3.A Official requirements
Her you will find answers to the following question:
- What official requirements must the operating rooms satisfy?
Operating rooms must ensure that operations can be carried out properly regardless of type, size, number, location and facility - particularly with respect to the faultless production, analysis, storage, packaging and distribution of medicinal products.
The requirements for the design of the operating rooms depend on the type and scope of the drug production.
As a basic rule, the lighting, temperature, humidity and ventilation must be suitable for the relevant production step and must not have a negative impact on the quality of the products or operability of the facilities and equipment. Lighting is particularly important in areas where visual checks must be carried out during the course of production.
It should be possible to clean the premises thoroughly and also to disinfect them. The compatibility of substances that act on floors and walls as well as the rest of the facility during production, cleaning and disinfection must be verified. An adequate standard of hygiene in these rooms (to be specified by the manufacturer) is essential to ensure the quality of the medicinal products. By means of appropriate controls it must be verified that this standard is always maintained. (See chapter 3.E Construction elements and chapter 11.C Production hygiene.)
The necessary precautions must be taken to prevent the entry of insects and other animals.
The operating rooms must be maintained on a regular basis to always be in a good state of repair.
The rooms should be arranged in such a way that production may be carried out using a logical step-by-step approach (that corresponds with the sequence of work steps). (See chapter 3.C Material flow, personnel flow and layout.)
The receipt and dispatch areas should be organised so that materials and products are protected from external influences.
Cross-contamination in the production areas must be prevented through appropriate layout of the rooms or the application of a suitable ventilation concept. Particular attention must be paid to the production of highly potent medicines (e.g. b-lactam antibiotics, hormones, zytostatics). Suitable measures, such as separate manufacturing areas and ventilation systems or campaign manufacturing, must ensure the prevention of cross-contamination. (See chapter 11.J Prevention of cross-contamination.)
Sufficient space must be available in the manufacturing zone for the provision and interim storage of materials. Facilities must be assembled in such a way that they can be accessed to carry out the necessary scope of cleaning and maintenance work.
Areas for carrying out in-process controls should be physically segregated from production. If this is not possible, suitable measures must be taken to ensure that the controls will not be affected by current production. (See chapter 11.I In-process control.)
Sufficient area should be available in the storage rooms to ensure that the various categories of materials and products may be properly stored. The rooms must be clean and dry and must also guarantee that the appropriate temperature and humidity range will be provided in each case.
Control laboratories should be separated from the production rooms to exclude external influences. Defined and sufficient storage conditions must exist for the storage of samples and records.
Staff rooms must be segregated from other areas.
The number of changing rooms, wash rooms and toilets available should be suitable for the number of users. Toilets should not open directly onto production rooms.
Rooms where animals are kept must be separated from other areas and also have their own access and ventilation system.
Plans of the existing operating rooms are an integral part of the company description (see chapter 15.E Site master file) and should be available drawn to scale. At the same time the points listed in figure 3.A-1 must be observed.
Figure 3.A-1 Description of operating rooms
Description of operating rooms
- Plan, to scale
- Numbering of individual rooms
- Visual representation of positions of windows, doors, locks, hatches
- Assignment of functions to the room numbers
- Assignment of hygiene categories to the room numbers
The suitability of rooms used to carry out manufacturing operations that are of decisive importance for the quality of medicinal products must be checked (qualification). The type and scope of the qualification requirements (cp. figure 3.A-2) depend on the specific operations that are to be carried out in the various premises. (See chapter 3.G Room qualification.)
Figure 3.A-2 Factors used to assess the suitability of operating rooms
Factors used to assess the suitability of operating rooms
- Location, connection with other rooms
- Size: area and height
- State of repair (maintenance)
- Hygiene status incl. pest control
- Installations/supply of utilities
- Lighting, ventilation and/or air-conditioning
- Construction of doors and/or locks
- Materials: floors, walls, ceilings
To assess the suitability of the rooms an acceptance inspection is to be carried out by the relevant authorities before manufacturing authorisation is granted. Manufacturing authorisation is to be refused to manufacturers who do not have suitable operating rooms, or withdrawn if rooms are subsequently determined to be unsuitable.
Operating rooms must ensure that operations may be carried out properly - particularly with respect to the faultless production, analysis, storage, packaging and distribution of medicinal products. The individual requirements depend on the type and scope of the production.