Font size
WorksheetsPT716A_Day8_18601917108_Documentation,Premises andequipment
Total questions: 10
Worksheet time: 5mins
The_____ should provide information to the ______on the layout, construction and finish of buildings and services (heating, ventilation and air-conditioning (HVAC), temperature, relative humidity, water, power, and compressed air), which have an impact on the product, process or method to be transferred.
(a)
The SU should provide information on which of the following issues?
relevant health
safety
environmental issues
All of the above
The SU should provide information about premises including:
inherent risks of the manufacturing processes (e.g. reactive chemical hazards, exposure limits, fire and explosion risks)
health and safety requirements to minimize operator exposure (e.g.atmospheric containment of pharmaceutical dust)
emergency planning considerations (e.g.in case of gas or dust release, spillage, fire and firewater run-off)
identification of waste streams and provisions for re-use, recycling and/or disposal
The SU should not provide a list of equipment, makes and models involved in the manufacture, filling, packing and or control of the product, process or method to be transferred, together with existing qualification and validation documentation.
True
False
The RU should review the information provided by the SU together with its own inventory list including the qualification status (IQ, OQ, PQ) of all equipment and systems, and perform a (a) of equipment at the two sites in terms of their functionality, makes, models and qualification status.
The RU should perform a (a) to identify requirements for adaptation of existing equipment, or acquisition of new equipment, or a change in the process, to enable the RU to reproduce the process being transferred.
The facility- and building-specific location of all equipment at the RU should be considered at the time of drawing up process maps or fl ow charts of the manufacturing process to be transferred, including flows of personnel and material.
true
false
Any modification of existing equipment that needs to be adapted to become capable of reproducing the process being transferred should be documented in the (a) .
The documentation required for the transfer project itself is narrow-ranging.
true
false
in case of facility assessment, which of the following documents is provided by SU?
Plans and layout of facility
buildings (construction, finish)
Product-specific waste management plans
Qualification status (DQ, IQ, OQ) and reports
