Consulting to GxP standards
Helping ensure your proposed facilities comply with GMP, GPP under the ACMPR, GLP and ISO 17025 requirements. To date, we have assisted several companies to design and construct their facilities. This involved being in the meetings and consulting with the engineers, architects, head contractors, and the various Trades (HVAC, plumbers, electrical, etc.).
We are also routinely requested to be on site during the construction phases to provide specific guidance to the trades people, while they are (for example) painting the walls in the production rooms, or installing the air ventillation system. This approach ensures that “quality is built into the facilities” and prevents expensive “fix-its” at a later date (i.e.: being proactive vs. reactive).
We have inspected well over 80 different drug & NHP production & lab facilities (not including other QA programs). Our audits have enabled us to see how other QA-compliant facilities have been designed and thus many differing ways in which GxP 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, dosage forms, etc.
Just some of the examples of our proactive quality assurance input during the design & construction includes:
- 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 microbial organism growth;
- sanitation requirements to GxP standards;
- addressing pest control issues;
- controlling dusty operations;
- 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;
- 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);
- ensuring the layout of the facilities optimizes the flow of personnel and materials from receipt to storage, to weighing to, blending, encapsulating, to bottling, to shipping, etc., according to GxP:
- equipment & process validation services;
- that the air intake and exhaust grilles are placed in proper locations within each room; and
- many other issues which will need to be considered prior to creating the official blueprints for the proposed layout of the facilities & equipment therein.
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:
- identifying appropriately-qualified GxP building contractors, such as the General Contractor, Architect, HVAC, plumbing (for purified water), flooring, etc. Please be aware that many Contractors might say they can build GxP 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.
- For more information, see our web page on Sourcing services.
- determining if the area of town is amenable to GxP 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).
- identifying & locating appropriate production equipment (grinder, mixer, encapsulator, tube filler, liquid fill, capsule bottler, labeller, etc).
- comparing/contrasting equipment from different suppliers (initial capital costs, size/capacity, pricing, repair service, training supplied by equipment supplier, consumables, warranties, construction materials, etc.).
- identifying, then providing all of the electrical specifications for all of the production equipment to the electrical contractor.
- being on site during construction to ensure walls, floors, air and water systems are installed and/or painted to GxP standards.
- 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 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.
Like the saying goes: “An ounce of prevention is worth a pound of cure”.
Why use a consultant?
Weighing the numerous pros & cons of bringing in a consultant vs. tackling it all in-house? Please see our web page “Why Use a Consultant” as part of that critical thinking process. Based in British Columbia, but covering all of Western Canada.