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FACILITY DESIGN AND CONSTRUCTION OVERSIGHT SERVICES TO GMP STANDARDS
Our services are in the area of ensuring your proposed production facilities are designed and constructed in a manner which will comply with the GMP requirements. To date, we have assisted several companies to design and construct their facilities for GMP compliance. This involved being in the meetings with the General Contractors, Architects, and specific Trades (plumbers, electrical, etc.).
We are also routinely requested to be on site during the construction to provide specific guidance to the various trades people, while they are (for example) painting the walls in the production rooms, (or installing the air ducting system). This approach ensures that "Quality is built into the facilities" and prevents expensive "fix-its" at a later date.
We have inspected well over 50 different GMP production facilities (not including other QA programs). Our audits have enabled us to see how other GMP compliant facilities have been constructed and thus many differing ways in which GMP compliance may be "built in". These facilities range from a 3-person operation to some that have up to 500 personnel. Therefore, we know what to take into consideration during the design and construction, considering the size of the operation, number of different products, etc.
Just some of the examples of our proactive GMP input during the design and construction includes:
a) ensuring the doors, windows, walls, floors and ceilings are made of the appropriate materials for cleanability, durability (so as not to shed) and prevention of organism growth;
b) sanitation requirements to GMP standards;
c) addressing pest control issues;
d) controlling dusty operations to GMP requirements;
e) if applicable, ensuring the ventilation system can provide the pre-determined amount of cubic feet of air per minute (CFMs), and an acceptable amount of air changes per hour;
f) if applicable, ensuring that pressure differentials are established between production and non-production areas (including the equipment to monitor those differentials are in place and are of appropriate quality);
g) ensuring the layout of the facilities optimizes the flow of personnel and materials from receipt to storage, to weighing to, blending, encapsulating, to bottling, etc., according to GMP;
h) that the air intake and exhaust grilles are placed in proper locations within each room, according to GMP; and
i) many other issues which will need to be considered prior to developing the blueprints for the proposed layout of the facilities.
In addition to the above-mentioned considerations, some of the other overall assistance we can provide, based on our direct experience and well-developed industry contacts over the years are:
j) identifying appropriately-qualified GMP building contractors, such as the General contractor, Architect, Heating & A/C, air filtration (HEPA, if required), plumbing (for purified water), flooring, etc. Please be aware that many Contractors might say they can build GMP compliant or at least Food Grade facilities, but there are only a few in each province that can do a good job - in our opinion.
k) determining if the area of town is amenable to GMP requirements for outside air quality, pest control, municipal zoning restrictions, etc., (such as the location being too close to a major secondary roadway for dust considerations).
l) identifying & locating appropriate production equipment (grinder, mixer, encapsulator, tube filler, liquid fill, capsule bottler, labeler, etc).
m) comparing/contrasting equipment from different suppliers (initial capital costs, size/capacity, pricing, repair service, training supplied by equipment supplier, consumables, warranties, construction materials, etc.).
n) identifying, then providing all of the electrical specifications for all of the production equipment to the electrical contractor.
o) being on site during construction to ensure walls, floors, air and water systems are installed and/or painted to GMP standards.
p) inviting the Health Canada staff and liaising with them during the design and construction in order to ensure the facilities will meet their expectations prior to their eventual audit.
The amount of time that you may wish us to spend assisting you (so that the design & construction of these facilities meet GMP requirements for NHPs) is negotiable.
Wherever possible, we try to plan our travel so that we can see as many other clients in the same geographic region as feasible. Thus, our travel costs can be distributed proportionally among all clients seen on that trip.
Since we perform this service on a routine basis, we have become rather efficient in addressing all of the GMP requirements during the design and construction processes. This can greatly reduce the probability of overlooking an important GMP or regulatory aspect (in the design phase), only for that issue to arise either during the construction or auditing phases.
Like the saying goes: "An ounce of prevention is worth a pound of cure".