At Venogen we are focused on providing our customers with confidence and assurance that our products are of the utmost quality. We achieve this by 3rd testing each new production batch against established specifications. In order to maintains transparency with our customers, we disclose all 3rd party test results in our searchable QC database.
What is COA?
A Certificate of Analysis document consists of a number of chemical tests used for certifying the identity and purity of a chemical. A COA document provides the chemical its authenticity.
What is a MSDS sheet?
A Material Safety Data Sheet (MSDS) contains important information concerning a material’s safe working procedures, potential health effects of exposure to the chemical, and proper material handling.
Additionally, the document contains hazard evaluations on the use, storage, handling of the material, what to expect if the recommendations are not followed, and what to do if accidents occur.
Why are these documents important?
Without these two important documents, it would be impossible to know essential data such as purity, the risks of the material, and how it should be handled safely.
How does this pertain to the audit process?
Our company independently audits each product batch produced within our partnering factory within China. Furthermore, we conduct frequent on-site auditing of all production facilities four times a year.
After the production phase is complete we conduct our independent sample analysis. If the chemical passes the initial test, we ship the chemical to our packaging facilities under preliminary quarantine.
Within our packaging facility, we conduct another test of the received chemical. If the second test is in line with our primary test, we approve the chemical for packaging.
With base materials being engineered in one location and being packaged in another location, from stage to stage of the product chain, it is important to have all production material elucidated.
After we have finished that quality control process and have 3rd-party tested all our batches, we then add the testing documents to our Analytical Database so that our customers may reference them at any time.
Access our Analytical Database here if you have already purchased a product from us.
cGMP (Good Manufacturing Practice)
Good manufacturing practices (GMP) are the step-by-step activities needed to comply with the guidelines to provide an audited log of each step of the manufacturing process. GMP guidelines provide a minimum standard to mitigate any error during any step of the manufacturing process.
The main purpose of GMP guidelines is to produce an audited log of each step of the manufacturing process and prevent harm from occurring to the end-user.
Why use cGMP?
To provide a system that ensures that proper monitoring and quality control are enforced during the manufacturing process.
Factories that follow cGMP test and log the identity, strength, quality, and purity of the products that they produce in a traceable manner. In the event of any unexpected occurrence during the manufacturing process, cGMP guidelines provide a traceable log that will allow the manufacture to pinpoint the occurrence within the manufacturing process.
cGMP mainly entails the following quality-focused operations:
- Management Systems
- Quality Raw Materials
- Operating Procedures
- Detecting Deviations
- Investigating Deviations
- Reliable Testing
- Batch related numbering system
cGMP vs GMP
The “c” stands for “current”, meaning that manufacturers are required to stay up to date with their systems and technologies. For example, testing equipment and machines used to prevent contamination may have been first rate 20 years ago but have been replaced by more reliable equipment.
Why does cGMP matter?
The end customer is not able to detect if a chemical was contaminated during the production or packaging phases by using their senses and opinions. An audited log of production, testing, and handling of each chemical provides the customer with assurance of quality.
While, it is extremely important and required by cGMP that testing is done on all products, testing alone is not enough to ensure quality. As in most cases, testing is only conducted on a small sample of a production run (for example, a manufacturer may only test 100 tablets from a batch of 1 million). Hence, all products must be manufactured in conditions and practices that comply with cGMP to assure that quality is built into the design and manufacturing process at every step.
In addition to the extensive testing methods that cGMP requires, high standards of sanitation, property conditions, equipment must be properly maintained and calibrated, the employees have received the correct safety and production training, and that each process has a verification process.
If you have any questions regarding cGMP, please contact us here.
Packaging Fingerprint Logging
In order to track and production and quality control, we stamp every product with a production number and expiration date. The production number is the fingerprint I.D. that is constant from the moment the batch is engineered to the finalized packaged chemical.
To ensure that our products are pure and the concentration is correct, we third-party test our products two times. The first test is conducted on-site at our production facility. Then once the production process is complete, a second testing phase is conducted by a 3rd party laboratory to confirm there was no mix-up of the chemicals and to confirm the factory test results are accurate. You can read more about our testing methods here.
Once we have confirmed that the final chemical meets the specification, the aforementioned production number is stamped to each unit. The production number allows all certification documents including the C.O.A., NMR, HPLC testing reports, and SDS sheet to be traced through our fingerprint database and can be located here.
In order to ensure that our products are of the specified quality, Venogen conducts the following tests on each batch that is produced.
Importance of Testing
Product testing and verification are mandatory for determining the identification and purity of chemicals. We believe that conducting 3rd party testing on every batch is integral to maintaining high production standards in addition to transparency with our customers. We perform 3rd party tests can are conducted without bias. These tests increase the credibility of our chemicals by offering additional verification documents to our customers.
N.M.R. (Nuclear Magnetic Resonance)
NMR is a vital part of structural biology, in which, the analysis method is unambiguously suited to look at changes within the conformation, structure, and quality of biomolecules resolution. This test method is essential for qualitative analysis of a chemical.
Basic magnetic resonance applications may be used for assessing sample purity, chemical changes, binding events, and effects of mutations. You may read more about NMR testing and its importance here.
HPLC (High-performance liquid chromatography)
High-performance liquid chromatography is a testing method used in analytical chemistry to separate, identify, and quantify the purity of a test chemical to an approved reference standard.
An assay is an investigative (analytic) procedure within analytical chemistry for qualitatively assessing or quantitatively measuring the presence, amount, or functional activity of a target entity (the analyte). This test method is important to determine the percentage of an active compound within a unit of measure.