GMP offers crucial advantages here. The focus is on minimum GMP requirements that have to be integrated into the URS. Here the engineers must be left with sufficient leeway for their implementation. Appropriately prepared requirement specifications can – and should – serve as a basis to be referenced in the subsequent risk analysis. Also as a starting point for technical change control and the later design qualification. Thus the full benefits of the URS are realised while GMP compliance and traceability are assured.
Efficiency in Spite of the Diversity of Technical Concepts and Requirement Specifications
There is no need to reinvent the wheel. Fundamental and technical GMP requirements can be standardised to a certain extent. Such a standard basis serves as the starting point and is adapted to the specific requirements. That saves time and reduces costs. gempex offers support for:
- new construction or upgrades or reconstruction in manufacturing, packaging, warehousing and also laboratory units
- new procurement of chemistry, biotechnology and pharmaceuticals apparatus and equipment
- procurement of standard equipment/ devices
- new installation of utilities such as water installations, technical building equipment, compressed air and nitrogen
- and many more
A special advantage: For every requirement specification, gempex provides a basic template and corresponding risk analysis as a bundle. Comprehensive service.
- a clear understanding of the meaning, contents and structure of the requirement and technical specification
- professional preparation of requirement specifications that can be used as the basis for the risk analysis, technical change control and the design qualification
- access to proven solutions that are then adapted to specific needs
- support and relief when it has to go quickly or gets to be too much
- seamless integration of the requirement specification into the overall qualification and validation concept