Safeguarding the Quality Process—It Starts at the Beginning

A few years ago we published an article in Natural Product Insider called Proper
Raw Material Qualification Prevents Garbage In, Garbage Out. This article still rings
true today. The process of testing the raw ingredients and vendor qualification will
help ensure the finished product meets label claims and is not contaminated.

Recently, a customer sent in a botanical shake product that failed an irradiation
screening test called pulsed photo stimulated luminescence or PPSL. This screening
reveals if an ingredient or blend has been irradiated to kill microorganisms.
Irradiation methods are not acceptable for ridding supplement products of
microorganisms. Testing the botanical raw materials before blending, would have
found the single irradiated component and saved this blend before manufacturing
the product on a larger scale—a costly mistake! It’s important to note that there are
other acceptable ways to kill microorganisms in botanical ingredients, such as steam
sterilization.

A few more examples of how raw ingredient testing is integral to finished product
quality include testing for heavy metals, pesticide residue, contaminates including
microorganisms and active ingredient potency. The raw ingredient can be tested
before the manufacturing process to identify a marker that cannot be introduced
during manufacturing. Additionally, microbiology testing, some potencies or other
markers may also need to be verified during blending or again before shipping the
finished product. Failing to test raw ingredients before manufacturing can lead to a
failing test result in the finished product. This results in an out-of-specification
(OOS) investigation that prompts a review of the raw ingredient results. If the raw
ingredient was not tested for contaminates or potency level, then there is often a
scramble to determine where the unwanted result is coming from. Going back and
testing all the raw ingredients in the blend after manufacturing, is costly and time
consuming. This is why a good vendor qualification program is essential to
manufacturing quality products and following the FDA’s GMPs is a necessary and
required practice.

Vendor qualification and testing of raw ingredients is a key step in producing a
quality finished product. Without initial qualification of raw ingredients, the
blended finished product is at risk for contamination or low potency. Also, ensuring
the finished product meets label claims may require testing at various stages in the
manufacturing process and on-going stability testing if an expiration date is listed.
Consistently safeguarding the quality process may seem like a daunting process, but
SORA Labs is here to help! We can help take the stress and worry out of your raw
ingredient testing, by helping to make sure that only the best goes into your finished
product. Contact us today for a testing quote!

Getting Testing Right Every Time—A Guide to Ordering for Successful Outcomes

Looking for a simplified way to figure out your testing needs? Here is a chart of SORA Labs billing codes and associated microbiology testing, which shows how test results will be formatted.
Using this chart can help you determine which microbiology test to order to match your given specification and turn-around-time (TAT) required.

Micro Spec Charts:

AOAC Petrifilm™ Methods

[table id=1 /]

Pour Plate Methods (FDA/BAM or USP)

[table id=2 /]

Rapid Biolumix Methods

These methods report </> your specification and are not quantitative

[table id=3 /]
Occasionally, customers need a certificate of analysis (cofa) to be updated due to a specification
issue. Here is one scenario:
Question: Can a cofa be updated to reflect a microbiology specification of negative on Escherichia coliform (E.coli) instead of <10 cfu/g?
Answer: No, because the E.coli test that reported as “negative” was not ordered.
How to place the right testing order: If you need Staphylococcus aureus (S.aureus) to report as negative/10g, then you need to order test codes B0191 or B0371 (see chart). Both these test codes have results that can be reported as negative. The B0371 Biolumix® option will only report as negative or positive, whereas the pour plate method will give you an actual count if there is S.aureus present in the sample.
Quality control is a continual process. Understanding which method to order to give you the
required results can be a challenge because of the many microbiology method choices. We’re the experts—Let us know what specifications you need and we can suggest the best method to meet your requirements. We are here to help! Call or email us anytime!

Trusted testing services—the team approach

For ingredient suppliers, contract manufacturers and brand owners, partnership with a testing lab is often a necessary component. Even with an in-house lab, a company may not be able to perform every test required for their products due to the extensive nature of various testing practices and methods. When complicated, cost prohibitive, or specialty methods are required, partnership with an experienced testing lab, makes perfect sense—enter specialty 3rd party testing labs like SORA Labs.
The FDA Code of Federal Regulations requires that a vendor be qualified, and just like any other vendor, labs should be questioned about the expertise of methods they run. Reviewing proficiency testing; requesting staff qualification and reviewing standard operating procedures (SOP), can provide valuable insight when evaluating a lab. Ultimately, an on-site audit is the best strategy when making a final determination of a lab’s worthiness. Another qualifier when choosing a lab is the ISO 17025:2005 accreditation from the International Organization of Standardization. This signifies that the lab has met stringent criteria and passed audits to be considered a high quality international testing lab.
A lab partnership should also include a Quality Agreement (QA), which defines responsibilities, methods, out-of-specification communication and more. As regulations are increasing, the industry continues to see more findings regarding quality control procedures. An in-place agreement will ensure the quality process has been defined for outsourced testing, and both companies understand each other’s roles and expectations. If a Quality Agreement has not yet been established, you can find our QA form here (Quality Agreement Form Request). Since ISO already requires the highest level of confidentiality, a Non-Disclosure Agreement (NDA) is less important than the Quality Agreement; however some companies choose to have both agreements in place.
Although you may not need outside testing services on a daily basis, it’s a smart idea to have a qualified and experienced lab in your corner when the need arises. Sometimes, it can take a team to get your project completed and partnering with a high-quality testing lab like SORA Labs, is a great place to start. Let us help you today!

What mistakes is your testing lab making?

Is your lab using reference standards when performing testing? We’ve found that not all labs do this—in fact, we tested against one lab recently that was not using a reference standard with their FIP Lipase method. What a mistake! Without a reference standard, how do you know if your method is working appropriately and providing accurate results for the unknown sample? You don’t! Purchasing reference standards and performing proficiency testing gives a lab credibility and is an investment in quality—which as a testing customer, you should expect.
Another big mistake is not using positive and negative controls when performing microbiology We have spoken to several labs that do not test each method using a negative control, which is compared to a positive control test. While these microbiology quality control pellets are expensive, they are highly beneficial for accurate results—it’s unfortunate that some labs do not fully understand the benefit. SORA performs a positive and a negative control test with each microbiology method daily. These test results prove that our method is working that day.
Throughout the year SORA participates in microbiology and chemistry proficiency testing studies. We perform various methods on identical samples, testing against other labs or peer groups. These results are statistically calculated to determine our proficiency with the method tested. Proficiency testing builds confidence with the lab technicians and customers and demonstrates that the method is being performed accurately. Is your testing lab doing this?
And while this is just a couple of ways a testing laboratory can invest in quality control, these steps pave the way for accurate results. There’s a reason that some labs charge unusually low prices—and it’s a good idea to ask questions before purchasing services that may not provide you with the most accurate results. Ask about reference standards, microbiology controls and proficiency Are they actually spending the time and money required to give accurate results? If not, go elsewhere! “Quality means doing it right when no one is looking”—Henry Ford.