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 having a third party test each new production batch against established specifications. In order to maintain transparency with our customers, we disclose all 3rd party test results in our searchable QC database.
What is a certificate of analysis?
A Certificate of Analysis (COA) document consists of a number of chemical tests used for certifying the identity and purity of a chemical. A COA document gives the chemical its authenticity.
What is an Material Safety Data Sheet (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, and 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 in 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 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 third-party tested all our batches, we 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.
Good Manufacturing Practise (cGMP)
Good manufacturing practises (GMP) are the step-by-step activities needed to comply with the guidelines and 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.
For factories that follow the 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 manufacturer 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 instance, more dependable equipment has taken the place of testing tools and machines that may have been excellent 20 years ago.
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 be 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 practises that comply with cGMP to assure that quality is built into the design and manufacturing process at every step.
CGMP requires a lot of testing methods, as well as high standards for cleanliness, property conditions, and equipment that is well-kept and calibrated. Employees must also have had the right safety and production training, and there is a verification process for each process.
If you have any questions regarding cGMP, please contact us here.
Packaging Fingerprint Logging
In order to track production and quality control, we stamp every product with a production number and expiration date. The production number is the fingerprint ID that is constant from the moment the batch is engineered to the final packaged chemical.
To ensure that our products are pure and the concentration is correct, we third-party test our products twice. The first test is conducted on-site at our production facility. Once the production process is complete, a second testing phase is conducted by a third-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 on 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:
The importance of Testing
Product testing and verification are mandatory for determining the identification and purity of chemicals. We believe that conducting third-party testing on every batch is integral to maintaining high production standards, in addition to transparency with our customers. We perform third-party tests that can be conducted without bias. These tests increase the credibility of our chemicals by offering additional verification documents to our customers.
Nuclear Magnetic Resonance (NMR)
The NMR method is an important part of structural biology because it clearly shows how changes in the shape, structure, and quality of biomolecules can be studied. This test method is essential for the qualitative analysis of a chemical.
Magnetic resonance can be used for simple tasks like checking the purity of a sample, looking at chemical changes, detecting binding events, and studying the effects of mutations. You can read more about NMR testing and its importance here.
High-performance liquid chromatography (HPLC)
In analytical chemistry, high-performance liquid chromatography is a way to separate, identify, and measure how pure a test chemical is compared to a recognised standard.
According to analytical chemistry, an assay is a way to find out about the presence, amount, or function of a target substance (the analyte). It can be qualitative or quantitative. This test method is important to determine the percentage of an active compound within a unit of measure.