- What are the standard lead times for an order?
- What types of manufacturing do you perform at the facility?
- Is Global Health Industries registered with the Food and Drug Administration (FDA)?
- What are Good Manufacturing Practices (GMP)?
- What is a Certificate of Analysis? (CofA)
- What is your company pricing structure?
- Do you offer microbial testing?
- What about chemical testing?
What are the standard lead times for an order?
Orders for product manufacturing for current clients take between four to eight weeks to complete from the date the order is placed. This variance depends on lead times for raw materials and components. First time orders require more time as we must define specifications and build master documents.
What types of manufacturing do you perform at the facility?
We offer a range of supplement manufacturing services for capsules (gelatin, vegetable and pullulan), tablets (directly compressible, granulated, coated, and un-coated) and powder blends. Our product capabilities include the following:
- Herbal products
- Encapsulated yeast products (at isolated production facility)
- Flavored drink mixes
- Blister packs
- Single serve powder sachets
- Stick packs
Is Global Health Industries registered with the Food and Drug Administration (FDA)?
Yes, and our registration is updated each year. Visit our Quality section for more information about our Good Manufacturing Practices (GMP) certifications.
What are Good Manufacturing Practices (GMP)?
GMP are certifications used internationally to describe a set of principles and procedures that ensure that products are manufactured at levels safe for human consumption. A basic tenet of GMP is that quality cannot be tested at the batch level, but must be integrated into each batch of product during all stages of the manufacturing process. GMP are guidelines established by the US Food and Drug Administration, Australian TGA, Health Canada, and other governmental regulatory agencies.
What is a Certificate of Analysis? (CofA)
A Certificate of Analysis lists the specifications and test results of physical and chemical attributes, microbial levels, water activity, identification and quantification, and separation and loss on drying moisture content.
What is your company pricing structure?
In order to adhere to a fair and accurate price structure, we monitor the daily fluctuation of raw material costs. When a client places an order, we factor in the cost of each individual raw material ingredient as it stands at that specific date and time, and then prepare a price quote accordingly.
Do you offer microbial testing?
We are a multidisciplinary microbiotic laboratory that provides an array of high-quality testing capabilities by performing materials analysis and failure analysis on a variety of products including Pathogens, Yeast and Mold, Enumerations and Total Aerobic Plate Count. Because quality is our top priority we take special care in efficient sample management and quick turnaround times.
Our onsite microbiologists’ testing capabilities extend to:
- Total coliforms
- Staphylococcus aureus
- Yeast and Mold
- Lactic Acid Bacteria
- Total Aerobic Plate Count
What about chemical testing?
GHI’s chemical analysts use the following advanced instrumentation and methods to ensure validation: (Identity, qualitative and quantitative)
- High Performance Thin Layer Chromatography (HPTLC)
- Infrared Spectroscopy (Mid-FTIR and Near-FTIR)
- Botanical Microscopy
- High Pressure Liquid Chromatography (HPLC)
- Ultraviolet-Visible Spectroscopy (UV-Vis)
Mineral and Heavy Metal Assays
- Inductively Coupled Plasma Mass Spectrometry (ICP-MS)
- USP dissolution
- Plant Identification Capability
- PH detection
- Moisture analysis
- ATP Screening
- Foreign Organic/Inorganic