EU
No. Observations
1 other products manufactured in the
same room
2 Only one airlock for personnel and
product
3 Airlock too small to put 2 pallets at the 3.1 - not possible to follow point 1, lot of
same time
4 HVAC set at <65%RH, supplier
requirement is 40-50%
5 no monitoring of the temperature and
humidity
6 insects entering the milling room (and
sampling room)
7 no control of the people entering the
room
8 Non dedicated parts in direct contact
with product
9 floor cracked
environment not easy to clean: light
10 fitting not smooth, pipes on the walls,
square corners, air vent with recesses
blowing the powder outside the ficility
11 without a filter, risk for people and
environment
3.13 - health risk for the staff, cross
12 no laminar flow to weight the powder 3.14 -
3.22 - contamination when opening other
3.40 product bags in the same room
13 no wash bay to clean the equipment
and machine not moveable
14 pipes and plugs not labelled
no money to hire an engineer to do
15 the installation and training, will have
to do it on our own
16 lot of space taken by the CFM, cannot
be moved out
17 still not space for the big hammer mill
vacuum to be installed outside the
18 room but not possible to put on the
ceiling (as per supplier plan)
19 no equipment for cleaning of the room N/A using the stores cleaning material
Effective
Risk Proposed corrective actions Estimated cost Risk assessment after corrective actions Responsible Target date
GMP DD/MM/YY date
ref DD/MM/YY
protect the CFM with an airtight cover: cuboid plastic cover easy to Difficult to find a made to measure one, cost. But
take apart and put back together, easy to clean and airtight on the ? very practical and easy to clean. The space will then
floor (rail). To be found be too small for making the Alkaline bulk
If not possible to find an airtight cover: will make sure the machine is clean (only if cleaning firstly choose
3.1 contamination of the capsule filling - clean the CFM before and after each use, the cleaning validation staff time spent validation done) but will take time and staff to do it. the corrective
machine (CFM) will then include all the products manufactured in the room on cleaning The space will then be too small for making the action
(Alkaline...) Alkaline bulk
not satisfying because no other place to do it. The
- dedicate the room for the capsules and use the other equipment 0 filtration room (only one under HVAC) is not
somewhere else designed for powders and is too big and difficult to
clean
define 4 areas:
3.1 - risk of contamination of the product by - storage (clothing, protective, cleaning material)
3.6 - human and of humans by the product, - passage With good training of the staff, and drawing and
3.7 - risk of cross contamination between - pallet of products processed
- pallet of products to be processed 0 labelling of the areas, the risk of contamination and Nadine
3.8 - product to be processed and processed Cf. Suggestion airlock.docx cross contamination will be very low
3.18 products Write the SOP and train the staff. Posters to explain the flow to be
put up
Buy smaller pallets (4 to be comfortable) max size 1.15x1.3m, must
3.18 pallets movements be plastic. ex: http://www.masterjack.co.za/pharmaceutical R 1 695.00 each 2 smaller pallets can fit in the airlock Stefan
%20pallet.html
set the HVAC at 45%RH while using the room (also for sampling 0 will increase electricity consumption for the time Marten
room if weighing there). Marten to check if the HVAC can do it the room is used, but if possible will be reliable
if higher than 50% make the powder be
3.3 sticky and wet, if lower than 40%
increase the static electricity dehumidifyer cost when buying, use electricity, need
or buy a dehumidifyer and set it in the room. See the list of 2,720 to 5,480 proper maintenance, and difficult to clean. Marten Marten/Nadine
dehumidifyers to compare costs between both proposed action
3.3 not seeing an out of spec for the logger to be set in the room 0 - recycling satisfactory Stefan
environment loggers
3.4 contamination of the products and Marten to investigate with pest control companies to find a ? ? Marten
equipment satisfactory solution
3.5 unhautorised people can mess the add signs on the door "only for authorized people". Also need a sign 10 still need a better control by swipe card or door Marten
equipment and products with the name of the RP code
3.6 cross contamination proof of cleaning efficiency must be established during cleaning cleaning depends on the result of the cleaning validation Nadine
validation, before cleaning validated, should be dedicated validation cost
not easy to clean, can lead to
3.9 contamination if not able to clean put new epoxy to fix the floor 40,000 satisfactory Stefan
properly
change the light fitting to put a smooth one ? satisfactory Marten
not cleaning properly and letting dust in cover the pipes with a square box ? satisfactory Marten/Stefan
3.1 the room that can contaminate the
product add silicon to round the corners ? satisfactory Marten/Stefan
get small brush to clean in between the grating ? satisfactory Marten
Debra to do a risk assessment for side effects of the products that 0 depends on the result of the risk assessment Debra
can be blown outside and inhaled by people
3.12 effects on people inhaling the powder
outside (eg lactose allergen) 5,000/roll, only
Marten to check if it is feasible to put a dust filter need small qty will avoid to blow out product, best for safety Marten
of this
weight in the sampling room, empty and clean the room between
each product, only 1 product at a time. Seal the containers and No risk for the sampling room car stays a weighing
transfer to the milling room for blending. Need to buy a bigger scale scale price? step only, just for bigger amounts. Cleaning between
each product so if need to sample, can be done Marten
to weigh biggest amounts. Marten to tell what scale capacity is
needed between 2 products
take apart the small parts, seal them in plastic bags of get 2 big
plastic pallet boxes (1 for dirty, 1 for clean product) and transfer to plastic bags or
3.36 - not being able to properly wash the
3.37 equipment
the wash bay to clean.
Clean in place the rest of the machine with dry or damp cloth plastic pallet cleaning validation to be performed Nadine
(depends on how easy to clean) boxes price?
http://www.goplasticpallets.com/gobox-1208-hygienic-low.html
3.42 could lead to error of use label the pipes and plugs, label flow direction if required 10 satisfactory Marten
get the warranty T&C and fine prints if any, signed off by the supplier
N/A jeopardize the warranty (still waiting for supplier's feedback) 0 will make us know exactly what we can an can't do Nadine
See Suggestion milling room.docx for room organisation. Do only 1 increase the run enough space if only 1 process is done at a time: will
N/A not much space left for the other
machines process at a time (sieving, machine out, blending, machine out, time for a increase the time spent per batch but decrease the
amount of staff involved => better specialisation of Nadine
capsulating). process the staff
Send it to Waterkloof for them to mill (production staff to be sent transport, The powder they make will be received as our raw
N/A not being able to mill big batches there to do the milling). paperwork material (like plant powders we receive from other Marten
suppliers)
increasing too much the temperature of
N/A the milling room, contamination by the put the pump outside the room: requires additional pipes and drills R 6,000 satisfactory Marten/Stefan
vacuum pump
? Material to be satisfactory
need a dedicated vacuum, broum, brushes stored in the airlock determined Marten
TOTAL
Marten 13
Stefan 6
Debra 1
Nadine 6