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If and to what extent room qualification is to be carried out, should be decided on in agreement with quality assurance, depending on the product. It is certain that fulfilment of the requirements of the EC Directive 2003/94/EC [Article 8.3] must be demonstrated in an appropriate manner: "Premises and equipment to be used for manufacturing operations, which are critical to the quality of the products, shall be subjected to appropriate qualification and validation" It is therefore beneficial to use the qualification instrument for rooms in the same way as for facility qualification (see chapter 4.E Examples of facility qualification). This procedure should be applied for sterile areas. For the remaining production and packaging rooms, it is necessary that all the documentation concerning the quality of the rooms be collected, archived and managed so that the current status can be reflected at any time.
An easy way to carry out qualification without having to compile new forms is to use the room log as the qualification template. The quality-relevant room features are defined in the plans. The proper implementation or availability can be indicated by ticking the corresponding lines or columns and approving them directly in the room log. In most cases, the review method is limited to a visual check. Structural and facilities management final acceptance logs can often be used as proof. All necessary specifications, order copies, test certificates or delivery notes are collected and saved with the room log. During qualification of rooms, the temperatures, humidity values, particle counts, pressure and flow rates must be checked. These values are usually measured during qualification of the ventilation technology, and are simply referred to in the room qualification. (See chapter 3.H.7 Qualification of air conditioning ventilation systems.)
Test points for room qualification in addition to the room log are:
- Quality of walls/ceiling/floor: Surface properties, joints: material and version, penetrations, constructive design, documentation of drawings
- Recess: Test criteria: available, version, or inspection of the radius, store drawing of the recess
- Version and material of isolated pipes
- Wall and ceiling colour/floor: Material proof (harmless emissions)
- Gullies: Version, quality of installation, or piping plan
- Lighting: Construction and installation of the lights
- In sterile areas: Inspection of the gas tightness of rooms, operability of locks (locking), see also VDI 2083 Sheet 3 Final acceptance measurements for clean rooms)
The scope of the room qualification depends on the class of the room and the influence of the room on the product. The most extensive qualification is required for sterile areas.
Room qualification is based on the room log and layout, where proof of the room ventilation conditions must be included in the qualification of the ventilation technology.
The aim of room qualification is to check the suitability of the rooms for critical manufacturing operations that could influence the product quality.