Quality
The Process Analysis
During manufacturing should conduct testing to ensure homogeneity in the mixing
of the ingredients to ensure that each capsule will contain the amount of each ingredient
stated on the label. Quality control personnel supervise all aspects of the manufacturing
process and check the work of all individuals involved in the process to make sure
all procedures are followed and all products are manufactured in accordance with
their master manufacturing record.
STRINGENT SPECIFICATIONS
The consistency and integrity of our products is of utmost importance to us, to
regulatory agencies, and ultimately to the people who are taking our products to
enhance their health. In order to assure the consistency and the integrity of our
products we have developed detailed and documented specifications for all raw materials
& packaging containers. We utilize these strict specifications to guide our purchasing,
manufacturing and quality control personnel in their quest to ensure we provide
the highest quality supplements to our customers. If any ingredient or component
does not meet our specifications they are rejected and sent back to the supplier.
If any final product does not meet our strict specifications it is not release for
sale.
Our purchasing department follows our stringent specifications to help them source
raw materials and components only from the best suppliers who are certified by us
to meet our requirements and consistently provide materials that comply with our
specifications.
DROI Pharma's standards and specifications for testing raw materials and finished
products meet or exceed the standards set by both the U.S. Food and Drug Administration,
thus providing worldwide governmental acceptance of our products. Every raw material
and finished product is tested for identity, potency, purity, microbiological contaminants,
heavy metals, and other reasonably expected environmental contaminants.
Our In-House Laboratory
Having an in-house, state-of-the-art laboratory is absolutely necessary for the
comprehensive quality control essential to the manufacture of superior dietary supplements.
DROI Pharma's laboratory is a primary component of our mission of maintaining strict
control over every aspect of manufacture and quality and is an integral piece of
NSF certification, and FDA compliance. Our in-house laboratory allows for timely,
accurate, cost-effective testing that ensures every product, from raw material to
finished goods, meets all quality requirements.
DROI Pharma's state-of-the art lab equipment includes:
- Fourier-transform Near-infrared Spectrophotometry
- Inductively Coupled Plasma Spectrometer (ICP)
- Inductively Coupled Plasma Mass Spectrometer (ICP-MS)
- 3 High Performance Liquid Chromatographs (HPLC)
- Direct Sample Analysis Time of Flight Mass Spectrometer (DSA TOF MS)
- U.S.P. dissolution
- Full Microbiology lab
Every ingredient we receive in our manufacturing facility is quarantined and is
not released for production until it has been tested and its identity has been confirmed.
Unless this testing conclusively demonstrates the correct ingredient and its respective
properties for a particular product, the material will not be used in production.
DROI Pharma's in-house quality control laboratory and select third-party laboratories
perform our precise testing methodologies to consistently:
- Verify the identity, potency, and purity of each ingredient listed on the product
label.
- Identify all known pathogens and other reasonably expected contaminants that might
pose a health risk to the users of our products.
- Provide timely and transparent testing information on every product.
- Ensure the integrity of each supplier in our supply chain.
We accomplish these objectives by conducting testing that utilizes state-of-the-art
testing equipment operated by trained and experienced in-house and third-party chemists,
microbiologists, and laboratory professionals.
This includes testing for:
- Microbiological contaminants: Testing that screens for the presence of microbial
contamination or overgrowth.
- Expected contaminants: Testing that screens for contaminants reasonably expected
to be present based on the ingredient being tested; for example, pesticides in botanical
extracts and heavy metals in fish oil.
- Ingredient Analysis: Testing that confirms the identity, potency, and purity of
the raw material; for example, analytical testing to confirm the identity of a raw
material is what it should be - as well as the concentration and intensity of the
active ingredient.