Facility Design or Validation
Mtech is skilled in assisting organizations as they encounter facilities design, construction, or adaptation — or as they encounter facilities-related compliance problems. We have a lot of experience in designing GMP facilities that will be easy to keep clean, have logical product and personnel flow, and pass regulatory inspection. Through our powerful blend of compliance, regulatory, scientific, and technical expertise, we are highly effective in:
- Analyzing, developing, and/or enhancing engineering requirements, specifications, and drawings, including HVAC, water, sterilization, and dust-control systems
- Developing environmental and processing-room requirements
- Recommending effective flow of materials, equipment, and personnel
- Assessing and enhancing facilities requirements vis-à-vis manufacturing, assembly, packaging/labeling, and distribution operations
- Addressing the facilities requirements of laboratory operations
- Performing factory acceptance testing of equipment (FAT)
- Conducting audits during construction and installation phases
- Qualifying facilities for sterile, low-bioburden, and non-sterile products
- Qualifying facilities for intermediates, APIs, and finished drug products
- Qualifying facilities for medical device components and finished products
We can resolve your issues also using our experience and helping you out with the following:
- Review your current design plans
- Help you figure out a scientifically based remodel
- Help you investigate problem areas
- Inform you of the latest industry practices
- Determine the best room classifications
- Integrate your design so it meets both FDA and EU regulations
- Get your facility operating smoothly, with fewer investigations and corrective actions to slow down the day to day operations
Once your facility is up and running, we can help you validate and monitor its effectiveness.
- Set environmental monitoring limits
- Set up an effective, reasonable environmental monitoring program, taking into account FDA, USP, EU, and ISO considerations
- Set up a reasonable personnel monitoring program
- Set up a data trending system